| Subject | Object |
|---|---|
| dailymed-drugs:1 |
Note: Cefizox (ceftizoxime for injection, USP) in the ADD-Vantage' vial is intended for intravenous infusion only after dilution with the appropriate volume of ADD-Vantage diluent solution. The usual adult dosage is 1 or 2 grams of Cefizox (ceftizoxime for injection, USP) every 8 to 12 hours. Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organisms. Because of the serious nature of urinary tract infections due to P. aeruginosa and because many strains of Pseudomonas species are only moderately susceptible to Cefizox, higher dosage is recommended. Other therapy should be instituted if the response is not prompt. A single, 1 gram IM dose is the usual dose for treatment of uncomplicated gonorrhea. The IV route may be preferable for patients with bacterial septicemia, localized parenchymal abscesses (such as intra��abdominal abscess), peritonitis, or other severe or life���threatening infections. In those with normal renal function, the IV dosage for such infections is 2 to 12 grams of Cefizox (ceftizoxime for injection, USP) daily. In conditions such as bacterial septicemia, 6 to 12 grams/day may be given initially by the IV route for several days, and the dosage may then be gradually reduced according to clinical response and laboratory findings. Dosage may be increased to a total daily dose of 200 mg/kg (not to exceed the maximum adult dose for serious infection).<br/>Impaired Renal Function: Modification of Cefizox dosage is necessary in patients with impaired renal function. Following an initial loading dose of 500 mg-1 gram IM or IV, the maintenance dosing schedule shown below should be followed. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organisms. When only the serum creatinine level is available, creatinine clearance may be calculated from the following formula. The serum creatinine level should represent current renal function at the steady state. Males Females are 0.85 of the calculated clearance values for males. In patients undergoing hemodialysis, no additional supplemental dosing is required following hemodialysis; however, dosing should be timed so that the patient receives the dose (according to the table below) at the end of the dialysis.<br/>Reconstitution: Cefizox in the ADD-Vantage vial is intended for use with ADD-Vantage diluent containers only, available in 50 mL and 100 mL sizes of Sodium Chloride Injection 0.9% and Dextrose Injection 5%. Ordinarily, the ADD-Vantage vials should be reconstituted only when it is certain that the patient is ready to receive the drug. However, reconstitued Cefizox is stable for 24 hours at room temperature or 96 hours under refrigeration 5��C (41��F). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.<br/>To Open ADD-Vantage ' Diluent Containers: Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.<br/>To Assemble Vial and Flexible Diluent Container (Use Aseptic Technique): 1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Once the breakaway cap has been removed, do not access vial with syringe. b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull further to remove the cover. (SEE FIGURE 3.) 2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately��turn (180��) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is sealed, do not attempt to remove. (SEE FIGURE 4.) 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.<br/>To Prepare Admixture:<br/>Preparation for Administration (Use Aseptic Technique): WARNING: Do not use flexible container in series connections.
|
| dailymed-drugs:2 |
FLOVENT DISKUS should be administered by the orally inhaled route only in patients 4 years of age and older. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. After asthma stability has been achieved, it is always desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control. The safety and efficacy of FLOVENT DISKUS when administeredin excess of recommended dosages have not been established. The recommended starting dosage and the highest recommended dosage of FLOVENT DISKUS, based on prior asthma therapy, are listed in Table 2. Table 2. Recommended Dosages of FLOVENT DISKUS Starting dosages above 100 mcg twice daily for adults and adolescents and 50 mcg twice daily for children 4 to 11 years of age may be considered for patients with poorer asthma control or those who have previously required doses of inhaled corticosteroids that are in the higher range for that specific agent. For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with FLOVENT DISKUS. Patients should be carefully monitored for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency (see WARNINGS). Once prednisone reduction is complete, the dosage of fluticasone propionate should be reduced to the lowest effective dosage. The choice of starting dosage should be made on the basis of individual patient assessment. A controlled clinical study of 111 oral corticosteroid-dependent patients with asthma showed few significant differences between the 2 doses of FLOVENT DISKUS on safety and efficacy endpoints. However, inability to decrease the dose of oral corticosteroids further during corticosteroid reduction may be indicative of the need to increase the dose of fluticasone propionate up to the maximum of 1,000 mcg twice daily.<br/>Pediatric Use: Because individual responses may vary, children previously maintained on other inhaled corticosteroids may require dosage adjustments upon transfer to FLOVENT DISKUS.<br/>Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS: Geriatric Use) have been treated with fluticasone propionate inhalation powder, efficacy and safety did not differ from that in younger patients. Based on available data for FLOVENT DISKUS, no dosage adjustment is recommended.<br/>Directions for Use: Illustrated Patient's Instructions for Use accompany each package of FLOVENT DISKUS.
|
| dailymed-drugs:3 |
DOSAGE MUST BE INDIVIDUALIZED. NADOLOL MAY BE ADMINISTERED WITHOUT REGARD TO MEALS.<br/>Angina Pectoris: The usual initial dose is 40 mg nadolol once daily. Dosage may be gradually increased in 40 to 80 mg increments at 3 to 7 day intervals until optimum clinical response is obtained or there is pronounced slowing of the heart rate. The usual maintenance dose is 40 or 80 mg administered once daily. Doses up to 160 or 240 mg administered oncedaily may be needed. The usefulness and safety in angina pectoris of dosage exceeding 240 mg per day have not been established. If treatment is to be discontinued, reduce the dosage gradually over a period of one to two weeks (see WARNINGS).<br/>Hypertension: The usual initial dose is 40 mg nadolol once daily, whether it is used alone or in addition to diuretic therapy. Dosage may be gradually increased in 40 to 80 mg increments until optimum blood pressure reduction is achieved. The usual maintenance dose is 40 or 80 mg administered once daily. Doses up to 240 or 320 mg administered once daily may be needed.<br/>Dosage Adjustment in Renal Failure: Absorbed nadolol is excreted principally by the kidneys and, although nonrenal elimination does occur, dosage adjustments are necessary in patients with renal impairment. The following dose intervals are recommended:
|
| dailymed-drugs:4 |
The recommended dosage of Kepivance is 60 mcg/kg/day, administered as an IV bolus injection for 3 consecutive days before and 3 consecutive days after myelotoxic therapy for a total of 6 doses. Pre-myelotoxic therapy: The first 3 doses should be administered prior to myelotoxic therapy, with the third dose 24 to 48 hours before myelotoxic therapy . Post-myelotoxic therapy: The last 3 doses should be administered post-myelotoxic therapy; the first of these doses should be administered after, but on the same day of hematopoietic stem cell infusion and at least 4 days after the most recent administration of Kepivance . No dose adjustment is recommended for patients with renal impairment .<br/>Preparation of Kepivance: Do not use Kepivance beyond the date stamped on the vial label. Kepivance lyophilized powder should only be reconstituted with Sterile Water for Injection, USP (not supplied). Kepivance should be reconstituted aseptically by slowly injecting 1.2 mL of Sterile Water for Injection, USP (not supplied) to yield a final concentration of 5 mg/mL. The contents should be swirled gently during dissolution. Do not shake or vigorously agitate the vial. Generally, dissolution of Kepivance takes less than 3 minutes. PROTECT FROM LIGHT The reconstituted solution contains no preservatives and is intended for single use only. Following reconstitution, it is recommended that the product be used immediately. If not used immediately, the reconstituted solution of Kepivance may be stored refrigerated in its carton at 2��to 8��C (36��to 46��F) for up to 24 hours. Prior to injection���Kepivance may be allowed to reach room temperature for a maximum of 1 hour but should be protected from light. Discard Kepivance left at room temperature for more than 1 hour. Do not freeze the reconstituted solution. The reconstituted solution should be clear and colorless. Visually inspect the solution for discoloration and particulate matter before administration. Kepivance should not be administered if discoloration or particulates are observed. DO NOT FILTER the reconstituted solution during preparation or administration.<br/>Administration of Kepivance: Kepivance should be administered by intravenous bolus injection. If heparin is used to maintain an IV line, saline should be used to rinse the line prior to and after Kepivance administration .
|
| dailymed-drugs:5 |
The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance and the physical condition of the patient. The smallest dose and concentration required to produce the desired result should be administered. Dosages of mepivacaine hydrochloride should be reduced for elderly and debilitated patients and patients with cardiac and/or liver disease. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional doses should be used when feasible. For specific techniques and procedures, refer to standard textbooks. The recommended single adult dose (or the total of a series of doses given in one procedure) of mepivacaine hydrochloride for unsedated, healthy, normal-sized individuals should not usually exceed 400 mg. The recommended dosage is based on requirements for the average adult and should be reduced for elderly or debilitated patients. While maximum doses of 7 mg/kg (550 mg) have been administered without adverse effect, these are not recommended, except in exceptional circumstances and under no circumstances should the administration be repeated at intervals of less than 1/hours. The total dose for any 24-hour period should not exceed 1,000 mg because of a slow accumulation of the anesthetic or its derivatives or slower than normal metabolic degradation or detoxification with repeat administration. . Pediatric patients tolerate the local anesthetic as well as adults. However, the pediatric dose should be carefully measured as a percentage of the total adult dose based on weight, and should not exceed 5 mg/kg to 6 mg/kg (2.5 mg/lb to 3 mg/lb) in pediatric patients, especially those weighing less than 30 lbs. In pediatric patients under 3 years of age or weighing less than 30 lbs concentrations less than 2% (eg, 0.5% to 1.5%) should be employed. Unused portions of solutions not containing preservatives, ie, those supplied in single-dose vials, should be discarded following initial use. This product should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are discolored or which contain particulate matter should not be administered.
|
| dailymed-drugs:6 |
Not for oral administration<br/>Intravenous Administration: The dosage of MUSTARGEN varies with the clinical situation, the therapeutic response and the magnitude of hematologic depression. A total dose of 0.4 mg/kg of body weight for each course usually is given either as a single dose or in divided doses of 0.1 to 0.2 mg/kg per day. Dosage should be based on ideal dry body weight. The presence of edema or ascites must be considered so that dosage will be based on actual weight unaugmented by these conditions. The margin of safety in therapy with MUSTARGEN is narrow and considerable care must be exercised in the matter of dosage. Repeated examinations of blood are mandatory as a guide to subsequent therapy. Within a few minutes after intravenous injection, MUSTARGEN undergoes chemical transformation, combines with reactive compounds, and is no longer present in its active form in the blood stream. Subsequent courses should not be given until the patient has recovered hematologically from the previous course; this is best determined by repeated studies of the peripheral blood elements awaiting their return to normal levels. It is often possible to give repeated courses of MUSTARGEN as early as three weeks after treatment.<br/>Preparation of Solution for Intravenous Administration: This drug is HIGHLY TOXIC and both powder and solution must be handled and administered with care. Since MUSTARGEN is a powerful vesicant, it is intended primarily for intravenous use, and in most cases is given by this route. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Appropriate protective equipment should be worn when handling MUSTARGEN. Should accidental eye contact occur, copious irrigation for at least 15 minutes with water, normal saline or a balanced salt ophthalmic irrigating solution should be instituted immediately, followed by prompt ophthalmologic consultation. Should accidental skin contact occur, the affected part must be irrigated immediately with copious amounts of water, for at least 15 minutes while removing contaminated clothing and shoes, followed by 2% sodium thiosulfate solution. Medical attention should be sought immediately. Contaminated clothing should be destroyed. Each vial of MUSTARGEN contains 10 mg of mechlorethamine hydrochloride triturated with sodium chloride q.s. 100 mg. In neutral or alkaline aqueous solution it undergoes rapid chemical transformation and is highly unstable. Although solutions prepared according to instructions are acidic and do not decompose as rapidly, they should be prepared immediately before each injection since they will decompose on standing. When reconstituted, MUSTARGEN is a clear colorless solution. Do not use if the solution is discolored or ifdroplets of water are visible within the vial prior to reconstitution. Using a sterile 10 mL syringe, inject 10 mL of Sterile Water for Injection or 10 mL of 0.9% Sodium Chloride Injection into a vial of MUSTARGEN. With the needle (syringe attached) still in the rubber stopper, shake the vial several times to dissolve the drug completely. The resultant solution contains 1 mg of mechlorethamine hydrochloride per mL. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.<br/>Special Handling: Animal studies have shown mechlorethamine to be corrosive to skin and eyes, a powerful vesicant, irritating to the mucous membranes of the respiratory tract and highly toxic by the oral route. It has also been shown to be carcinogenic, mutagenic and teratogenic. Due to the drug's toxic properties, appropriate precautions including the use of appropriate safety equipment are recommended for the preparation of MUSTARGEN for parenteral administration. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Avoid exposure during pregnancy. The National Institutes of Health presently recommends that the preparation of injectable antineoplastic drugs should be performed in a Class II laminar flow biological safety cabinet.Personnel preparing drugs of this class should wear chemical resistant, impervious gloves, safety goggles, outer garments and shoe covers. Additional body garments should be used based upon the task being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces and inhalation of vapors and dust. Appropriate techniques should be used to remove potentially contaminated clothing. Several other guidelines for proper handling and disposal of antineoplastic drugs have been published and should be considered.<br/>Accidental Contact Measures: Should accidental eye contact occur, copious irrigation for at least 15 minutes with water, normal saline or a balanced salt ophthalmic irrigating solution should be instituted immediately, followed by prompt ophthalmologic consultation. Should accidental skin contact occur, the affected part must be irrigated immediately with copious amounts of water, for at least 15 minutes while removing contaminated clothing and shoes, followed by 2% sodium thiosulfate solution. Medical attention should be sought immediately. Contaminated clothing should be destroyed.<br/>Technique for Intravenous Administration: Withdraw into the syringe the calculated volume of solution required for a single injection. Dispose of any remaining solution after neutralization (see below). Although the drug may be injected directly into any suitable vein, it is injected preferably into the rubber or plastic tubing of a flowing intravenous infusion set. This reduces the possibility of severe local reactions due to extravasation or high concentration of the drug. Injecting the drug into the tubing rather than adding it to the entire volume of the infusion fluid minimizes a chemical reaction between the drug and the solution. The rate of injection apparently is not critical provided it is completed within a few minutes.<br/>Intracavitary Administration: Nitrogen mustard has been used by intracavitary administration with varying success in certain malignant conditions for the control of pleural,peritoneal,and pericardial,effusions caused by malignant cells. The technique and the dose used by any of these routes varies. Therefore, if MUSTARGEN is given by the intracavitary route, the published articles concerning such use should be consulted. Because of the inherent risks involved, the physician should be experienced in the appropriate injection techniques, and be thoroughly aware of the indications, dosages, hazards, and precautions as set forth in the published literature. When using MUSTARGEN by the intracavitary route, the general precautions concerning this agent should be borne in mind. As a general guide, reference is made especially to the techniques of Weisberger et al.Intracavitary use is indicated in the presence of pleural, peritoneal, or pericardial effusion due to metastatic tumors. Local therapy with nitrogen mustard is used only when malignant cells are demonstrated in the effusion. Intracavitary injection is not recommended when the accumulated fluid is chylous in nature, since results are likely to be poor. Paracentesis is first performed with most of the fluid being removed from the pleural or peritoneal cavity. The intracavitary use of MUSTARGEN may exert at least some of its effect through production of a chemical poudrage. Therefore, the removal of excess fluid allows the drug to more easily contact the peritoneal and pleural linings. For intrapleural or intrapericardial injection nitrogen mustard is introduced directly through the thoracentesis needle. For intraperitoneal injection it is given through a rubber catheter inserted into the trocar used for paracentesis or through a No. 18 gauge needle inserted at another site. This drug should be injected slowly, with frequent aspiration to ensure that a free flow of fluid is present. If fluid cannot be aspirated, pain and necrosis due to injection of solution outside the cavity may occur.Free flow of fluid also is necessary to prevent injection into a loculated pocket and to ensure adequate dissemination of nitrogen mustard. The usual dose of nitrogen mustard for intracavitary injection is 0.4 mg/kg of body weight, though 0.2 mg/kg (or 10 to 20 mg) has been used by the intrapericardial route.The solution is prepared, as previously described for intravenous injection, by adding 10 mL of Sterile Water for Injection or 10 mL of 0.9% Sodium Chloride Injection to the vial containing 10 mg of mechlorethamine hydrochloride. (Amounts of diluent of 50 to 100 mL of normal saline have also been used.) The position of the patient should be changed every 5 to 10 minutes for an hour after injection to obtain more uniform distribution of the drug throughout the serous cavity. The remaining fluid may be removed from the pleural or peritoneal cavity by paracentesis 24 to 36 hours later. The patient should be followed carefully by clinical and x-ray examination to detect reaccumulation of fluid. Pain occurs rarely with intrapleural use; it is common with intraperitoneal injection and is often associated with nausea, vomiting, and diarrhea of 2 to 3 days duration. Transient cardiac irregularities may occur with intrapericardial injection. Death, possibly accelerated by nitrogen mustard, has been reported following the use of this agent by the intracavitary route.Although absorption of MUSTARGEN when given by the intracavitary route is probably not complete because of its rapid deactivation by body fluids, the systemic effect is unpredictable. The acute side effects such as nausea and vomiting are usually mild. Bone marrow depression is generally milder than when the drug is given intravenously. Care should be taken to avoid use by the intracavitary route when other agents which may suppress bone marrow function are being used systemically.<br/>Neutralization of Equipment and Unused Solution: To clean rubber gloves, tubing, glassware, etc., after giving MUSTARGEN, soak them in an aqueous solution containing equal volumes of sodium thiosulfate (5%) and sodium bicarbonate (5%) for 45 minutes. Excess reagents and reaction products are washed away easily with water. Any unused injection solution should be neutralized by mixing with an equal volume of sodium thiosulfate/sodium bicarbonate solution. Allow the mixture to stand for 45 minutes. Vials that have contained MUSTARGEN should be treated in the same way with thiosulfate/bicarbonate solution before disposal.
|
| dailymed-drugs:7 |
Dosage and Administration in Adults: SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy. The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient's response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse. Oropharyngeal candidiasis: The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse. Esophageal candidiasis: The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms. Systemic Candida infections: For systemic Candida infections including candidema, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used. Urinary tract infections and peritonitis: For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50 to 200 mg have been used in open, noncomparative studies of small numbers of patients. Cryptococcal meningitis: The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient's response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of fluconazole for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily. Prophylaxis in patients undergoing bone marrow transplantation: The recommended fluconazole daily dosage for the prevention of candidiasis of patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start fluconazole prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.<br/>Dosage and Administration in Children: The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients: Experience with fluconazole in neonates is limited to pharmacokinetic studies in premature newborns. Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. No information regarding fluconazole pharmacokinetics in full-term newborns is available. Oropharyngeal candidiasis: The recommended dosage of fluconazole for oropharyngeal candidiasis in children is 6 mg/kg on the first day, followed by 3mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse. Esophageal candidiasis: For the treatment of esophageal candidiasis, the recommended dosage of fluconazole in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used based on medical judgment of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least 2 weeks following the resolution of symptoms. Systemic Candida infections: For the treatment of candidemia and disseminated Candida infections, daily doses of 6 to 12 mg/kg/day have been used in an open, noncomparative study of a small number of children. Cryptococcal meningitis: For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg one daily may be used, based on medical judgment of the patient's response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose fluconazole is 6 mg/kg once daily.<br/>Dosage in Patients With Impaired Renal Function: Fluconazole is cleared primarily by renal excretion as unchanged drug. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table: These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition. When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults: Males: Weight (kg)��(140-age)���������������������������������������������72��serum creatinine (mg/100 mL) Females: 0.85 x above value Although the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children: K��linear length or height (cm)������������������������������������serum creatinine (mg/100 mL) (Where K=0.55 for children older than 1 year and 0.45 for infants.)<br/>Administration: Fluconazole injection is administered by intravenous infusion. Fluconazole injection has been used safely for up to fourteen days of intravenous therapy. The intravenous infusion of fluconazole should be administered at a maximum rate of approximately 200 mg/hour, given as a continuous infusion. Fluconazole injection in glass container is intended only for intravenous administration using sterile equipment. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if the solution is cloudy or precipitated or if the seal is not intact.
|
| dailymed-drugs:8 |
Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated .
|
| dailymed-drugs:1230 |
Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated .
|
| dailymed-drugs:9 |
LUPRON DEPOT Must Be Administered Under The Supervision
Of A Physician.<br/>Endometriosis: The recommended
duration of treatment with LUPRON DEPOT 3.75 mg alone or in combination
with norethindrone acetate is six months. The choice of LUPRON DEPOT
alone or LUPRON DEPOT plus norethindrone acetate therapy for initial
management of the symptoms and signs of endometriosis should be made
by the health care professional in consultation with the patient and
should take into consideration the risks and benefits of the addition
of norethindrone to LUPRON DEPOT alone. If the symptoms of endometriosis recur after a course of therapy,
retreatment with a six-month course of LUPRON DEPOT monthly and norethindrone
acetate 5 mg daily may be considered. Retreatment beyond this one
six-month course cannot be recommended. It is recommended that bone
density be assessed before retreatment begins to ensure that values
are within normal limits. LUPRON DEPOT alone isnot recommended for
retreatment. If norethindrone acetate is contraindicated for the individual
patient, then retreatment is not recommended. An assessment of cardiovascular risk and management of risk factors
such as cigarette smoking is recommended before beginning treatment
with LUPRON DEPOT and norethindrone acetate.<br/>Uterine Leiomyomata (Fibroids): Recommended duration of therapy with LUPRON DEPOT
3.75 mg is up to 3 months. The
symptoms associated with uterine leiomyomata will recur following
discontinuation of therapy. If additional treatment with LUPRON DEPOT
3.75 mg is contemplated, bone density should be assessed prior to
initiation of therapy to ensure that values are within normal limits. The recommended dose of LUPRON DEPOT is
3.75 mg, incorporated in a depot formulation. The lyophilized microspheres
are to be reconstituted and administered monthly as a single intramuscular
injection. For optimal performance of
the prefilled dual chamber syringe (PDS), read and follow the following
instructions: Since the product does not contain a preservative, the suspension
should be discarded if not used immediately. As with other drugs administered by injection, the injection site
should be varied periodically.
|
| dailymed-drugs:10 |
Betimol Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent Betimol in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5 percent solution in the affected eye(s) twice a day. If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day. Since in some patients the pressure-lowering response to Betimol may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Betimol. Dosages above one drop of 0.5 percent Betimol twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine, and/or systemically administered carbonic anhydrase inhibitors, such as acetazolamide, can be instituted.
|
| dailymed-drugs:11 |
Start dosage at 10 mg/kg or 350 mg/mevery eight hours for five days. Initiation of therapy at higher doses is not recommended. (See Table II for Dosing chart and number of capsules.) Reduce frequency of administration to 10 mg/kg or 350 mg/mevery 12 hours (two-thirds of initial daily dosage) for an additional two weeks of therapy. A course of treatment lasts 19 days. Repeated courses may be necessary if indicated by weekly monitoring of blood lead concentration. A minimum of two weeks between courses is recommended unless blood lead levels indicate the need for more prompt treatment. In young pediatric patients who cannot swallow capsules, CHEMET can be administered by separating the capsule and sprinkling the medicated beads on a small amount of soft food or putting them in a spoon and following with fruit drink. Identification of the source of lead in the pediatric patient's environment and its abatement are critical to a successful therapy outcome. Chelation therapy is not a substitute for preventing further exposure to lead and should not be used to permit continued exposure to lead. Patients who have received CaNaEDTA with or without BAL may use CHEMET for subsequent treatment after an interval of four weeks. Data on the concomitant use of CHEMET with CaNaEDTA with or without BAL are not available, and such use is not recommended.
|
| dailymed-drugs:12 |
Initial Treatment: The recommended starting
dose for REMERON' (mirtazapine) Tablets is 15 mg/day, administered in a single
dose, preferably in the evening prior to sleep. In the controlled clinical trials
establishing the efficacy of REMERON' in the treatment of major depressive
disorder, the effective dose range was generally 15���45 mg/day. While the
relationship between dose and satisfactory response in the treatment of major
depressive disorder for REMERON' has not been adequately explored, patients not
responding to the initial 15 mg dose may benefit from dose increases up to a
maximum of 45 mg/day. REMERON' has an elimination half-life of approximately 20���40
hours; therefore, dose changes should not be made at intervals of less than one to
two weeks in order to allow sufficient time for evaluation of the therapeutic
response to a given dose.<br/>Elderly and Patients with Renal
or Hepatic Impairment: The clearance of
mirtazapine is reduced in elderly patients and in patients with moderate to severe
renal or hepatic impairment. Consequently, the prescriber should be aware that
plasma mirtazapine levels may be increased in these patient groups, compared to
levels observed in younger adults without renal or hepatic impairment (see
PRECAUTIONS and
CLINICAL
PHARMACOLOGY).<br/>Maintenance/Extended Treatment: It is generally agreed that
acute episodes of depression require several months or longer of sustained
pharmacological therapy beyond response to the acute episode. Systematic
evaluation of REMERON' (mirtazapine) Tablets has demonstrated that its efficacy in
major depressive disorder is maintained for periods of up to 40 weeks following
8���12 weeks of initial treatment at a dose of 15���45 mg/day (see CLINICAL
PHARMACOLOGY). Based on these limited data, it is unknown whether or
not the dose of REMERON' needed for maintenance treatment is identical to the dose
needed to achieve an initial response. Patients should be periodically reassessed
to determine the need for maintenance treatment and the appropriate dose for such
treatment.<br/>Switching Patients To or From a
Monoamine Oxidase Inhibitor: At least 14 days should
elapse between discontinuation of an MAOI and initiation of therapy with REMERON'
(mirtazapine) Tablets. In addition, at least 14 days should be allowed after
stopping REMERON' before starting an MAOI.
|
| dailymed-drugs:13 |
Adults: The usual dose for adults is one teaspoonful HYCOMINE Syrup (hydrocodone bitartrate 5 mg and phenylpropanolamine hydrochloride 25 mg/5 cc) every four hours as needed, not to exceed six teaspoonfuls in a 24 hour period. Children 6 to 12 years of age: The usual dose for children 6 to 12 years of age is one teaspoonful HYCOMINE Pediatric Syrup (hydrocodone bitartrate 2.5 mg and phenylpropanolamine hydrochloride 12.5 mg/5 cc) every four hours as needed, not to exceed six teaspoonfuls in a 24 hour period.
|
| dailymed-drugs:14 |
BenzaClin Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.
|
| dailymed-drugs:2267 |
BenzaClin Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.
|
| dailymed-drugs:15 |
Streptococcal (Group A)
Upper Respiratory Infections (for example, pharyngitis) Adults���a single injection of 1,200,000 units; older
pediatric patients���a single injection of 900,000 units; infants
and pediatric patients under 60 lbs.���300,000 to 600,000 units. Syphilis Primary, secondary, and latent���2,400,000 units
(1 dose). Late (tertiary and neurosyphilis)���2,400,000 units
at 7-day intervals for three doses. Congenital���under
2 years of age: 50,000 units/kg/body weight; ages 2 to 12 years: adjust
dosage based on adult dosage schedule. Yaws, Bejel, and Pinta���1,200,000
units (1 injection). Prophylaxis���for rheumatic fever and glomerulonephritis. Following an acute attack, penicillin G benzathine (parenteral)
may be given in doses of 1,200,000 units once a month or 600,000 units
every 2 weeks.
|
| dailymed-drugs:16 |
As directed by a
physician. Dosage is dependent upon the age, weight and clinical
condition of the patient as well as laboratory determinations. Parenteral drug
products should be inspected visually for particulate matter anddiscoloration prior to administration whenever solution and container
permit. Do not administer unless solution is clear and seal is intact.
Use of a final filter is recommended during administration of all
parenteral solutions, where possible. All injections in
AVIVA plastic containers are intended for intravenous administration
using sterile equipment. Additives may be
incompatible. Complete information is not available. Those additives
known to be incompatible should not be used. Consult with pharmacist, if
available. If, in the informed judgment of the physician, it is deemed
advisable to introduce additives, use aseptic technique. Mix thoroughly
when additives have been introduced. Do not store solutions containing
additives.
|
| dailymed-drugs:17 |
The dose of Amantadine Hydrochloride may need reduction in patients with congestive heart failure, peripheral edema, orthostatic hypotension, or impaired renal function (see Dosage for Impaired Renal Function).<br/>Dosage for Prophylaxis and Treatment of Uncomplicated Influenza A Virus Illness:<br/>Adult: The adult daily dosage of Amantadine Hydrochloride is 200 mg: four teaspoonfuls of oral solution as a single daily dose. The daily dosage may be split into two teaspoonfuls of oral solution twice a day. If central nervous system effects develop in once-a-day dosage, a split dosage schedule may reduce such complaints. In persons 65 years of age or older, the daily dosage of Amantadine Hydrochloride is 100 mg. A 100 mg daily dose has also been shown in experimental challenge studies to be effective as prophylaxis in healthy adults who are not at high risk for influenza-related complications. However, it has not been demonstrated that a 100 mg daily dose is as effective as a 200 mg daily dose for prophylaxis, nor has the 100 mg daily dose been studied in the treatment of acute influenza illness. In recent clinical trials, the incidence of central nervous system (CNS) side effects associated with the 100 mg daily dose was at or near the level of placebo. The 100 mg dose is recommended for persons who have demonstrated intolerance to 200 mg of amantadine hydrochloride daily because of CNS or other toxicities.<br/>Pediatric Patients:<br/>Dosage for Parkinsonism:<br/>Adult: The usual dose of Amantadine Hydrochloride is 100 mg twice a day when used alone. Amantadine Hydrochloride has an onset of action usually within 48 hours. The initial dose of Amantadine Hydrochloride is 100 mg daily for patients with serious associated medical illnesses or who are receiving high doses of other antiparkinson drugs. After one to several weeks at 100 mg once daily, the dose may be increased to 100 mg twice daily, if necessary. Occasionally, patients whose responses are not optimal with Amantadine Hydrochloride at 200 mg daily may benefit from an increase up to 400 mg daily in divided doses. However, such patients should be supervised closely by their physicians. Patients initially deriving benefit from Amantadine Hydrochloride not uncommonly experience a fall-off of effectiveness after a few months. Benefit may be regained by increasing the dose to 300 mg daily. Alternatively, temporary discontinuation of Amantadine Hydrochloride for several weeks followed by reinitiation ofthe drug, may result in regaining benefit in some patients. A decision to use other antiparkinson drugs may be necessary.<br/>Dosage for Concomitant Therapy: Some patients who do not respond to anticholinergic antiparkinson drugs may respond to Amantadine Hydrochloride. When Amantadine Hydrochloride or anticholinergic antiparkinson drugs are each used with marginal benefit, concomitant use may produce additional benefit. When Amantadine Hydrochloride and levodopa are initiated concurrently, the patient can exhibit rapid therapeutic benefits. Amantadine Hydrochloride should be held constant at 100 mg daily or twice daily while the daily dose of levodopa is gradually increased to optimal benefit. When Amantadine Hydrochloride is added to optimal well-tolerated doses of levodopa, additional benefit may result, including smoothing out the fluctuations in improvement which sometimes occur in patients on levodopa alone. Patients who require a reduction in their usual dose of levodopa because of development of side effects may possibly regain lost benefit with the addition of Amantadine Hydrochloride.<br/>Dosage for Drug-Induced Extrapyramidal Reactions:<br/>Adult: The usual dose of Amantadine Hydrochloride is 100 mg twice a day. Occasionally, patients whose responses are not optimal with Amantadine Hydrochloride at 200 mg daily may benefit from an increase up to 300 mg daily in divided doses.<br/>Dosage for Impaired Renal Function: Depending upon creatinine clearance, the following dosage adjustments are recommended: The recommended dosage for patients on hemodialysis is 200 mg every 7 days.
|
| dailymed-drugs:18 |
Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement.The recommended dose is 75-100 mg four times daily as an adjunct to the usual warfarin therapy. Please note that aspirin is not to be administered concomitantly with coumarin anticoagulants.
|
| dailymed-drugs:19 |
Do not inject into or near an artery
or nerve. Injection into or near a nerve may result in permanent neurologic
damage . Penicillin G procaine (aqueous)
is for intramuscular injection only. Administer by
DEEP INTRAMUSCULAR INJECTION in the upper, outer quadrant of the buttock.
In neonates, infants and small children, the midlateral aspect of the thigh
may be preferable. When doses are repeated, vary the injection site. The TUBEX cartridge for this product
incorporates several features that are designed to facilitate the visualization
of blood on aspiration if a blood vessel is inadvertently entered. The
design of this cartridge is such that blood which enters its needle will be
quickly visualized as a red or dark-colored���spot.���This���spot���will appear on the barrel of the glass cartridge immediately proximal to the
blue hub. The TUBEX is designed with two
orientation marks, in order to determine where this���spot���can
be seen. First insert and secure the cartridge in the TUBEX injector in the usual fashion. Locate the yellow rectangle at the
base of the blue hub. This yellow rectangle is aligned with the blood visualization���spot.���An imaginary straight line, drawn from this yellow rectangle
to the shoulder of the glass cartridge, will point to the area on the cartridge
where the���spot���can be visualized. When the needle cover is
removed, a second yellow rectangle will be visible. The second yellow rectangle
is also aligned with the blood visualization���spot���to assist
the operator in locating this���spot.���If the 2 mL metal or plastic
syringe is used, the glass cartridge should be rotated by turning the plunger
of the syringe clockwise until the yellow rectangle is visualized. If the
1 mL metal syringe is used, it will not be possible to continue to rotate
the glass cartridge clockwise once it is properly engaged and fully threaded;
itcan, however, then be rotated counterclockwise as far as necessary to properly
orient the yellow rectangles and locate the observation area. (In this same
area in some cartridges, a dark spot may sometimes be visualized prior to
injection. This is the proximal end of the needle and does not represent a
foreign body in, or other abnormality of, the suspension.) Thus,
before the needle is inserted into the selected muscle, it is important for
the operator to orient the yellow rectangles so that any blood which may enter
after needle insertion and during aspiration can be visualized in the area
on the cartridge where it will appear and not be obscured by any obstructions. After
selection of the proper site and insertion of the needle into the selected
muscle, aspirate by pulling back on the plunger. While maintaining negative
pressure for 2 to 3 seconds, carefully observe the barrel of the cartridge
in the area previously identified (see above) for the appearance of a red
or dark-colored���spot.��� Blood or���typical
blood color���may not be seen if a blood vessel has been entered-only
a mixture of blood and Penicillin G Procaine Injectable Suspension. The appearance
of any discoloration is reason to withdraw the needle and discard the glass TUBEX cartridge. If it is elected to inject at
another site, a new cartridge should be used. If no blood or discoloration
appears, inject the contents of the cartridge slowly. Discontinue delivery
of the dose if the subject complains of severe immediate pain at the injection
site or if, especially in neonates, infants and young children, symptoms or
signs occur suggesting onset of severe pain. Some TUBEX cartridges may contain a small air bubble
which should be disregarded, since it does not affect administration of the
product. DO NOT clear any air bubbles from the cartridge or needle as this
may interfere with the visualization of any blood or discoloration during
aspiration. Because of the high concentration of suspended
material in this product, the needle may be blocked if the injection is not
made at a slow, steady rate. Pneumonia (pneumococcal),
moderately severe (uncomplicated): 600,000 to 1,000,000 units daily. Streptococcal
infections (Group A), moderately severe to severe tonsillitis, erysipelas,
scarlet fever, upper respiratory tract, skin and soft tissue: 600,000 to 1,000,000
units daily for 10-day minimum. Staphylococcal infections,
moderately severe to severe: 600,000 to 1,000,000 units daily. In
pneumonia, streptococcal (Group A) and staphylococcal infections in pediatric
patients under 60 pounds: 300,000 units daily. Bacterial
endocarditis (Group A streptococci) only in extremely sensitive infections:
600,000 to 1,000,000 units daily. Penicillin G procaine
is not recommended for prophylaxis against bacterial endocarditis. For prophylaxis
against bacterial endocarditis in patients with congenital heart disease or
rheumatic or other acquired valvular heart disease when undergoing dental
procedures or surgical procedures of the upper respiratory tract, use penicillin
V. For patients unable to take oral medications, aqueous penicillin G is recommended.<br/>Syphilis: Primary, secondary, and latent with a negative spinal fluid
in adults and pediatric patients over 12 years of age: 600,000 units daily
for 8 days-total 4,800,000 units. Late (tertiary, neurosyphilis,
and latent syphilis with positive spinal-fluid examination or no spinal-fluid
examination): 600,000 units daily for 10 to 15 days-total 6 to 9 million units. Congenital
syphilis under 70-lb. body weight: 50,000 units/kg/day for 10 days. Yaws,
Bejel, and Pinta: Treatment as for syphilis in corresponding stage of disease. Diphtheria-adjunctive
therapy with antitoxin: 300,000 to 600,000 units daily. Diphtheria
carrier state: 300,000 units daily for 10 days. Anthrax-cutaneous:
600,000 to 1,000,000 units/day. Anthrax-inhalational
(post-exposure): 1,200,000 units every 12 hours in adults, 25,000 units per
kilogram of body weight (maximum 1,200,000 unit) every 12 hours in children.
The available safety data for penicillin G procaine at this dose would best
support a duration of therapy of 2 weeks or less. Treatment for inhalational
anthrax (post-exposure) must be continued for a total of 60 days. Physicians
must consider the risks and benefits of continuing administration of penicillin
G procaine for more than 2 weeks or switching to an effective alternative
treatment. Vincent's infection (fusospirochetosis):
600,000 to 1,000,000 units/day. Erysipeloid: 600,000
to 1,000,000 units/day. Streptobacillus
moniliformis and Spirillum minus (rat-bite
fever): 600,000 to 1,000,000 units/day. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit.
|
| dailymed-drugs:20 |
Hypertension:<br/>Monotherapy:: The recommended initial dosage of quinapril tablets in patients not on diuretics is 10 or 20 mg once daily. Dosage should be adjusted according to blood pressure response measured at peak (2-6 hours after dosing) and trough (predosing). Generally, dosage adjustments should be made at intervals of at least 2 weeks. Most patients have required dosages of 20, 40, or 80 mg/day, given as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients an increase in dosage or twice daily administration may be warranted. In general, doses of 40 to 80 mg and divided doses give a somewhat greater effect at the end of the dosing interval.<br/>Concomitant Diuretics:: If blood pressure is not adequately controlled with quinapril tablets monotherapy, a diuretic may be added. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of quinapril tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued 2 to 3 days prior to beginning therapy with quinapril tablets (see WARNINGS). Then, if blood pressure is not controlled with quinapril tablets alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 5 mg quinapril tablets should be used with careful medical supervision for several hours and until blood pressure has stabilized. The dosage should subsequently be titrated (as described above) to the optimal response (see WARNINGS, PRECAUTIONS, and Drug Interactions).<br/>Renal Impairment:: Kinetic data indicate that the apparent elimination half-life of quinaprilat increases as creatinine clearance decreases. Recommended starting doses, based on clinical and pharmacokinetic data from patients with renal impairment, are as follows: Patients should subsequently have their dosage titrated (as described above) to the optimal response.<br/>Elderly (���65 years):: The recommended initial dose of quinapril tablets in elderly patients is 10 mg given once daily followed by titration (as described above) to the optimal response. Following the initial dose of quinapril tablets, the patient should be observed under medical supervision for at least two hours for the presence of hypotension or orthostatis and, if present, until blood pressure stabilizes. The appearance of hypotension, orthostatis, or azotemia early in dose titration should not preclude further careful dose titration. Consideration should be given to reducing the dose of concomitant diuretics.
|
| dailymed-drugs:21 |
Initial Glaucoma Therapy. The usual dosage of dipivefrin hydrochloride ophthalmic solution, 0.1%, is one drop in the eye(s) every 12 hours. Replacement With Dipivefrin Hydrochloride Ophthalmic Solution: When patients are being transferred to dipivefrin from antiglaucoma agents other than epinephrine, on the first day continue the previous medication and add one drop of dipivefrin to each eye(s) every 12 hours. On the following day, discontinue the previously used antiglaucoma agent and continue with dipivefrin. In transferring patients from conventional epinephrine therapy to dipivefrin, simply discontinue the epinephrine medication and institute the dipivefrin regimen. Addition of Dipivefrin Hydrochloride Ophthalmic Solution: When patients on other antiglaucoma agents require additional therapy, add one drop of dipivefrin every 12 hours. Concomitant Therapy. For difficult to control patients, the addition of dipivefrin hydrochloride ophthalmic solution to other agents such as pilocarpine, carbachol, echothiophate iodide or acetazolamide has been shown to be effective. Note: Not for injection.
|
| dailymed-drugs:22 |
This solution is for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. The usual adult dose is one to two liters per day. In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride). Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly.Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|
| dailymed-drugs:23 |
To achieve maximum
contraceptive effectiveness, NuvaRing' must be used as directed (see
When to
Start NuvaRing' below). One NuvaRing' is inserted in the
vagina. The ring is to remain in place
continuously for three weeks. It is removed for a one-week
break, during which a withdrawal bleed usually occurs. A new ring is
inserted one week after the last ring was removed. The user can choose
the insertion position that is most comfortable to her, for example,
standing with one leg up, squatting, or lying down. The ring is to be
compressed and inserted into the vagina. The exact position of NuvaRing'
inside the vagina is not critical for its function. The vaginal ring
must be inserted on the appropriate day and left in place for three
consecutive weeks. This means that the ring is removed three weeks later
on the same day of the week as it was inserted and at about the same
time. NuvaRing' can be removed by hooking the index finger under the
forward rim or by grasping the rim between the index and middle finger
and pulling it out. The used ring should be placed in the sachet (foil
pouch) and discarded in a waste receptacle out of the reach of children
and pets (do not flush in toilet). After a one-week break, during which
a withdrawal bleed usually occurs, a new ring is inserted on the same
day of the week as it was inserted in the previous cycle. The withdrawal
bleed usually starts on day 2-3 after removal of the ring and may not
have finished before the next ring is inserted. In order to maintain
contraceptive effectiveness, the new ring must be inserted one week
after the previous one was removed even if menstrual bleeding has not
finished.<br/>When to Start
NuvaRing': IMPORTANT:
The possibility of ovulation and conception prior to the first
use of NuvaRing' should be considered.<br/>No hormonal contraceptive use
in the preceding cycle: Insert NuvaRing' on the first day of the woman's
natural cycle (i.e., the first day of her menstrual
bleeding). NuvaRing' may also be started on days 2-5 of
the woman's cycle, but in this case a barrier method,
such as male condoms or spermicide, is recommended for
the first seven days of NuvaRing' use in the first
cycle.<br/>Changing from a combined
hormonal contraceptive: The
woman may switch from her previous combined hormonal
contraceptive on any day, but at the latest on the day
following the usual hormone-free interval, if she has
been using her hormonal method consistently and
correctly, or if it is reasonably certain that she is
not pregnant.<br/>Changing from a
progestagen-only method (minipill, implant, or
injection) or from a progestagen-releasing intrauterine
system (IUS): The
woman may switch on any day from the minipill. She
should switch from an implant or the IUS on the day of
its removal and from an injectable on the day when the
next injection would be due. In all of these cases, the
woman should use an additional barrier method such as a
male condom or spermicide, for the first seven
days.<br/>Following complete first
trimester abortion: The
woman may start using NuvaRing' within the first five
days following a complete first trimester abortion and
does not need to use an additional method of
contraception. If use of NuvaRing' is not started within
five days following a first trimester abortion, the
woman should follow the instructions for���No hormonal
contraceptive use in the preceding cycle.���In the
meantime she should be advised to use a non-hormonal
contraceptive method.<br/>Following delivery or second
trimester abortion: The
use of NuvaRing' for contraception may be initiated four
weeks postpartum in women who elect not to breast-feed.
Women who are breast-feeding should be advised not to
use NuvaRing' but to use other forms of contraception
until the child is weaned. NuvaRing' use may be
initiated four weeks after a second trimester abortion.
When NuvaRing' is used postpartum or postabortion, the
increased risk of thromboembolic disease must be
considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic
disease. See PRECAUTIONS for���Nursing Mothers���.) If a
woman begins using NuvaRing' postpartum, she should be
instructed to use an additional method of contraception,
such as male condoms or spermicide, for the first seven
days. If she has not yet had a period, the possibility
of ovulation and conception occurring prior to
initiation of NuvaRing' should be
considered.<br/>Deviations from the
Recommended Regimen: To prevent
loss of contraceptive efficacy, women should not deviate from
the recommended regimen. NuvaRing' should be left in the vagina
for a continuous period of three weeks.<br/>Inadvertent removal,
expulsion, or prolonged ring-free interval: If
the ring is accidentally expelled and is left outside of
the vagina for less than three
hours contraceptive efficacy is not
reduced. NuvaRing' can be rinsed with cool to lukewarm
(not hot) water and reinserted
as soon as possible, but at the latest
within three hours. If NuvaRing' is lost, a new vaginal
ring shouldbe inserted and the regimen should be
continued without alteration. If NuvaRing' is out of the
vagina for more than three hours, the directions listed
under PRECAUTIONS, EXPULSION should be
followed. If
the ring-free interval has been extended beyond one
week, the possibility of pregnancy should be considered,
and an additional method of contraception, such as male
condoms or spermicide, MUST be used until NuvaRing' has been used
continuously for seven
days.<br/>Prolonged Use of
NuvaRing': If
NuvaRing' has been left in place for up to one extra
week (i.e., up to four weeks total), the woman will
remain protected. NuvaRing' should be removed and the
woman should insert a new ring after a one-week
ring-free interval. The mean serum etonogestrel
concentration during the fourth week of continuous use
of NuvaRing' was 1272��311 pg/mL compared to a mean
concentration range of 1578��408 to 1374��328 pg/mL
during weeks one to three. The mean serum ethinyl
estradiol concentration during the fourth week of
continuous use of NuvaRing' was 16.8��4.6 pg/mL
compared to a mean concentration range of 19.1��4.5 to
17.6��4.3 pg/mL during weeks one to three. If NuvaRing'
has been left in place for longer than four weeks,
pregnancy should be ruled out, and an additional method
of contraception, such as male condoms or spermicide,
MUST be used
until a new NuvaRing' has been used continuously for seven
days.<br/>In the event of a
missed menstrual period:
|
| dailymed-drugs:24 |
Nystatin Ointment should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder. This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.
|
| dailymed-drugs:25 |
Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. It is not possible to prescribe a single dosage schedule of Surmontil that will be therapeutically effective in all patients. The physical psychodynamic factors contributing to depressive symptomatology are very complex; spontaneous remissions or exacerbations of depressive symptoms may occur with or without drug therapy. Consequently, therecommended dosage regimens are furnished as a guide which may be modified by factors such as the age of the patient, chronicity and severity of the disease, medical condition of the patient, and degree of psychotherapeutic support. Most antidepressant drugs have a lag period of ten days to four weeks before a therapeutic response is noted. Increasing the dose will not shorten this period but rather increase the incidence of adverse reactions.<br/>Usual Adult Dose: Outpatients and Office Patients���Initially, 75 mg/day in divided doses, increased to 150 mg/day. Dosages over 200 mg/day are not recommended. Maintenance therapy is in the range of 50 to 150 mg/day. For convenient therapy and to facilitate patient compliance, the total dosage requirement may be given at bedtime. Hospitalized Patients���Initially, 100 mg/day in divided doses. This may be increased gradually in a few days to 200 mg/day, depending upon individual response and tolerance. If improvement does not occur in 2 to 3 weeks, the dose may be increased to the maximum recommended dose of 250 to 300 mg/day. Adolescent and Geriatric Patients���Initially, a dose of 50 mg/day is recommended, with gradual increments up to 100 mg/day, depending upon patient response and tolerance. Maintenance���Following remission, maintenance medication may be required for a longer period of time, at the lowest dose that will maintain remission. Maintenance therapy is preferably administered as a single dose at bedtime. To minimize relapse, maintenance therapy should be continued for about three months.
|
| dailymed-drugs:26 |
One LACRISERT ophthalmic insert in each eye once daily is usually sufficient to relieve the symptoms associated with moderate to severe dry eye syndromes. Individual patients may require more flexibility in the use of LACRISERT; some patients may require twice daily use for optimal results. Clinical experience with LACRISERT indicates that in some patients several weeks may be required before satisfactory improvement of symptoms is achieved. LACRISERT is inserted into the inferior cul-de-sac of the eye beneath the base of the tarsus, not in apposition to the cornea, nor beneath the eyelid at the level of the tarsal plate. If not properly positioned, it will be expelled into the interpalpebral fissure, and may cause symptoms of a foreign body. Illustrated instructions are included in each package. While in the licensed practitioner's office, the patient should read the instructions, then practice insertion and removal of LACRISERT until proficiency is achieved. NOTE: Occasionally LACRISERT is inadvertently expelled from the eye, especially in patients with shallow conjunctival fornices. The patient should be cautioned against rubbing the eye(s) containing LACRISERT, especially upon awakening, so as not to dislodge or expel the insert. If required, another LACRISERT ophthalmic insert may be inserted. If experience indicates that transient blurred vision develops in an individual patient, the patient may want to remove LACRISERT a few hours after insertion to avoid this. Another LACRISERT ophthalmic insert maybe inserted if needed. If LACRISERT causes worsening of symptoms, the patient should be instructed to inspect the conjunctival sac to make certain LACRISERT is in the proper location, deep in the inferior cul-de-sac of the eye beneath the base of the tarsus. If these symptoms persist, LACRISERT should be removed and the patient should contact the practitioner.
|
| dailymed-drugs:27 |
Initial Treatment:<br/>Dosage for Adults:<br/>Maintenance/Continuation/Extended Treatment:<br/>Major Depressive Disorder:<br/>Switching Patients to or from a Monoamine Oxidase Inhibitor:<br/>Special Populations:<br/>Dosage for Hepatically Impaired Patients:<br/>Treatment of Pregnant Women During the Third Trimester:<br/>Discontinuation of Treatment with Sertraline Hydrochloride:<br/>Sertraline Hydrochloride Oral Concentrate:
|
| dailymed-drugs:28 |
14.6% Sodium Chloride Injection, USP Additive Solution is
administered intravenously only after addition
to a larger volume of fluid. The dose, dilution
and rate of injection are dependent upon the individual needs of each patient. All
or part of the contents of one or more additive containers may be added to
an intravenous solution container. Concentrations of up to 5% sodium chloride
have been administered. Parenteral drug products should
be inspected visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. See PRECAUTIONS.
|
| dailymed-drugs:29 |
Darvon is given orally. The usual dosage is 65 mg propoxyphene hydrochloride every 4 hours as needed for pain. The maximum recommended dose of propoxyphene hydrochloride is 390 mg/day. Consideration should be given to a reduced total daily dosage in patients with hepatic or renal impairment.
|
| dailymed-drugs:30 |
Recent MI, Recent Stroke, or Established Peripheral Arterial
Disease: The recommended
daily dose of PLAVIX is 75 mg once daily.<br/>Acute Coronary Syndrome: For patients with
non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave
MI), PLAVIX should be initiated with a single 300-mg loading dose
and then continued at 75 mg once daily. Aspirin (75 mg-325 mg once
daily) should be initiated and continued in combination with PLAVIX.
In CURE, most patients with Acute Coronary Syndrome also received
heparin acutely . For patients
with ST-segment elevation acute myocardial infarction, the recommended
dose of PLAVIX is 75 mg once daily, administered in combination with
aspirin, with or without thrombolytics. PLAVIX may be initiated with
or without a loading dose . PLAVIX
can be administered with or without food. No dosage adjustment is necessary for elderly patients or patients
with renal disease. (See Clinical Pharmacology: Special Populations.)
|
| dailymed-drugs:31 |
Very moist lesions are best treated with the topical dusting powder.<br/>Nyamyc���(Nystatin Topical Powder, USP)Adults and Pediatric Patients(Neonates and Older):: Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.
|
| dailymed-drugs:32 |
Amiodarone shows considerable interindividual variation in response. Thus, although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose as needed is essential. The recommended starting dose of amiodarone hydrochloride injection is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen: After the first 24 hours, the maintenance infusion rate of 0.5 mg/min (720 mg/24 hours) should be continued utilizing a concentration of 1 to 6 mg/mL (amiodarone concentrations greater than 2 mg/mL should be administered via a central venous catheter). In the event of breakthrough episodes of VF or hemodynamically unstable VT, 150-mg supplemental infusions of amiodarone mixed in 100 mL of DW may be administered. Such infusions should be administered over 10 minutes to minimize the potential for hypotension. The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression. The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. The initial infusion rate should not exceed 30 mg/min. Based on the experience from clinical studies of amiodarone, a maintenance infusion of up to 0.5 mg/min can be cautiously continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving amiodarone for longer than 3 weeks. The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone must be delivered by a volumetric infusion pump. Amiodarone HCl injection should, whenever possible, be administered through a central venous catheter dedicated to that purpose. An in-line filter should be used during administration. Amiodarone HCl injection concentrations greater than 3 mg/mL in DW have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, amiodarone concentrations should not exceed 2 mg/mL unless a central venous catheter is used . Amiodarone infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing DW. Use of evacuated glass containers for admixing amiodarone is not recommended as incompatibility with a buffer in the container may cause precipitation. It is well known that amiodarone adsorbs to polyvinyl chloride (PVC) tubing and the clinical trial dose administration schedule was designed to account for this adsorption. All of the clinical trials were conducted using PVC tubing and its use is therefore recommended. The concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect doses identified in these studies. It is important that the recommended infusion regimen be followed closely. Amiodarone has been found to leach out plasticizers, including DEHP [di-(2- ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. Amiodarone HCl injection does not need to be protected from light during administration.<br/>Intravenous to Oral Transition: Patients whose arrhythmias have been suppressed by amiodarone may be switched to oral amiodarone. The optimal dose for changing from intravenous to oral administration of amiodarone will depend on the dose of amiodarone already administered, as well as the bioavailability of oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. Since there are some differences between the safety and efficacy profiles of the intravenous and oral formulations, the prescriber is advised to review the package insert for oral amiodarone when switching from intravenous to oral amiodarone therapy. Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, grapefruit juice should not be taken during treatment with oral amiodarone . The following table provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone administration. These recommendations are made on the basis of a comparable total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.<br/>Syringe Assembly Directions: The Luer-Jet���connector is the basic unit upon which all other syringe systems are built. Shown below is the assembly with the Dilute-A-Jet System. Assembly directions for the Luer-Jet���system remain essentially the same. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY.
|
| dailymed-drugs:33 |
INFANTS: 2 mL (200, 000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.<br/>CHILDREN AND ADULTS: 4-6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing. Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.
|
| dailymed-drugs:34 |
Adults:<br/>For Edema:<br/>For Control of Hypertension:<br/>Infants and Children:<br/>For Diuresis and For Control of Hypertension:
|
| dailymed-drugs:35 |
Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with etodolac, the dose and frequency should be adjusted to suit an individual patient's needs. Dosage adjustment of etodolac is generally not required in patients with mild to moderate renal impairment. Etodolac should be used with caution in such patients, because, as with other NSAIDs, it may further decrease renal function in some patients with impaired renal function (see WARNINGS, Renal Effects).<br/>Analgesia: The recommended total daily dose of etodolac for acute pain is up to 1000 mg, given as 200-400 mg every 6 to 8 hours. Doses of etodolac greater than 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.<br/>Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose of etodolac for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials. In chronic conditions, a therapeutic response to therapy with etodolac is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.
|
| dailymed-drugs:36 |
Geocillin is available as a coated tablet to be administered orally.
|
| dailymed-drugs:37 |
Initial Treatment: The recommended starting dose for Mirtazapine tablets is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep. In the controlled clinical trials establishing the efficacy of mirtazapine in the treatment of major depressive disorder, the effective dose range was generally 15-45 mg/day. While the relationship between dose and satisfactory response in the treatment of major depressive disorder for mirtazapine has not been adequately explored, patients not responding to the initial 15 mg dose may benefit from dose increases up to a maximum of 45 mg/day. Mirtazapine has an elimination half-life of approximately 20-40 hours; therefore, dose changes should not be made at intervals of less than one to two weeks in order to allow sufficient time for evaluation of the therapeutic response to a given dose.<br/>Elderly and Patients with Renal or Hepatic Impairment: The clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment. Consequently, the prescriber should be aware that plasma mirtazapine levels may be increased in these patient groups, compared to levels observed in younger adults without renal or hepatic impairment .<br/>Maintenance/Extended Treatment: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systemic evaluation of mirtazapine has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to 40 weeks following 8-12 weeks of initial treatment at a dose of 15-45 mg/day. Based on these limited data, it is unknown whether or not the dose of mirtazapine needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.<br/>Switching Patients To or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with mirtazapine. In addition, at least 14 days should be allowed after stopping mirtazapine before starting an MAOI.
|
| dailymed-drugs:38 |
Dosage in Patients with Reduced U G T1 A1 Activity: When administered as a single-agent, a reduction in the starting dose by at least one level of Irinotecan Hydrochloride Injection should be considered for patients known to be homozygous for the UGT1A1*28 allele . However, the precise dose reduction in this patient population is not known and subsequent dose modifications should be considered based on individual patient tolerance to treatment (See Tables 7 to 8).<br/>Single-Agent Dosage Schedules:<br/>Dosage Regimens: Irinotecan Hydrochloride Injection should be administered as an intravenous infusion over 90 minutes for both the weekly and once-every-3-week dosage schedules (see Preparation of Infusion Solution). Single-agent dosage regimens are shown in Table 7. A reduction in the starting dose by one dose level of Irinotecan Hydrochloride Injection may be considered for patients with any of the following conditions: age���65 years, prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels. Dosing for patients with bilirubin>2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients. It is recommended that patients receive premedication with antiemetic agents. Prophylactic or therapeutic administration of atropine should be considered in patients experiencing cholinergic symptoms. See PRECAUTIONS, General.<br/>Dose Modifications: Patients should be carefully monitored for toxicity and doses of Irinotecan Hydrochloride Injection should be modified as necessary to accommodate individual patient tolerance to treatment. Based on recommended dose-levels described in Table 7, Single-Agent Regimens of Irinotecan Hydrochloride Injection and Dose Modifications, subsequent doses should be adjusted as suggested in Table 8, Recommended Dose Modifications for Single-Agent Schedules. All dose modifications should be based on the worst preceding toxicity. A new cycle of therapy should not begin until the toxicity has recovered to NCI grade 1 or less. Treatment may be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicity. If the patient has not recovered, consideration should be given to discontinuing this combination therapy. Provided intolerable toxicity does not develop, treatment with additional cycles of Irinotecan Hydrochloride Injection may be continued indefinitely as long as patients continue to experience clinical benefit.<br/>Preparation&Administration Precautions: As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of infusion solutions prepared from Irinotecan Hydrochloride Injection. The use of gloves is recommended. If a solution of Irinotecan Hydrochloride Injection contacts the skin, wash the skin immediately and thoroughly with soap and water. IfIrinotecan Hydrochloride Injection contacts the mucous membranes, flush thoroughly with water. Several published guidelines for handling and disposal of anticancer agents areavailable.<br/>Preparation of Infusion Solution: Inspect vial contents for particulate matter and repeat inspection when drug product is withdrawn from vial into syringe. Irinotecan Hydrochloride Injection must be diluted prior to infusion. Irinotecan Hydrochloride Injection should be diluted in 5% Dextrose Injection, USP, (preferred) or 0.9% Sodium Chloride Injection,USP, to a final concentration range of 0.12 to 2.8 mg/mL. In most clinical trials, Irinotecan Hydrochloride Injection was administered in 250 mL to 500 mL of5 % Dextrose Injection, USP. The solution is physically and chemically stable for up to 24 hours at room temperature (approximately 25��C) and in ambient fluorescent lighting. Solutions diluted in 5% Dextrose Injection, USP, and stored at refrigerated temperatures (approximately 2��to 8��C), and protected from light are physically and chemically stable for 48 hours. Refrigeration of admixtures using 0.9% Sodium Chloride Injection, USP, is not recommended due to a low and sporadic incidence of visible particulates. Freezing Irinotecan Hydrochloride Injection and admixtures of Irinotecan Hydrochloride Injection may result in precipitation of the drug and should be avoided. Because of possible microbial contamination during dilution, it is advisable to use the admixture prepared with 5%Dextrose Injection, USP, within 24 hours if refrigerated (2��to 8��C, 36��to 46��F). In the case of admixtures prepared with 5% Dextrose Injection, USP, or Sodium Chloride Injection, USP, the solutions should be used within 6 hours if kept at room temperature (15��to 30��C, 59��t o 86��F). Other drugs should not be added to the infusion solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
|
| dailymed-drugs:39 |
Prevention of Endometrial Hyperplasia: PROMETRIUM Capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to postmenopausal women with a uterus who are receiving daily conjugated estrogens tablets. Secondary Amenorrhea: PROMETRIUM Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days. Some women may experience difficulty swallowing PROMETRIUM Capsules. For these women, PROMETRIUM Capsules should be taken with a glass of water while in the standing position.
|
| dailymed-drugs:40 |
Instructions for Individualized Dose Initiation:<br/>Initiation of TIKOSYN Therapy: Step 1. Electrocardiographic assessment: Prior to administration of the first dose, the QTc must be determined using an average of 5���10 beats. If the QTc is greater than 440 msec (500 msec in patients with ventricular conduction abnormalities), TIKOSYN is contraindicated. If heart rate is less than 60 beats per minute, QT interval should be used. Patients with heart rates<50 beats per minute have not been studied. Step 2. Calculation of creatinine clearance: Prior to the administration of the first dose, the patient's creatinine clearance must be calculated using the following formula: creatinine clearance (male) = (140-age)��actual body weight in kg72��serum creatinine (mg/dL) creatinine clearance (female) = (140-age)��actual body weight in kg��0.8572��serum creatinine (mg/dL) When serum creatinine is given in��mol/L, divide the value by 88.4 (1 mg/dL = 88.4��mol/L). Step 3. Starting Dose: The starting dose of TIKOSYN is determined as follows: Step 4. Administer the adjusted TIKOSYN dose and begin continuous ECG monitoring. Step 5. At 2���3 hours after administering the first dose of TIKOSYN, determine the QTc. If the QTc has increased by greater than 15% compared to the baseline established in Step 1 OR if the QTc is greater than 500 msec (550 msec in patients with ventricular conduction abnormalities), subsequent dosing should be adjusted as follows: Step 6. At 2���3 hours after each subsequent dose of TIKOSYN, determine the QTc (for in-hospital doses 2���5). No further down titration of TIKOSYN based on QTc is recommended. NOTE: If at any time after the second dose of TIKOSYN is given, the QTc is greater than 500 msec (550 msec in patients with ventricular conduction abnormalities) TIKOSYN should be discontinued. Step 7. Patients are to be continuously monitored by ECG for a minimum of three days, or for a minimum of 12 hours after electrical or pharmacological conversion to normal sinus rhythm, whichever is greater. The steps described above are summarized in the following diagram:<br/>Maintenance of TIKOSYN Therapy: Renal function and QTc should be re-evaluated every three months or as medically warranted. If QTc exceeds 500 milliseconds (550 msec in patients with ventricular conduction abnormalities), TIKOSYN therapy should be discontinued and patients should be carefully monitored until QTc returns to baseline levels. If renal function deteriorates, adjust dose as described in Initiation of TIKOSYN Therapy, Step 3.<br/>Special Considerations:<br/>Consideration of a Dose Lower than that Determined by the Algorithm: The dosing algorithm shown above should be used to determine the individualized dose of TIKOSYN. In clinical trials , the highest dose of 500 mcg BID of TIKOSYN as modified by the dosing algorithm led to greater effectiveness than lower doses of 125 or 250 mcg BID as modified by the dosing algorithm. The risk of torsade de pointes, however, is related to dose as well as to patient characteristics . Physicians, in consultation with their patients, may therefore in some cases choose doses lower than determined by the algorithm. It is critically important that if at any time this lower dose is increased, the patient needs to be rehospitalized for three days. Previous toleration of higher doses does not eliminate the need for rehospitalization. The maximum recommended dose in patients with a calculated creatinine clearance greater than 60 mL/min is 500 mcg BID; doses greater than 500 mcg BID have been associated with an increased incidence of torsade de pointes. A patient who misses a dose should NOT double the next dose. The next dose should be taken at the usual time.<br/>Cardioversion: If patients do not convert to normal sinus rhythm within 24 hours of initiation of TIKOSYN therapy, electrical conversion should be considered. Patients continuing on TIKOSYN after successful electrical cardioversion should continue to be monitored by electrocardiography for 12 hours post cardioversion, or a minimum of 3 days after initiation of TIKOSYN therapy, whichever is greater.<br/>Switch to TIKOSYN from Class I or other Class III Antiarrhythmic Therapy: Before initiating TIKOSYN therapy, previous antiarrhythmic therapy should be withdrawn under careful monitoring for a minimum of three (3) plasma half-lives. Because of the unpredictable pharmacokinetics of amiodarone, TIKOSYN should not be initiated following amiodarone therapy until amiodarone plasma levels are below 0.3 mcg/mL or until amiodarone has been withdrawn for at least three months.<br/>Stopping TIKOSYN Prior to Administration of Potentially Interacting Drugs: If TIKOSYN needs to be discontinued to allow dosing of other potentially interacting drug(s), a washout period of at least two days should be followed before starting the other drug(s).
|
| dailymed-drugs:41 |
The total daily dose of the solution depends on the
daily protein requirements and on the patient's metabolic and
clinical response. In many patients, provision of adequate calories
in the form of hypertonic dextrose may require the administration
of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent
rebound hypoglycemia, a solution containing 5% dextrose should be
administered when hypertonic dextrose infusions are abruptly discontinued. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration,
whenever solution and container permit. COLOR VARIATION FROM PALE
YELLOW TO YELLOW IS NORMAL AND DOES NOT ALTER EFFICACY. Adults Solutions containing 3.5 to 5% amino acids with 5 to 10%
glucose may be coinfused with a fat emulsion by peripheral vein to
provide approximately 1400 to 2000 kcal/day. Fat emulsion coadministration
should be considered when prolonged parenteral nutrition is required
in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum
lipids should be monitored for evidence of EFAD in patients maintained
on fat-free total parenteral nutrition. Aminosyn
5%, 7%, 8.5% and 10% solutions should only be infused via a central
vein when admixed with sufficient dextrose to provide full caloric
requirements in patients who require prolonged total parenteral nutrition.
I.V. lipid may be administered separately to provide part of the calories,
if desired. Total parenteral nutrition (TPN)
may be started with 10% dextrose added to the calculated daily requirement
of amino acids (1.5 g/kg for a metabolically stable patient). Dextrose
content is gradually increased over the next few days to the estimated
daily caloric need as the patient adapts to the increasing amounts
of dextrose. Each gram of dextrose provides approximately 3.4 kcal.
Each gram of fat provides 9 kcal. The average
depleted major surgical patient with complications requires between
2500 and 4000 kcal and between 12 and 24 grams of nitrogen per day.
An adult patient in an acceptable weight range with restricted activity
who is not hypermetabolic, requires about 30 kcal/kg of body weight/day.
Average daily adult fluid requirements are between 2500 and 3000 mL
and may be much higher with losses from fistula drainage or severe
burns. Typically, a hospitalized patient may lose 12 to 18 grams of
nitrogen a day, and in severe trauma the daily loss may be 20 to 25
grams or more. Aminosyn solutions without electrolytes
are intended for patients requiring individualized electrolyte therapy.
Sodium, chloride, potassium, phosphate, calcium and magnesium are
major electrolytes which should be added to Aminosyn as required. SERUM ELECTROLYTES SHOULD BE MONITORED AS INDICATED. Electrolytes
may be added to the nutrient solution as indicated by the patient's
clinical condition and laboratory determinations of plasma values.
Major electrolytes are sodium, chloride, potassium, phosphate, magnesium
and calcium. Vitamins, including folic acid and vitamin K are required
additives. The trace element supplements should be given when long-term
parenteral nutrition is undertaken. Calcium
and phosphorus are added to the solution as indicated. The usual dose
of phosphate added to a liter of TPN solution (containing 25% dextrose)
is 12 mM. This requirement is related to the carbohydrate calories
delivered. Iron is added to the solution or given intramuscularly
in depot form as indicated. Vitamin B, vitamin K and
folic acid are given intramuscularly or added to the solution as desired. Calcium and phosphate additives are potentially incompatible
when added to the TPN admixture. However, if one additive is added
to the amino acid bottle, and the other to the bottle of concentrated
dextrose, and if the contents of both bottles are swirled before they
are combined, then the likelihood of physical incompatibility is reduced. In patients with hyperchloremic or other metabolic acidosis,
sodium and potassium may be added as the acetate or lactate salts
to provide bicarbonate alternates. In adults,
hypertonic mixtures of amino acids and dextrose may be safely administered
by continuous infusion through a central venous catheter with the
tip located in the vena cava. Typically, the 7%, 8.5% or 10% solution
is used in equal volume with 50% dextrose to provide an admixture
containing 3.5%, 4.25% or 5% amino acids and 25% dextrose. The rate of intravenous infusion initially should be 2
mL/min and may be increased gradually. If administration should fall
behind schedule, no attempt to���catch up���to planned
intake should be made. In addition to meeting protein needs, the rate
of administration is governed by the patient's glucose tolerance
estimated by glucose levels in blood and urine. Aminosyn 10% solution, when mixed with an appropriate volume of concentrated
dextrose, offers a higher concentration of calories and nitrogen per
unit volume. This solution is indicated for patients requiring larger
amounts of nitrogen than could otherwise be provided or where total
fluid load must be kept to a minimum, for example, patients with renal
failure. Provision of adequate calories in the
form of hypertonic dextrose may require exogenous insulin to prevent
hyperglycemia and glycosuria. To prevent rebound hypoglycemia, do
not abruptly discontinue administration of nutritional solutions.<br/>Pediatric: Pediatric requirements for parenteral nutrition are
constrained by the greater relative fluid requirements of the infant
and greater caloric requirements per kilogram. Amino acids are probably
best administered in a 2.5% concentration. For most pediatric patients
on intravenous nutrition, 2.5 grams amino acids/kg/day with dextrose
alone or with I.V. lipid calories of 100 to 130 kcal/kg/day is
recommended. In cases of malnutrition or stress, these requirements
may be increased. It is acceptable in pediatrics to start with a nutritional
solution of half strength at a rate of about 60 to 70 mL/kg/day. Within
24 to 48 hours the volume and concentration of the solution can be
increased until the full strength pediatric solution (amino acids
and dextrose) is given at a rate of 125 to 150 mL/kg/day. Supplemental electrolytes and vitamin additives should
be administered as deemed necessary by careful monitoring of blood
chemistries and nutritional status. Addition of iron is more critical
in the infant than the adult because of the increasing red cell mass
required for the growing infant. Serum lipids should be monitored
for evidence of essential fatty acid deficiency in patients maintained
on fat-free TPN. Bicarbonate should not be administered during infusion
of the nutritional solution unless deemed absolutely necessary. To insure the precise delivery of the small volumes of
fluid necessary for total parenteral nutrition in infants, accurately
calibrated and reliable infusion systems should be used. A basic solution for pediatric use should contain 25 grams
of amino acids and 200 to 250 grams of glucose per 1000 mL, administered
from bottles containing 250 or 500 mL. Such a solution given at the
rate of 145 mL/kg/day provides 130 kcal/kg/day. WARNING: Do not use flexible container
in series connections.
|
| dailymed-drugs:42 |
Dexamethasone
Sodium Phosphate Injection, 4 mg/mL-For
intravenous, intramuscular, intra-articular, intralesional and soft
tissue injection. Dexamethasone
Sodium Phosphate Injection, 10 mg/mL-For
intravenous and intramuscular injection only. Dexamethasone
Sodium Phosphate Injection can be given directly from the vial or it can
be added to Sodium Chloride Injection or Dextrose Injection and
administered by intravenous drip. Solutions used for
intravenous administration or further dilution of this product should be
preservative-free when used in the neonate, especially the premature
infant. When it is mixed
with an infusion solution, sterile precautions should be observed. Since
infusion solutions generally do not contain preservatives, mixtures
should be used within 24 hours. DOSAGE REQUIREMENTS ARE VARIABLE AND MUST
BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF
THE PATIENT.<br/>INTRAVENOUS AND
INTRAMUSCULAR INJECTION: The initial
dosage of Dexamethasone Sodium Phosphate Injection varies from
0.5 to 9 mg a day depending on the disease being treated. In
less severe diseases doses lower than 0.5 mg may suffice, while in severe diseases doses higher than 9 mg may be required. The initial
dosage should be maintained or adjusted until the patient's
response is satisfactory. If a satisfactory clinical response
does not occur after a reasonable period of time, discontinue
Dexamethasone Sodium Phosphate Injection and transfer the
patient to other therapy. After a
favorable initial response, the proper maintenance dosage should
be determined by decreasing the initial dosage in small amounts
to the lowest dosage that maintains an adequate clinical
response. Patients
should be observed closely for signs that might require dosage
adjustment, including changes in clinical status resulting from
remissions or exacerbations of the disease, individual drug
responsiveness and the effect of stress (e.g., surgery,
infection, trauma). During stress it may be necessary to
increase dosage temporarily. If the drug
is to be stopped after more than a few days of treatment, it
usually should be withdrawn gradually. When the
intravenous route of administration is used, dosage usually
should be the same as the oral dosage. In certain overwhelming,
acute, life-threatening situations, however, administration in
dosages exceeding the usual dosages may be justified and may be
in multiples of the oral dosages. The slower rate of absorption
by intramuscular administration should be
recognized.<br/>Shock: There is a tendency in current medical practice to use
high (pharmacologic) doses of corticosteroids for the
treatment of unresponsive shock. The following dosages
of Dexamethasone Sodium Phosphate Injection have been
suggested by various authors: Administration of high dose corticosteroid therapy
should be continued only until the patient's condition
has stabilized and usually not longer than 48 to 72
hours. Although adverse reactions associated with high dose, short term corticosteroid therapy are uncommon, peptic
ulceration may occur.<br/>Cerebral
Edema: Dexamethasone Sodium Phosphate Injection is generally
administered initially in a dosage of 10 mg
intravenously followed by four mg every six hours
intramuscularly until the symptoms of cerebral edema
subside. Response is usually noted within 12 to 24 hours
and dosage may be reduced after two to four days and
gradually discontinued over a period of five to seven
days. For palliative management of patients with
recurrent or inoperable brain tumors, maintenance
therapy with two mg two or three times a day may be
effective.<br/>Acute
Allergic Disorders: In
acute, self-limited allergic disorders or acute
exacerbations of chronic allergic disorders the following dosage schedule combining parenteral and oral
therapy is suggested: Dexamethasone Sodium Phosphate Injection, 4 mg/mL -First day, 1
or 2 mL (4 or 8 mg) intramuscularly. Dexamethasone tablets, 0.75 mg - Second and third days,
4 tablets in two divided doses each day; fourth day 2 tablets
in two divided doses; fifth
and sixth days, 1 tablet each day;seventh day,
no treatment; eighth
day, follow-up visit. This schedule is designed to ensure adequate therapy
during acute episodes, while minimizing the risk of
overdosage in chronic cases.<br/>Intra-articular,
Intralesional and Soft Tissue Injection: Intra-articular, intralesional and soft tissue injections are
generally employed when the affected joints or areas are limited
to one or two sites. Dosage and frequency of injection varies
depending on the condition and the site of injection. The usual
dose is from 0.2 to 6 mg. The frequency usually ranges from once
every three to five days to once every two to three weeks.
Frequent intra-articular injection may result in damage to joint
tissues. Some of the usual single doses are: Dexamethasone Sodium Phosphate Injection is particularly
recommended for use in conjunction with one of the less soluble,
longer-acting steroids for intra-articular and soft tissue
injection. Parenteral drug products should be
inspected visually for particulate matter and discoloration
prior to administration, whenever the solution and container
permit.
|
| dailymed-drugs:43 |
The dose of any local anesthetic administered varies
with the anesthetic procedure, the area to be anesthetized, the vascularity
of the tissues, the number of neuronal segments to be blocked, the
depth of anesthesia and degree of muscle relaxation required, the
duration of anesthesia desired, individual tolerance, and the physicalcondition of the patient. The smallest dose and concentration required
to produce the desired result should be administered. Dosages of Bupivacaine
Hydrochloride should be reduced for elderly and/or debilitated patients
and patients with cardiac and/or liver disease. The rapid injection
of a large volume of local anesthetic solution should be avoided and
fractional (incremental) doses should be used when feasible. For specific techniques and procedures, refer to standard
textbooks. In recommended doses, Bupivacaine
Hydrochloride produces complete sensory block, but the effect on motor
function differs among the three concentrations. 0.25%���when used for caudal, epidural, or peripheral nerve
block, produces incomplete motor block. Should be used for operations
in which muscle relaxation is not important, or when another means
of providing muscle relaxation is used concurrently. Onset of action
may be slower than with the 0.5% or 0.75% solutions. 0.5%���provides motor blockade for caudal, epidural,
or nerve block, but muscle relaxation may be inadequate for operations
in which complete muscle relaxation is essential. 0.75%���produces complete motor block. Most
useful for epidural block in abdominal operations requiring complete
muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical
anesthesia. The duration of anesthesia with
Bupivacaine Hydrochloride is such that for most indications, a single
dose is sufficient. Maximum dosage limit must
be individualized in each case after evaluating the size and physical
status of the patient, as well as the usual rate of systemic absorption
from a particular injection site. Most experience to date is with
single doses of Bupivacaine Hydrochloride up to 225 mg with epinephrine
1:200,000 and 175 mg without epinephrine; more or less drug may be
used depending on individualization of each case. These doses may be repeated up to once every three hours. In clinical
studies to date, total daily doses have been up to 400 mg. Until further
experience is gained, this dose should not be exceeded in 24 hours.
The duration of anesthetic effect may be prolonged by the addition
of epinephrine. The dosages in Table 1 have
generally proved satisfactory and are recommended as a guide for use
in the average adult. These dosages should be reduced for elderly
or debilitated patients. Until further experience is gained, Bupivacaine
Hydrochloride is not recommended for pediatric patients younger than
12 years. Bupivacaine Hydrochloride is contraindicated for obstetrical
paracervical blocks, and is not recommended for intravenous regional
anesthesia (Bier Block). Use in Epidural Anesthesia: During epidural
administration of Bupivacaine Hydrochloride, 0.5% and 0.75% solutions
should be administered in incremental doses of 3 mL to 5 mL with sufficient
time between doses to detect toxic manifestations of unintentional
intravascular or intrathecal injection. In obstetrics, only the 0.5%
and 0.25% concentrations should be used; incremental doses of 3 mL
to 5 mL of the 0.5% solution not exceeding 50 mg to 100 mg at any
dosing interval are recommended. Repeat doses should be preceded by
a test dose containing epinephrine if not contraindicated. Use only
the single-dose ampuls and single-dose vials for caudal or epidural
anesthesia; the multiple-dose vials contain a preservative and therefore
should not be used for these procedures. Test Dose for Caudal and Lumbar Epidural Blocks: The Test Dose of Bupivacaine Hydrochloride (0.5% bupivacaine with
1:200,000 epinephrine in a 3 mL ampul) is recommended for use as a
test dose when clinical conditions permit prior to caudal and lumbar
epidural blocks. This may serve as a warning of unintended intravascular
or subarachnoid injection. (See PRECAUTIONS.) The pulse rate and other
signs should be monitored carefully immediately following each test
dose administration to detect possible intravascular injection, and
adequate time for onset of spinal block should be allotted to detect
possible intrathecal injection. An intravascular or subarachnoid injection
is still possible even if results of the test dose are negative. The
test dose itself may produce a systemic toxic reaction, high spinal
or cardiovascular effects from the epinephrine. (See WARNINGS and
OVERDOSAGE.) Unused portions of solution not
containing preservatives, i.e., those supplied in single-dose ampuls
and single-dose vials, should be discarded following initial use. This product should be inspected visually for particulate
matter and discoloration prior to administration whenever solution
and container permit. Solutions which are discolored or which contain
particulate matter should not be administered.
|
| dailymed-drugs:45 |
Major Depressive Disorder:<br/>Initial Treatment:<br/>Maintenance/Continuation/Extended Treatment: It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.<br/>Daily Dosing: Systematic evaluation of fluoxetine in adult patients has shown that its efficacy in major depressive disorder is maintained for periods of up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) at a dose of 20 mg/day .<br/>Switching Patients to a Tricyclic Antidepressant (TCA): Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered
or has been recently discontinued .<br/>Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI): At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with fluoxetine. In addition, at least 5 weeks, perhaps longer, should be allowed after stopping fluoxetine before starting an MAOI .<br/>Obsessive-Compulsive Disorder:<br/>Initial Treatment:<br/>Maintenance/Continuation Treatment: While there are no systematic studies that answer the question of how long to continue fluoxetine, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine after 13 weeks has not been documented in controlled trials, adult patients have been continued in therapy under double-blind conditions for up to an additional 6 months without loss of benefit. However, dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for treatment.<br/>Bulimia Nervosa:<br/>Initial Treatment: In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of bulimia nervosa, patients were administered fixed daily fluoxetine doses of 20 or 60 mg, or placebo . Only the 60 mg dose was statistically significantly superior to placebo in reducing the frequency of binge eating and vomiting. Consequently, the recommended dose is60 mg/day, administered in the morning. For some patients it may be advisable to titrate up to this target dose over several days. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with bulimia. As with the use of fluoxetine in the treatment of major depressive disorder and OCD, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly , and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary .<br/>Maintenance/Continuation Treatment: Systematic evaluation of continuing fluoxetine 60 mg/day for periods of up to 52 weeks in patients with bulimia who have responded while taking fluoxetine 60 mg/day during an 8 week acute treatment phase has demonstrated a benefit of such maintenance treatment . Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.<br/>Panic Disorder:<br/>Initial Treatment: In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of panic disorder, patients were administered fluoxetine doses in the range of 10 to 60 mg/day . Treatment should be initiated with a dose of 10 mg/day. After one week, the dose should be increased to 20 mg/day. The most frequently administered dose in the 2 flexible-dose clinical trials was 20 mg/day. A dose increase may be considered after several weeks if no clinical improvement is observed. Fluoxetine doses above 60 mg/day have not been systematically evaluated in patients with panic disorder. As with the use of fluoxetine in other indications, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly , and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary .<br/>Maintenance/Continuation Treatment: While there are no systematic studies that answer the question of how long to continue fluoxetine, panic disorder is a chronic condition and it is reasonable to consider continuation for a responding patient. Nevertheless, patients should be periodically reassessed to determine the need for continued treatment.<br/>Special Populations:<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to fluoxetine and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding . When treating pregnant women with fluoxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering fluoxetine in the third trimester.<br/>Discontinuation of Treatment with Fluoxetine: Symptoms associated with discontinuation of fluoxetine and other SSRIs and SNRIs, have been reported . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. Plasma fluoxetine and norfluoxetine concentration decrease gradually at the conclusion of therapy which may minimize the risk of discontinuation symptoms with this drug.
|
| dailymed-drugs:46 |
Emetogenic Chemotherapy: The recommended adult dosage of oral granisetron hydrochloride tablets is 2 mg once daily or 1 mg twice daily. In the 2 mg once-daily regimen, two 1 mg tablets are given up to 1 hour before chemotherapy. In the 1 mg twice-daily regimen, the first 1 mg tablet is given up to 1 hour before chemotherapy, and the second tablet, 12 hours after the first. Either regimen is administered only on the day(s) chemotherapy is given. Continued treatment, while not on chemotherapy, has not been found to be useful.<br/>Use in the Elderly, Pediatric Patients, Renal Failure Patients or Hepatically Impaired Patients: No dosage adjustment is recommended (see CLINICAL PHARMACOLOGY, Pharmacokinetics).<br/>Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation): The recommended adult dosage of oral granisetron hydrochloride tablets is 2 mg once daily. Two 1 mg tablets are taken within 1 hour of radiation.<br/>Pediatric Use: There is no experience with oral granisetron hydrochloride tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.<br/>Use in the Elderly: No dosage adjustment is recommended.
|
| dailymed-drugs:47 |
INTRAVENOUS DOSAGE: Adults. A dose of 30 mL of the 50 percent solution administered intravenously with or without compression produces diagnostic shadows in the majority of adults subjected to partial dehydration and to effective purgation. If the administration of 30 mL does not provide satisfactory visualization, this dose may be repeated in 15 to 30 minutes. In persons of slight build 20 mL may produce adequate shadows. Larger doses ranging from 50 mL to 60 mL of the 50 percent solution may be used for routine excretory urography in adults. The increased dosage offers better and more complete visualization of the urinary tract. This technique requires neither compression nor dehydration and is more effective in obese patients. Adverse reactions to the larger dose are similar to those encountered with lower doses without an increase in incidence, severity, or type of reactions. Voiding cystourethrograms may be obtained when desired. For the best results and minimal side effects, it is advisable to inject the total amount of solution intravenously in one to three minutes. Children. The dosage of the 50 percent solution for children under 6 months of age is 5 mL; for children 6 to 12 months of age, 6 mL to 8 mL; for children 1 to 2 years of age, 8 mL to 10 mL; for children 2 to 5 years of age, 10 mL to 12 mL; for children 5 to 7 years of age, 12 mL to 15 mL; for children 7 to 11 years of age, 15 mL to 18 mL, and for children 11 to 15 years ofage, 18 mL to 20mL.<br/>Subcutaneous or Intramuscular Urography: HYPAQUE sodium 50 percent may be used for excretory urography via intramuscular injection, undiluted or diluted; or subcutaneously diluted with equal quantities of sterile water for injection. The intramuscular injection site generally used is the gluteal muscles in two separate, equal doses. Used subcutaneously the medium is generally injected in divided equal doses over each scapula. In both locations the contrast medium is rapidly absorbed providing urograms beginning variously 5 to 10 minutes following intramuscular injection; subsequent exposures being made according to degree of pyelographic contrast. Radiographs with subcutaneous injection are usually exposed at 10, 20, and 30 minutes. The urograms achieved with either methods will be almost equal to that following intravenous injection. The usual intramuscular or subcutaneous (diluted) dose of HYPAQUE sodium 50 percent in adults and older children is about 20 mL to 30 mL. For infants and young children, the dose ranges from 5 mL to 16 mL.<br/>Roentgenography: A plain film is often made prior to IVP. A nephrogram effect is available in 30 to 60 seconds. Its duration is dose dependent. Urograms may be available as early as two minutes.However, urograms of optimal density are usually made at 5, 10, or 15 minutes following injection. Ureteric films are usually made between 10 and 20 minutes, and cystograms at 30 minutes. In impaired renal function, delayed films may be required.
|
| dailymed-drugs:48 |
Active Duodenal Ulcer���The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily. Maintenance of Healed Duodenal Ulcer���The recommended oral dosage for adults is 150 mg once daily at bedtime. Gastroesophageal Reflux Disease���The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily. Active Benign Gastric Ulcer���The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration. Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency���The dose for patients with renal dysfunction should be reduced as follows: Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.
|
| dailymed-drugs:49 |
Following suitable
admixture of prescribed drugs, the dosage is usually dependent upon age,
weight and clinical condition of the patient as well as laboratory
determinations. See directions accompanying drugs. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. Do not administer
unless solution is clear and seal is intact. Use of a final
filter is recommended during administration of all parenteral solutions
where possible. 50% and 70%
Dextrose Injection, USP in the Pharmacy Bulk Package is intended for use
in the preparation of sterile, intravenous admixtures. Additives may be
incompatible with the fluid withdrawn from this container. Complete
information is not available. Those additives known to be incompatible
should not be used. Consult with pharmacist, if available. When
compounding admixtures, use aseptic technique. Mix thoroughly. Do not
store any unused portion of the 50% and 70% Dextrose Injection,
USP.
|
| dailymed-drugs:51 |
Patients over 12 years of age: The recommended initial dosage of minoxidil tablets is 5 mg of minoxidil given as a single daily dose. Daily dosage can be increased to 10, 20 and then to 40 mg in single or divided doses if required for optimum blood pressure control. The effective dosage range is usually 10 to 40 mg per day. The maximum recommended dosage is 100 mg per day.<br/>Patients under 12 years of age: The initial dosage is 0.2 mg/kg minoxidil as a single daily dose. The dosage may be increased in 50 to 100% increments until optimum blood pressure control is achieved. The effective dosage range is usually 0.25 mg to 1 mg/kg/day. The maximum recommended dosage is 50 mg daily .<br/>Dose frequency: The magnitude of within-day fluctuation of arterial pressure during therapy with minoxidil is directly proportional to the extent of pressure reduction. If supine diastolic pressure has been reduced less than 30 mm Hg, the drug need be administered only once a day; if supine diastolic pressure has been reduced more than 30 mm Hg, the dailydosage should be divided into two equal parts.<br/>Frequency of dosage adjustment: Dosage must be titrated carefully according to individual response. Intervals between dosage adjustments normally should be at least 3 days since the full response to a given dose is not obtained for at least that amount of time. Where a more rapid management of hypertension is required, dose adjustments can be made every 6 hours if the patient is carefully monitored.<br/>Concomitant therapy: Diuretic and beta-blocker or other sympathetic nervous system suppressant.<br/>Diuretics: Minoxidil must be used in conjunction with a diuretic in patients relying on renal function for maintaining salt and water balance. Diuretics have been used at the following dosages when starting therapy with minoxidil: hydrochlorothiazide (50 mg, b.i.d.) or other thiazides at equieffective dosage; chlorthalidone (50 to 100 mg, once daily); furosemide (40 mg, b.i.d.). If excessive salt and water retention results in a weight gain of more than 5 pounds, diuretic therapy should bechanged to furosemide; if the patient is already taking furosemide, dosage should be increased in accordance with the patient's requirements.<br/>Beta-blocker or other sympathetic nervous system suppressants: When therapy with minoxidil is begun, the dosage of a beta-adrenergic receptor blocking drug should be the equivalent of 80 to 160 mg of propranolol per day in divided doses. If beta-blockers are contraindicated, methyldopa (250 to 750 mg, b.i.d.) may be used instead. Methyldopa must be given for at least 24 hours before starting therapy with minoxidil because of the delay in the onset of methyldopa's action. Limited clinical experience indicates that clonidine may also be used to prevent tachycardia induced by minoxidil; the usual dosage is 0.1 to 0.2 mg twice daily. Sympathetic nervous system suppressants may not completely prevent an increase in heart rate due to minoxidil but usually do prevent tachycardia. Typically, patients receiving a beta-blocker prior to initiation of therapy with minoxidil have a bradycardia and can be expected to have an increase in heart rate toward normal when minoxidil is added. When treatment with minoxidil and beta-blocker or other sympathetic nervous system suppressant are begun simultaneously, their opposing cardiac effects usually nullify each other, leading to little change in heart rate.
|
| dailymed-drugs:52 |
The addition of Phenytoin Sodium Injection to intravenous infusion is not recommended due to the lack of solubility and resultant
precipitation. Not to exceed 50 mg per minute, intravenously in adults, and not exceeding 1-3 mg/kg/min in
neonates. There is a relatively small margin between full therapeutic effect and minimally toxic doses of this drug. The solution is suitable for use as long as it remains free of haziness and precipitate. Upon refrigeration or freezing, a
precipitate might form; this will dissolve again after the solution is allowed to stand at room temperature. The product is still suitable for use. Only a clear solution should be used.
A faint yellow coloration may develop; however, this has no effect on the potency of the solution. In the treatment of status epilepticus, the intravenous route is preferred because of the delay in absorption of phenytoin when
administered intramuscularly. Serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid
form. Phenytoin Sodium Injection is formulated with the sodium salt of phenytoin. Because there is approximately an 8% increase in drug
content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the sodium salt
and vice versa.<br/>Status Epilepticus: In adults, a loading dose of 10 to 15 mg/kg should be administered slowly intravenously, at a rate not exceeding 50 mg per
minute (this will require approximately 20 minutes in a 70 kg patient). The loading dose should be followed by maintenance doses of 100 mg orally or intravenously every 6-8 hours. Recent work in neonates and pediatric patients has shown that absorption of phenytoin is unreliable after oral administration,
but a loading dose of 15-20 mg/kg of phenytoin intravenously will usually produce plasma concentrations of phenytoin within the generally accepted therapeutic range (10-20 mcg/mL). The drug should be injected slowly intravenously at a rate not exceeding 1-3 mg/kg/min. Phenytoin Sodium Injection should be injected slowly and directly into a large vein
through a large-gauge needle or intravenous catheter. Each injection of intravenous phenytoin should be followed by an injection of sterile saline through the same needle or catheter
to avoid local venous irritation due to alkalinity of the solution. Continuous infusion should be avoided; the addition of Phenytoin Sodium Injection to intravenous infusion fluids
is not recommended because of the likelihood of precipitation. Continuous monitoring of the electrocardiogram and blood pressure is essential. The patient should be observed for signs of
respiratory depression. Determination of phenytoin plasma levels is advised when using phenytoin in the management of status epilepticus and in the subsequent establishment of
maintenance dosage. Other measures, including concomitant administration of an intravenous benzodiazepine such as diazepam, or an intravenous
short-acting barbiturate, will usually be necessary for rapid control of seizures because of the required slow rate of administration of phenytoin. If administration of Phenytoin Sodium Injection does not terminate seizures, the use of other anticonvulsants, intravenous
barbiturates, general anesthesia and other appropriate measures should be considered. Intramuscular administration should not be used in the treatment of status epilepticus because the attainment of peak plasma
levels may require up to 24 hours.<br/>Neurosurgery: Prophylactic dosage���100 to 200 mg (2 to 4 mL) intramuscularly at approximately 4-hour intervals during surgery and continued
during the postoperative period. When intramuscular administration is required for a patient previously stabilized orally, compensating dosage adjustments are necessary to maintain
therapeutic plasma levels. An intramuscular dose 50% greater than the oral dose is necessary to maintain these levels. When returned to oral administration, the dose should be
reduced by 50% of the original oral dose for one week to prevent excessive plasma levels due to sustained release from intramuscular tissue sites. If the patient requires more than a week of IM phenytoin, alternative routes should be explored, such as gastric intubation.
For time periods less than one week, the patient shifted back from IM administration should receive one half the original oral dose for the same period of time the patient received
IM phenytoin. Monitoring plasma levels would help prevent a fall into the subtherapeutic range. Serum blood level determinations are especially helpful when possible drug
interactions are suspected. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container
permit.
|
| dailymed-drugs:53 |
The recommended dose for CASODEX therapy in combination with an LHRH analogue is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that CASODEX be taken at the same time each day. Treatment with CASODEX should be started at the same time as treatment with an LHRH analogue.<br/>Dosage Adjustment in Renal Impairment:: No dosage adjustment is necessary for patients with renal impairment . Dosage Adjustment in Hepatic Impairment: No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. Although there is a 76% (5.9 and 10.4 days for normal and impaired patients, respectively) increase in the half-life of the active enantiomer of bicalutamide in patients with severe liver impairment (n=4), no dosage adjustment is necessary .
|
| dailymed-drugs:54 |
Rifampin can be administered by the oral route or by IV infusion . IV doses are the same as those for oral. See CLINICAL PHARMACOLOGY for dosing information in patients with renal failure.<br/>Tuberculosis: Adults: 10 mg/kg, in a single daily administration, not to exceed 600 mg/day, oral or IV Pediatric Patients: 10���20 mg/kg, not to exceed 600 mg/day, oral or IV It is recommended that oral rifampin be administered once daily, either 1 hour before or 2 hours after a meal with a full glass of water. Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide (eg, RIFATER) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug shouldbe reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Following the initial phase, treatment should be continued with rifampin and isoniazid (eg, RIFAMATE) for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.<br/>Preparation of Solution for IV Infusion: Reconstitute the lyophilized powder by transferring 10 mL of sterile water for injection to a vial containing 600 mg of rifampin for injection. Swirl vial gently to completely dissolve the antibiotic. The reconstituted solution contains 60 mg rifampin per mL and is stable at room temperature for 24 hours. Prior to administration, withdraw from the reconstituted solution a volume equivalent to the amount of rifampin calculated to be administered and add to 500 mL of infusion medium. Mix well and infuse at a rate allowing for complete infusion within 3 hours. Alternatively, the amount of rifampin calculated to be administered may be added to 100 mL of infusion medium and infused in 30 minutes. Dilutions in dextrose 5% for injection (D5W) are stable at room temperature for up to 4 hours and should be prepared and used within this time. Precipitation of rifampin from the infusion solution may occur beyond this time. Dilutions in normal saline are stable at room temperature for up to 24 hours and should be prepared and used within this time. Other infusion solutions are not recommended.<br/>Incompatibilities: Physical incompatibility (precipitate) was observed with undiluted (5 mg/mL) and diluted (1 mg/mL in normal saline) diltiazem hydrochloride and rifampin (6 mg/mL in normal saline) during simulated Y-site administration.<br/>Meningococcal Carriers: Adults: For adults, it is recommended that 600 mg rifampin be administered twice daily for two days. Pediatric Patients: Pediatric patients 1 month of age or older: 10 mg/kg (not to exceed 600 mg per dose) every 12 hours for two days. Pediatric patients under 1 month of age: 5 mg/kg every 12 hours for two days.<br/>Preparation of Extemporaneous Oral Suspension: For pediatric and adult patients in whom capsule swallowing is difficult or where lower doses are needed, a liquid suspension may be prepared as follows: RIFADIN 1% w/v suspension (10 mg/mL) can be compounded using one of four syrups���Simple Syrup (Syrup NF), Simple Syrup (Humco Laboratories), Syrpalta Syrup (Emerson Laboratories), or Raspberry Syrup (Humco Laboratories). This compounding procedure results in a 1% w/v suspension containing 10 mg rifampin/mL. Stability studies indicate that the suspension is stable when stored at room temperature (25��3��C) or in a refrigerator (2���8��C) for four weeks. This extemporaneously prepared suspension must be shaken well prior to administration.
|
| dailymed-drugs:55 |
Cephalexin Capsules, USP is administered orally. Adults���The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Cephalexin Capsules, USP greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered. Pediatric Patients���Cephalexin Oral Suspension may be better suited for certain dosages in the pediatric population. The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours. In severe infections, the dosage may be doubled. In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required. In the treatment of��-hemolytic streptococcal infections, a therapeutic dosage of Cephalexin Capsules, USP should be administered for at least 10 days.
|
| dailymed-drugs:56 |
Dosage must be adjusted according to each patient's needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. Nifedipine extended-release tablets should be swallowed whole and should not be bitten or divided. In general, titration should proceed over a 7���14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. Since steady-state plasma levels are achieved on the second day of dosing, if symptoms so warrant, titration may proceed more rapidly provided the patient is assessed frequently. Titration to doses above 120 mg are not recommended. Angina patients controlled on nifedipine immediate-release capsules alone or in combination with other antianginal medications may be safely switched to nifedipine extended-release tablets at the nearest equivalent total daily dose (e.g., 30 mg t.i.d. of nifedipine immediate-release capsules may be changed to 90 mg once daily of nifedipine extended-release tablets). Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patients with angina is limited. Therefore, doses greater than 90 mg should be used with caution and only when clinically warranted. No "rebound effect" has been observed upon discontinuation of nifedipine extended-release tablets. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision. Care should be taken when dispensing nifedipine extended-release to assure that the extended release dosage form has been prescribed.<br/>Co-Administration with Other Antianginal Drugs: Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during nifedipine titration. See PRECAUTIONS: Drug Interactions, for information on co-administration of nifedipine with beta blockers or long-acting nitrates.
|
| dailymed-drugs:1497 |
Dosage must be adjusted according to each patient's needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. Nifedipine extended-release tablets should be swallowed whole and should not be bitten or divided. In general, titration should proceed over a 7���14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. Since steady-state plasma levels are achieved on the second day of dosing, if symptoms so warrant, titration may proceed more rapidly provided the patient is assessed frequently. Titration to doses above 120 mg are not recommended. Angina patients controlled on nifedipine immediate-release capsules alone or in combination with other antianginal medications may be safely switched to nifedipine extended-release tablets at the nearest equivalent total daily dose (e.g., 30 mg t.i.d. of nifedipine immediate-release capsules may be changed to 90 mg once daily of nifedipine extended-release tablets). Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patients with angina is limited. Therefore, doses greater than 90 mg should be used with caution and only when clinically warranted. No "rebound effect" has been observed upon discontinuation of nifedipine extended-release tablets. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision. Care should be taken when dispensing nifedipine extended-release to assure that the extended release dosage form has been prescribed.<br/>Co-Administration with Other Antianginal Drugs: Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during nifedipine titration. See PRECAUTIONS: Drug Interactions, for information on co-administration of nifedipine with beta blockers or long-acting nitrates.
|
| dailymed-drugs:58 |
General Considerations: Dosage of glipizide and metformin hydrochloride tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glipizide/2000 mg metformin. Glipizide and metformin hydrochloride tablets should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to glipizide), to reduce GI side effects (largely due to metformin), and to permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient. With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to glipizide and metformin hydrochloride tablets and to identify the minimum effective dose for the patient. Thereafter, HbAshould be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG, and HbAto normal or as near normal as possible. Ideally, the response to therapy should be evaluated using HbA(glycosylated hemoglobin), which is a better indicator of long-term glycemic control than FPG alone. No studies have been performed specifically examining the safety and efficacy of switching to glipizide and metformin hydrochloride tablet therapy in patients taking concomitant glipizide (or other sulfonylurea) plus metformin. Changes in glycemic control may occur in such patients, with either hyperglycemia or hypoglycemia possible. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring.<br/>Glipizide and Metformin Hydrochloride Tablets as Initial Therapy: For patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, the recommended starting dose of glipizide and metformin hydrochloride tablets is 2.5 mg/250 mg once a day with a meal. For patients whose FPG is 280 to 320 mg/dL a starting dose of glipizide and metformin hydrochloride tablets, 2.5 mg/500 mg twice daily should be considered. The efficacy of glipizide and metformin hydrochloride tablets in patients whose FPG exceeds 320 mg/dL has not been established. Dosage increases to achieve adequate glycemic control should be made in increments of one tablet per day every twoweeks up to maximum of 10 mg/1000 mg or 10 mg/2000 mg glipizide and metformin hydrochloride tablets per day given in divided doses. In clinical trials of glipizide and metformin hydrochloride tablets as initial therapy, there was no experience with total daily doses greater than 10 mg/2000 mg per day.<br/>Glipizide and Metformin Hydrochloride Tablets as Second-Line Therapy: For patients not adequately controlled on either glipizide (or another sulfonylurea) or metformin alone, the recommended starting dose of glipizide and metformin hydrochloride tablets is 2.5 mg/500 mg or 5 mg/500 mg twice daily with the morning and evening meals. In order to avoid hypoglycemia, the starting dose of glipizide and metformin hydrochloride tablets should not exceed the daily doses of glipizide or metformin already being taken. The daily dose should be titrated in increments of no more than 5 mg/500 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 20 mg/2000 mg per day. Patients previously treated with combination therapy of glipizide (or another sulfonylurea) plus metformin may be switched to glipizide and metformin hydrochloride tablets, 2.5 mg/500 mg or 5 mg/500 mg; the starting dose should not exceed the daily dose of glipizide (or equivalent dose of another sulfonylurea) and metformin already being taken. The decision to switch to the nearest equivalent dose or to titrate should be based on clinical judgment. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of glipizide and metformin hydrochloride tablets should be titrated as described above to achieve adequate control of blood glucose.<br/>Specific Patient Populations: Glipizide and metformin hydrochloride tablets are not recommended for use during pregnancy or for use in pediatric patients. The initial and maintenance dosing of glipizide and metformin hydrochloride tablets should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment requires a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of glipizide and metformin hydrochloride tablets to avoid the risk of hypoglycemia. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly. (See WARNINGS.)
|
| dailymed-drugs:59 |
When BUSULFEX (busulfan) Injection is administered as a component of the BuCy conditioning regimen prior to bone marrow or peripheral blood progenitor cell replacement, the recommended doses are as follows: Adults (BuCy2):The usual adult dose is 0.8 mg/kg of ideal body weight or actual body weight, whichever is lower, administered every six hours for four days (a total of 16 doses). For obese, or severely obese patients, BUSULFEX should be administered based on adjusted ideal body weight. Ideal body weight (IBW) should be calculated as follows (height in cm, and weight in kg): IBW (kg; men)= 50 + 0.91x (height in cm -152); IBW (kg; women)= 45 + 0.91x (height in cm - 152). Adjusted ideal body weight (AIBW) should be calculated as follows: AIBW= IBW + 0.25x (actual weight -IBW). Cyclophosphamide is given on each of two days as a one-hour infusion at a dose of 60 mg/kg beginning on BMT day���3, no sooner than six hours following the 16 th dose of BUSULFEX. BUSULFEX clearance is best predicted when the BUSULFEX dose is administered based on adjusted ideal body weight. Dosing BUSULFEX based on actual body weight, ideal body weight or other factors can produce significant differences in BUSULFEX (busulfan) Injection clearance among lean, normal and obese patients. BUSULFEX should be administered intravenously via a central venous catheter as a two-hour infusion every six hours for four consecutive days for a total of 16 doses. All patients should be premedicated with phenytoin as busulfan is known to cross the blood brain barrier and induce seizures. Phenytoin reduces busulfan plasma AUC by 15%. Use of other anticonvulsants may result in higher busulfan plasma AUCs, and an increased risk of VOD or seizures. In cases where other anticonvulsants must be used, plasma busulfan exposure should be monitored (See DRUG INTERACTIONS). Antiemetics should be administered prior to the first dose of BUSULFEX and continued on a fixed schedule through administration of BUSULFEX. Where available, pharmacokinetic monitoring may be considered to further optimize therapeutic targeting. Pediatrics:The effectiveness of BUSULFEX in the treatment of CML has not been specifically studied in pediatric patients. For additional information see Special Populations -Pediatric section.<br/>Preparation and Administration Precautions:: An administration set with minimal residual hold-up volume (2-5 cc) should be used for product administration. As with other cytotoxic compounds, caution should be exercised in handling and preparing the solution of BUSULFEX. Skin reactions may occur with accidental exposure. The use of gloves is recommended. If BUSULFEX or diluted BUSULFEX solution contacts the skin or mucosa, wash the skin or mucosa thoroughly with water. BUSULFEX is a clear, colorless solution. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever the solution and container permit. If particulate matter is seen in the BUSULFEX ampoule the drug should not be used.<br/>Preparation for Intravenous Administration:: BUSULFEX must be diluted prior to use with either 0.9% Sodium Chloride Injection, USP (normal saline) or 5% Dextrose Injection, USP (DW). The diluent quantity should be 10 times the volume of BUSULFEX, so that the final concentration of busulfan is approximately 0.5 mg/mL. Calculation of the dose for a 70 kg patient, would be performed as follows: (70kg patient) x (0.8 mg/kg)��(6 mg/mL) = 9.3 mL BUSULFEX (56 mg total dose). To prepare the final solution for infusion, add 9.3 mL of BUSULFEX to 93 mL of diluent (normal saline or DW) as calculated below: (9.3 mL BUSULFEX)x(10)=93 mL of either diluent plus the 9.3 mL of BUSULFEX to yield a final concentration of busulfan of 0.54 mg/mL (9.3 mL x 6 mg/mL��102.3 mL = 0.54 mg/mL). All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood while wearing gloves and protective clothing. DO NOT put the BUSULFEX into an intravenous bag or large-volume syringe that does not contain normal saline or DW. Always add the BUSULFEX to the diluent, not the diluent to the BUSULFEX. Mix thoroughly by inverting several times. DO NOT USE POLYCARBONATE SYRINGES OR POLYCARBONATE FILTER NEEDLES WITH BUSULFEX. Infusion pumps should be used to administer the diluted BUSULFEX solution. Set the flow rate of the pump to deliver the entire prescribed BUSULFEX dose over two hours. Prior to and following each infusion, flush the indwelling catheter line with approximately 5mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. DO NOT infuse concomitantly with another intravenous solution of unknown compatibility. WARNING: RAPID INFUSION OF BUSULFEX HAS NOT BEEN TESTED AND IS NOT RECOMMENDED. STABILITY Unopened vials of BUSULFEX are stable until the date indicated on the package when stored under refrigeration at 2��-8��C (36��-46��F). BUSULFEX diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25��C) for up to 8 hours but the infusion must be completed within that time. BUSULFEX diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2��-8��C) for up to 12 hours but the infusion must be completed within that time.
|
| dailymed-drugs:60 |
Magnesium Sulfate in 5% Dextrose Injection, USP is intended
for intravenous use only. For the management of pre-eclampsia or eclampsia,
intravenous infusions of dilute solutions of magnesium (1% to 8%) are often
given in combination with intramuscular injections of 50% Magnesium Sulfate
Injection, USP. Therefore, in the clinical conditions cited below, both forms
of therapy are noted, as appropriate. In
Eclampsia In severe pre-eclampsia or eclampsia,
the total initial dose is 10 to 14 g of magnesium sulfate. To initiate therapy,
4 g of Magnesium Sulfate in 5% Dextrose Injection, USP may be administered
intravenously. The rate of I.V. infusion should generally not exceed 150 mg/minute,
or 7.5 mL of a 2% concentration (or its equivalent) per minute, except in
severe eclampsia with seizures. Simultaneously, 4 to 5 g (32.5 to 40.6 mEq)
of magnesium sulfate may be administered intramuscularly into each buttock
using undiluted 50% Magnesium Sulfate Injection, USP. After the initial I.V.
dose, some clinicians administer 1-2 g/hour by constant I.V. infusion. Subsequent
intramuscular doses of 4 to 5 g of magnesium sulfate may be injected into
alternate buttocks every four hours, depending on the continuing presence
of the patellar reflex, adequate respiratory function, and absence of signs
of magnesium toxicity. Therapy should continue until paroxysms cease. A
serum magnesium level of 6 mg/100 mL is considered optimal for control of
seizures. A total daily (24 hr) dose of 30 to 40 g magnesium sulfate should
not be exceeded. In the presence of severe renal insufficiency, frequent serum
magnesium concentrations must be obtained, and the maximum recommended dosage
of magnesium sulfate is 20 g per 48 hours. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. Do
not administer unless solution is clear. Discard unused portion.
|
| dailymed-drugs:61 |
Major Depressive Disorder:<br/>Usual Initial Dosage: Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of paroxetine hydrochloride in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 20 mg dose may benefit from dose increases, in 10 mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week.<br/>Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on them. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown. Systematic evaluation of the efficacy of paroxetine hydrochloride has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.<br/>Obsessive Compulsive Disorder:<br/>Usual Initial Dosage: Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of paroxetine tablets in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10 mg/day increments. Dose changes should occur at intervals of at least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine hydrochloride in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.<br/>Maintenance Therapy: Long-term maintenance of efficacy was demonstrated in a 6 month relapse prevention trial. In this trial, patients with OCD assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY, Clinical Trials). OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.<br/>Panic Disorder:<br/>Usual Initial Dosage: Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The target dose of paroxetine tablets in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine hydrochloride. The maximum dosage should not exceed 60 mg/day.<br/>Maintenance Therapy: Long-term maintenance of efficacy was demonstrated in a 3 month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY, Clinical Trials). Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients shouldbe periodically reassessed to determine the need for continued treatment.<br/>Social Anxiety Disorder:<br/>Usual Initial Dosage: Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day. In clinical trials the effectiveness of paroxetine hydrochloride was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of paroxetine hydrochloride has been evaluated in patients with social anxiety disorder at doses up to 60 mg/day, available information does not suggest any additional benefit for doses above 20 mg/day. (See CLINICAL PHARMACOLOGY, Clinical Trials.)<br/>Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on them. Although the efficacy of paroxetine hydrochloride beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.<br/>Generalized Anxiety Disorder:<br/>Usual Initial Dosage: Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of paroxetine was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of atleast 1 week.<br/>Maintenance Therapy: Systematic evaluation of continuing paroxetine hydrochloride for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking paroxetine hydrochloride during an 8 week acute treatment phase has demonstrated a benefit of such maintenance (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.<br/>Special Populations:<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to paroxetine hydrochloride and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see WARNINGS). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering paroxetine in the third trimester.<br/>Dosage for Elderly or Debilitated Patients, and Patients with Severe Renal or Hepatic Impairment: The recommended initial dose is 10 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.<br/>Switching Patients to or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with paroxetine tablets. Similarly, at least 14 days should be allowed after stopping paroxetine tablets before starting a MAOI.<br/>Discontinuation of Treatment with Paroxetine Tablets: Symptoms associated with discontinuation of paroxetine hydrochloride have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which paroxetine tablets are being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
|
| dailymed-drugs:62 |
DO NOT EXCEED RECOMMENDED DOSAGE. Adults: The recommended initial dosage is two tablets four times daily (20 mg per day). Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (two tablets) daily. Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of diphenoxylate hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration. Children: Diphenoxylate HCl and Atropine Sulfate is not recommended in children under 2 years of age and should be used with special caution in young children . The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use oral solution. Do not use tablets for this age group. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
|
| dailymed-drugs:63 |
Major Depressive Disorder:<br/>Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of paroxetine in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the fulleffect may be delayed. Some patients not responding to a 20 mg dose may benefit from dose increases, in 10-mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week.<br/>Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with paroxetine should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown. Systematic evaluation of the efficacy of paroxetine has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.<br/>Obsessive Compulsive Disorder:<br/>Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of paroxetine in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10 mg/day increments. Dose changes should occur at intervals of at least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine in the treatment ofOCD. The maximum dosage should not exceed 60 mg/day.<br/>Maintenance Therapy: Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients with OCD assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY - Clinical Trials). OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.<br/>Panic Disorder:<br/>Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The target dose of paroxetine in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine. The maximum dosage should not exceed 60 mg/day.<br/>Maintenance Therapy: Long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY - Clinical Trials). Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.<br/>Social Anxiety Disorder:<br/>Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day. In clinical trials the effectiveness of paroxetine was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of paroxetine has been evaluated in patients with social anxiety disorder at doses up to 60 mg/day, available information does not suggest any additional benefit for doses above 20 mg/day (see CLINICAL PHARMACOLOGY - Clinical Trials).<br/>Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with paroxetine should remain on it. Although the efficacy of paroxetine beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.<br/>Generalized Anxiety Disorder:<br/>Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of paroxetine was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week.<br/>Maintenance Therapy: Systematic evaluation of continuing paroxetine for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking paroxetine during an 8-week acute treatment phase has demonstrated a benefit of such maintenance (see CLINICAL PHARMACOLOGY - Clinical Trials). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.<br/>Posttraumatic Stress Disorder:<br/>Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended starting dosage and the established effective dosage is 20 mg/day. In 1 clinical trial, the effectiveness of paroxetine was demonstrated in patients dosed in a range of 20 to 50 mg/day. However, in a fixed dose study, there was not sufficient evidence tosuggest a greater benefit for a dose of 40 mg/day compared to 20 mg/day. Dose changes, if indicated, should occur in 10 mg/day increments and at intervals of at least 1 week.<br/>Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with paroxetine should remain on it. Although the efficacy of paroxetine beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, PTSD is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.<br/>Special Populations:<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to paroxetine and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see
WARNINGS). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering paroxetine in the third trimester.<br/>Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment: The recommended initial dose is 10 mg/day for elderly
patients, debilitated patients, and/or patients with severe renal or hepatic
impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.<br/>Switching Patients to or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with paroxetine. Similarly, at least 14 days should be allowed after stopping paroxetine before starting an MAOI.<br/>Discontinuation of Treatment with Paroxetine: Symptoms associated with discontinuation of paroxetine have been reported (see
PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which paroxetine is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. NOTE: SHAKE
SUSPENSION WELL BEFORE USING.
|
| dailymed-drugs:64 |
Heparin sodium is not effective by oral administration and
these premixed formulations should be given by intermittent intravenous injection
or intravenous infusion. The dosage of heparin sodium
should be adjusted according to the patient's coagulation test results.
When heparin is given by continuous intravenous infusion, the coagulation
time should be determined approximately every 4 hours in the early stages
of treatment. When the drug is administered intermittently by intravenous
injection, coagulation tests should be performed before each injection during
the early stages of treatment and at appropriate intervals thereafter. Dosage
is considered adequate when the activated partial thromboplastin time (APTT)
is 1.5 to 2 times the normal or when the whole blood clotting time is elevated
approximately 2.5 to 3 times the control value. Periodic
platelet counts, hematocrits and tests for occult blood in stool are recommended
during the entire course of heparin therapy, regardless of the route of administration. Converting to Oral Anticoagulant: When
an oral anticoagulant of the coumarin or similar type is to be begun in patients
already receiving heparin sodium, baseline and subsequent tests of prothrombin
activity must be determined at a time when heparin activity is too low to
affect the prothrombin time. If continuous I.V. heparin infusion is used,
prothrombin time can usually be measured at any time. In
converting from heparin to an oral anticoagulant, the dose of the oral anticoagulant
should be the usual initial amount and thereafter prothrombin time should
be determined at the usual intervals. To ensure continuous anticoagulation,
it is advisable to continue full heparin therapy for several days after the
prothrombin time has reached the therapeutic range. Heparin therapy may then
be discontinued without tapering. Therapeutic
Anticoagulant Effect with Full-Dose Heparin Although
dosage must be adjusted for the individual patient according to the results
of suitable laboratory tests, the following dosage schedules may be used as
guidelines: *Based on 150 lb. (68 kg) patient. Pediatric Use: Follow recommendations of
appropriate pediatric reference texts. In general, the following dosage schedule
may be used as a guideline: Geriatric Use: Patients
over 60 years of age may require lower doses of heparin. Surgery of the Heart and Blood Vessels: Patients
undergoing total body perfusion for open-heart surgery should receive an initial
dose of not less than 150 units of heparin sodium per kilogram of body weight.
Frequently, a dose of 300 units per kilogram is used for procedures estimated
to last less than 60 minutes or 400 units per kilogram for those estimated
to last longer than 60 minutes. Extracorporeal
Dialysis: Follow equipment manufacturer's operating directions
carefully. Parenteral drug products should be inspected
visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. Slight discoloration does not alter
potency. See PRECAUTIONS. Do not administer unless the
solution is clear and seal is intact. Discard unused portion.
|
| dailymed-drugs:65 |
Levocarnitine Injection is administered intravenously. The recommended dose is 50 mg/kg given as a slow 2 to 3 minute bolus injection or by infusion. Often a loading dose is given in patients with severe metabolic crisis followed by an equivalent dose over the following 24 hours. It should be administered q3h or q4h, and never less than q6h either by infusion or by intravenous injection. All subsequent daily doses are recommended to be in the range of 50 mg/kg or as therapy may require. The highest dose administered has been 300 mg/kg. It is recommended that a plasma carnitine level be obtained prior to beginning this parenteral therapy. Weekly and monthly monitoring is recommended as well. This monitoring should include blood chemistries, vital signs, plasma carnitine concentrations (the plasma free carnitine level should be between 35 and 60 micromoles/liter) and overall clinical condition. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.<br/>Compatibility and Stability: Levocarnitine Injection USP is compatible and stable when mixed in parenteral solutions of Sodium Chloride 0.9% or Lactated Ringer's in concentrations ranging from 250 mg/500 mL (0.5 mg/mL) to 4200 mg/500 mL (8.0 mg/mL) and stored at room temperature (25��C) for up to 24 hours in PVC plastic bags.
|
| dailymed-drugs:66 |
The objective of nutritional management of patients with
liver disease is the provision of sufficient amino acid and caloric support
for protein synthesis without exacerbating hepatic encephalopathy. The
total daily dose of Aminosyn-HF 8% (amino acid injection 8%) depends on daily
protein requirements and on the patient's metabolic and clinical response.
The determination of nitrogen balance and accurate daily body weights, corrected
for fluid balance, are probably the best means of assessing individual protein
requirements. Dosage should also be guided by the patient's fluid intake
limits and glucose and nitrogen tolerances, as well as by metabolic and clinical
response. The recommended dosage is 80 to 120 g of amino
acids (12 to 18 g of nitrogen) as Aminosyn-HF 8% per day. Typically, 500 mL
of Aminosyn-HF 8% appropriately mixed with 500 mL of 50% dextrose supplemented
with electrolytes and vitamins is administered over an 8 to 12 hour period.
This results in a total daily fluid intake of approximately 2 to 3 liters.
Patients with fluid restrictions may only tolerate 1 to 2 liters. Although
nitrogen requirements may be higher in severely hypercatabolic ordepleted
patients, provision of additional nitrogen may not be possible due to fluid
intake limits, nitrogen, or glucose intolerance. In
many patients, provision of adequate calories in the form of hypertonic dextrose
may require the administration of exogenous insulin to prevent hyperglycemia
and glycosuria. To prevent rebound hypoglycemia, a solution containing 5%
dextrose should be administered when hypertonic dextrose solutions are abruptly
discontinued. Fat emulsion co-administration should
be considered when prolonged (more than 5 days) parenteral nutrition is required
in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should
be monitored for evidence of EFAD in patients maintained on fat-free TPN.
Caution should be exercised in administering fat emulsions to patients with
severe liver damage. Fat emulsion may obscure the presence of precipitate
formation. The provision of sufficient intracellular
electrolytes, principally potassium, magnesium, and phosphate, is required
for optimum utilization of amino acids. Approximately 60 to 180 mEq of potassium,
10 to 30 mEq of magnesium, and 10 to 40 mMol of phosphorus per day appear
necessary to achieve optimum metabolic response. In addition, sufficient quantities
of the major extracellular electrolytes (sodium, calcium, and chloride) must
be given. In patients with hyperchloremic or other metabolic acidoses, sodium
and potassium may be added as the acetate salts to provide bicarbonate precursor.
The electrolyte content of Aminosyn-HF 8% must be considered when calculating
daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus,
should be monitored frequently. Hypertonic mixtures
of amino acid and dextrose may be safely administered by continuous infusion
through a central venous catheter with the tip located in the superior vena
cava. Initial infusion rates should be slow, and gradually increased to the
recommended 60 to 125 mL/hour. If the administration rate should fall behind
schedule, no attempt to "catch up" to planned intake should be made. In addition
to meeting protein needs, the rate of administration, particularly during
the first few days of therapy, is governed by the patient's glucose
tolerance. Daily intake of amino acids and dextrose should be increased gradually
to the maximum required dose as indicated by frequent determinations of glucose
levels in blood and urine. For patients in whom the
central venous route is not indicated and who can consume adequate calories
enterally, Aminosyn-HF 8% may be administered by peripheral vein with or without
parenteral carbohydrate calories. Such infusates can be prepared by dilutions
of Aminosyn-HF 8% with Sterile Water for Injection, USP or 5% to 10% dextrose
to prepare isotonic or slightly hypertonic solutions for peripheral infusion.
It is essential that peripheral infusion be accompanied by adequate caloric
supplementation. Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. Care must be
taken to avoid incompatible admixtures. Consult with pharmacist. WARNING: Do not use flexible container in series connections.
|
| dailymed-drugs:67 |
Use only the components [SPORANOX (itraconazole) Injection ampule, 0.9% Sodium Chloride Injection, USP (Normal Saline) bag and filtered infusion set] provided in the kit: DO NOT SUBSTITUTE. SPORANOX Injection should not be diluted with 5% Dextrose Injection, USP, or with Lactated Ringer's Injection, USP, alone or in combination with any other diluent. The compatibility of SPORANOX Injection with diluents other than 0.9% Sodium Chloride Injection, USP (Normal Saline) is not known. NOT FOR IV BOLUS INJECTION. NOTE: After reconstitution, the diluted SPORANOX Injection may be stored refrigerated (2���8��C) or at room temperature (15���25��C) for up to 48 hours, when protected from direct light. During administration, exposure to normal room light is acceptable. NOTE: Use only a dedicated infusion line for administration of SPORANOX Injection. Do not introduce concomitant medication in the same bag nor through the same line as SPORANOX Injection. Other medications may be administered after flushing the line/catheter with 0.9% Sodium Chloride Injection, USP, as described below, and removing and replacing the entire infusion line. Alternatively, utilize another lumen, in the case of a multi-lumen catheter. Correct preparation and administration of SPORANOX Injection are necessary to ensure maximal efficacy and safety. A precise mixing ratio is required in order to obtain a stable admixture. It is critical to maintain a 3.33 mg/mL itraconazole:diluent ratio. Failure to maintain this concentration will lead to the formation of a precipitate. Add the full contents (25 mL) of the SPORANOX Injection ampule into the infusion bag provided, which contains 50 mL of 0.9% Sodium Chloride Injection, USP (Normal Saline). Mix gently after the solution is completely transferred. Withdraw and discard 15 mL of the solution before administering to the patient. Using a flow control device, infuse 60 mL of the dilute solution (3.33 mg/mL = 200 mg itraconazole, pH apx. 4.8) intravenously over 60 minutes, using an extension line and the infusion set provided. After administration, flush the infusion set with 15���20 mL of 0.9% Sodium Chloride Injection, USP, over 30 seconds���15 minutes, via the two-way stopcock. Do not use Bacteriostatic Sodium Chloride Injection, USP. The compatibility of SPORANOX Injection with flush solutions other than 0.9% Sodium Chloride Injection, USP (Normal Saline) is not known. Discard the entire infusion line. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.<br/>Empiric Therapy in Febrile, Neutropenic Patients with Suspected Fungal Infections (ETFN): The recommended dose of SPORANOX Injection is 200 mg b.i.d. for four doses, followed by 200 mg once daily for up to 14 days. Each intravenous dose should be infused over 1 hour. Treatment should be continued with SPORANOX Oral Solution 200 mg (20 mL) b.i.d. until resolution of clinically significant neutropenia. The safety and efficacy of SPORANOX use exceeding 28 days in ETFN is not known.<br/>Treatment of Blastomycosis, Histoplasmosis and Aspergillosis: The recommended intravenous dose is 200 mg b.i.d. for four doses, followed by 200 mg q.d. Each intravenous dose should be infused over 1 hour. For the treatment of blastomycosis, histoplasmosis and aspergillosis, SPORANOX can be given as oral capsules or intravenously. The safety and efficacy of SPORANOX Injection administered for greater than 14 days is not known. Total itraconazole therapy (SPORANOX Injection followed by SPORANOX Capsules) should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate that the active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. SPORANOX Injection should not be used in patients with creatinine clearance<30 mL/min.
|
| dailymed-drugs:68 |
Dosage of TEMODAR Capsules must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and the neutrophil and platelet counts at the time of initiating the next cycle. For TEMODAR dosage calculations based on body surface area (BSA) see Table 9. For suggested capsule combinations on a daily dose see Table 10.<br/>Patients with Newly Diagnosed High Grade Glioma:<br/>Concomitant Phase: TEMODAR is administered orally at 75 mg/mdaily for 42 days concomitant with focal radiotherapy (60Gy administered in 30 fractions) followed by maintenance TEMODAR for 6 cycles. Focal RT includes the tumor bed or resection site with a 2���3 cm margin. No dose reductions are recommended during the concomitant phase; however, dose interruptions or discontinuation may occur based on toxicity. The TEMODAR dose should be continued throughout the 42 day concomitant period up to 49 days if all of the following conditions are met: absolute neutrophil count���1.5��10/L platelet count���100��10/L common toxicity criteria (CTC) non-hematological toxicity���Grade 1 (except for alopecia, nausea, and vomiting). During treatment, a complete blood count should be obtained weekly. Temozolomide dosing should be interrupted or discontinued during concomitant phase according to the hematological and non-hematological toxicity criteria as noted in Table 5. PCP prophylaxis is required during the concomitant administration of TEMODAR and radiotherapy andshould be continued in patients who develop lymphocytopenia until recovery from lymphocytopenia (CTC grade���1).<br/>Maintenance Phase Cycle 1: Four weeks after completing the TEMODAR + RT phase, TEMODAR is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/monce daily for 5 days followed by 23 days without treatment.<br/>Cycles 2���6: At the start of Cycle 2, the dose is escalated to 200 mg/m, if the CTC non-hematologic toxicity for Cycle 1 is Grade���2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is���1.5��10/L, and the platelet count is���100��10/L. The dose remains at 200 mg/mper day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.<br/>Dose reduction or discontinuation during maintenance: Dose reductions during the maintenance phase should be applied according to Tables 6 and 7. During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose of TEMODAR) or within 48 hours of that day, and weekly until the ANC is above 1.5��10/L (1,500/��L) and the platelet count exceeds 100��10/L (100,000/��L). The next cycle of TEMODAR should not be started until the ANC and platelet count exceed these levels. Dose reductions during the next cycle should be based on the lowest blood counts and worst non-hematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to Tables 6 and 7.<br/>Patients with Refractory Anaplastic Astrocytoma: For adults the initial dose is 150 mg/morally once daily for 5 consecutive days per 28-day treatment cycle. For adult patients, if both the nadir and day of dosing (Day 29, Day 1 of next cycle) ANC are���1.5��10/L (1,500/��L) and both the nadir and Day 29, Day 1 of next cycle platelet counts are���100��10/L (100,000/��L), the TEMODAR dose may be increased to 200 mg/m/day for 5 consecutive days per 28-day treatment cycle. During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5��10/L (1,500/��L) and the platelet count exceeds 100��10/L (100,000/��L). The next cycle of TEMODAR should not be started until the ANC and platelet count exceed these levels. If the ANC falls to<1.0��10/L (1,000/��L) or the platelet count is<50��10/L (50,000/��L) during any cycle, the next cycle should be reduced by 50 mg/m, but not below 100 mg/m, the lowest recommended dose (see Table 8). TEMODAR therapy can be continued until disease progression. In the clinical trial, treatment could be continued for a maximum of 2 years; but the optimum duration of therapy is not known. In clinical trials, TEMODAR was administered under both fasting and non-fasting conditions; however, absorption is affected by food and consistency of administration with respect to food is recommended. There are no dietary restrictions with TEMODAR. To reduce nausea and vomiting, TEMODAR should be taken on an empty stomach. Bedtime administration may be advised. Antiemetic therapy may be administered prior to and/or following administrationof TEMODAR Capsules. TEMODAR (temozolomide) Capsules should not be opened or chewed. They should be swallowed whole with a glass of water.<br/>Handling and Disposal: TEMODAR causes the rapid appearance of malignant tumors in rats. Capsules should not be opened. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
|
| dailymed-drugs:70 |
Important: Coly-Mycin
M Parenteral is supplied in vials containing colistimethate sodium equivalent
to 150 mg colistin base activity per vial. Reconstitution: The 150 mg vial should be reconstituted with 2.0 mL Sterile Water for Injection, USP. The reconstituted
solution provides colistimethate sodium at a concentration equivalent to 75
mg/mL colistin base activity. During reconstitution
swirl gently to avoid frothing. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. If these
conditions are observed, the product should not be used.<br/>Dosage: Adults
and pediatric patients���Intravenous or Intramuscular Administration: Coly-Mycin M Parenteral should
be given in 2 to 4 divided doses at dose levels of 2.5 to 5 mg/kg per day
for patients with normal renal function, depending on the severity of the
infection. In obese individuals, dosage should be based
on ideal body weight. The daily dose should be reduced
in the presence of renal impairment. Modifications of dosage in the presence
of renal impairment are presented in Table 1. Note: The suggested
unit dose is 2.5���5 mg/kg; however, the time INTERVAL between injections
should be increased in the presence of impaired renal function. INTRAVENOUS ADMINISTRATION 0.9%
NaCI 5%
dextrose in 0.9% NaCI 5%
dextrose in water 5%
dextrose in 0.45% NaCI 5%
dextrose in 0.225% NaCI lactated
Ringer's solution 10%
invert sugar solution There are not sufficient data
to recommend usage of Coly-Mycin M Parenteral with other drugs or other than
the above listed infusion solutions. Administer the
second half of the total daily dose by slow intravenous infusion, starting
1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the
presence of impaired renal function, reduce the infusion rate depending on
the degree of renal impairment. The choice of intravenous
solution and the volume to be employed are dictated by the requirements of
fluid and electrolyte management. Any
infusion solution containing colistimethate sodium should be freshly prepared
and used for no longer than 24 hours.
|
| dailymed-drugs:71 |
Initial Treatment: Citalopram HBr Tablets should be administered at an initial dose of 20 mg citalopram once daily, generally with an increase to a dose of 40 mg/day. Dose increases should usually occur in increments of 20 mg at intervals of no less than one week. Although certain patients may require a dose of 60 mg/day, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/daydose over the 40 mg/day dose; doses above 40 mg are therefore not ordinarily recommended. Citalopram HBr Tablets should be administered once daily, in the morning or evening, with or without food.<br/>Special Populations: 20 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment, with titration to 40 mg/day only for nonresponding patients. No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram should be used with caution in patients with severe renal impairment.<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to citalopram and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding . When treating pregnant women with citalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering citalopram in the third trimester.<br/>Maintenance Treatment: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of citalopram in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of citalopram (20-60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of citalopram 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups . Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.<br/>Discontinuation of Treatment with Citalopram: Symptoms associated with discontinuation of citalopram and other SSRIs and SNRIs have been reported . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.<br/>Switching Patients To or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of citalopram therapy. Similarly, at least 14 days should be allowed after stopping citalopram before starting an MAOI .
|
| dailymed-drugs:72 |
Promethazine HCl suppositories are contraindicated for children under 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients
). Promethazine HCl suppositories are for rectal administration only.<br/>Allergy: The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25-mg doses at bedtime of 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine HCl in 25-mg doses will control minor transfusion reactions of an allergic nature.<br/>Motion Sickness: The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, promethazine HCl rectal suppositories, 12.5 to 25 mg, twice daily, may be administered.<br/>Nausea and vomiting: Antiemetics should not be used in vomiting of unknown etiology in children and adolescents . The average effective dose of promethazine HCl for the active therapy of nausea and vomiting in children or adults is 25 mg. 12.5- to 25-mg doses may be repeated, as necessary, at 4- to 6-hour intervals. For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated. For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4- to 6-hour intervals, as necessary.<br/>Sedation: This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg promethazine HCl rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.<br/>Pre- and Postoperative Use: Promethazine HCl in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Usual adult dosage is 50 mg promethazine HCl with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid. Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25- to 50-mg doses in adults. Promethazine HCl rectal suppositories are contraindicated for children under 2 years of age.
|
| dailymed-drugs:73 |
Aseptically remove the sterile vial from the blister package by peeling the backing paper and dropping the vial onto a sterile tray. Withdraw the contents into a dry sterile syringe, and replace the needle with an atraumatic cannula prior to intraocular irrigation. No more than one-half milliliter should be gently instilled into the anterior chamber for the production of satisfactory miosis. It may be instilled before or after securing sutures. Miosis is usually maximal within two to five minutes after application.
|
| dailymed-drugs:74 |
Essential Hypertension: The dose of verapamil hydrochloride extended-release should be individualized by titration. The usual daily dose of extended-release verapamil hydrochloride in clinical trials has been 240 mg given by mouth once daily in the morning. However, initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (e.g., elderly, small people, etc.). Upward titration should be based on therapeutic efficacy and safety evaluated approximately 24 hours after dosing. The antihypertensive effects of verapamil hydrochloride extended-release are evident within the first week of therapy. If adequate response is not obtained with 120 mg of verapamil hydrochloride extended-release, the dose may be titrated upward in the following manner: Verapamil extended-release capsules are for once-a-day administration. When switching from immediate-release verapamil to verapamil hydrochloride extended-release capsules, the same total daily dose of verapamil hydrochloride extended-release capsules can be used. As with immediate-release verapamil, dosages of verapamil hydrochloride extended-release capsules should be individualized and titration may be needed in some patients.<br/>Sprinkling the Capsule Contents on Food: Verapamil Hydrochloride Extended-release Bead Filled Capsules may also be administered by carefully opening the capsule and sprinkling the beads on a spoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the beads. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any bead/applesauce mixture should be used immediately and not stored for future use. Subdividing the contents of a verapamil hydrochloride extended-release capsule is not recommended.
|
| dailymed-drugs:75 |
In the treatment of tuberculosis, a major cause of
the emergence of drug-resistant organisms, and thus treatment failure,
is patient nonadherence to prescribed treatment. Treatment failure
and drug-resistant organisms can be life-threatening and may result
in other serious health risks. It is, therefore, important that patients
adhere to the drug regimen for the full duration of treatment. Directly
observed therapy is recommended when patients are receiving treatment
for tuberculosis. Consultation with an expert in the treatment of
drug-resistant tuberculosis is advised for patients in whom drug-resistant
tuberculosis is suspected or likely. Ethionamide should be administered
with at least one, sometimes two, other drugs to which the organism
is known to be susceptible . Trecator is administered orally. The usual adult dose
is 15 to 20 mg/kg/day, administered once daily or, if patient
exhibits poor gastrointestinal tolerance, in divided doses, with a
maximum daily dosage of 1 gram. Trecator
tablets have been reformulated from a sugar-coated tablet to a film-coated
tablet. Patients should be monitored and have their dosage retitrated
when switching from the sugar-coated tablet to the film-coated tablet
. Therapy should be initiated at
a dose of 250 mg daily, with gradual titration to optimal doses as
tolerated by the patient. A regimen of 250 mg daily for 1 or 2 days,
followed by 250 mg twice daily for 1 or 2 days with a subsequent increase
to 1 gm in 3 or 4 divided doses has been reported.4,5 Thus far, there is insufficient evidence
to indicate the lowest effective dosage levels. Therefore, in order
to minimize the risk of resistance developing to the drug or to the
companion drug, the principle of giving the highest tolerated dose
(based on gastrointestinal intolerance) has been followed. In the
adult this would seem to be between 0.5 and 1.0 gm daily, with
an average of 0.75 gm daily. The optimum dosage
for pediatric patients has not been established. However, pediatric
dosages of 10 to 20 mg/kg p.o. daily in 2 or 3 divided doses
given after meals or 15 mg/kg/24 hrs as a single daily dose have
been recommended.1,2 As with
adults, ethionamide may be administered to pediatric patients once
daily. It should be noted that in patients with concomitant tuberculosis
and HIV infection, malabsorption syndrome may be present. Drug malabsorption
should be suspected in patients who adhere to therapy, but who fail
to respond appropriately. In such cases, consideration should be given
to therapeutic drug monitoring . The best times of administration are those which the individual
patient finds most suitable in order to avoid or minimize gastrointestinal
intolerance, which is usually at mealtimes. Every effort should be
made to encourage patients to persevere with treatment when gastrointestinal
side effects appear, since they may diminish in severity as treatment
proceeds. Concomitant administration of pyridoxine
is recommended. Duration of treatment should
be based on individual clinical response. In general, continue therapy
until bacteriological conversion has become permanent and maximal
clinical improvement has occurred.
|
| dailymed-drugs:76 |
ZOVIRAX Cream should
be applied 5 times per day for 4 days. Therapy should be initiated
as early as possible following onset of signs and symptoms (i.e., during the
prodrome or when lesions appear). For adolescents 12 years of age and
older, the dosage is the same as in adults.
|
| dailymed-drugs:77 |
Apply a thin film of Desoximetasone Gel USP, 0.05% to the affected skin areas twice daily. Rub in gently.
|
| dailymed-drugs:78 |
Apply a thin film of fluticasone propionate ointment to the affected skin areas twice daily. Rub in gently. Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with fluticasone propionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
|
| dailymed-drugs:79 |
REBETOL'/INTRON' A Combination Therapy:<br/>Adults: The recommended dose of REBETOL Capsules depends on the patient's body weight. The recommended dose of REBETOL is provided in TABLE 11. The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen . After 24 weeks of treatment virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population. In patients who relapse following non-pegylated interferon monotherapy, the recommended duration of treatment is 24 weeks. There are no safety and efficacy data on treatment for longer than 24 weeks in the relapse patient population.<br/>Pediatrics: The recommended dose of REBETOL is 15 mg/kg per day orally (divided dose AM and PM). For children weighing���25 kg or who cannot swallow capsules, REBETOL Oral Solution is supplied in a concentration of 40 mg/mL. For children weighing>25 kg, either the Oral Solution or 200-mg capsule may be administered. Refer to TABLE 12 for dosing recommendations for the 200-mg capsule to achieve the recommended dose. The recommended duration of treatment is 48 weeks for pediatric patients with genotype 1. After 24 weeks of treatment virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV RNA below the limit of detection of the assay by this time. The recommended duration of treatment for pediatric patients with genotype 2/3 is 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in pediatrics. REBETOL may be administered without regard to food, but should be administered in a consistent manner with respect to food intake . Under no circumstances should REBETOL Capsules be opened, crushed, or broken .<br/>REBETOL/PegIntron Combination Therapy: The recommended dose of REBETOL Capsules is 800 mg/day in 2 divided doses: two capsules (400 mg) in the morning with food and two capsules (400 mg) in the evening with food.<br/>Dose Modifications: If severe adverse reactions or laboratory abnormalities develop during combination REBETOL/INTRON A therapy the dose should be modified, or discontinued if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, REBETOL/INTRON A therapy should be discontinued. REBETOL should not be used in patients with creatinine clearance<50 mL/min. Subjects with impaired renal function and/or those over the age of 50 should be carefully monitored with respect to development of anemia . REBETOL should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped . For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by���2 g/dL during any 4-week period. In addition, for these cardiac history patients, if the hemoglobin remains<12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination REBETOL/INTRON A therapy. It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her REBETOL dose reduced to 600 mg daily (1��200-mg capsule AM, 2��200 mg capsules PM) for adults and 7.5 mg/kg per day (divided dose AM and PM) for pediatric patients. A patient whose hemoglobin level falls below 8.5 g/dL should be permanently discontinued from REBETOL therapy .
|
| dailymed-drugs:80 |
Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 4 to 16 years. Oxcarbazepine is also recommended as monotherapy in the treatment of partial seizures in adults and children aged 4 to 16 years. All dosing should be given in a twice-a-day (BID) regimen. Oxcarbazepine oral suspension and oxcarbazepine film���coated tablets may be interchanged at equal doses. Oxcarbazepine tablets should be kept out of the reach and sight of children. Oxcarbazepine can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokinetics).<br/>Adults:<br/>Adjunctive Therapy: Treatment with oxcarbazepine tablets should be initiated with a dose of 600 mg/day, given in a BID regimen. If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day show somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. It is recommended that the patient be observed closely and plasma levels of the concomitant AEDs be monitored during the period of oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine doses greater than 1200 mg/day (see PRECAUTIONS, Drug Interactions).<br/>Conversion to Monotherapy: Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at 600 mg/day (given in a BID regimen) while simultaneously initiating the reduction of the dose of the concomitant AEDs. The concomitant AEDs should be completely withdrawn over 3 to 6 weeks, while the maximum dose of oxcarbazepine tablets should be reached in about 2 to 4 weeks. Oxcarbazepine tablets may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achieve the recommended daily dose of 2400 mg/day. A daily dose of 1200 mg/day has been shown in one study to be effective in patients in whom monotherapy has been initiated with oxcarbazepine. Patients should be observed closely during this transition phase.<br/>Initiation of Monotherapy: Patients not currently being treated with AEDs may have monotherapy initiated with oxcarbazepine tablets. In these patients, oxcarbazepine tablets should be initiated at a dose of 600 mg/day (given in a BID regimen); the dose should be increased by 300 mg/day every third day to a dose of 1200 mg/day. Controlled trials in these patients examined the effectiveness of a 1200 mg/day dose; a dose of 2400 mg/day has been shown to be effective in patients converted from other AEDs to oxcarbazepine tabletmonotherapy (see above).<br/>Pediatric Patients:<br/>Adjunctive Therapy (Aged 4 to 16 Years): In pediatric patients aged 4 to 16 years, treatment should be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a BID regimen. The target maintenance dose of oxcarbazepine tablets should be achieved over two weeks, and is dependent upon patient weight, according to the following chart: 20 to 29 kg - 900 mg/day 29.1 to 39 kg - 1200 mg/day >39 kg - 1800 mg/day In the clinical trial, in which the intention was to reach these target doses, the median daily dose was 31 mg/kg with a range of 6 to 51 mg/kg. Under adjunctive therapy (with and without enzyme-inducing AEDs), when normalized by body weight, apparent clearance (L/hr/kg) decreased when age increased such that children 4 to���12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults. Pediatric dosing and drug clearance information for pediatric patients ages 2 to<4 years is approved for Novartis Pharmaceuticals Corporation's oxcarbazepine tablets and oral suspension. However due to Novartis' marketing exclusivity rights, this drug product is not labeled for this age group.<br/>Conversion to Monotherapy (Aged 4 to 16 Years): Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at approximately 8 to 10 mg/kg/day given in a BID regimen, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks while oxcarbazepine tablets may be increased as clinically indicated by a maximum increment of 10 mg/kg/day at approximately weekly intervals to achieve the recommended daily dose. Patients should be observed closely during this transition phase. The recommended total daily dose of oxcarbazepine tablets is shown in the table below.<br/>Initiation of Monotherapy (Aged 4 to 16 Years): Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine tablets. In these patients, oxcarbazepine tablets should be initiated at a dose of 8 to 10 mg/kg/day given in a BID regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown in the table below.<br/>Patients with Hepatic Impairment: In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations).<br/>Patients with Renal Impairment: In patients with impaired renal function (creatine clearance<30 mL/min) oxcarbazepine tablet therapy should be initiated at one-half the usual starting dose (300 mg/day) and increased slowly to achieve the desired clinical response (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations).
|
| dailymed-drugs:81 |
To minimize the risk of dermal exposure, always wear impervious
gloves when handling bottles containing HYDREA capsules. This includes all
handling activities in clinical settings, pharmacies, storerooms, and home
healthcare settings, including during unpacking and inspection, transport
within a facility, and dose preparation and administration. Procedures for proper handling and disposal of antineoplastic drugs
should be considered. Several guidelines on this subject have been published.There
is no general agreement that all of the procedures recommended in the guidelines
are necessary or appropriate. Because of the rarity of melanoma, resistant chronic myelocytic
leukemia, carcinoma of the ovary, and carcinomas of the head and neck in pediatric
patients, dosage regimens have not been established. All dosage should be based on the patient's actual or ideal weight,
whichever is less. Concurrent use of HYDREA with other myelosuppressive agents
may require adjustment of dosages.<br/>Solid Tumors:<br/>Intermittent Therapy: 80 mg/kg administered orally as a single dose every third day<br/>Continuous Therapy: 20 to 30 mg/kg administered orally as a single dose daily<br/>Concomitant Therapy with Irradiation: Carcinoma of the head and neck���80 mg/kg
administered orally as a single dose every third day Administration of hydroxyurea should begin at least seven days
before initiation of irradiation and continued during radiotherapy as well
as indefinitely afterwards provided that the patient may be kept under adequate
observation and evidences no unusual or severe reactions.<br/>Resistant Chronic Myelocytic Leukemia: Until the intermittent therapy regimen has been evaluated, CONTINUOUS
therapy (20 to 30 mg/kg administered orally as a single dose daily)
is recommended. An adequate trial period for determining the antineoplastic effectivenessof hydroxyurea is six weeks of therapy. When there is regression in tumor
size or arrest in tumor growth, therapy should be continued indefinitely.
Therapy should be interrupted if the white blood cell count drops below 2500/mm,
or the platelet count below 100,000/mm. In these
cases, the counts should be reevaluated after three days, and therapy resumed
when the counts return to acceptable levels. Since the hematopoietic rebound
is prompt, it is usually necessary to omit only a few doses. If prompt rebound
has not occurred during combined HYDREA and irradiation therapy, irradiation
may also be interrupted. However, the need for postponement of irradiation
has been rare; radiotherapy has usually been continued using the recommended
dosage and technique. Severe anemia, if it occurs, should be corrected without
interrupting hydroxyurea therapy. Because hematopoiesis may be compromised
by extensive irradiation or by other antineoplastic agents, it is recommended
that hydroxyurea be administered cautiously to patients who have recently
received extensive radiation therapy or chemotherapy with other cytotoxic
drugs. Pain or discomfort from inflammation of the mucous membranes at
the irradiated site (mucositis) is usually controlled by measures such as
topical anesthetics and orally administered analgesics. If the reaction is
severe, hydroxyurea therapy may be temporarily interrupted; if it is extremely
severe, irradiation dosage may, in addition, be temporarily postponed. However,
it has rarely been necessary to terminate these therapies. Severe gastric distress, such as nausea, vomiting, and anorexia,
resulting from combined therapy may usually be controlled by temporary interruption
of hydroxyurea administration.<br/>Renal Insufficiency: As renal excretion is a pathway of elimination, consideration should
be given to decreasing the dosage of HYDREA in patients with renal impairment.
(See PRECAUTIONS and CLINICAL
PHARMACOLOGY.) Close monitoring of hematologic parameters is
advised in these patients.<br/>Hepatic Insufficiency: There are no data that support specific guidance for dosage adjustment
in patients with hepatic impairment. Close monitoring of hematologic parameters
is advised in these patients.
|
| dailymed-drugs:83 |
The dose is 1-2 drops in each eye 4-6 times a day at regular intervals. One drop contains approximately 1.6 mg cromolyn sodium. Patients should be advised that the effect of cromolyn sodium ophthalmic solution, USP 4% therapy is dependent upon its administration at regular intervals, as directed. Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement. If required, corticosteroids may be used concomitantly with cromolyn sodium ophthalmic solution, USP 4%.
|
| dailymed-drugs:85 |
Administer by deep IM injection in the upper outer quadrant of the buttock. In infants and small children, the mid-lateral aspect of the thigh may be preferable. When doses are repeated, vary the injection site .<br/>Pediatric Dosage Schedule: In children under 12 years of age, dosage should be adjusted in accordance with the age and weight of the child and the severity of the infection. Under 2 years of age, the dose may be divided between the two buttocks if necessary.<br/>Streptococcal Infections (group A) pharyngitis: A single injection of 900,000 units for older children; l,200,000 units for adults.<br/>Venereal Infections:<br/>Syphilis: Primary, secondary, and latent: 2.4 million units (1 dose).<br/>Late Syphilis (tertiary and neurosyphilis): 3 million units at 7 day intervals for a total of 6���9 million units.<br/>Congenital Syphilis (asymptomatic with normal cerebrospinal fluid): Under 2 years of age���50,000 units/kg body weight in a single dose; ages 2���12 years���adjust dosage based on adult dosage schedule.<br/>Yaws, Bejel, and Pinta: 1.2 million units (1 injection).<br/>Prophylaxis: For rheumatic fever and glomerulonephritis. Following an acute attack, penicillin G benzathine (parenteral) may be given in doses of 1,200,000 units once a month or 600,000 units every 2 weeks. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
|
| dailymed-drugs:87 |
The treatment regimens described below are based on those used in controlled clinical trials of ClomiPRAMINE in 520 adults, and 91 children and adolescents with OCD. During initial titration, ClomiPRAMINE should be given in divided doses with meals to reduce gastrointestinal side effects. The goal of this initial titration phase is to minimize side effects by permitting tolerance to side effects to develop or allowing the patient time to adapt if tolerancedoes not develop. Because both ClomiPRAMINE and its active metabolite, desmethylclomipramine, have long elimination half-lives, the prescriber should take into consideration the fact that steady-state plasma levels may not be achieved until 2 to 3 weeks after dosage change (see CLINICAL PHARMACOLOGY). Therefore, after initial titration, it may be appropriate to wait 2 to 3 weeks between further dosage adjustments.<br/>Initial Treatment/Dose Adjustment (Adults): Treatment with ClomiPRAMINE hydrochloride should be initiated at a dosage of 25 mg daily and gradually increased, as tolerated, to approximately 100 mg during the first 2 weeks. During initial titration, ClomiPRAMINE should be given in divided doses with meals to reduce gastrointestinal side effects. Thereafter, the dosage may be increased gradually over the next several weeks, up to a maximum of 250 mg daily. After titration, the total daily dose may be given once daily at bedtime to minimize daytime sedation.<br/>Initial Treatment/Dose Adjustment (Children and Adolescents): As with adults, the starting dose is 25 mg daily and should be gradually increased (also given in divided doses with meals to reduce gastrointestinal side effects) during the first 2 weeks, as tolerated, up to a daily maximum of 3 mg/kg or 100 mg, whichever is smaller. Thereafter, the dosage may be increased gradually over the next several weeks up to a daily maximum of 3 mg/kg or 200 mg, whichever is smaller (see PRECAUTIONS, PediatricUse). As with adults, after titration, the total daily dose may be given once daily at bedtime to minimize daytime sedation.<br/>Maintenance/Continuation Treatment (Adults, Children, and Adolescents): While there are no systematic studies that answer the question of how long to continue ClomiPRAMINE, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of ClomiPRAMINE after 10 weeks has not been documented in controlled trials, patients have been continued in therapy under double-blind conditions for up to 1 year without loss of benefit. However, dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for treatment. During maintenance, the total daily dose may be given once daily at bedtime.
|
| dailymed-drugs:88 |
FOR INTRAVENOUS ADMINISTRATION ONLY. Dosage recommendations for closure of the ductus arteriosus depend on the age of the infant at the time of therapy. A course of therapy is defined as three intravenous doses of INDOCIN I.V. given at 12-24 hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output<0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of INDOCIN I.V., no additional doses should be given until laboratory studies indicate that renal function has returned to normal . Dosage according to age is as follows: If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of INDOCIN I.V., no further doses are necessary. If the ductus arteriosus re-opens, a second course of 1-3 doses may be given, each dose separated by a 12-24 hour interval as described above. If the neonate remains unresponsive to therapy with INDOCIN I.V. after 2 courses, surgery may be necessary for closure of the ductus arteriosus. If severe adverse reactions occur, STOP THE DRUG.<br/>Directions For Use: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The reconstituted solution is clear, slightly yellow and essentially free from visible particles. The solution should be prepared only with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, all diluents should be preservative-free. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Any unused portion of the solution should be discarded because there is no preservative contained in the vial. A fresh solution should be prepared just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20-30 minutes. INDOCIN I.V. is not buffered. Further dilution with intravenous infusion solutions is not recommended.
|
| dailymed-drugs:89 |
Dosage should be adjusted according to the indication
for therapy, severity of symptoms and the response of the patient.<br/>CAPSULES , 300 mg:<br/>Usual Adult Dosage: One 300 mg capsule t.i.d. or q.i.d.<br/>INJECTABLE, 100 mg/mL (not for use in children):<br/>Usual Adult Dosage: 2 mL (200 mg) t.i.d. or q.i.d. intramuscularly. NOTE: The injectable
form is intended for intramuscular administration only; it is not
recommended for intravenous use. Intramuscular
administration may cause pain, stinging, burning, redness and swelling
at the site of injection. Such effects may be minimized by deep injection
into the upper outer quadrant of the gluteal region, and by avoiding
the escape of solution along the route.
|
| dailymed-drugs:90 |
Bipolar Disorder: Depression Usual Dose: SEROQUEL should be administered once daily at bedtime to reach 300 mg/day by day 4. In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for days 1-4 respectively. Patients receiving 600 mg increased to 400 mg on day 5 and 600 mg on day 8 (Week 1). Antidepressant efficacy was demonstrated with SEROQUEL at both 300 mg and 600 mg however, no additional benefit was seen in the 600 mg group.<br/>Mania: Usual Dose: When used as monotherapy or adjunct therapy (with lithium or divalproex), SEROQUEL should be initiated in bid doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in bid divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicates that the majority of patients responded between 400 to 800 mg/day. The safety of doses above 800mg/day has not been evaluated in clinical trials.<br/>Schizophrenia: Usual Dose: SEROQUEL should generally be administered with an initial dose of 25 mg bid, with increases in increments of 25-50 mg bid or tid on the second and third day, as tolerated, to a target dose range of 300 to 400 mg daily by the fourth day, given bid or tid. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for SEROQUEL would not be achieved for approximately 1-2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25-50 mg bid are recommended. Most efficacy data with SEROQUEL were obtained using tid regimens, but in one controlled trial 225 mg bid was also effective. Efficacy in schizophrenia was demonstrated in a dose range of 150 to 750 mg/day in the clinical trials supporting the effectiveness of SEROQUEL. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400-500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.<br/>Dosing in Special Populations: Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions . When indicated, dose escalation should be performed with caution in these patients. Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25-50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient. The elimination of quetiapine was enhanced in the presence of phenytoin. Higher maintenance doses of quetiapine may be required when it is coadministered with phenytoin and other enzyme inducers such as carbamazepine and phenobarbital . Maintenance Treatment: While there is no body of evidence available to answer the question of how long the patient treated with SEROQUEL should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment. Reinitiation of Treatment in Patients Previously Discontinued: Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off SEROQUEL, titration of SEROQUEL is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off SEROQUEL for more than one week, the initial titration schedule should be followed. Switching from Antipsychotics: There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to SEROQUEL, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate SEROQUEL therapy in place of the next scheduledinjection. The need for continuing existing EPS medication should be reevaluated periodically.
|
| dailymed-drugs:91 |
The usual dosage used in adult and pediatric patients is 6 grams per day administered orally in divided doses of 3 grams two times per day. Dosages of up to 20 grams per day have been necessary to control homocysteine levels in some patients. In pediatric patients less than 3 years of age, dosage may be started at 100 mg/kg/day and then increased weekly by 50 mg/kg increments. In one study by Matthewset al., pharmacokinetic and pharmacodynamic simulation indicated minimal benefit from exceeding a twice-daily dosing schedule and a 150 mg/kg/day dosage for betaine. Dosage in all patients can be gradually increased until plasma total homocysteine is undetectable or present only in small amounts. Plasma methionine concentrations should be monitored in patients with CBS-deficiency. See PRECAUTIONS: Hypermethioninemia. The prescribed amount of Cystadane (betaine anhydrous for oral solution) should be measured with the measuring scoop provided (one level 1.7 cc scoop is equal to 1 gram of betaine anhydrous powder) and then dissolved in 4 to 6 ounces (120 to 180 mL) of water, juice, milk, or formula, or mixed with food for immediate ingestion.
|
| dailymed-drugs:92 |
If diarrhea occurs during therapy, this antibiotic should be discontinued
. Adults: Parenteral (IM or IV Administration): Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium
species other than Clostridium perfringens): 600���1200 mg/day in 2, 3 or 4 equal doses. More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens: 1200���2700 mg/day in 2, 3 or 4 equal doses. For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intra-venously to adults. See Dilution and Infusion Rates section below. Single intramuscular injections of greater than 600 mg are not recommended. Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows: Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures. Pediatric patients 1 month of age to 16 years: Parenteral (IM or IV) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m/day for serious infections and 450 mg/m/day for more severe infections. Parenteral therapy may be changed to oral CLEOCIN PEDIATRIC
Flavored Granules (clindamycin palmitate hydrochloride) or CLEOCIN HCl Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician. In cases of��-hemolytic streptococcal infections, treatment should be continued for at least 10 days.<br/>Dilution and Infusion Rates: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute. The usual infusion dilutions and rates are as follows: Administration of more than 1200 mg in a single 1-hour infusion is not recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of CLEOCIN PHOSPHATE Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin. The following drugs are physically incompatible with clindamycin phosphate:
ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate. The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions. For current information regarding compatibilities of clindamycin phosphate under specific conditions, please contact the Medical and Drug Information Unit, Pharmacia&Upjohn Company (Division of Pfizer Inc).<br/>Physico-Chemical Stability of diluted solutions of CLEOCIN PHOSPHATE: Room temperature: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25��C. Also, 18 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, in minibags, demonstrated physical and chemical stability for at least 16 days at 25��C. Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in
dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4��C. IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible. Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in minibags demonstrated physical and chemical stability for at least eight weeks at���10��C. Frozen solutions should be thawed at room temperature and not refrozen.<br/>DIRECTIONS FOR DISPENSING: Pharmacy Bulk Package���Not for Direct Infusion The Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only under a laminar flow hood. Entry into the vial should be made with a small diameter sterile transfer set or other small diameter sterile dispensing device, and contents dispensed in aliquots using aseptic technique. Multiple entries with a needle and syringe are not recommended. AFTER ENTRY USE ENTIRE CONTENTS OF VIAL PROMPTLY. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 24 HOURS AFTER INITIAL ENTRY.<br/>DIRECTIONS FOR USE: CLEOCIN PHOSPHATE IV Solution in Galaxy Plastic Container Premixed CLEOCIN PHOSPHATE IV Solution is for intravenous administration using sterile equipment. Check for minute leaks prior to use by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not add supplementary medication. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not useunless solution is clear and seal is intact. Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.<br/>Preparation for Administration:: Preparation of CLEOCIN PHOSPHATE in ADD-Vantage System���For IV Use Only. CLEOCIN PHOSPHATE 600 mg and 900 mg may be reconstituted in 50 mL or 100 mL, respectively, of Dextrose Injection 5% or Sodium Chloride Injection 0.9% in the ADD-diluent container. Refer to separate instructions for ADD-VantageSystem.
|
| dailymed-drugs:93 |
Adult Patients:<br/>Treatment of mild to moderate malaria in adults caused by P. vivax or mefloquine-susceptible strains of P. falciparum: Five tablets (1250 mg) mefloquine hydrochloride to be given as a single oral dose. The drug should not be taken on an empty stomach and should be administered with at least 8 oz (240 mL) of water. If a full-treatment course with mefloquine does not lead to improvement within 48 to 72 hours, mefloquine should not be used for retreatment. An alternative therapy should be used. Similarly, if previous prophylaxis with mefloquine has failed, mefloquine should not be used for curative treatment.<br/>Malaria Prophylaxis: One 250 mg mefloquine hydrochloride tablet once weekly. Prophylactic drug administration should begin 1 week before arrival in an endemic area. Subsequent weekly doses should be taken regularly, always on the same day each week, preferably, after the main meal. To reduce the risk of malaria after leaving an endemic area, prophylaxis must be continued for 4 additional weeks to ensure suppressive blood levels of the drug when merozoites emerge from the liver. Tablets should not be taken on an empty stomach and should be administered with at least 8 oz (240 mL) of water. In certain cases, eg, when a traveler is taking other medication, it may be desirable to start prophylaxis 2 to 3 weeks prior to departure, in order to ensure that the combination of drugs is well tolerated . When prophylaxis with mefloquine fails, physicians should carefully evaluate which antimalarial to use for therapy.<br/>Pediatric Patients:<br/>Treatment of mild to moderate malaria in pediatric patients caused by mefloquine-susceptible strains of P. falciparum: twenty (20) to 25 mg/kg body weight. Splitting the total therapeutic dose into 2 doses taken 6 to 8 hours apart may reduce the occurrence or severity of adverse effects. Experience with mefloquine in infants less than 3 months old or weighing less than 5 kg is limited. The drug should not be taken on an empty stomach and should be administered with ample water. The tablets may be crushed and suspended in a small amount of water, milk or other beverage for administration to small children and other persons unable to swallow them whole. If a full-treatment course with mefloquine does not lead to improvement within 48 to 72 hours, mefloquine should not be used for retreatment. An alternative therapy should be used. Similarly, if previous prophylaxis with mefloquine has failed, mefloquine should not be used for curative treatment. In pediatric patients, the administration of mefloquine for the treatment of malaria has been associated with early vomiting. In some cases, early vomiting has been cited as a possible cause of treatment failure . If a significant loss of drug product is observed or suspected because of vomiting, a second full dose of mefloquine should be administered to patients who vomit less than 30 minutes after receiving the drug. If vomiting occurs 30 to 60 minutes after a dose, an additional half-dose should be given. If vomiting recurs, the patient should be monitored closely and alternative malaria treatment considered if improvement is not observed within a reasonable period of time. The safety and effectiveness of mefloquine to treat malaria in pediatric patients below the age of 6 months have not been established.<br/>Malaria Prophylaxis: The following doses have been extrapolated from the recommended adult dose. Neither the pharmacokinetics, nor the clinical efficacy of these doses have been determined in children owing to the difficulty of acquiring this information in pediatric subjects. The recommended prophylactic dose of mefloquine is approximately 5 mg/kg body weight once weekly. One 250 mg mefloquine hydrochloride tablet should be taken once weekly in pediatric patients weighing over 45 kg. In pediatric patients weighing less than 45 kg, the weekly dose decreases in proportion to body weight: 30 to 45 kg:��tablet20 to 30 kg:��tablet10 to 20 kg:��tablet5 to 10 kg:���tablet Experience with mefloquine in infants less than 3 months old or weighing less than 5 kg is limited.
|
| dailymed-drugs:94 |
ARIXTRA Injection is administered by subcutaneous
injection once daily.<br/>Deep Vein Thrombosis Prophylaxis
Following Hip Fracture, or Hip or Knee Replacement Surgeries: In patients undergoing
hip fracture, hip replacement, or knee replacement surgery, the recommended
dose of ARIXTRA is 2.5 mg administered by subcutaneous injection
once daily. After hemostasis has been established, the initial dose
should be given 6 to 8 hours after surgery. Administration before
6 hours after surgery has been associated with an increased risk of
major bleeding. The usual duration of administration is 5 to 9 days,
and up to 11 days administration has been tolerated. In patients
undergoing hip fracture surgery, an extended prophylaxis course of
up to 24 additional days is recommended. In patients undergoing
hip fracture surgery, a total of 32 days (peri-operative and
extended prophylaxis) has been tolerated. (See CLINICAL STUDIES, WARNINGS:
Laboratory Testing and ADVERSE REACTIONS.)<br/>Deep Vein Thrombosis Prophylaxis
Following Abdominal Surgery: In patients undergoing abdominal surgery, the recommended
dose of ARIXTRA is 2.5 mg administered by subcutaneous injection
once daily after hemostasis has been established. The initial dose
should be given 6 to 8 hours after surgery. Administration before
6 hours after surgery has been associated with an increased risk
of major bleeding. The usual duration of administration is 5 to 9 days,
andup to 10 days of ARIXTRA injection has been administered.<br/>Deep Vein Thrombosis and Pulmonary
Embolism Treatment: In patients with acute symptomatic DVT and in patients
with acute symptomatic PE the recommended dose of ARIXTRA is 5 mg
(body weight<50 kg), 7.5 mg (body weight 50-100 kg),
or 10 mg (body weight>100 kg) by subcutaneous injection
once daily (ARIXTRA treatment regimen). Treatment with ARIXTRA should
be continued for at least 5 days and until a therapeutic oral
anticoagulant effect is established (INR 2.0 to 3.0). Concomitant
treatment with warfarin sodium should be initiated as soon as possible,
usually within 72 hours. The usual duration of administration
of ARIXTRA is 5 to 9 days; up to 26 days of ARIXTRA injection
has been administered. (See CLINICAL STUDIES, WARNINGS: Laboratory
Testing and ADVERSE REACTIONS.)
|
| dailymed-drugs:95 |
Usual Adult Dosage: The usual adult dosage of Ridaura (auranofin) is 6 mg daily, given either as 3 mg twice daily or 6 mg once daily. Initiation of therapy at dosages exceeding 6 mg daily is not recommended because it is associated with an increased incidence of diarrhea. If response is inadequate after six months, an increase to 9 mg (3 mg three times daily) may be tolerated. If response remains inadequate after a three-month trial of 9 mg daily, Ridaura therapy should be discontinued. Safety at dosages exceeding 9 mg daily has not been studied.<br/>Transferring from Injectable Gold:: In controlled clinical studies, patients on injectable gold have been transferred to Ridaura (auranofin) by discontinuing the injectable agent and starting oral therapy with Ridaura, 6 mg daily. When patients are transferred to Ridaura, they should be informed of its adverse reaction profile, in particular the gastrointestinal reactions. At six months, control of disease activity of patients transferred to Ridaura and those maintained on the injectable agent was not different. Data beyond six months are not available.
|
| dailymed-drugs:96 |
The recommended dose of Ipratropium Bromide Nasal Spray 0.03% is two sprays (42 mcg) per nostril two or three times daily (total dose 168 to 252 mcg/day) for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Optimum dosage varies with the response of the individual patient. Initial pump priming requires seven sprays of the pump. If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for morethan seven days, the pump will require seven sprays to reprime.
|
| dailymed-drugs:97 |
Dosage should be individualized with careful monitoring of patient response.<br/>Oral Administration: The usual total daily dosage of bumetanide is 0.5 to 2 mg and in most patients is given as a single dose. If the diuretic response to an initial dose of bumetanide is not adequate, in view of its rapid onset and short duration of action, a second or third dose may be given at 4 to 5 hour intervals up to a maximum daily dose of 10 mg. An intermittent dose schedule, whereby bumetanide is given on alternate days or for 3 to 4 days with rest periods of 1 to 2 days in between, is recommended as the safest and most effective method for the continued control of edema. In patients with hepatic failure, the dosage should be kept to a minimum, and if necessary, dosage increased very carefully. Because cross-sensitivity with furosemide has rarely been observed, bumetanide can be substituted at approximately a 1:40 ratio of bumetanide to furosemide in patients allergic to furosemide. Parenteral Administration: Bumetanide injection may be administered parenterally (IV or IM) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical. Parenteral treatment should be terminated and oral treatment instituted as soon as possible.
|
| dailymed-drugs:98 |
Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2-4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels. The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydralazine. In a few resistant patients, up to 300 mg of hydralazine daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydralazine combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.
|
| dailymed-drugs:99 |
SHAKE WELL BEFORE USING. Two drops in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (SEE PRECAUTIONS). The dosing of Prednisolone Acetate Ophthalmic Suspension USP, 1% may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications. FOR TOPICAL OPHTHALMIC USE ONLY.
|
| dailymed-drugs:100 |
There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with RIOMET or any other pharmacologic agent. Dosage of RIOMET must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of RIOMET is 2550 mg (25.5 mL) in adults and 2000 mg (20 mL) in pediatric patients (10-16 years of age). RIOMET should be given in divided doses with meals. RIOMET should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration(see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to RIOMET and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of RIOMET, either when used as monotherapy or in combination with sulfonylurea or insulin. Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness. Short-term administration of RIOMET may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.<br/>Recommended Dosing Schedule:<br/>Adults: In general, clinically significant responses are not seen at doses below 1500 mg (15 mL) per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms. The usual starting dose of RIOMET (metformin hydrochloride oral solution) is 500 mg (5 mL) twice a day or 850 mg (8.5 mL) once a day, given with meals. Dosage increases should be made in increments of 500 mg (5 mL) weekly or 850 mg (8.5 mL) every 2 weeks, up to a total of 2000 mg (20 mL) per day, given in divided doses. Patients can also be titrated from 500 mg (5 mL) twice a day to 850 mg (8.5 mL) twice a day after 2 weeks. For those patients requiring additional glycemic control, RIOMET may be given to a maximum daily dose of 2550 mg(25.5 mL) per day. Doses above 2000 mg (20 mL) may be better tolerated given three times a day with meals.<br/>Pediatrics: The usual starting dose of RIOMET is 500 mg (5 mL) twice a day, given with meals. Dosage increases should be made in increments of 500 mg (5 mL) weekly up to a maximum of 2000 mg (20 mL) per day, given in divided doses.<br/>Transfer From Other Antidiabetic Therapy: When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to RIOMET, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.<br/>Concomitant Metformin and Oral Sulfonylurea Therapy in Adult Patients: If patients have not responded to four weeks of the maximum dose of RIOMET monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing RIOMET at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide). With concomitant Metformin and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. In a clinical trial of patients with type 2 diabetes and prior failure on glyburide, patients started on metformin 500 mg and glyburide 20 mg were titrated to 1000 mg/20 mg, 1500 mg/20 mg, 2000 mg/20 mg or 2500 mg/20 mg of metformin and glyburide, respectively, to reach the goal of glycemic control as measured by FPG, HbAand plasma glucose response (see CLINICAL PHARMACOLOGY: Clinical Studies). However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant RIOMET and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (See Package Insert of the respective sulfonylurea.) If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of RIOMET and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without RIOMET.<br/>Concomitant Metformin and Insulin Therapy in Adult Patients: The current Insulin dose should be continued upon initiation of RIOMET therapy. RIOMET therapy should be initiated at 500 mg (5 mL) once daily in patients on insulin therapy. For patients not responding adequately, the dose of RIOMET should be increased by 500 mg (5 mL) after approximately 1 week and by 500 mg (5 mL) every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose for RIOMET is 2500 mg (25 mL). It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and RIOMET. Further adjustment should be individualized based on glucose-lowering response.<br/>Specific Patient Populations: RIOMET is not recommended for use in pregnancy. RIOMET is not recommended in patients below the age of 10 years. The initial and maintenance dosing of RIOMET should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of RIOMET. Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly. (see WARNINGS.)
|
| dailymed-drugs:101 |
Central Cranial Diabetes Insipidus: DDAVP Nasal Spray dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients with nasal congestion and blockage have often responded well to intranasal DDAVP. The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of DDAVP administered intranasally. Fluid restriction should be observed. The nasal spray pump can only deliver doses of 0.1 mL (10 mcg) or multiples of 0.1 mL. If doses other than these are required, the rhinal tube delivery system may be used. The spray pump must be primed prior to the first use. To prime pump, press down four times. The bottle will now deliver 10 mcg of drug per spray. Discard DDAVP Nasal Spray after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10��g of drug.<br/>Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
|
| dailymed-drugs:102 |
As directed by a
physician. Dosage is dependent upon the age, weight and clinical
condition of the patient as well as laboratory determinations. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. Use of a final filter is recommended during administration of
all parenteral solutions, where possible. All injections in
VIAFLEX Plus plastic containers are intended for intravenous
administration using sterile equipment. Additives may be
incompatible. Complete information is not available. Those additives
known to be incompatible should not be used. Consult with pharmacist, if
available. If, in the informed judgment of the physician, it is deemed
advisable to introduce additives, use aseptic technique. Mix thoroughly
when additives have been introduced. Do not store solutions containing
additives.
|
| dailymed-drugs:3389 |
As directed by a
physician. Dosage is dependent upon the age, weight and clinical
condition of the patient as well as laboratory determinations. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. Use of a final filter is recommended during administration of
all parenteral solutions, where possible. All injections in
VIAFLEX Plus plastic containers are intended for intravenous
administration using sterile equipment. Additives may be
incompatible. Complete information is not available. Those additives
known to be incompatible should not be used. Consult with pharmacist, if
available. If, in the informed judgment of the physician, it is deemed
advisable to introduce additives, use aseptic technique. Mix thoroughly
when additives have been introduced. Do not store solutions containing
additives.
|
| dailymed-drugs:104 |
Usual Adult Dosage:<br/>Perioperative Prophylactic Use: To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: It is important that (1) the preoperative done be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the lime of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibiotic at the anticipated moments of greatest exposure to infective organisms. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic asthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.<br/>Dosage Adjustment for Patients with Reduced Renal Function: Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patents with a creatinine clearance of 55 mL/min or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See Human Pharmacology.<br/>Pediatric Dosage: In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into three or four equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection, USP in these patients is not recommended. In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/,min), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.
|
| dailymed-drugs:105 |
Cataract Surgery: One drop of diclofenac sodium ophthalmic solution should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the post operative period.<br/>Corneal Refractive Surgery: One or two drops of diclofenac sodium ophthalmic solution should be applied to the operative eye within the hour prior to corneal refractive surgery. Within 15 minutes after surgery, one or two drops should be applied to the operative eye and continued 4 times daily for up to 3 days.
|
| dailymed-drugs:106 |
In the treatment of superficial ocular infections, erythromycin ophthalmic ointment approximately 1 cm in length should be applied directly to the infected eye(s) up to six times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial ophthalmia, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.
|
| dailymed-drugs:107 |
For patients with breast cancer, the recommended daily dose is 20-40 mg. Dosages greater than 20 mg per day should be given in divided doses (morning and evening). In three single agent adjuvant studies in women, one 10 mg NOLVADEX tablet was administered two (ECOG and NATO) or three (Toronto) times a day for two years. In the NSABP B-14 adjuvant study in women with node-negative breast cancer, one 10 mg NOLVADEX tablet was given twice a day for at least 5 years. Results of the B-14 study suggest that continuation of therapy beyond five years does not provide additional benefit . In the EBCTCG 1995 overview, the reduction in recurrence and mortality was greater in those studies that used tamoxifen for about 5 years than in those that used tamoxifen for a shorter period of therapy. There was no indication that doses greater than 20 mg per day were more effective. Current data from clinical trials support 5 years of adjuvant NOLVADEX therapy for patients with breast cancer.<br/>Ductal Carcinoma in Situ (DCIS):: The recommended dose is NOLVADEX 20 mg daily for 5 years.<br/>Reduction in Breast Cancer Incidence in High Risk Women:: The recommended dose is NOLVADEX 20 mg daily for 5 years. There are no data to support the use of NOLVADEX other than for 5 years .
|
| dailymed-drugs:108 |
General: COREG CR is an extended-release capsule intended
for once-daily administration. Patients controlled with immediate-release
carvedilol tablets alone or in combination with other medications
may be switched to COREG CR extended-release capsules based on
the total daily doses shown in Table 6. Subsequent titration to higher
or lower doses may be necessary as clinically warranted. COREG CR should be taken once daily in the
morning with food. COREG CR should be swallowed as a whole capsule.
COREG CR and/or its contents should not be crushed, chewed, or
taken in divided doses.<br/>Alternative Administration: The capsules may be carefully opened and the beads
sprinkled over a spoonful of applesauce. The applesauce should not
be warm because it could affect the modified-release properties of
this formulation. The mixture of drug and applesauce should be consumed
immediately in its entirety. The drug and applesauce mixture shouldnot be stored for future use. Absorption of the beads sprinkled on
other foods has not been tested.<br/>Heart Failure: DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED
BY A PHYSICIAN DURING UP-TITRATION. Prior to initiation of COREG CR,
it is recommended that fluid retention be minimized. The recommended
starting dose of COREG CR is 10 mg once daily for 2 weeks.
Patients who tolerate a dose of 10 mg once daily may have their
dose increased to 20, 40, and 80 mg over successive intervals
of at least 2 weeks. Patients should be maintained on lower doses
if higher doses are not tolerated. Patients
should be advised that initiation of treatment and (to a lesser extent)
dosage increases may be associated with transient symptoms of dizziness
or lightheadedness (and rarely syncope) within the first hour after
dosing. Thus during these periods they should avoid situations such
as driving or hazardous tasks, where symptoms could result in injury.
Vasodilatory symptoms often do not require treatment, but it may be
useful to separate the time of dosing of COREG CR from that of
the ACE inhibitor or to reduce temporarily the dose of the ACE inhibitor.
The dose of COREG CR should not be increased until symptoms of
worsening heart failure or vasodilation have been stabilized. Fluid retention (with or without transient worsening
heart failure symptoms) should be treated by an increase in the dose
of diuretics. The dose of COREG CR should
be reduced if patients experience bradycardia (heart rate<55 beats/minute). Episodes of dizziness or fluid retention during initiation
of COREG CR can generally be managed without discontinuation
of treatment and do not preclude subsequent successful titration of,
or a favorable response to, COREG CR.<br/>Left Ventricular Dysfunction Following
Myocardial Infarction: DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING
UP-TITRATION. Treatment with COREG CR may be started as an inpatient
or outpatient and should be started after the patient is hemodynamically
stable and fluid retention has been minimized. It is recommended that
COREG CR be started at 20 mg once daily and increased after
3 to 10 days, based on tolerability to 40 mg once daily,
then again to the target dose of 80 mg once daily. A
lower starting dose may be used (10 mg once daily) and/or, the
rate of up-titration may be slowed if clinically indicated (e.g.,
due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are
not tolerated. The recommended dosing regimen need not be altered
in patients who received treatment with an IV or oral��-blocker
during the acute phase of the myocardial infarction.<br/>Hypertension: DOSAGE MUST BE INDIVIDUALIZED. The recommended starting
dose of COREG CR is 20 mg once daily. If this dose is tolerated,
using standing systolic pressure measured about one hour after
dosing as a guide, the dose should be maintained for 7 to 14 days,
and then increased to 40 mg once daily if needed, based on trough
blood pressure, again using standing systolic pressure one hour after
dosing as a guide for tolerance. This dose should also be maintained
for 7 to 14 days and can then be adjusted upward to 80 mg
once daily if tolerated and needed. Although not specifically studied,
it is anticipated the full antihypertensive effect of COREG CR
would be seen within 7 to 14 days as had been demonstrated with
immediate-release carvedilol. Total daily dose should not exceed 80 mg. Addition of a diuretic to COREG CR, or COREG CR
to a diuretic can be expected to produce additive effects and exaggerate
the orthostatic component of COREG CR action.<br/>Use in Patients with Hepatic Impairment: COREG CR should not be given to patients with
severe hepatic impairment (see CONTRAINDICATIONS).
|
| dailymed-drugs:109 |
To achieve maximum contraceptive and PMDD effectiveness, YAZ (drospirenone and ethinyl estradiol) must be taken exactly as directed at intervals not exceeding 24 hours. YAZ consists of 24 light pink active tablets of a monophasic combined hormonal preparation plus 4 inert white tablets. The dosage of YAZ is one light pink tablet daily for 24 consecutive days followed by 4 white inert tablets per menstrual cycle. A patient should begin to take YAZ either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start). Day 1 Start. During the first cycle of YAZ use, the patient should be instructed to take one light pink YAZ daily, beginning on Day one (1) of her menstrual cycle. (The first day of menstruation is Day one.) She should take one light pink YAZ daily for 24 consecutive days, followed by one white inert tablet daily on menstrual cycle days 25 through 28. It is recommended that YAZ be taken at the same time each day, preferably after the evening meal or at bedtime. YAZ can be taken without regard to meals. If YAZ is first taken later than the first day of the menstrual cycle, YAZ should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. The possibility of ovulation and conception prior to initiation of medication should be considered. Sunday Start. During the first cycle of YAZ use, the patient should be instructed to take one light pink YAZ daily, beginning on the first Sunday after the onset of her menstrual period. She should take one light pink YAZ daily for 24 consecutive days, followed by one white inert tablet daily on menstrual cycle days 25 through 28. It is recommended that YAZ be taken at the same time each day, preferably after the evening meal or at bedtime. YAZ can be taken without regard to meals. YAZ should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should begin her next and all subsequent 28-day regimens of YAZ on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her light pink tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of YAZ is started later than the day following administration of the last white tablet, the patient should use another method of contraception until she has taken a light pinkYAZ daily for seven consecutive days. When switching from another oral contraceptive, YAZ should be started on the same day that a new pack of the previous oral contraceptive would have been started. Withdrawal bleeding usually occurs within 3 days following the last light pink tablet. If spotting or breakthrough bleeding occurs while taking YAZ, the patient should be instructed to continue taking her YAZ as instructed and by the regimen described above. She should be instructed that this type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient should be advised to consult her physician. Although the occurrence of pregnancy is low if YAZ is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), the possibility of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed. The risk of pregnancy increases with each active light pink tablet missed. For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING which follows. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more white tablets, she should still be protected against pregnancy provided she begins taking light pink tablets again on the proper day. In the nonlactating mother, YAZ may be initiated 4���6 weeks postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered.
|
| dailymed-drugs:110 |
Adults and Adolescents (���16 years of age): The recommended dose of telbivudine for the treatment of chronic hepatitis B is 600 mg once daily, taken orally, with or without food. The optimal treatment duration has not been established. Renally Impaired Subjects: Telbivudine may be used for the treatment of chronic hepatitis B in patients with impaired renal function. No adjustment to the recommended dose of telbivudine is necessary in patients whose creatinine clearance is���50 mL/min. Adjustment of dose interval is required in patients with creatinine clearance<50 mL/min including those with ESRD on hemodialysis (Table 6). For patients with ESRD, telbivudine should be administered after hemodialysis. No adjustment to the recommended dose of telbivudine is necessary in patients with hepatic impairment.
|
| dailymed-drugs:111 |
The recommended dose of cevimeline hydrochloride is 30 mg taken three times a day. There is insufficient safety information to support doses greater than 30 mg tid. There is also insufficient evidence for additional efficacy of cevimeline hydrochloride at doses greater than 30 mg tid.
|
| dailymed-drugs:112 |
Days 1 through 3:Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring. Day 4 through treatment completion:Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake.
|
| dailymed-drugs:113 |
Osteoarthritis and Rheumatoid Arthritis:: Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . After observing the response to initial therapy with meloxicam, the dose should be adjusted to suit an individual patient's needs. For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily. For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of meloxicam is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily. The maximum recommended daily oral dose of meloxicam is 15 mg regardless of formulation. Meloxicam may be taken without regard to timing of meals.
|
| dailymed-drugs:114 |
CARMOL HC (Hydrocortisone Acetate Cream USP, 1%) is generally applied to the affected area as a thin film two to four times daily, depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
|
| dailymed-drugs:115 |
Dihydroergotamine mesylate injection should be administered in a dose of 1 mL intravenously, intramuscularly or subcutaneously. The dose can be repeated, as needed, at 1 hour intervals to a total dose of 3 mL for intramuscular or subcutaneous delivery or 2 mL for intravenous delivery in a 24 hour period. The total weekly dosage should not exceed 6 mL. Dihydroergotamine mesylate injection should not beused for chronic daily administration. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.
|
| dailymed-drugs:116 |
Duodenal Ulcer:<br/>Active Duodenal Ulcer: Clinical studies have indicated that suppression of nocturnal acid is the most important factor in duodenal ulcer healing . This is supported by recent clinical trials . Therefore, there is no apparent rationale, except for familiarity with use, for treating with anything other than a once-daily at bedtime oral dosage regimen (h.s.). In a U.S. oral dose-ranging study of 400 mg h.s., 800 mg h.s. and 1600 mg h.s., a continuous dose response relationship for ulcer healing was demonstrated. However, 800 mg h.s. is the dose of choice for most patients, as it provides a high healing rate (the difference between 800 mg h.s. and 1600 mg h.s. being small), maximal pain relief, a decreased potential for drug interactions and maximal patient convenience. Patients unhealed at four weeks, or those with persistent symptoms, have been shown to benefit from two to four weeks of continued therapy. It has been shown that patients who both have an endoscopically demonstrated ulcer larger than 1 cm and are also heavy smokers (i.e., smoke one pack of cigarettes or more per day) are more difficult to heal. There is some evidence which suggests that more rapid healing can be achieved in this subpopulation with cimetidine 1600 mg at bedtime. While early pain relief with either 800 mg h.s. or 1600 mg h.s. is equivalent in all patients, 1600 mg h.s. provides an appropriate alternative when it is important to ensure healing within four weeks for this subpopulation. Alternatively, approximately 94% of all patients will also heal in eight weeks with cimetidine 800 mg h.s. Other cimetidine oral regimens in the U.S. which have been shown to be effective are: 300 mg four times daily, with meals and at bedtime, the original regimen with which U.S. physicians have the most experience, and 400 mg twice daily, in the morning and at bedtime . Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. While healing with cimetidine often occurs during the first week or two, treatment should be continued for 4 to 6 weeks unless healing has been demonstrated by endoscopic examination.<br/>Maintenance Therapy for Duodenal Ulcer: In those patients requiring maintenance therapy, the recommended adult oral dose is 400 mg at bedtime.<br/>Active Benign Gastric Ulcer: The recommended adult oral dosage for short-term treatment of active benign gastric ulcer is 800 mg h.s., or 300 mg four times a day with meals and at bedtime. Controlled clinical studies were limited to six weeks of treatment . 800 mg h.s. is the preferred regimen for most patients based upon convenience and reduced potential for drug interactions. Symptomatic response to cimetidine does not preclude the presence of a gastric malignancy. It is important to follow gastric ulcer patients to assure rapid progress to complete healing.<br/>Erosive Gastroesophageal Reflux Disease (GERD): The recommended adult oral dosage for the treatment of erosive esophagitis that has been diagnosed by endoscopy is 1600 mg daily in divided doses (800 mg b.i.d. or 400 mg q.i.d.) for 12 weeks. The use of cimetidine beyond 12 weeks has not been established.<br/>Pathological Hypersecretory Conditions: (such as Zollinger-Ellison Syndrome) Recommended adult oral dosage: 300 mg four times a day with meals and at bedtime. In some patients it may be necessary to administer higher doses more frequently. Doses should be adjusted to individual patient needs, but should not usually exceed 2400 mg per day and should continue as long as clinically indicated.<br/>Dosage Adjustment for Patients with Impaired Renal Function: Patients with severely impaired renal function have been treated with cimetidine. However, such usage has been very limited. On the basis of this experience the recommended dosage is 300 mg every 12 hours orally or by intravenous injection. Should the patient's condition require, the frequency of dosing may be increased to every 8 hours or even further with caution. In severe renal failure, accumulation may occur and the lowest frequency of dosing compatible with an adequate patient response should be used. When liver impairment is also present, further reductions in dosage may be necessary. Hemodialysis reduces the level of circulating cimetidine. Ideally, the dosage schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.
|
| dailymed-drugs:117 |
Duodenal Ulcer:<br/>Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.<br/>Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.<br/>Benign Gastric Ulcer: Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.<br/>Gastroesophageal Reflux Disease (GERD): The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks .<br/>Dosage for Pediatric Patients 1-16 years of age: See PRECAUTIONS, Pediatric Patients 1-16 years of age. The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age. Peptic Ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day. Gastroesophageal Reflux Disease with or without Esophagitis Including Erosions and Ulcerations���1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.<br/>Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas): The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.<br/>Oral Suspension: Famotidine for oral suspension may be substituted for famotidine tablets in any of the above indications.<br/>Concomitant Use of Antacids: Antacids may be given concomitantly if needed.<br/>Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency: In adult patients with moderate (creatinine clearance<50 mL/min) or severe (creatinine clearance<10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48hours as indicated by the patient's clinical response. Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
|
| dailymed-drugs:118 |
Carefully consider the potential benefits and risks
of INDOCIN and other treatment options before deciding to use INDOCIN.
Use the lowest effective dose for the shortest duration consistent
with individual patient treatment goals . After
observing the response to initial therapy with INDOCIN, the dose and
frequency should be adjusted to suit an individual patient's
needs. Oral Suspension INDOCIN contains 25 mg of indomethacin per 5 mL. Adverse reactions appear to correlate with the size of the dose of INDOCIN in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.<br/>Pediatric Use: INDOCIN ordinarily should not be prescribed for pediatric
patients 14 years of age and under .<br/>Adult Use: Dosage Recommendations for Active Stages of the Following:
|
| dailymed-drugs:119 |
Adults: Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). CLAFORAN may be administered IM or IV after reconstitution. Premixed CLAFORAN Injection is intended for IV administration after thawing. The maximum daily dosage should not exceed 12 grams. If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism. To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery.<br/>Cesarean Section Patients: The first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose.<br/>Neonates, Infants, and Children: The following dosage schedule is recommended: Neonates (birth to 1 month): ���1 week of age 50 mg/kg per dose every 12 hours IV1���4 weeks of age 50 mg/kg per dose every 8 hours IV It is not necessary to differentiate between premature and normal-gestational age infants. Infants and Children (1 month to 12 years): For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.<br/>Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.<br/>Impaired Renal Function: see PRECAUTIONS, General. NOTE: As with antibiotic therapy in general, administration of CLAFORAN should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller thanthose indicated above should not be used.<br/>Preparation of CLAFORAN Sterile: CLAFORAN for IM or IV administration should be reconstituted as follows: Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of CLAFORAN range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.<br/>For intramuscular use: Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.<br/>For intravenous use: Reconstitute VIALS with at least 10 mL of Sterile Water for Injection. Reconstitute INFUSION BOTTLES with 50 or 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection. For other diluents, see COMPATIBILITY AND STABILITY section. NOTE: Solutions of CLAFORAN must not be admixed with aminoglycoside solutions. If CLAFORAN and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection. A SOLUTION OF 1 G CLAFORAN IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.<br/>IM Administration: As with all IM preparations, CLAFORAN should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.<br/>IV Administration: The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending. For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. . With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing CLAFORAN, it is advisable to discontinue temporarily the administration of other solutions at the same site. For the administration of higher doses by continuous IV infusion, a solution of CLAFORAN may be added to IV bottles containing the solutions discussed below.<br/>Directions for use of CLAFORAN Injection in Galaxy Container (PL 2040 Plastic): CLAFORAN Injection in Galaxy containers (PL 2040 plastic) is for continuous or intermittent infusion using sterile equipment.<br/>Storage: Store in a freezer capable of maintaining a temperature of -20��C/-4��F.<br/>Thawing of Plastic Container: Thaw frozen container at room temperature or under refrigeration (at or below 5��C). [DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.] Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired. DO NOT ADD SUPPLEMENTARY MEDICATION. The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded. The thawed solution is stable for 10 days under refrigeration (at or below 5��C) or 24 hours at or below 22��C. Do not refreeze thawed antibiotics. CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.<br/>Preparation for Intravenous Administration:<br/>Preparation of CLAFORAN Sterile in ADD-Vantage System: CLAFORAN Sterile 1 g or 2 g may be reconstituted in 50 mL or 100 mL of 5% Dextrose or 0.9% Sodium Chloride in the ADD-Vantage diluent container. Refer to enclosed, separate INSTRUCTIONS FOR ADD-VANTAGE SYSTEM.<br/>Compatibility and Stability: Solutions of CLAFORAN Sterile reconstituted as described above remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes: Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen. Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22��C, and at least 5 days under refrigeration (at or below 5��C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL (Amino Acid) Injection without Electrolytes. Solutions of CLAFORAN Sterile reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in Viaflex plastic containers maintain satisfactory potency for 24 hours at or below 22��C, 5 days under refrigeration (at or below 5��C) and 13 weeks frozen. Solutions of CLAFORAN Sterile reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in the ADD-Vantage flexible containers maintain satisfactory potency for 24 hours at or below 22��C. DO NOT FREEZE. NOTE: CLAFORAN solutions exhibit maximum stability in the pH 5���7 range. Solutions of CLAFORAN should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|
| dailymed-drugs:120 |
Single-Agent Vinorelbine: The usual initial dose of single-agent Vinorelbine is 30 mg/madministered weekly. The recommended method of administration is an intravenous injection over 6 to 10 minutes. In controlled trials, single-agent Vinorelbine was given weekly until progression or dose-limiting toxicity.<br/>Vinorelbine in Combination with Cisplatin: Vinorelbine may be administered weekly at a dose of 25 mg/min combination with cisplatin given every 4 weeks at a dose of 100 mg/m. Blood counts should be checked weekly to determine whether dose reductions of Vinorelbine and/or cisplatin are necessary. In the SWOG study, most patients required a 50% dose reduction of Vinorelbine at day 15 of each cycle and a 50% dose reduction of cisplatin by cycle 3. Vinorelbine may also be administered weekly at a dose of 30 mg/min combination with
cisplatin, given on days 1 and 29, then every 6 weeks at a dose of 120 mg/m.<br/>Dose Modifications for Vinorelbine: The dosage should be adjusted according to hematologic toxicity or hepatic insufficiency, whichever results in the lower dose for the corresponding starting dose of Vinorelbine (see Table 5). Dose Modifications for Hematologic Toxicity: Granulocyte counts should be���1,000 cells/mmprior to the administration of Vinorelbine. Adjustments in the dosage of Vinorelbine should be based on granulocyte counts obtained on the day of treatment according to Table 5. Dose Modifications for Hepatic Insufficiency: Vinorelbine should be administered with caution to patients with hepatic insufficiency. In patients who develop hyperbilirubinemia during treatment with Vinorelbine, the dose should be adjusted for total bilirubin according to Table 6. Dose Modifications for Concurrent Hematologic Toxicity and Hepatic Insufficiency: In patients with both hematologic toxicity and hepatic insufficiency, the lower of the doses based on the corresponding starting dose of Vinorelbine determined from Table 5 and Table 6 should be administered. Dose Modifications for Renal Insufficiency: No dose adjustments for Vinorelbine are required for renal insufficiency. Appropriate dose reductions for cisplatin should be made when
Vinorelbine is used in combination. Dose Modifications for Neurotoxicity: If Grade���2 neurotoxicity develops, Vinorelbine should be discontinued.<br/>Administration Precautions: Caution - Vinorelbine must be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any
Vinorelbine is injected. Leakage into surrounding tissue during intravenous administration of
Vinorelbine may cause considerable irritation, local tissue necrosis, and/orthrombophlebitis. If
extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Since there are no established guidelines for the treatment of extravasation injuries with Vinorelbine, institutional guidelines may be used. The ONS Chemotherapy Guidelines provide additional recommendations for the prevention of extravasation injuries. As with other toxic compounds, caution should be exercised in handling and preparing the solution of Vinorelbine. Skin reactions may occur with accidental exposure. The use of gloves is recommended. If the solution of Vinorelbine contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water. Severe irritation of the eye has been reported with accidental contamination of the eye with another vinca alkaloid. If this happens with Vinorelbine, the eye should be flushed with water immediately and thoroughly. Procedures for proper handling and disposal of anticancer drugs should be used. Several guidelines on this subject have been published.There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Vinorelbine Injection is a clear, colorless to pale yellow solution. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. If particulate matter is seen, Vinorelbine should not be administered.<br/>Preparation for Administration: Vinorelbine Injection must be diluted in either a syringe or
IV bag using one of the recommended solutions. The diluted Vinorelbine should be administered over 6 to 10 minutes into the side port of a free-flowing IV closest to the IV bag followed by flushing with at least 75 to 125 mL of one of the solutions. Diluted Vinorelbine may be used for up to 24 hours under normal room light when stored in polypropylene syringes or polyvinyl ch loride bags at 5��to 30��C (41��to 86��F). Syringe:The calculated dose of Vinorelbine should be diluted to a concentration between 1.5 and 3.0 mg/mL. The following solutions may be used for dilution: IV Bag: The calculated dose of Vinorelbine should be diluted to a concentration between 0.5 and 2 mg/mL. The following solutions may be used for dilution:<br/>Stability: Unopened vials of Vinorelbine are stable until the date indicated on the package when stored under refrigeration at 2��to 8��C (36��to 46��F) and protected from light in the carton.
Unopened vials of Vinorelbine are stable at temperatures up to 25��C (77��F) for up to 72 hours.
This product should not be frozen.
|
| dailymed-drugs:122 |
IF THERE IS ANY QUESTION OF OCCULT OPIOID DEPENDENCE, PERFORM A NALOXONE CHALLENGE TEST AND DO NOT INITIATE NALTREXONE THERAPY UNTIL THE NALOXONE CHALLENGE IS NEGATIVE.<br/>Treatment of Alcoholism:: A dose of 50 mg once daily is recommended for most patients (see Individualization of Dosage). The placebo-controlled studies that demonstrated the efficacy of naltrexone hydrochloride as an adjunctive treatment of alcoholism used a dose regimen of naltrexone hydrochloride 50 mg once daily for up to 12 weeks. Other dose regimens or durations of therapy were not evaluated in these trials. A patient is a candidate for treatment with naltrexone if: Refer to CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS Sections for additional information. Naltrexone should be considered as only one of many factors determining the success of treatment of alcoholism. Factors associated with a good outcome in the clinical trials with naltrexone were the type, intensity, and duration of treatment; appropriate management of comorbid conditions; use of community-based support groups; and good medication compliance. To achieve the best possible treatment outcome, appropriate compliance-enhancing techniques should be implemented for all components of the treatment program, especially medication compliance.<br/>Treatment of Opioid Dependence::<br/>Initiate treatment with naltrexone using the following guidelines::<br/>Intravenous:: Inject 0.2 mg naloxone.Observe for 30 seconds for signs or symptoms of withdrawal.If no evidence of withdrawal, inject 0.6 mg of naloxone.Observe for an additional 20 minutes.<br/>Subcutaneous:: Administer 0.8 mg naloxone.Observe for 20 minutes for signs or symptoms of withdrawal.Note: Individual patients, especially those with opioid dependence, may respond to lower doses of naloxone. In some cases, 0.1 mg IV naloxone has produced a diagnostic response.<br/>Alternative Dosing Schedules:: Once the patient has been started on naltrexone hydrochloride, 50 mg every 24 hours will produce adequate clinical blockade of the actions of parenterally administered opioids (i.e., this dose will block the effects of a 25 mg intravenous heroin challenge). A flexible approach to a dosing regimen may need to be employed in cases of supervised administration. Thus, patients may receive 50 mg of naltrexone hydrochloride every weekday with a 100 mg dose on Saturday, 100 mg every other day, or 150 mg every third day. The degree of blockade produced by naltrexone may be reduced by these extended dosing intervals. There may be a higher risk of hepatocellular injury with single doses above 50 mg, and use of higher doses and extended dosing intervals should balance the possible risks against the probable benefits (see WARNINGS and Individualization of Dosage).<br/>Patient Compliance:: Naltrexone should be considered as only one of many factors determining the success of treatment. To achieve the best possible treatment outcome, appropriate compliance-enhancing techniques should be implemented for all components of the treatment program, including medication compliance.
|
| dailymed-drugs:123 |
Vial contents must be mixed and diluted before use.<br/>Dose:: Totect���should be given once daily for 3 consecutive days. The first infusion should be initiated as soon as possible and within the first six hours after extravasation. The Totect���dose should be reduced by 50% in patients with creatinine clearance values<40 mL/min.<br/>Preparation and administration:: The indicated dose should be administered as an intravenous infusion over 1 to 2 hours in a large caliber vein in an extremity/area other than the one affected by the extravasation. Cooling procedures such as ice packs, if used, should be removed from the area at least 15 minutes before Totect���administration in order to allow sufficient blood flow to the area of extravasation. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the first day.<br/>Directions for Mixing and Diluting:: Read this entire section carefully before mixing and diluting. Aseptic technique should be used during preparation. Totect���should not be mixed or administered with any other drug during infusion. The individual dosage is based on calculation of the body surface area (BSA) up to a maximum dose of 2000 mg (each on Day 1 and 2) and 1000 mg (Day 3), corresponding to a BSA of 2 m. Totect���is provided in a carton containing 10 vials of Totect���(dexrazoxane for injection) and 10 vials of diluent, to provide 3 days of treatment for 1 patient. Before infusion, each vial of dexrazoxane (contains 589 mg dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane) must be mixed with 50 mL of diluent. The mixed solution should be further diluted in 1000 mL 0.9% NaCl.<br/>Preparation of the Totect���mixed and diluted solution.: The solution of Totect���is slightly yellow. Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Solutions containing a precipitate should be discarded. Vials are for single use only. Unused solution should be discarded. The reconstituted product should be used immediately after mixing and diluting as it contains no antibacterial preservative. The product is stable for 4 hours from the time of mixing and diluting when stored below 25��C (77��F).<br/>Instructions for handling and disposal: Caution must be exercised when handling Totect, preparing the mixed solution and disposing of the product. Procedures for proper handling of cytotoxic drugs should be adopted, as outlined in the references. Direct contact of Totectwith the skin or mucous membranes prior to and following reconstitution should be avoided. If contact occurs, wash immediately and thoroughly with water.
|
| dailymed-drugs:124 |
This product is intended for intravenous administration only.<br/>Dosage:<br/>Adults: The usual adult dosage range for cefuroxime is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days. In uncomplicated urinary tract infections, skin and skin-structure infections, disseminated gonococcal infections, and uncomplicated pneumonia, a 750 mg dose every 8 hours is recommended. In severe or complicated infections, a 1.5 gram dose every 8 hours is recommended. In bone and joint infections, a 1.5 gram dose every 8 hours is recommended. In clinical trials, surgical intervention was performed when indicated as an adjunct to cefuroxime therapy. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of cefuroxime. In life-threatening infections or infections due to less susceptible organisms, 1.5 grams every 6 hours may be required. In bacterial meningitis, the dosage should not exceed 3 grams every 8 hours. For preventive use for clean-contaminated or potentially contaminated surgical procedures, a 1.5 gram dose administered intravenously justbefore surgery (approximately one-half to 1 hour before the initial incision) is recommended. Thereafter, give 750 mg intravenously every 8 hours when the procedure is prolonged. For preventive use during open heart surgery, a 1.5 gram dose administered intravenously at the induction of anesthesia and every 12 hours thereafter for a total of 6 grams is recommended.<br/>Impaired Renal Function: A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism (see Table 2). When only serum creatinine is available, the following formula(based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function. Note: As with antibiotic therapy in general, administration of Cefuroxime for Injection USP and Dextrose Injection USP should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment for several weeks; and doses smaller than those indicated above should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.<br/>Pediatric Patients Above 3 Months of Age: Administration of 50 to 100 mg/kg/day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to cefuroxime. The higher dosage of 100 mg/kg/day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections. In bone and joint infections, 150 mg/kg/day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hours. In clinical trials, a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of cefuroxime. In cases of bacterial meningitis, a larger dosage of cefuroxime is recommended, 200 to 240 mg/kg/day intravenously in divided doses every 6 to 8 hours. In pediatric patients with renal insufficiency, the frequency of dosing should be modified consistent with the recommendations for adults. Cefuroxime for Injection USP and Dextrose for Injection USP in the DUPLEX Container is designed to deliver a 750 mg or 1.5 g dose of cefuroxime. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose. For intermittent IV infusion with a Y-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing Cefuroxime, it is advisable to temporarily discontinue administration of any other solutions at the same site. Solutions of cefuroxime, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction. However, if concurrent therapy with cefuroxime and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient. Use sterile equipment. Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.<br/>DUPLEX Drug Delivery System Directions for Use: Patient Labeling and Drug Powder/Diluent Inspection Reconstitution (Activation) Administration Precautions
|
| dailymed-drugs:125 |
Adults: The usual dose for the relief of dyspnea caused by acute bronchospasm is one or two inhalations. Start with a single inhalation. If no relief is evident after two to five minutes, a second inhalation may be taken. For daily maintenance, use one or two inhalations four to six times daily or as directed by the physician. The physician should be careful to instruct the patient in the proper technique of administration so that the number of inhalations per treatment and the frequency of retreatment may be titrated to the patient's response. No more than two inhalations should be taken at any one time, nor more than six inhalations in any one hour during a 24-hour period, unless advised by the physician. Lower doses in elderly patients may be required due to increased sympathomimetic sensi��tivity. Each depression of the valve delivers through the oral adapter 0.16 mg isoproterenol hydrochloride and 0.24 mg phenylephrine bitartrate. Children: Safety and effectiveness for children under 12 years have not yet been established (see Pediatric Use).
|
| dailymed-drugs:126 |
Cardene I.V. (nicardipine hydrochloride) is intended for intravenous use. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing. Blood pressure should be monitored both during and after the infusion; too rapid or excessive reduction in either systolic or diastolic blood pressure during parenteral treatment should be avoided.<br/>PREPARATION: WARNING: AMPULS MUST BE DILUTED BEFORE INFUSION Dilution:Cardene I.V. is administered by slow continuous infusion at a CONCENTRATION OF 0.1 MG/ML. Each ampul (25 mg) should be diluted with 240 mL of compatible intravenous fluid (see below), resulting in 250 mL of solution at a concentration of 0.1 mg/mL. Cardene I.V. has been found to be compatible and stable in glass or polyvinyl chloride containers for 24 hours at controlled room temperature with: Dextrose (5%) Injection, USPDextrose (5%) and Sodium Chloride (0.45%) Injection, USPDextrose (5%) and Sodium Chloride (0.9%) Injection, USPDextrose (5%) with 40 mEq Potassium, USPSodium Chloride (0.45%) Injection, USPSodium Chloride (0.9%) Injection, USP Cardene I.V. is NOT compatible with Sodium Bicarbonate (5%) Injection, USP or Lactated Ringer's Injection, USP. THE DILUTED SOLUTION IS STABLE FOR 24 HOURS AT ROOM TEMPERATURE. Inspection:As with all parenteral drugs, Cardene I.V. should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Cardene I.V. is normally light yellow in color.<br/>DOSAGE: As a Substitute for Oral Nicardipine Therapy The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table: For Initiation of Therapy in a Drug Free Patient The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. Cardene I.V. is administered by slow continuous infusion at a CONCENTRATION OF 0.1 MG/ML. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes and does not reach final steady state for about 50 hours. When treating acute hypertensive episodes in patients with chronic hypertension, discontinuation of infusion is followed by a 50% offset of action in 30��7 minutes but plasma levels of drug and gradually decreasing antihypertensive effects exist for about 50 hours. Titration: For gradual reduction in blood pressure, initiate therapy at 50 mL/hr (5.0 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 15 minutes up to a maximum of 150 mL/hr (15.0 mg/hr), until desired blood pressure reduction is achieved. For more rapid blood pressure reduction, initiate therapy at 50 mL/hr (5.0 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 5 minutes up to a maximum of 150 mL/hr (15.0 mg/hr), until desired blood pressure reduction is achieved. Following achievement of the blood pressure goal, the infusion rate should be decreased to 30 mL/hr (3 mg/hr). Maintenance: The rate of infusion should be adjusted as needed to maintain desired response.<br/>CONDITIONS REQUIRING INFUSION ADJUSTMENT: Hypotension or Tachycardia:If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. When blood pressure has stabilized, infusion of Cardene I.V. may be restarted at low doses such as 30 - 50 mL/hr (3.0 - 5.0 mg/hr) and adjusted to maintain desired blood pressure. Infusion Site Changes:Cardene I.V. should be continued as long as blood pressure control is needed. The infusion site should be changed every 12 hours if administered via peripheral vein. Impaired Cardiac, Hepatic, or Renal Function:Caution is advised when titrating Cardene I.V. in patients with congestive heart failure or impaired hepatic or renal function (see���Precautions���).<br/>TRANSFER TO ORAL ANTIHYPERTENSIVE AGENTS: If treatment includes transfer to an oral antihypertensive agent other than Cardene capsules, therapy should generally be initiated upon discontinuation of Cardene I.V. If Cardene capsules are to be used, the first dose of a TID regimen should be administered 1 hour prior to discontinuation of the infusion.
|
| dailymed-drugs:128 |
Ativan (lorazepam) is administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available. The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day. For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d. For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime. For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated. The dosage of Ativan (lorazepam) should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.
|
| dailymed-drugs:129 |
In the treatment of interdigital tinea pedis, ERTACZO Cream, 2%, should be applied twice daily for 4 weeks. Sufficient ERTACZO Cream, 2%, should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis. If a patient shows no clinical improvement 2 weeks after the treatment period, the diagnosis should be reviewed.
|
| dailymed-drugs:131 |
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor: It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
|
| dailymed-drugs:132 |
The dosage of Visken (pindolol) should be individualized. The recommended initial dose of Visken (pindolol) is 5 mg b.i.d. alone or in combination with other antihypertensive agents. An antihypertensive response usually occurs within the first week of treatment. Maximal response, however, may take as long as or occasionally longer than 2 weeks. If a satisfactory reduction in blood pressure does not occur within 3-4 weeks, the dose may be adjusted in increments of 10 mg/day at these intervals up to a maximum of 60 mg/day.
|
| dailymed-drugs:134 |
Active Duodenal Ulcer: The current recommended adult oral dosage of ZANTAC
for duodenal ulcer is 150 mg or 10 mL of syrup (2 teaspoonfuls
of syrup equivalent to 150 mg of ranitidine) twice daily. An
alternative dosage of 300 mg or 20 mL of syrup (4 teaspoonfuls
of syrup equivalent to 300 mg of ranitidine) once daily after
the evening meal or at bedtime can be used for patients in whom dosing
convenience is important. The advantages of one treatment regimen
compared to the other in a particular patient population have yet
to be demonstrated (see Clinical Trials: Active Duodenal Ulcer). Smaller doses have been shown to be equally effective
in inhibiting gastric acid secretionin US studies, and several foreign
trials have shown that 100 mg twice daily is as effective as
the 150-mg dose. Antacid should be given
as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).<br/>Maintenance of Healing of
Duodenal Ulcers: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) at bedtime.<br/>Pathological Hypersecretory
Conditions (such as Zollinger-Ellison syndrome): The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) twice a day. In some patients it may be
necessary to administer ZANTAC 150-mg doses more frequently. Dosages
should be adjusted to individual patient needs, and should continue
as long as clinically indicated. Dosages up to 6 g/day have been
employed in patients with severe disease.<br/>Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) twice a day.<br/>Maintenance of Healing of
Gastric Ulcers: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) at bedtime.<br/>GERD: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) twice a day.<br/>Erosive Esophagitis: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) 4 times a day.<br/>Maintenance of Healing of
Erosive Esophagitis: The current recommended adult oral dosage is 150 mg
or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to
150 mg of ranitidine) twice a day.<br/>Pediatric Use: The safety and effectiveness of ZANTAC have been
established in the age-group of 1 month to 16 years. There
is insufficient information about the pharmacokinetics of ZANTAC in
neonatal patients (less than 1 month of age) to make dosing recommendations. The following 3 subsections provide dosing information
for each of the pediatric indications. Also, see the subsection on
Preparation of ZANTAC 25 EFFERdose Tablets, below.<br/>Treatment of Duodenal and
Gastric Ulcers: The recommended oral dose for the treatment of active
duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a
maximum of 300 mg/day. This recommendation is derived from adult
clinical studies and pharmacokinetic data in pediatric patients.<br/>Maintenance of Healing of
Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of
healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily
to a maximum of 150 mg/day. This recommendation is derived from
adult clinical studies and pharmacokinetic data in pediatric patients.<br/>Treatment of GERD and Erosive
Esophagitis: Although limited data exist for these conditions
in pediatric patients, published literature supports a dosage of 5
to 10 mg/kg per day, usually given as 2 divided doses.<br/>Dosage Adjustment for Patients
With Impaired Renal Function: On the basis of experience with a group of subjects
with severely impaired renal function treated with ZANTAC, the recommended
dosage in patients with a creatinine clearance<50 mL/min
is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup
equivalent to 150 mg of ranitidine) every 24 hours. Should
the patient's condition require, the frequency of dosing may be increased
to every 12 hours or even further with caution. Hemodialysis
reduces the level of circulating ranitidine. Ideally, the dosing schedule
should be adjusted so that the timing of a scheduled dose coincides
with the end of hemodialysis. Elderly patients
are more likely to have decreased renal function, therefore caution
should be exercised in dose selection, and it may be useful to monitor
renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics
and PRECAUTIONS: Geriatric Use).<br/>Preparation of ZANTAC 25 EFFERdose
Tablets: Tablets should
not be chewed, swallowed whole, or dissolved on the tongue. Dissolve
1 tablet in no less than 5 mL (1 teaspoonful) of water in an
appropriate measuring cup. Wait until the tablet is completely dissolved
before administering the solution to the infant/child. The solution
may be administered by medicine dropper or oral syringe for infants.
|
| dailymed-drugs:135 |
Treatment of Erosive Esophagitis: The recommended
adult oral dose is 40 mg given once daily for up to 8 weeks.
For those patients who have not healed after 8 weeks of treatment,
an additional 8-week course of PROTONIX may be considered .<br/>Maintenance of Healing of Erosive Esophagitis: The recommended
adult oral dose is PROTONIX 40 mg, taken daily (see CLINICAL PHARMACOLOGY, Clinical
Studies).<br/>Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome: The dosage of PROTONIX
in patients with pathological hypersecretory conditions varies with
the individual patient. The recommended adult starting dose is 40 mg
twice daily. Dosage regimens should be adjusted to individual patient
needs and should continue for as long as clinically indicated. Doses
up to 240 mg daily have been administered. Some patients have
been treated continuously with PROTONIX for more than 2 years. No dosage adjustment is
necessary in patients with renal impairment, hepatic impairment, or
for elderly patients. Doses higher than 40 mg/day have not been
studied in hepatically-impaired patients. No dosage adjustment is
necessary in patients undergoing hemodialysis. PROTONIX Delayed-Release Tablets should be swallowed whole, with
or without food in the stomach. If patients are unable to swallow
a 40 mg tablet, two 20 mg tablets may be taken. Concomitant
administration of antacids does not affect the absorption of PROTONIX
Delayed-Release Tablets.<br/>Administration Options:<br/>PROTONIX For Delayed-Release Oral Suspension
- Oral Administration in Applesauce::<br/>PROTONIX For Delayed-Release Oral Suspension
- Oral Administration in Apple Juice::<br/>PROTONIX For Delayed-Release Oral Suspension
- Nasogastric Tube Administration: For patients who have a nasogastric tube in place,
PROTONIX For Delayed-Release Oral Suspension can be administered as
follows:
|
| dailymed-drugs:136 |
Alprazolam extended-release tablets may be administered once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken. The suggested total daily dose ranges between 3 to 6 mg/day. Dosage should be individualized for maximum beneficial effect. While the suggested total daily dosages given will meet the needs of most patients, there will be some patients who require doses greater than 6 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.<br/>Dosing in Special Populations: In elderly patients, in patients with advanced liver disease, or in patients with debilitating disease, the usual starting dose of alprazolam extended-release tablets is 0.5 mg once daily. This may be gradually increased if needed and tolerated (see Dose Titration). The elderly may be especially sensitive to the effects of benzodiazepines.<br/>Dose Titration: Treatment with alprazolam extended-release tablets may be initiated with a dose of 0.5 mg to 1 mg once daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. Slower titration to the dose levels may be advisable to allow full expression of the pharmacodynamic effect of alprazolam extended-release tablets. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (i.e., a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.<br/>Dose Maintenance: In controlled trials conducted to establish the efficacy of alprazolam extended-release tablets in panic disorder, doses in the range of 1 to 10 mg/day were used. Most patients showed efficacy in the dose range of 3 to 6 mg/day. Occasional patients required as much as 10 mg/day to achieve a successful response. The necessary duration of treatment for panic disorder patients responding to alprazolam extended-release tablets is unknown. However, periodic reassessment is advised. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.<br/>Dose Reduction: Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided . In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction. In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled post-marketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every three days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.<br/>Switch from Alprazolam (immediate-release) Tablets to Alprazolam Extended-Release Tablets: Patients who are currently being treated with divided doses of alprazolam (immediate-release) tablets, for example 3 to 4 times a day, may be switched to alprazolam extended-release tablets at the same total daily dose taken once daily. If the therapeutic response after switching is inadequate, the dosage may be titrated as outlined above.
|
| dailymed-drugs:137 |
Major Depressive Disorder:<br/>Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of paroxetine in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 20-mg dose may benefit from dose increases, in 10-mg/dayincrements, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week.<br/>Maintenance Therapy: There is no body of evidence available to answer the question
of how long the patient treated with paroxetine should remain on it. It is generally
agreed that acute episodes of major depressive disorder require several months
or longer of sustained pharmacologic therapy. Whether the dose needed to induce
remission is identical to the dose needed to maintain and/or sustain euthymia
is unknown. Systematic evaluation of the efficacy of
paroxetine has shown that efficacy is maintained for periods of up to 1 year
with doses that averaged about 30 mg.<br/>Obsessive Compulsive Disorder:<br/>Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of paroxetine in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10-mg/day increments. Dose changes should occur at intervals of at least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.<br/>Maintenance Therapy: Long-term maintenance of efficacy was demonstrated in a
6-month relapse prevention trial. In this trial, patients with OCD assigned
to paroxetine demonstrated a lower relapse rate compared to patients on placebo
(see CLINICAL PHARMACOLOGY���Clinical Trials). OCD is a chronic condition,
and it is reasonable to consider continuation for a responding patient. Dosage
adjustments should be made to maintain the patient on the lowest effective
dosage, and patients should be periodically reassessed to determine the need
for continued treatment.<br/>Panic Disorder:<br/>Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The target dose of paroxetine in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10-mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine. The maximum dosage should not exceed 60 mg/day.<br/>Maintenance Therapy: Long-term maintenance of efficacy was demonstrated in a
3-month relapse prevention trial. In this trial, patients with panic disorder
assigned to paroxetine demonstrated a lower relapse rate compared to patients
on placebo (see CLINICAL PHARMACOLOGY���Clinical Trials). Panic disorder
is a chronic condition, and it is reasonable to consider continuation for
a responding patient. Dosage adjustments should be made to maintain the patient
on the lowest effective dosage, and patients should be periodically reassessed
to determine the need for continued treatment.<br/>Social Anxiety Disorder:<br/>Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day. In clinical trials the effectiveness of paroxetine was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of paroxetine has been evaluated in patients with social anxiety disorder at doses up to 60 mg/day, available information does not suggest any additional benefit for doses above 20 mg/day (see CLINICAL PHARMACOLOGY���Clinical Trials).<br/>Maintenance Therapy: There is no body
of evidence available to answer the question of how long the patient treated
with paroxetine should remain on it. Although the efficacy of paroxetine beyond 12 weeks
of dosing has not been demonstrated in controlled clinical trials, social
anxiety disorder is recognized as a chronic condition, and it is reasonable
to consider continuation of treatment for a responding patient. Dosage adjustments
should be made to maintain the patient on the lowest effective dosage, and
patients should be periodically reassessed to determine the need for continued
treatment.<br/>Generalized Anxiety Disorder:<br/>Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of paroxetine was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week.<br/>Maintenance Therapy: Systematic evaluation
of continuing paroxetine for periods of up to 24 weeks in patients with Generalized
Anxiety Disorder who had responded while taking paroxetine during an 8-week acute
treatment phase has demonstrated a benefit of such maintenance (see CLINICAL
PHARMACOLOGY���Clinical Trials). Nevertheless, patients should be periodically
reassessed to determine the need for maintenance treatment.<br/>Special Populations:<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to paroxetine and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see WARNINGS). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering paroxetine in the third trimester.<br/>Dosage for Elderly or Debilitated Patients, and Patients With Severe
Renal or Hepatic Impairment: The recommended initial dose is 10 mg/day for elderly
patients, debilitated patients, and/or patients with severe renal or hepatic
impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.<br/>Switching Patients to or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with paroxetine. Similarly, at least 14 days should be allowed after stopping paroxetine before starting an MAOI.<br/>Discontinuation of Treatment With Paroxetine: Symptoms associated with discontinuation of paroxetine have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which paroxetine is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
|
| dailymed-drugs:139 |
PARENTERAL:: Intravenous. Dissolve 500,000 polymyxin B units in 300 to 500 mL solutions for parenteral dextrose injection 5% for continuous drip. Adults and children. 15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day. Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects. Intramuscular. Not recommended routinely because of severe pain at injection sites, particularly in infants and children. Dissolve 500,000 polymyxin B units in 2 mL sterile water for injection or sodium chloride injection or procaine hydrochloride injection 1%. Adults and children. 25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals. Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects. Note: Doses as high as 45,000 units/kg/day have been used in limited clinical studies in treating prematures and newborn infants for sepsis caused by Ps aeruginosa. Intrathecal. A treatment of choice for Ps aeruginosa meningitis. Dissolve 500,000 polymyxin B units in 10 mL sodium chloride injection USP for 50,000 units per mL dosage unit. Adults and children over 2 years of age. Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal. Children under 2 years of age. 20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal. IN THE INTEREST OF SAFETY, SOLUTIONSOF PARENTERAL USE SHOULD BE STOREDUNDER REFRIGERATION, AND ANYUNUSED PORTIONS SHOULD BE DISCARDEDAFTER 72 HOURS.<br/>TOPICAL:: Ophthalmic.Dissolve 500,000 polymyxin B units in 20 to 50 mL sterile water for injection or sodium chloride injection USP for a 10,000 to 25,000 units per mL concentration. For the treatment of Ps aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates. Subconjunctival injection of up to 100,000 units/day may be used for the treatment of Ps aeruginosa infections of the cornea and conjunctiva. Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.
|
| dailymed-drugs:3771 |
PARENTERAL:: Intravenous. Dissolve 500,000 polymyxin B units in 300 to 500 mL solutions for parenteral dextrose injection 5% for continuous drip. Adults and children. 15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day. Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects. Intramuscular. Not recommended routinely because of severe pain at injection sites, particularly in infants and children. Dissolve 500,000 polymyxin B units in 2 mL sterile water for injection or sodium chloride injection or procaine hydrochloride injection 1%. Adults and children. 25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals. Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects. Note: Doses as high as 45,000 units/kg/day have been used in limited clinical studies in treating prematures and newborn infants for sepsis caused by Ps aeruginosa. Intrathecal. A treatment of choice for Ps aeruginosa meningitis. Dissolve 500,000 polymyxin B units in 10 mL sodium chloride injection USP for 50,000 units per mL dosage unit. Adults and children over 2 years of age. Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal. Children under 2 years of age. 20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal. IN THE INTEREST OF SAFETY, SOLUTIONSOF PARENTERAL USE SHOULD BE STOREDUNDER REFRIGERATION, AND ANYUNUSED PORTIONS SHOULD BE DISCARDEDAFTER 72 HOURS.<br/>TOPICAL:: Ophthalmic.Dissolve 500,000 polymyxin B units in 20 to 50 mL sterile water for injection or sodium chloride injection USP for a 10,000 to 25,000 units per mL concentration. For the treatment of Ps aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates. Subconjunctival injection of up to 100,000 units/day may be used for the treatment of Ps aeruginosa infections of the cornea and conjunctiva. Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.
|
| dailymed-drugs:140 |
These solutions are for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|
| dailymed-drugs:141 |
Depending on the severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 to 10 mg and should be divided and given at six- to eight- hour intervals. The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug may vary from patient to patient. In general, the oral dose has been found to be approximately two to three times the parenteral dose of fluphenazine. Treatment is best instituted with a low initial dosage, which may be increased, if necessary, until the desired clinical effects are achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage. Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses. When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1 to 5 mg, often given as a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may be necessary during the course of therapy to meet the patient's requirements. For psychotic patients who have been stabilized on a fixed daily dosage of orally administered Fluphenazine Hydrochloride dosage forms, conversion to the long-acting injectable Fluphenazine Decanoate may be indicated [see package insert for Fluphenazine Decanoate Injection for conversion information]. For geriatric patients, the suggested starting dose is 1 to 2.5 mg daily, adjusted according to the response of the patient. When the Oral Concentrate dosage form is to be used, the desired dose (measured by a calibrated device only) should be added to at least 60 mL (2 fl oz) of a suitable diluent just prior to administration to ensure palatability and stability. Suggested diluents include tomato or fruit juice, milk, and uncaffeinated soft drinks. The Oral Concentrate should not be mixed with beverages containing caffeine (coffee, cola), tannics (tea), or pectinates (apple juice)because of the potential incompatibility. Fluphenazine Hydrochloride Injection USP is useful when psychotic patients are unable or unwilling to take oral therapy.
|
| dailymed-drugs:142 |
The absorption of cefaclor extended-release tablets is enhanced when it is administered with food. (See CLINICAL PHARMACOLOGY.) Therefore, cefaclor extended-release tablets should be administered with meals (i.e., at least within one hour of eating). The extended-release tablets should not be cut, crushed, or chewed. See INDICATIONS AND USAGE for information about patients for whom cefaclor extended-release tablets are indicated. NOTE: 500 mg BID of cefaclor extended-release tablets is clinically equivalent to 250 mg TID of cefaclor immediate-release as a capsule in those indications listed in the INDICATIONS AND USAGE section of this label. 500 mg BID of cefaclor extended-release tablets is NOT equivalent to 500 mg TID of other cefaclor formulations.<br/>Adults (age 16 years and older): Elderly patients with normal renal function do not require dosage adjustments.
|
| dailymed-drugs:144 |
CHC Monoinfection: The recommended dose of ribavirin tablet is provided in Table 5. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks. The daily dose of ribavirin tablet is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 5). In the pivotal clinical trials, patients were instructed to take ribavirin tablets with food; therefore, patients are advised to take ribavirin tablets with food.<br/>CHC with HIV Coinfection: The recommended dose for hepatitis C in HCV/HIV coinfected patients is peginterferon alfa-2a 180 mcg sc once weekly and ribavirin tablets 800 mg po daily for a total of 48 weeks, regardless of genotype.<br/>Dose Modifications: If severe adverse reactions or laboratory abnormalities develop during combination ribavirin tablets/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, ribavirin tablets/peginterferon alfa-2a therapy should be discontinued. Ribavirin tablets should be administered with caution to patients with pre-existing cardiac disease (see Table 6). Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped . Once ribavirin tablet has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin tablets at 600 mg daily and further increase the dose to 800 mg daily depending upon the physician's judgment. However, it is not recommended that ribavirin tablets be increased to its original assigned dose (1000 mg to 1200 mg). Renal Impairment Ribavirin tablets should not be used in patients with creatinine clearance<50 mL/min .
|
| dailymed-drugs:145 |
The dose is dependent upon the age, weight and clinical
condition of the patient. Drug Interactions Additives may be
incompatible. Consult with pharmacist, if available. When introducing
additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration,
whenever solution and container permit. See PRECAUTIONS.
|
| dailymed-drugs:146 |
Mania: DEPAKOTE tablets are administered orally. The recommended
initial dose is 750 mg daily in divided doses. The dose should be increased
as rapidly as possible to achieve the lowest therapeutic dose which produces
the desired clinical effect or the desired range of plasma concentrations.
In placebo-controlled clinical trials of acute mania, patients were dosed
to a clinical response with a trough plasma concentration between 50 and 125��g/mL.
Maximum concentrations were generally achieved within 14 days. The maximum
recommended dosage is 60 mg/kg/day. There is
no body of evidence available from controlled trials to guide a clinician
in the longer term management of a patient who improves during DEPAKOTE treatment
of an acute manic episode. While it is generally agreed that pharmacological
treatment beyond an acute response in mania is desirable, both for maintenance
of the initial response and for prevention of new manic episodes, there are
no systematically obtained data to support the benefits of DEPAKOTE in such
longer-term treatment. Although there are no efficacy data that specifically
address longer-term antimanic treatment with DEPAKOTE, the safety of DEPAKOTE
in long-term use is supported by data from record reviews involving approximately
360 patients treated with DEPAKOTE for greaterthan 3 months.<br/>Epilepsy: DEPAKOTE tablets are administered orally. DEPAKOTE
is indicated as monotherapy and adjunctive therapy in complex partial seizures
in adults and pediatric patients down to the age of 10 years, and in simple
and complex absence seizures. As the DEPAKOTE dosage is titrated upward,
concentrations of phenobarbital, carbamazepine, and/or phenytoin may be affected
(see PRECAUTIONS - Drug Interactions).<br/>Complex Partial Seizures: For adults and children 10 years of age or older.<br/>Simple and Complex Absence Seizures: The recommended initial dose is 15 mg/kg/day,
increasing at one week intervals by 5 to 10 mg/kg/day until seizures
are controlled or side effects preclude further increases. The maximum recommended
dosage is 60 mg/kg/day. If the total daily dose exceeds 250 mg, it should
be given in divided doses. A good correlation
has not been established between daily dose, serum concentrations, and therapeutic
effect. However, therapeutic valproate serum concentrations for most patients
with absence seizures is considered to range from 50 to 100��g/mL.
Some patients may be controlled with lower or higher serum concentrations
(see CLINICAL PHARMACOLOGY). As the DEPAKOTE dosage is titrated upward, blood concentrations
of phenobarbital and/or phenytoin may be affected (see PRECAUTIONS). Antiepilepsy drugs should not
be abruptly discontinued in patients in whom the drug is administered to prevent
major seizures because of the strong possibility of precipitating status epilepticus
with attendant hypoxia and threat to life. In
epileptic patients previously receiving DEPAKENE (valproic acid) therapy,
DEPAKOTE tablets should be initiated at the same daily dose and dosing schedule.
After the patient is stabilized on DEPAKOTE tablets, a dosing schedule of
two or three times a day may be elected in selected patients.<br/>Migraine: DEPAKOTE tablets are administered orally. The recommended
starting dose is 250 mg twice daily. Some patients may benefit from
doses up to 1000 mg/day. In the clinical trials, there was no evidence that
higher doses led to greater efficacy.<br/>General Dosing Advice:<br/>Dosing in Elderly Patients: Due to a decrease in unbound clearance of valproate
and possibly a greater sensitivity to somnolence in the elderly, the starting
dose should be reduced in these patients. Dosage should be increased more
slowly and with regular monitoring for fluid and nutritional intake, dehydration,
somnolence, and other adverse events. Dose reductions or discontinuation
of valproate should be considered in patients with decreased food or fluid
intake and in patients with excessive somnolence. The ultimate therapeutic
dose should be achieved on the basis of both tolerability and clinical response
(see WARNINGS).<br/>Dose-Related Adverse Events: The frequency of adverse effects (particularly
elevated liver enzymes and thrombocytopenia) may be dose-related. The probability
of thrombocytopenia appears to increase significantly at total valproate concentrations
of���110��g/mL (females) or���135��g/mL
(males) (see PRECAUTIONS). The benefit
of improved therapeutic effect with higher doses should be weighed against
the possibility of a greater incidence of adverse reactions.<br/>G.I. Irritation: Patients who experience G.I. irritation may benefit
from administration of the drug with food or by slowly building up the dose
from an initial low level.
|
| dailymed-drugs:147 |
Adults: One (1) tablet or one (1) teaspoonful (5 mL) of the syrup
every 4 to 6 hours as needed; do not exceed six (6) tablets or
six (6) teaspoonfuls in 24 hours.<br/>Children 6 to 12 Years of Age: One-half (1/2) tablet or one-half (1/2) teaspoonful (2.5
mL) of the syrup every 4 to 6 hours as needed; do not exceed
three (3) tablets or three (3) teaspoonfuls in 24
hours.
|
| dailymed-drugs:148 |
Initial Treatment: Citalopram should be administered at an initial dose of 20 mg once daily, generally with an increase to a dose of 40 mg/day. Dose increases should usually occur in increments of 20 mg at intervals of no less than one week. Although certain patients may require a dose of 60 mg/day, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose; doses above 40 mg are therefore not ordinarily recommended. Citalopram should be administered once daily, in the morning or evening, with or without food.<br/>Special Populations: 20 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment, with titration to 40 mg/day only for nonresponding patients. No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram should be used with caution in patients with severe renal impairment.<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to citalopram and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with citalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering citalopram in the third trimester.<br/>Maintenance Treatment: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of citalopram in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of citalopram (20 to 60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of citalopram 20 or 40mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see Clinical Efficacy Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.<br/>Discontinuation of Treatment with Citalopram: Symptoms associated with discontinuation of citalopram and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.<br/>Switching Patients To or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of citalopram therapy. Similarly, at least 14 days should be allowed after stopping citalopram before starting a MAOI (see CONTRAINDICATIONS and WARNINGS).
|
| dailymed-drugs:150 |
Do NOT administer if solution is darker than slightly
yellow or discolored in any other way. Do NOT administer unless solution
is clear and container is undamaged. Discard unused portion. Dextrose solutions without electrolytes should not be
administered simultaneously with blood through the same infusion set
because of the possibility that pseudoagglutination of red cells may
occur. Do NOT add sodium bicarbonate or other
alkalinizing substance, since dopamine is inactivated in alkaline
solution. Dopamine Hydrochloride in 5% Dextrose
Injection should be infused into a large vein whenever possible to
prevent the infiltration of perivascular tissue adjacent to the infusion
site. Extravasation may cause necrosis and sloughing of the surrounding
tissue. Large veins of the antecubital fossa are preferred to veins
of the dorsum of the hand or ankle. Less suitable infusion sites should
be used only when larger veins are unavailable and the patient's
condition requires immediate attention. The physician should switch
to a more suitable site as soon as possible and the infusion site
in use should be continuously monitored for free flow. The less concentrated 800 mcg/mL solution may be preferred
when fluid expansion is not a problem. The more concentrated 1600
mcg/mL or 3200 mcg/mL solutions, may be preferred in patients with
fluid retention or when a slower rate of infusion is desired. Rate of Administration: Administration into an umbilical artery catheter is not recommended. Dopamine in 5% Dextrose Injection should not be infused
through ordinary I.V. apparatus, regulated only by gravity and mechanical
clamps. Only an infusion pump, preferably a volumetric pump, should
be used. Each patient must be individually
titrated to the desired hemodynamic or renal response to dopamine. In titrating to the desired increase in systolic blood
pressure, the optimum dosage rate for renal response may be exceeded,
thus necessitating a reduction in rate after the hemodynamic condition
is stabilized. If a disproportionate rise in
diastolic pressure (i.e., a marked decrease in pulse pressure) is
observed in patients receiving dopamine, the infusion rate should
be decreased and the patient observed carefully for further evidence
of predominant vasoconstrictor activity, unless such an effect is
desired. Administration rates greater than 50
mcg/kg/min have safely been used in adults in advanced circulatory
decompensation states. If unnecessary fluid expansion is of concern,
adjustment of drug concentration may be preferred over increasing
the flow rate of a less concentrated dilution. When discontinuing the infusion, it may be necessary to gradually
decrease the dose of dopamine HCl while expanding the blood volume
with I.V. fluids to prevent the development of marked hypotension. Suggested Regimen: 800 mcg/mL Dosing Chart
for Dopamine (mL/hr) Infusion Rate 1600 mcg/mL Dosing Chart
for Dopamine (mL/hr) Infusion Rate 3200 mcg/mL Dosing Chart for Dopamine (mL/hr) Infusion Rate Parenteral drug products should be visually inspected
for particulate matter and discoloration prior
to administration, whenever solution and container permit. INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution
container. Some opacity of the plastic due to moisture absorption
during the sterilization process may be observed. This is normal and
does not affect the solution quality or safety. The opacity will diminish
gradually. Preparation
for Administration (Use aseptic technique) WARNING: Do not use flexible
container in series connections.
|
| dailymed-drugs:151 |
Adults: The recommended starting dose of NIZORAL (ketoconazole)
Tablets is a single daily administration of 200 mg (one tablet). In very serious
infections or if clinical responsiveness is insufficient within the expected
time, the dose of NIZORAL Tablets may be increased to 400
mg (two tablets) once daily.<br/>Children: In small numbers of children over 2 years of age,
a single daily dose of 3.3 to 6.6 mg/kg has been used. NIZORAL Tablets
have not been studied in children under 2 years of age. There should be laboratory as well as clinical documentation
of infection prior to starting ketoconazole therapy. Treatment should be continued
until tests indicate that active fungal infection has subsided. Inadequate
periods of treatment may yield poor response and lead to early recurrence
of clinical symptoms. Minimum treatment for candidiasis is one or two weeks.
Patients with chronic mucocutaneous candidiasis usually require maintenance
therapy. Minimum treatment for the other indicated systemic mycoses is six
months. Minimum treatment for recalcitrant
dermatophyte infections is four weeks in cases involving glabrous skin. Palmar
and plantar infections may respond more slowly. Apparent cures may subsequently
recur after discontinuation of therapy in some cases.
|
| dailymed-drugs:152 |
Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.<br/>Adults:<br/>For Edema: The usual adult dosage is 25 to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.<br/>For Control of Hypertension: The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium . Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.<br/>Infants and Children:<br/>For Diuresis And For Control of Hypertension: The usual pediatric dosage is 0.5 to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required.
|
| dailymed-drugs:153 |
The dose and rate
of administration are dependent upon the specific condition of each
patient. Administer Intravenously only with a
calibrated infusion device at a slow, controlled rate. Because pain
associated with peripheral infusion of Potassium Chloride solution
has been reported, whenever possible, administration via a central
route is recommended for thorough dilution by the blood stream and
avoidance of extravasation. Highest concentrations (300 and 400
mEq/L) should be exclusively administered via central
route. Recommended
administration rates should not usually exceed 10mEq/hour or 200mEq for
a 24 hour period if the serum potassium level is greater than 2.5
mEq/liter. In urgent cases
where the serum potassium level is less than 2.0 mEq/liter or where
severe hypokalemia is a threat, (serum potassium level less than 2.0
mEq/liter and electrocardiographic changes and/or muscle paralysis)
rates up to 40 mEq/hour or 400 mEq over a 24 hour period can be
administered very carefully when guided by continuous monitoring of the
EKG and frequent serum K+ determinations to avoid hyperkalemia and
cardiac arrest. Parenteral drug
products should be inspected visually for particulate matter and
discoloration, whenever solution and container permit. Use of a final
filter is recommended during administration of all parenteral solutions
where possible.Do not add supplementary medication.
|
| dailymed-drugs:154 |
Each 100 mL of Aminosyn II contains: The total daily dose of the solution depends on
the daily protein requirements and on the patient's metabolic
and clinical response. In many patients, provision of adequate calories
in the form of hypertonic dextrose may require the administration
of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent
rebound hypoglycemia, a solution containing 5% dextrose should be
administered when hypertonic dextrose infusions are abruptly discontinued. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration,
whenever solution and container permit. Some
opacity of the plastic due to moisture absorption during the sterilization
process may be observed. This is normal and does not affect the solution
quality or safety. The opacity will diminish gradually. Aminosyn II in the 2000 mL flexible Pharmacy Bulk Package
is designed for use with manual, gravity flow operations and automated
gravimetric compounding devices for preparing intravenous nutritional
admixtures. Admixtures must be stored under refrigeration and used
within 24 hours of admixing. ADULTS Solutions containing 3.5 to 5% amino acids
with 5 to 10% glucose may be infused with a fat emulsion by peripheral
vein to provide approximately 1400 to 2000 kcal/day. Fat emulsion
administration should be considered when prolonged parenteral nutrition
is required in order to prevent essential fatty acid deficiency (E.F.A.D.).
Serum lipids should be monitored for evidence of E.F.A.D. in patients
maintained on fat-free TPN. Aminosyn II solution
should only be infused via a central vein when admixed with sufficient
dextrose to provide full caloric requirements in patients who require
prolonged total parenteral nutrition. I.V. lipid may be administered
to provide part of the calories, if desired. Serum lipids should be
monitored for evidence of essential fatty acid deficiency in patients
maintained on fat-free TPN. Total parenteral
nutrition (TPN) may be started with 10% dextrose added to the calculated
daily requirement of amino acids (1.5 g/kg for a metabolically stable
patient). Dextrose content is gradually increased over the next few
days to the estimated daily caloric need as the patient adapts to
the increasing amounts of dextrose. Each gram of dextrose provides
approximately 3.4 kcal. Each gram of fat provides 9 kcal. The average depleted major surgical patient with
complications requires between 2500 and 4000 kcal and between 12 and
24 grams of nitrogen per day. An adult patient in an acceptable weight
range with restricted activity who is not hypermetabolic, requires
about 30 kcal/kg of body weight/day. Average daily adult fluid requirements
are between 2500 and 3000 mL and may be much higher with losses from
fistula drainage orsevere burns. Typically, a hospitalized patient
may lose 12 to 18 grams of nitrogen a day, and in severe trauma the
daily loss may be 20 to 25 grams or more. Aminosyn II solutions without electrolytes are intended for
patients requiring individualized electrolyte therapy. Sodium, chloride,
potassium, phosphate, calcium and magnesium are major electrolytes
which should be added to Aminosyn II as required. SERUM ELECTROLYTES SHOULD BE MONITORED AS INDICATED. Electrolytes
may be added to the nutrient solution as indicated by the patient's
clinical condition and laboratory determinations of plasma values.
Major electrolytes are sodium, chloride, potassium, phosphate, magnesium
and calcium. Vitamins, including folic acid and vitamin K are required
additives. The trace element supplements should be given when long-term
parenteral nutrition is undertaken. Iron is
added to the solution or given intramuscularly in depot form as indicated.
Vitamin B, vitamin K and folic acid are given intramuscularly
or added to the solution as desired. Calcium
and phosphorus additives are potentially incompatible when added to
the TPN admixture. In patients with hyperchloremic
or other metabolic acidosis, sodium and potassium may be added as
the acetate or lactate salts to provide bicarbonate alternates. In adults, hypertonic mixtures of amino acids and dextrose
may be safely administered by continuous infusion through a central
venous catheter with the tip located in the vena cava. Typically,
each liter of central vein TPN solution for adults contains 42.5 to
50 g of Aminosyn II with approximately 250��100 g of dextrose;
supplementary nonprotein calories from intravenous fat emulsion may
be prescribed, at the discretion of the physician. The rate of intravenous infusion initially should be 2 mL/min and
may be increased gradually. If administration should fall behind schedule,
no attempt to���catch up���to planned intake should be
made. In addition to meeting protein needs, the rate of administration
is governed by the patient's glucose tolerance estimated by
glucose levels in blood and urine. Aminosyn
II solution, when mixed with an appropriate volume of concentrated
dextrose, offers a higher concentration of calories and nitrogen per
unit volume. This solution is indicated for patients requiring larger
amounts of nitrogen than could otherwise be provided or where total
fluid load must be kept to a minimum, for example, patients with renal
failure. Provision of adequate calories
in the form of hypertonic dextrose may require exogenous insulin to
prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia,
do not abruptly discontinue administration of nutritional solutions. PEDIATRIC Pediatric requirements for parenteral nutrition are constrained
by the greater relative fluid requirements of the infant and greater
caloric requirements per kilogram. Amino acids are probably best administered
in a 2.5% concentration. For most pediatric patients on intravenous
nutrition, 2.5 grams amino acids/kg/day with dextrose alone or
with I.V. lipid calories of 100 to 130 kcal/kg/day is recommended.
In cases of malnutrition or stress, these requirements may be increased.
It is acceptable in pediatrics to start with a nutritional solution
of half strength at a rateof about 60 to 70 mL/kg/day. Within 24
to 48 hours the volume and concentration of the solution can be increased
until the full strength pediatric solution (amino acids and dextrose)
is given at a rate of 125 to 150 mL/kg/day. Supplemental electrolytes and vitamin additives should be
administered as deemed necessary by careful monitoring of blood chemistries
and nutritional status. Addition of iron is more critical in the infant
than the adult because of the increasing red cell mass required for
the growing infant. Serum lipids should be monitored for evidence
of essential fatty acid deficiency in patients maintained on fat-free
TPN. Bicarbonate should not be administered during infusion of the
nutritional solution unless deemed absolutely necessary. To ensure the precise delivery of the small volumes
of fluid necessary for total parenteral nutrition in infants, accurately
calibrated and reliable infusion systems should be used. A basic solution
for pediatric use should contain 25 grams of amino acids and 200 to
250 grams of glucose per 1000 mL, administered from containers containing
250 or 500 mL. Such a solution given at the rate of 145 mL/kg/day
provides 130 kcal/kg/day. Recommended Directions for Use of the Pharmacy Bulk Package Use Aseptic Technique WARNING: Do not use flexible
container in series connections.
|
| dailymed-drugs:155 |
Gabapentin is given orally with or without food. Patients should be informed that, should they break the scored 600 or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half tablets not used within several days of breaking the scored tablet should be discarded. If gabapentin dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the descretion of the prescriber).<br/>Postherpetic Neuralgia: In adults with postherpetic neuralgia, gabapentin therapy may be initiated as a single 300 mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.<br/>Epilepsy: Gabapentin is recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established. Patients>12 years of age: The effective dose of gabapentin is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules, or 600 mg or 800 mg tablets. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules, or 600 mg or 800 mg tablets three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the TID schedule should not exceed 12 hours. Pediatric Patients Age 3 to 12 years: The starting dose should range from 10 to 15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin in patients 5 years of age and older is 25 to 35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see CLINICAL PHARMACOLOGY, Pediatrics.) Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well-tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours. It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin and other commonly used antiepileptic drugs, the addition of gabapentin does not alter the plasma levels of these drugs appreciably. If gabapentin is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.<br/>Dosage in Renal Impairment: Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (C) can be reasonably well estimated using the equation of Cockcroft and Gault: for females C= (0.85)(140-age)(weight)/[(72)(S)] for males C= (140-age)(weight)/[(72)(S)] where age is in years, weight is in kilograms and Sis serum creatinine in mg/dL. Dosage adjustment in patients���12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication). For patients with creatinine clearance<15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table. The use of gabapentin in patients<12 years of age with compromised renal function has not been studied.<br/>Dosage in Elderly: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
|
| dailymed-drugs:156 |
Serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid form. Phenytoin capsules, phenytoin for parenteral use, and phenytoin with phenobarbital are formulated with the sodium salt of phenytoin. The free acid form of phenytoin is used in phenytoin suspension and phenytoin tablets. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa.<br/>General: Dosage should be individualized to provide maximum benefit. In some cases serum blood level determinations may be necessary for optimal dosage adjustments���the clinically effective serum level is usually 10-20 mcg/mL. With recommended dosage, a period of seven to ten days may be required to achieve steady-state blood levels with phenytoin and changes in dosage (increase or decrease) should not be carried out at intervals shorter than seven to ten days.<br/>Adult Dose: Patients who have received no previous treatment may be started on one teaspoonful (5 mL) of Phenytoin Oral Suspension three times daily, and the dose is then adjusted to suit individual requirements. An increase to five teaspoonfuls daily may be made, if necessary.<br/>Pediatric Dose: Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over 6 years and adolescents may require the minimum adult dose (300 mg/day).
|
| dailymed-drugs:158 |
Labetalol HCl injection is intended for intravenous use in hospitalized patients. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing. Patients should always be kept in a supine position during the period of intravenous drug administration. A substantial fall in blood pressure on standing should be expected in these patients. The patient's ability to tolerate an upright position should be established before permitting any ambulation, such as using toilet facilities. Either of two methods of administration of labetalol HCl injection may be used: a) repeated intravenous injection, or b) slow continuous infusion.<br/>Repeated Intravenous Injection: Initially, labetalol HCl injection should be given in a 20 mg dose (which corresponds to 0.25 mg/kg for an 80 kg patient) by slow intravenous injection over a 2 minute period. Immediately before the injection and at 5 and 10 minutes after injection, supine blood pressure should be measured to evaluate response. Additional injections of 40 or 80 mg can be given at 10 minute intervals until a desired supine blood pressure is achieved or a total of 300 mg of labetalol HCl injection has been injected. The maximum effect usually occurs within 5 minutes of each injection.<br/>Slow Continuous Infusion: Labetalol HCl injection is prepared for continuous intravenous infusion by diluting the vial contents with commonly used intravenous fluids (see below). Examples of two methods of preparing the infusion solution are: The contents of either two 20 mL vials (40 mL), or one 40 mL vial, are added to 160 mL of a commonly used intravenous fluid such that the resultant 200 mL of solution contains 200 mg of labetalol HCl, 1 mg/mL. The diluted solution should be administered at a rate of 2 mL/min to deliver 2 mg/min. Alternatively, the contents of either two 20 mL vials (40 mL), or one 40 mL vial, of labetalol HCl injection are added to 250 mL of a commonly used intravenous fluid. The resultant solution will contain 200 mg of labetalol HCl, approximately 2 mg/3 mL. The diluted solution should be administered at a rate of 3 mL/min to deliver approximately 2 mg/min. The rate of infusion of the diluted solution may be adjusted according to the blood pressure response, at the discretion of the physician. To facilitate a desired rate of infusion, the diluted solution can be infused using a controlled administration mechanism, e.g., graduated burette or mechanically driven infusion pump. Since the half-life of labetalol is 5 to 8 hours, steady-state blood levels (in the face of a constant rate of infusion) would not be reached during the usual infusion time period. The infusion should be continued until a satisfactory response is obtained and should then be stopped and oral labetalol HCl started (see below). The effective intravenous dose is usually in the range of 50 to 200 mg. A total dose of up to 300 mg may be required in some patients.<br/>Blood Pressure Monitoring: The blood pressure should be monitored during and after completion of the infusion or intravenous injection. Rapid or excessive falls in either systolic or diastolic blood pressure during intravenous treatment should be avoided. In patients with excessive systolic hypertension, the decrease in systolic pressure should be used as an indicator of effectiveness in addition to the response of the diastolic pressure.<br/>Initiation of Dosing with Labetalol HCl Tablets: Subsequent oral dosing with labetalol HCl tablets should begin when it has been established that the supine diastolic blood pressure has begun to rise. The recommended initial dose is 200 mg, followed in 6 to 12 hours by an additional dose of 200 or 400 mg, depending on the blood pressure response. Thereafter, inpatient titration with labetalol HCl tablets may proceed as follows: The dosage of labetalol HCl tablets used in the hospital may be increased at 1-day intervals to achieve the desired blood pressure reduction. For subsequent outpatient titration or maintenance dosing, see DOSAGE AND ADMINISTRATION in the Labetalol HCl Tablet Product Information for additional recommendations.<br/>Compatibility with Commonly Used Intravenous Fluids: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit. Labetalol HCl injection was tested for compatibility with commonly used intravenous fluids at final concentrations of 1.25 mg to 3.75 mg of labetalol HCl per milliliter of the mixture. Labetalol HCl injection was found to be compatible with and stable (for 24 hours refrigerated or at room temperature) in mixtures with the following solutions: ringer's injection; lactated ringer's injection; 5% dextrose and ringer's injection; 5% lactated ringer's and 5% dextrose injection; 5% dextrose injection; 0.9% sodium chloride injection; 5% dextrose and 0.9% sodium chloride injection; and 5% dextrose and 0.33% sodium chloride injection. Labetalol HCl injection was NOT compatible with 5% sodium bicarbonate injection. Care should be taken when administering alkaline drugs, including furosemide, in combination with labetalol. Compatibility should be assured prior to administering these drugs together.
|
| dailymed-drugs:159 |
Dosage Must be Individualized: The initial dosage of doxazosin mesylate tablets in patients with hypertension and/or BPH is 1 mg given once daily in the a.m. or p.m. This starting dose is intended to minimize the frequency of postural hypotension and first dose syncope associated with doxazosin mesylate. Postural effects are most likely to occur between 2 and 6 hours after a dose. Therefore blood pressure measurements should be taken during this time period after the first dose and with each increase in dose. If doxazosin mesylate tablet administration is discontinued for several days, therapy should be restarted using the initial dosing regimen.<br/>A. Benign Prostatic Hyperplasia 1 to 8 mg once daily: The initial dosage of doxazosin mesylate is 1 mg, given once daily in the a.m. or p.m. Depending on the individual patient's urodynamics and BPH symptomatology, dosage may then be increased to 2 mg and thereafter to 4 mg and 8 mg once daily, the maximum recommended dose for BPH. The recommended titration interval is 1 to 2 weeks. Blood pressure should be evaluated routinely in these patients.<br/>B. Hypertension 1 to 16 mg once daily: The initial dosage of doxazosin mesylate is 1 mg given once daily. Depending on the individual patient's standing blood pressure response (based on measurements taken at 2 to 6 hours post-dose and 24 hours post-dose), dosage may then be increased to 2 mg and thereafter if necessary to 4 mg, 8 mg, and 16 mg to achieve the desired reduction in blood pressure. Increases in dose beyond 4 mg increase the likelihood of excessive postural effects including syncope, postural dizziness/vertigo, and postural hypotension. At a titrated dose of 16 mg once daily the frequency of postural effects is about 12% compared to 3% for placebo.
|
| dailymed-drugs:161 |
Initial Treatment: Citalopram hydrobromide tablets should be administered at an initial dose of 20 mg once daily, generally with an increase to a dose of 40 mg/day. Dose increases should usually occur in increments of 20 mg at intervals of no less than one week. Although certain patients may require a dose of 60 mg/day, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose; doses above 40 mg are therefore not ordinarily recommended. Citalopram hydrobromide tablets should be administered once daily, in the morning or evening, with or without food.<br/>Special Populations: 20 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment, with titration to 40 mg/day only for nonresponding patients. No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram hydrobromide tablets should be used with caution in patients with severe renal impairment.<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to citalopram hydrobromide tablets and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with citalopram hydrobromide tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering citalopram hydrobromide tablets in the third trimester.<br/>Maintenance Treatment: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of citalopram hydrobromide tablets in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of citalopram hydrobromide tablets (20 mg/day to 60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of citalopram hydrobromide tablets 20 mg/day or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups . Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.<br/>Discontinuation of Treatment with Citalopram Hydrobromide Tablets: Symptoms associated with discontinuation of citalopram hydrobromide tablets and other SSRIs and SNRIs have been reported . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.<br/>Switching Patients to or from a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of citalopram hydrobromide tablets therapy. Similarly, at least 14 days should be allowed after stopping citalopram hydrobromide tablets before starting a MAOI .
|
| dailymed-drugs:162 |
Therapy with this product should be limited to 7 days. A
thin film is applied 2 to 4 times daily to the affected area.
|
| dailymed-drugs:163 |
MYCOLOG-II Cream (Nystatin and Triamcinolone Acetonide Cream) is usually applied to the affected areas twice daily in the morning and evening by gently and thoroughly massaging the preparation into the skin. The cream should be discontinued if symptoms persist after 25 days of therapy . Mycolog II Cream should not be used with occlusive dressings.
|
| dailymed-drugs:164 |
Days 1 and 2:Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.Days 3 through 7:Instill one to two drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.
|
| dailymed-drugs:165 |
The dosage will vary depending upon the individual, the condition being treated, and its severity. The total daily oral dose may be administered singly or in divided (three or four) doses.<br/>Male hypogonadism: For complete replacement in the hypogonadal male, a daily dose of 5 to 20 mg will suffice in the majority of patients. It is usually preferable to begin treatment with full therapeutic doses which are later adjusted to individual requirements. Priapism is indicative of excessive dosage and is indication fortemporary withdrawal of the drug.<br/>Delayed puberty: Dosage should be carefully titrated utilizing a low dose, appropriate skeletal monitoring, and by limiting the duration of therapy to four to six months.<br/>Inoperable carcinoma of the breast in the female: The recommended total daily dose for palliative therapy in advanced inoperable carcinoma of the breast is 10 to 40 mg. Because of its short action, fluoxymesterone should be administered to patients in divided, rather than single, daily doses to ensure more stable blood levels. In general, it appears necessary to continue therapy for at least onemonth for a satisfactory subjective response, and for two to three months for an objective response.
|
| dailymed-drugs:166 |
Dosage should be individualized for maximum beneficial
effect. The usual recommended dose in older children and adults ranges
from 2 mg to 20 mg IM or IV, depending on the indication and its severity.
In some conditions, e.g., tetanus, larger doses may be required. (See
dosage for specific indications.) In acute conditions the injection
may be repeated within one hour although an interval of 3 to 4 hours
is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow
increase in dosage should be used for elderly or debilitated patients
and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.) For dosage in infants above the age of 30 days and children,
see the specific indications below. When intravenous use is indicated,
facilities for respiratory assistance should be readily available. Intramuscular: Diazepam injection should be injected deeply into the muscle. Intravenous Use: (See WARNINGS, particularly
for use in children.) The solution should be injected slowly, taking
at least one minute for each 5 mg (1 mL) given. Do not use small veins,
such as those on the dorsum of the hand or wrist. Extreme care should
be taken to avoid intra-arterial administration or extravasation. Do not mix or dilute diazepam with other solutions or
drugs in syringe or infusion flask. If it is not feasible to administer
diazepam directly IV, it may be injected slowly through the infusion
tubing as close as possible to the vein insertion. Once the acute symptomatology has been properly controlled with diazepam
injection, the patient may be placed on oral therapy with diazepam
if further treatment is required. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration,
whenever solution and container permit.
|
| dailymed-drugs:167 |
Hypertension:<br/>Adults: The recommended initial dose for patients not receiving a diuretic is 10 mg once-a-day. The usual maintenance dosage range is 20 to 40 mg per day administered as a single dose or in two equally divided doses. A dose of 80 mg gives an increased response, but experience with this dose is limited. The divided regimen was more effective in controlling trough(pre-dosing) blood pressure than the same dose given as a once-daily regimen. Dosage adjustment should be based on measurement of peak (2 to 6 hours after dosing) and trough responses. If a once-daily regimen does not give adequate trough response, an increase in dosage or divided administration should be considered. If blood pressure is not controlled with benazepril hydrochloride alone, a diuretic can be added. Total daily doses above 80 mg have not been evaluated. Concomitant administration of benazepril hydrochloride with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium . In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of benazepril hydrochloride. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapywith benazepril hydrochloride . Then, if blood pressure is not controlled with benazepril hydrochloride alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 5 mg benazepril hydrochloride should be used to avoid excessive hypotension.<br/>Pediatrics: In children, doses of benazepril hydrochloride between 0.1 and 0.6 mg/kg once daily have been studied, and doses greater than 0.1 mg/kg were shown to reduce blood pressure (see Pharmacodynamics). Based on this, the recommended starting dose of benazepril hydrochloride is 0.2 mg/kg once per day as monotherapy. Doses above 0.6 mg/kg (or in excess of 40 mg daily) have not been studied in pediatric patients. For pediatric patients who cannot swallow tablets, or for whom the calculated dosage (mg/kg) does not correspond to the available tablet strengths for benazepril hydrochloride, follow the suspension preparation instructions below to administer benazepril hydrochloride as a suspension. Treatment with benazepril hydrochloride is not advised for children below the age of 6 years and in pediatric patients with glomerular filtration rate<30 mL, as there are insufficient data available to support a dosing recommendation in these groups.<br/>For Hypertensive Patients with Renal Impairment: For patients with a creatinine clearance<30 mL/min/1.73 m(serum creatinine>3 mg/dL), the recommended initial dose is 5 mg benazepril hydrochloride once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 40 mg .<br/>Preparation of Suspension (for 150 mL of a 2 mg/mL suspension): Add 75 mL of Ora-Plusoral suspending vehicle to an amber polyethylene terephthalate (PET) bottle containing fifteen benazepril hydrochloride 20 mg tablets, and shake for at least 2 minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute. Add 75 mL of Ora-Sweetoral syrup vehicle to the bottle and shake the suspension to disperse the ingredients. The suspension should be refrigerated at 2 to 8��C (36 to 46��F) and can be stored for up to 30 days in the PET bottle with a child-resistant screw-cap closure. Shake the suspension before each use. Ora-Plus and Ora-Sweet are registered trademarks of Paddock Laboratories, Inc. Ora-Plus contains carrageenan, citric acid, methylparaben, microcrystalline cellulose, carboxymethylcellulose sodium, potassium sorbate, simethicone, sodium phosphate monobasic, xanthan gum, and water. Ora-Sweet contains citric acid, berry citrus flavorant, glycerin, methylparaben, potassium sorbate, sodium phosphate monobasic, sorbitol, sucrose, and water.
|
| dailymed-drugs:168 |
Dosage should be individualized according to the needs and responses of the patient. Directions���Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.<br/>Adults: Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.<br/>Children (6 years and over): Methylin should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued. Chewable Tablets: Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug. Methylin should be periodically discontinued to assess the child's condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued. Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
|
| dailymed-drugs:170 |
There is no fixed dosage regimen for the management of diabetes mellitus with MICRONASE Tablets or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient's blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, ie, inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, ie, loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient's response to therapy. Short-term administration of MICRONASE may be sufficient during periods of transient loss of control in patients usually controlled well on diet.<br/>Usual Starting Dose: The usual starting dose of MICRONASE Tablets is 2.5 to 5 mg daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1.25 mg daily. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.<br/>Transfer From Other Hypoglycemic Therapy Patients Receiving Other Oral Antidiabetic Therapy: Transfer of patients from other oral antidiabetic regimens to MICRONASE should be done conservatively and the initial daily dose should be 2.5 to 5 mg. When transferring patients from oral hypoglycemic agents other than chlorpropamide to MICRONASE, no transition period and no initial or priming dose are necessary. When transferring patients from chlorpropamide, particular care should be exercised during the first two weeks because the prolonged retention of chlorpropamide in the body and subsequent overlapping drug effects may provoke hypoglycemia.<br/>Patients Receiving Insulin: Some Type II diabetic patients being treated with insulin may respond satisfactorily to MICRONASE. If the insulin dose is less than 20 units daily, substitution of MICRONASE Tablets 2.5 to 5 mg as a single daily dose may be tried. If the insulin dose is between 20 and 40 units daily, the patient may be placed directly on MICRONASE Tablets 5 mg daily as a single dose. If the insulin dose is more than 40 units daily, a transition period is required for conversion to MICRONASE. In these patients, insulin dosage is decreased by 50% and MICRONASE Tablets 5 mg daily is started. Please refer to Titration to Maintenance Dose for further explanation.<br/>Titration to Maintenance Dose: The usual maintenance dose is in the range of 1.25 to 20 mg daily, which may be given as a single dose or in divided doses (See Dosage Interval section). Dosage increases should be made in increments of no more than 2.5 mg at weekly intervals based upon the patient's blood glucose response. No exact dosage relationship exists between MICRONASE and the other oral hypoglycemic agents. Although patients may be transferred from the maximum dose of other sulfonylureas, the maximum starting dose of 5 mg of MICRONASE Tablets should be observed. A maintenance dose of 5 mg of MICRONASE Tablets provides approximately the same degree of blood glucose control as 250 to 375 mg chlorpropamide, 250 to 375 mg tolazamide, 500 to 750 mg acetohexamide, or 1000 to 1500 mg tolbutamide. When transferring patients receiving more than 40 units of insulin daily, they may be started on a daily dose of MICRONASE Tablets 5 mg concomitantly with a 50% reduction in insulin dose. Progressive withdrawal of insulin and increase of MICRONASE in increments of 1.25 to 2.5 mg every 2 to 10 days is then carried out. During this conversion period when both insulin and MICRONASEare being used, hypoglycemia may rarely occur. During insulin withdrawal, patients should test their urine for glucose and acetone at least three times daily and report results to their physician. The appearance of persistent acetonuria with glycosuria indicates that the patient is a Type I diabetic who requires insulin therapy.<br/>Concomitant Glyburide and Metformin Therapy: MICRONASE Tablets should be added gradually to the dosing regimen of patients who have not responded to the maximum dose of metformin monotherapy after four weeks (see Usual Starting Dose and Titration to Maintenance Dose). Refer to metformin package insert. With concomitant glyburide and metformin therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the optimal dose of each drug needed to achieve this goal. With concomitant glyburide and metformin therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken .<br/>Maximum Dose: Daily doses of more than 20 mg are not recommended.<br/>Dosage Interval: Once-a-day therapy is usually satisfactory. Some patients, particularly those receiving more than 10 mg daily, may have a more satisfactory response with twice-a-day dosage.<br/>Specific Patient Populations: MICRONASE is not recommended for use in pregnancy or for use in pediatric patients. In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions.
|
| dailymed-drugs:171 |
For induction therapy in adult patients with AML the following dose schedule is recommended: IDAMYCIN PFS Injection 12 mg/mdaily for 3 days by slow (10 to 15 min) intravenous injection in combination with cytarabine. The cytarabine may be given as 100 mg/mdaily by continuous infusion for 7 days or as cytarabine 25 mg/mintravenous bolus followed by cytarabine 200 mg/mdaily for 5 days continuous infusion. In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered. Administration of the second course should be delayed in patients who experience severe mucositis, until recovery from this toxicity has occurred, and a dose reduction of 25% is recommended. In patients with hepatic and/or renal impairment, a dose reduction of IDAMYCIN PFS should be considered. IDAMYCIN PFS should not be administered if the bilirubin level exceeds 5 mg%. The benefit of consolidation in prolonging the duration of remissions and survival is not proven. There is no consensus regarding optional regimens to be used for consolidation.<br/>Preparation and Administration Precautions: Caution in handling the solution must be exercised as skin reactions associated with IDAMYCIN PFS may occur. Skin accidentally exposed to IDAMYCIN PFS should be washed thoroughly with soap and water and if the eyes are involved, standard irrigation techniques should be used immediately. The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug. Care in the administration of IDAMYCIN PFS will reduce the chance of perivenous infiltration. It may also decrease the chance of local reactions such as urticaria and erythematous streaking. During intravenous administration of IDAMYCIN PFS extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If it is known or suspected that subcutaneous extravasation has occurred, it is recommended that intermittent ice packs (1/2 hour immediately, then 1/2 hour 4 times per day for 3 days) be placed over the area of extravasation and that the affected extremity be elevated. Because of the progressive nature of extravasation reactions, the area of injection should be frequently examined and plastic surgery consultation obtained early if there is any sign of a local reaction such as pain, erythema, edema or vesication. If ulceration begins or there is severe persistent pain at the site of extravasation, early wide excision of the involved area should be considered. IDAMYCIN PFS should be administered slowly (over 10 to 15 minutes) into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP (0.9%) or 5% Dextrose Injection, USP. The tubing should be attached to a Butterfly needle or other suitable device and inserted preferably into a large vein.<br/>Incompatibility: Unless specific compatibility data are available, IDAMYCIN PFS should not be mixed with other drugs. Precipitation occurs with heparin. Prolonged contact with any solution of an alkaline pH will result in degradation of the drug. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and containers permit.<br/>Handling and Disposal: Procedures for handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
|
| dailymed-drugs:172 |
To achieve maximum contraceptive
effectiveness, LYBREL (levonorgestrel and ethinyl estradiol tablets)
must be taken exactly as directed and at intervals not exceeding 24
hours. The possibility of ovulation and conception prior to initiation
of medication should be considered. Women who do not wish to become
pregnant after discontinuation should be advised to immediately use
another method of birth control. The dosage of LYBREL is one yellow
tablet daily without any tablet-free interval. It is recommended that LYBREL tablets be taken at the same time each day.<br/>Initiation of Therapy: Instructions for
beginning LYBREL are provided in Table 4 below. If spotting or
unscheduled bleeding occurs, the patient is instructed to continue
on the same regimen. This type of bleeding is usually transient and
without significance; however, if the bleeding is persistent or prolonged,
the patient is advised to consult her health care professional. The
possibility of ovulation increases with each successive day that scheduled
yellow tablets are missed. If the patient has not adhered to the prescribed
schedule (missed one or more tablets or started taking them on a day
later than she should have), the probability of pregnancy should beconsidered. Hormonal contraception must be discontinued if pregnancy
is confirmed. The risk of pregnancy increases with each tablet missed. For additional
patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below. LYBREL may be initiated
no earlier than day 28 postpartum in the nonlactating mother or after
a second-trimester abortion due to the increased risk for thromboembolism
. The patient should
be advised to use a nonhormonal back-up method for the first 7 days
of tablet-taking. However, if intercourse has already occurred, pregnancy
should be excluded before the start of combined oral contraceptive
use or the patient must wait for her first menstrual period. In the case of first-trimester
abortion, if the patient starts LYBREL immediately, additional contraceptive
measures are not needed.
|
| dailymed-drugs:173 |
The usual intravenous dose for adults is 20 mL, with a range of 20 mL to 40 mL. Children require less in proportion to weight: Under 6 months of age���4 mL; 6 to 12 months���6 mL; 1 to 2 years���8 mL; 2 to 5 years���10 mL; 5 to 7 years���12 mL; 8 to 10 years���14 mL; 11 to 15 years���16 mL.
|
| dailymed-drugs:174 |
The recommended dose and
schedule of ELITEK is 0.15 or 0.20 mg/kg as a single daily dose for
5 days. Because the safety and effectiveness of other schedules have
not been established, dosing beyond 5 days or administration of more
than one course of ELITEK is not recommended. Chemotherapy should
be initiated 4 to 24 hours after the first dose of ELITEK. DO NOT ADMINISTER AS A BOLUS INFUSION.
ELITEK should be administered as an intravenous infusion over 30 minutes. TWO DIFFERENT STRENGTHS ARE AVAILABLE (1.5 mg vial
and 7.5 mg vial)<br/>Reconstitution Procedure: Determine the number
of vials of ELITEK needed to achieve the proper dosage, based on the
individual patient's weight and the dose per kilogram. ELITEK
must be reconstituted in the diluent provided. To each 1.5 mg vial of ELITEK, add 1 mL of the provided reconstitution
solution (diluent) and mix by swirling very gently. Do not shake or vortex. To each 7.5 mg vial of
ELITEK, add 5 mL of the provided reconstitution solution (diluent)
and mix by swirling very gently. Do not
shake or vortex. Reconstituted ELITEK
should be inspected visually for particulate matter and discoloration
prior to administration, and discarded if particulate matter is visible
or if product is discolored.<br/>Further Dilution and Administration: Using aseptic technique
and syringes of appropriate volume, remove the predetermined dose
of ELITEK from the reconstituted vials and inject into an infusion
bag containing the appropriate volume of 0.9% sterile sodium chloride,
to achieve a final total volume of 50 mL. This final solution for
injection is to be infused over 30 minutes. No filters should be used for the infusion. The reconstituted ELITEK
contains no preservatives and must be administered within 24 hours
of reconstitution. The reconstituted or diluted solution can be stored
up to 24 hours at 2���8��C. Discard any unused product. ELITEK should be infused
through a different line than that used for the infusion of other
concomitant medications. If use of a separate line is not possible,
the line should be flushed with at least 15 mL of saline solution
prior to and after infusion with ELITEK.
|
| dailymed-drugs:175 |
Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.<br/>Adults:<br/>For Edema: The usual adult dosage is 25 to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.<br/>For Control of Hypertension: The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium . Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.<br/>Infants and Children:<br/>For Diuresis and For Control of Hypertension: The usual pediatric dosage is 0.5 to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required.
|
| dailymed-drugs:3815 |
Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.<br/>Adults:<br/>For Edema: The usual adult dosage is 25 to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.<br/>For Control of Hypertension: The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium . Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.<br/>Infants and Children:<br/>For Diuresis and For Control of Hypertension: The usual pediatric dosage is 0.5 to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required.
|
| dailymed-drugs:176 |
Bacterial Vaginosis: Seven-day course of treatment���750 mg once daily by mouth for seven consecutive days. Flagyl ER 750 mg tablets should be taken under fasting conditions, at least one hour before or two hours after meals. The optimum extended-release characteristics of Flagyl ER 750 mg are obtained when the drug is taken under fasting conditions. Pregnant patients should not be treated during the first trimester. Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Close monitoring of plasma metronidazole levelsand toxicity is recommended. The dose of metronidazole should not be specifically reduced in anuric patients because accumulated metabolites may be rapidly removed by dialysis. In elderly patients, the pharmacokinetics of metronidazole may be altered and therefore, monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly.
|
| dailymed-drugs:177 |
For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day. The following factors are associated with increased plasma levels of sildenafil: age>65 (40% increase in AUC), hepatic impairment (e.g., cirrhosis, 80%), severe renal impairment (creatinine clearance<30 mL/min, 100%), and concomitant use of potent cytochrome P450 3A4 inhibitors [ketoconazole, itraconazole, erythromycin (182%), saquinavir (210%)]. Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered in these patients. Ritonavir greatly increased the systemic level of sildenafil in a study of healthy, non-HIV infected volunteers (11-fold increase in AUC, see Drug Interactions.) Based on these pharmacokinetic data, it is recommended not to exceed a maximum single dose of 25 mg of VIAGRA in a 48 hour period. VIAGRA was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated. When VIAGRA is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at the lowest dose (see Drug Interactions).
|
| dailymed-drugs:178 |
Adults: Myxedema coma is usually precipitated in the hypothyroid patient of long standing by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency. Therapy should be directed at the correction of electrolyte disturbances, possible infection, or other intercurrent illness in addition to the administration of intravenous liothyronine (T). Simultaneous glucocorticosteroids are required. Triostat (liothyronine sodium injection) (T) is for intravenous administration only. It should not be given intramuscularly or subcutaneously. No controlled clinical studies have been done with Triostat. The following dosing guidelines have been derived from data analysis of myxedema coma/precoma case reports collected by SmithKline Beecham Pharmaceuticals since 1963 and from scientific literature since 1956. An initial intravenous Triostat dose ranging from 25 mcg to 50 mcg is recommended in the emergency treatment of myxedema coma/precoma in adults. In patients with known or suspected cardiovascular disease, an initial dose of 10 mcg to 20 mcg is suggested . However, both the initial dose and subsequent doses should be determined on the basis of continuous monitoring of the patient's clinical condition and response to Triostat therapy. Normally at least four hours should be allowed between doses to adequately assess therapeutic response and no more than 12 hours should elapse between doses to avoid fluctuations in hormone levels. Caution should be exercised in adjusting the dose due to the potential of large changes to precipitate adverse cardiovascular events. Review of the myxedema case reports indicates decreased mortality in patients receiving at least 65 mcg/day in the initial days of treatment. However, there is limited clinical experience at total daily doses above 100 mcg. See PRECAUTIONS���Drug Interactions for potential interactions between thyroid hormones and digitalis and vasopressors.<br/>Pediatric Use: There is limited experience with Triostat in the pediatric population. Safety and effectiveness in pediatric patients have not been established.<br/>Switching to Oral Therapy: Oral therapy should be resumed as soon as the clinical situation has been stabilized and the patient is able to take oral medication. When switching a patient to liothyronine sodium tablets from Triostat, discontinue Triostat, initiate oral therapy at a low dosage, and increase gradually according to the patient's response. If L-thyroxine rather than liothyronine sodium is used in initiating oral therapy, the physician should bear in mind that there is a delay of several days in the onset of L-thyroxine activity and that intravenous therapy should be discontinued gradually.
|
| dailymed-drugs:179 |
Whether given with SINEMET (Carbidopa-Levodopa) or with levodopa, the optimal daily dosage of LODOSYN must be determined by careful titration. Most patients respond to a 1:10 proportion of carbidopa and levodopa, provided the daily dosage of carbidopa is 70 mg or more a day. The maximum daily dosage of carbidopa should not exceed 200 mg, since clinical experience with larger dosages is limited. If the patient is taking SINEMET (Carbidopa-Levodopa), the amount of carbidopa in SINEMET (Carbidopa-Levodopa) should be considered when calculating the total amount of LODOSYN to be administered each day.<br/>Patients Receiving SINEMET (Carbidopa-Levodopa) Who Require Additional Carbidopa: Some patients taking SINEMET (Carbidopa-Levodopa) may not have adequate reduction in nausea and vomiting when the dosage of carbidopa is less than 70 mg a day, and the dosage of levodopa is less than 700 mg a day. When these patients are taking SINEMET 10-100** (Carbidopa-Levodopa), 25 mg of LODOSYN may be given with the first dose of SINEMET (Carbidopa-Levodopa) each day. Additional doses of 12.5 mg or 25 mg may be given during the day with each dose of SINEMET (Carbidopa-Levodopa). When patients are taking SINEMET 25-250*** (Carbidopa-Levodopa) or SINEMET 25-100���(Carbidopa-Levodopa), 25 mg of LODOSYN may be given with any dose of SINEMET (Carbidopa-Levodopa) as required for optimum therapeutic response. The maximum daily dosage of carbidopa, given as LODOSYN and as SINEMET (Carbidopa-Levodopa), should not exceed 200 mg. ������������������������������������<br/>Patients Requiring Individual Titration of Carbidopa and Levodopa Dosage: Although SINEMET (Carbidopa-Levodopa) is the preferred method of carbidopa and levodopa administration, there may be an occasional patient who requires individually titrated doses of these two drugs. In these patients, LODOSYN (Carbidopa) should be initiated at a dosage of 25 mg three or four times a day. The two drugs should be given at the same time, starting with no more than one-fifth (20%) to one-fourth (25%) of the previous or recommended daily dosage of levodopa when given without LODOSYN (Carbidopa). In patients already receiving levodopa therapy, at least twelve hours should elapse between the last dose of levodopa and initiation of therapy with LODOSYN (Carbidopa) and levodopa. A convenient way to initiate therapy in these patients is in the morning following a night when the patient has not taken levodopa for at least twelve hours. Physicians who prescribe separate doses of LODOSYN and levodopa should be thoroughly familiar with the directions for use of each drug.<br/>Dosage Adjustment: Dosage of LODOSYN may be adjusted by adding or omitting one-half or one tablet a day. Because both therapeutic and adverse responses occur more rapidly with combined therapy than when only levodopa is given, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly when LODOSYN and levodopa are given concomitantly than when levodopa is given without LODOSYN. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients. Current evidence indicates other standard antiparkinsonian drugs may be continued while carbidopa and levodopa are being administered. However, the dosage of such other standard antiparkinsonian drugs may require adjustment.<br/>Interruption of Therapy: Sporadic cases of a symptom complex resembling the Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of SINEMET (Carbidopa-Levodopa) or SINEMET CR (Carbidopa-Levodopa) Sustained-Release. Patients should be observed carefully if abrupt reduction or discontinuation of SINEMET (Carbidopa-Levodopa) or SINEMET CR (Carbidopa-Levodopa) Sustained-Release is required, especially if the patient is receiving neuroleptics. If general anesthesia is required, therapy may be continued as long as the patient is permitted to take fluids and medication by mouth. When therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be resumed as soon as the patient is able to take medication orally.
|
| dailymed-drugs:180 |
Apply a thin film of Betamethasone Valerate Cream or Ointment to the affected skin areas one to three times a day. Dosage once or twice a day is often effective. Apply a few drops of Betamethasone Valerate Lotion to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night. Dosage may be increased in stubborn cases. Following improvement, apply once daily. For the most effective and economical use, apply nozzle very close to affected area and gently squeeze bottle.
|
| dailymed-drugs:181 |
DOSAGE MUST BE INDIVIDUALIZED ACCORDING TO PATIENT'S
RESPONSE. Captopril and Hydrochlorothiazide tablets may be substituted for
the previously titrated individual components. Alternatively, therapy may be instituted with a single tablet of
Captopril and Hydrochlorothiazide 25 mg/15 mg taken once daily. For
patients insufficiently responsive to the initial dose, additional
captopril or hydrochlorothiazide may be added as individual components
or by using Captopril and Hydrochlorothiazide tablets 50 mg/15 mg, 25
mg/25 mg or 50 mg/25 mg, or divided doses may be used. Because the full effect of a given dose may not be attained for 6
to 8 weeks, dosage adjustments should generally be made at 6 week
intervals, unless the clinical situation demands more rapid adjustment. In general, daily doses of captopril should not exceed 150 mg and of hydrochlorothiazide should not exceed 50 mg. Captopril and Hydrochlorothiazide tablets should be taken one
hour before meals.<br/>Dosage Adjustment in Renal Impairment: Because captopril and hydrochlorothiazide are excreted
primarily by the kidneys, excretion rates are reduced in
patients with impaired renal function. These patients will take
longer to reach steady-state captopril levels and will reach
higher steady-state levels for a given daily dose than patients
with normal renal function. Therefore, these patients may
respond to smaller or less frequent doses of Captopril and
Hydrochlorothiazide tablets. After the desired therapeutic effect has been achieved,
the dose intervals should be increased or the total daily dose
reduced until the minimal effective dose is achieved. When
concomitant diuretic therapy is required in patients with severe
renal impairment, a loop diuretic (e.g., furosemide), rather
than a thiazide diuretic is preferred for use with captopril;
therefore, for patients with severe renal dysfunction the
captopril-hydrochlorothiazide combination tablet is not usually
recommended (See WARNINGS:
Captopril: Anaphylactoid reactions during membrane
exposure and PRECAUTIONS:
Hemodialysis).
|
| dailymed-drugs:182 |
Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.
|
| dailymed-drugs:184 |
Hypertension: The dosage of metoprolol tartrate should be individualized. Metoprolol tartrate should be taken with or immediately following meals. The usual initial dosage is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. The effective dosage range is 100���450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Betaselectivity diminishes as the dose of metoprolol tartrate is increased.<br/>Angina Pectoris: The dosage of metoprolol tartrate should be individualized. Metoprolol tartrate should be taken with or immediately following meals. The usual initial dosage is 100 mg daily, given in two divided doses. The dosage may be gradually increased at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range is 100���400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1���2 weeks.<br/>Myocardial Infarction:<br/>Early Treatment: During the early phase of definite or suspected acute myocardial infarction, treatment with metoprolol tartrate can be initiated as soon as possible after the patient's arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient's hemodynamic condition has stabilized. Treatment in this early phase should begin with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each; the injections should be given at approximately 2-minute intervals. During the intravenous administration of metoprolol tartrate, blood pressure, heart rate, and electrocardiogram should be carefully monitored. In patients who tolerate the full intravenous dose (15 mg), metoprolol tartrate tablets, 50 mg every 6 hours, should be initiated 15 minutes after the last intravenous dose and continued for 48 hours. Thereafter, patients should receive a maintenance dosage of 100 mg twice daily (see Late Treatment below). Patients who appear not to tolerate the full intravenous dose should be started on metoprolol tartrate tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, treatment with metoprolol tartrate should be discontinued .<br/>Late Treatment: Patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason should be started on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Therapy should be continued for at least 3 months. Although the efficacy of metoprolol tartrate beyond 3 months has not been conclusively established, data from studies with other beta blockers suggest that treatment should be continued for 1���3 years.
|
| dailymed-drugs:186 |
Amiodarone shows considerable interindividual variation in response. Thus, although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose as needed is essential. The recommended starting dose of amiodarone I.V. is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen: AMIODARONE I.V. DOSE RECOMMENDATIONS ���FIRST 24 HOURS��� After the first 24 hours, the maintenance infusion rate of 0.5 mg/min (720 mg/24 hours) should be continued utilizing a concentration of 1 to 6 mg/mL (amiodarone I.V. concentrations greater than 2 mg/mL should be administered via a central venous catheter). In the event of breakthrough episodes of VF or hemodynamically unstable VT, 150 mg supplemental infusions of amiodarone I.V. mixed in 100 mL of D5W may be administered. Such infusions should be administered over 10 minutes to minimize the potential for hypotension. The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression. The first 24-hour dose may be individualized for each patient; however, in controlled clinical trials, mean daily doses above 2100 mg were associated with an increased risk of hypotension. The initial infusion rate should not exceed 30 mg/min. Based on the experience from clinical studies of amiodarone I.V., a maintenance infusion of up to 0.5 mg/min can be cautiously continued for 2 to 3 weeks regardless of the patient's age, renal function, or left ventricular function. There has been limited experience in patients receiving amiodarone I.V. for longer than 3 weeks. The surface properties of solutions containing injectable amiodarone are altered such that the drop size may be reduced. This reduction may lead to underdosage of the patient by up to 30% if drop counter infusion sets are used. Amiodarone I.V. must be delivered by a volumetric infusion pump. Amiodarone I.V. should, whenever possible, be administered through a central venous catheter dedicated to that purpose. An in-line filter should be used during administration. Amiodarone I.V. loading infusions at much higher concentrations and rates of infusion much faster than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death . Amiodarone I.V. concentrations greater than 3 mg/mL in D5W have been associated with a high incidence of peripheral vein phlebitis; however, concentrations of 2.5 mg/mL or less appear to be less irritating. Therefore, for infusions longer than 1 hour, amiodarone I.V. concentrations should not exceed 2 mg/mL unless a central venous catheter is used . Amiodarone I.V. infusions exceeding 2 hours must be administered in glass or polyolefin bottles containing D5W. Use of evacuated glass containers for admixing amiodarone I.V. is not recommended as incompatibility with a buffer in the container may cause precipitation. It is well known that amiodarone adsorbs to polyvinyl chloride (PVC) tubing and the clinical trial dose administration schedule was designed to account for this adsorption. All of the clinical trials were conducted using PVC tubing and its use is therefore recommended. The concentrations and rates of infusion provided in DOSAGE AND ADMINISTRATION reflect doses identified in these studies. Amiodarone I.V. has been found to leach out plasticizers, including DEHP [di-(2-ethylhexyl)phthalate] from intravenous tubing (including PVC tubing). The degree of leaching increases when infusing amiodarone I.V. at higher concentrations and lower flow rates than provided in DOSAGE AND ADMINISTRATION. In addition, polysorbate 80, a component of amiodarone I.V., is also known to leach DEHP from PVC . Therefore, it is important that the recommendations in DOSAGE AND ADMINISTRATION be followed closely. Amiodarone I.V. does not need to be protected from light during administration.<br/>Admixture Incompatibility: Amiodarone I.V. in DW is incompatible with the drugs shown below.<br/>Intravenous to Oral Transition: Patients whose arrhythmias have been suppressed by amiodarone I.V. may be switched to oral amiodarone. The optimal dose for changing from intravenous to oral administration of amiodarone will depend on the dose of amiodarone I.V. already administered, as well as the bioavailability of oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients. Since there are some differences between the safety and efficacy profiles of the intravenous and oral formulations, the prescriber is advised to review the package insert for oral amiodarone when switching from intravenous to oral amiodarone therapy. Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, grapefruit juice should not be taken during treatment with oral amiodarone (see PRECAUTIONS, Drug interactions). The following table provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone I.V. administration. These recommendations are made on the basis of a comparable total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone. #Assuming a 720 mg/day infusion (0.5 mg/min). *Amiodarone I.V. is not intended for maintenance treatment. Parenteral drug products should be inspected visually for particulate matter, whenever solution and container permit.
|
| dailymed-drugs:187 |
Rifampin for Injection is administered by IV infusion only . IV doses are the same as those for oral. See CLINICAL PHARMACOLOGY for dosing information in patients with renal failure.<br/>Tuberculosis: Adults: 10 mg/kg, in a single daily administration, not to exceed 600 mg/day, oral or IV. Pediatric Patients: 10 to 20 mg/kg, not to exceed 600 mg/day IV. Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.<br/>Preparation of Solution for IV Infusion: Reconstitute the lyophilized powder by transferring 10 mL of sterile water for injection to a vial containing 600 mg of rifampin for injection. Swirl vial gently to completely dissolve the antibiotic. The reconstituted solution contains 60 mg rifampin per mL and is stable at room temperature for 24 hours. Prior to administration, withdraw from the reconstituted solution a volume equivalent to the amount of rifampin calculated to be administered and add to 500 mL of infusion medium. Mix well and infuse at a rate allowing forcomplete infusion in 3 hours. Alternatively, the amount of rifampin calculated to be administered may be added to 100 mL of infusion medium and infused in 30 minutes. Dilutions in dextrose 5% for injection (D5W) are stable at room temperature for up to 4 hours and should be prepared and used within this time. Precipitation of rifampin from the infusion solution may occur beyond this time. Dilutions in normal saline are stable at room temperature for up to 24 hours and should be prepared and used within this time. Other infusion solutions are not recommended.<br/>Incompatibilities: Physical incompatibility (precipitate) was observed with undiluted (5 mg/mL) and diluted (1 mg/mL in normal saline) diltiazem hydrochloride and rifampin (6 mg/mL, in normal saline) during simulated Y-site administration.<br/>Meningococcal Carriers: Adults: For adults, it is recommended that 600 mg rifampin be administered twice daily for two days. Pediatric Patients: Pediatric patients 1 month of age or older: 10 mg/kg (not to exceed 600 mg per dose) every 12 hours for two days. Pediatric patients under 1 month of age: 5 mg/kg every 12 hours for two days. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|
| dailymed-drugs:188 |
The recommended starting dose of Isosorbide Mononitrate Tablets is 30 mg (given as a single 30 mg tablet or as 1/2 of a 60 mg tablet) or 60 mg (given as a single tablet) once daily. After several days, the dosage may be increased to 120 mg (given as a single 120 mg tablet or as two 60 mg tablets) once daily. Rarely, 240 mg may be required. The daily dose of Isosorbide Mononitrate Tablets should be taken in the morning on arising. Isosorbide Mononitrate Extended-Release Tablets should not be chewed or crushed and should be swallowed together with a half-glassful of fluid.
|
| dailymed-drugs:189 |
The suspension is intended for intramuscular administration only. Endometrial or renal carcinoma���doses of 400 mg to 1000 mg of DEPO-PROVERA Sterile Aqueous Suspension per week are recommended initially. If improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month. Medroxyprogesterone acetate is not recommended as primary therapy, but as adjunctive and palliative treatment in advanced inoperable cases including those with recurrent or metastatic disease. When multi-dose vials are used, special care to prevent contamination of the contents is essential .
|
| dailymed-drugs:190 |
Premenstrual Dysphoric Disorder:<br/>Initial Treatment: The recommended dose of SARAFEM for the treatment of PMDD is 20 mg/day given continuously (every day of the menstrual cycle) or intermittently (defined as starting a daily dose 14 days prior to the anticipated onset of menstruation through the first full day of menses and repeating with each new cycle). The dosing regimen should be determined by the physician based on individual patient characteristics. In a study comparing continuous dosing of fluoxetine 20 and 60 mg/day to placebo, both doses were proven to be effective, but there was no statistically significant added benefit for the 60���mg/day compared with the 20���mg/day dose. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with PMDD. The maximum fluoxetine dose should not exceed 80 mg/day. As with many other medications, a lower or less frequent dosage should be considered in patients with hepatic impairment. A lower or less frequent dosage should also be considered for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary .<br/>Maintenance/Continuation Treatment: Systematic evaluation of SARAFEM has shown that its efficacy in PMDD is maintained for periods of up to 6 months at a dose of 20 mg/day given continuously and up to 3 months at a dose of 20 mg/day given intermittently . Patients should be periodically reassessed to determine the need for continued treatment.<br/>Special Populations:<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to fluoxetine and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding . When treating pregnant women with fluoxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering fluoxetine in the third trimester.<br/>Discontinuation of Treatment with SARAFEM: Symptoms associated with discontinuation of SARAFEM and other SSRIs and SNRIs, have been reported . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. Plasma fluoxetine and norfluoxetine concentration decrease gradually at the conclusion of therapy which may minimize the risk of discontinuation symptoms with this drug.
|
| dailymed-drugs:191 |
The objective of
nutritional management of patients with liver disease is the provision
of sufficient amino acid and caloric support for protein synthesis
without exacerbating hepatic encephalopathy. The total daily
dose of 8% Hepatasol (Amino Acid) Injection depends on daily
protein requirements and on the patient's metabolic and clinical
response. The determination of nitrogen balance and accurate daily body
weights, corrected for fluid balance, are probably the best means of
assessing individual protein requirements. Dosage should also be guided
by the patient's fluid intake limits and glucose and nitrogen
tolerances, as well as by metabolic and clinical response. The recommended
dosage is 80-120 grams of amino acids (12-18 grams of nitrogen) as 8%
Hepatasol (Amino Acid) Injection per day. Typically, 500
mL of 8% Hepatasol (Amino Acid) Injection appropriately
mixed with 500 mL of 50% dextrose supplemented with electrolytes and
vitamins is administered over an 8-12 hour period. This results in a
total daily fluid intake of approximately 2-3 liters. Patients with
fluid restrictions may only tolerate 1-2 liters. Although nitrogen
requirements may be higher in severely hypercatabolic or depleted
patients, provision of additional nitrogen may not be possible due to
fluid intake limits, nitrogen, or glucose intolerance.<br/>Pediatric Use:: Use of 8%
Hepatasol (Amino Acid) Injection in pediatric patients is governed by the same considerations that affect the
use of any amino acid solution in pediatrics. The amount
administered is dosed on the basis of grams of amino acids/kg of
body weight/day. Two to three g/kg of body weight for infants
with adequate calories are generally sufficient to satisfy
protein needsand promote positive nitrogen balance. Solutions
administered by peripheral vein should not exceed twice normal
serum osmolarity (718 m0smol/L). In many
patients, provision of adequate calories in the form of
hypertonic dextrose may require the administration of exogenous
insulin to prevent hyperglycemia and glycosuria. To prevent
rebound hypoglycemia, a solution containing 5% dextrose should
be administered when hypertonic dextrose solutions are abruptly
discontinued. Fat
emulsion coadministration should be considered when prolonged
(more than 5 days) parenteral nutrition is required in order to
prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids
should be monitored for evidence of E.F.A.D. in patients
maintained on fat free TPN. Caution should be exercised in
administering fat emulsions to patients with severe liver
damage. Fat
emulsion may obscure the presence of precipitate formation. The
provision of sufficient intracellular electrolytes, principally
potassium, magnesium, and phosphate, is required for optimum
utilization of amino acids. Approximately 60-160 mEq of
potassium, 10-30 mEq of magnesium, and 10-40 mmoles of phosphate
per day appear necessary to achieve optimum metabolic response.
In addition, sufficient quantitiesof the major extracellular
electrolytes sodium, calcium, and chloride, must be given. In
patients with hyperchloremic or other metabolic acidoses, sodium
and potassium may be added as the acetate salts to provide
bicarbonate precursor. The electrolyte content of 8%
Hepatasol (Amino Acid) Injection must be
considered when calculating daily electrolyte intake. Serum
electrolytes, including magnesium and phosphorus, should be monitored frequently. Hypertonic
mixtures of amino acids and dextrose may be safely administered
by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion
rates should be slow, and gradually increased to the recommended
60-125 mL/hr. If administration rate should fall behind
schedule, no attempt to "catch up" to planned intake should be
made. In addition to meeting protein needs, the rate of
administration, particularly during the firstfew days of
therapy, is governed by the patient's glucose tolerance. Daily
intake of amino acids and dextrose should be increased gradually
to the maximum required dose as indicated by frequent
determinations of glucose levels in blood and urine. For
patients in whom the central venous route is not indicated and
who can consume adequate calories enterally, 8%
Hepatasol (Amino Acid) Injection may be administered
by peripheral vein with or without parenteral carbohydrate
calories. Such infusates can be prepared by dilution of 8%
Hepatasol (Amino Acid) Injection with Sterile
Water for Injection or 5%-10% dextrose to prepare isotonic or slightly hypertonic solutions for peripheral infusion. It is
essential that peripheral infusion be accompanied by adequate
caloric supplementation. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718
mOsmol/L). Parenteral
drug products should be inspected visually for particulate
matter and discoloration prior to administration, whenever
solution and container permit. Care must
be taken to avoid incompatible admixtures. Consult with
pharmacist.
|
| dailymed-drugs:192 |
Myocardial Infarction:<br/>Early Treatment: During the early phase of definite or suspected acute myocardial infarction, treatment with metoprolol tartrate can be initiated as soon as possible after the patient's arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient's hemodynamic condition has stabilized. Treatment in this early phase should begin with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each; the injections should be given at approximately 2-minute intervals. During the intravenous administration of metoprolol tartrate, blood pressure, heart rate, and electrocardiogram should be carefully monitored. In patients who tolerate the full intravenous dose (15 mg), metoprolol tartrate tablets, 50 mg every 6 hours, should be initiated 15 minutes after the last intravenous dose and continued for 48 hours. Thereafter, patients should receive a maintenance dosage of 100 mg twice daily (see Late Treatment below). Patients who appear not to tolerate the full intravenous dose should be started on metoprolol tartrate tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, treatment with metoprolol tartrate should be discontinued .<br/>Late Treatment: Patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason should be started on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Therapy should be continued for at least 3 months. Although the efficacy of metoprolol tartrate beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years.<br/>Note 1: For further information on oral therapy continuation, please refer to the package insert of metoprolol tartrate tablets.<br/>Note 2: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|
| dailymed-drugs:193 |
THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. Vitamin D Resistant Rickets:12,000 to 500,000 IU units daily. Hypoparathyroidism:50,000 to 200,000 IU units daily concomitantly with calcium lactate 4 g, six times per day. DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION. Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.
|
| dailymed-drugs:194 |
For the treatment of acute bleeding syndromes due to elevated fibrolytic activity, it is suggested that 4 teaspoonfuls (5 g) of aminocaproic acid oral solution be administered during the first hour of treatment, followed by a continuing rate of 1 teaspoonful (1.25 g) of syrup per hour. This method of treatment would ordinarily be continued for about 8 hours or until the bleeding situation has been controlled.
|
| dailymed-drugs:195 |
As required for irrigation. When used as a diluent, or vehicle for other drugs, the drug
manufacturer's recommendations should be followed. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
|
| dailymed-drugs:196 |
Recommended Dose: The BEXXAR therapeutic
regimen consists of four components administered in two discrete steps:
the dosimetric step, followed 7-14 days later by a therapeutic step. Note: The safety of
the BEXXAR therapeutic regimen was established only in the setting
of patients receiving thyroid blocking agents and premedication to
ameliorate/prevent infusion reactions (see Concomitant Medications). Dosimetric step Therapeutic
step Note: Do not administer the therapeutic step if biodistribution is altered
(see Assessment of Biodistribution of Iodine
I 131 Tositumomab).<br/>Concomitant Medications: The safety of
the BEXXAR therapeutic regimen was established in studies in which
all patients received the following concurrent medications: Patients should not
receive the dosimetric dose of Iodine I 131 Tositumomab if they have
not yet received at least three doses of SSKI, three doses of Lugol's
solution, or one dose of 130 mg potassium iodide tablet (at least
24 hours prior to the dosimetric dose). The BEXXAR therapeutic regimen is administered
via an IV tubing set with an in-line 0.22 micron filter. THE SAME IV TUBING SET AND FILTER MUST BE USED THROUGHOUT
THE ENTIRE DOSIMETRIC OR THERAPEUTIC STEP. A CHANGE IN FILTER CAN
RESULT IN LOSS OF DRUG. Figure1 shows an overview of the dosing schedule. PREPARATION OF THE
BEXXAR THERAPEUTIC REGIMEN GENERAL Read all directions thoroughly and assemble all
materials before preparing the dose for administration. The Iodine I
131 Tositumomab dosimetric and therapeutic doses should be measured
by a suitable radioactivity calibration system immediately prior to
administration. The dose calibrator must be operated in accordance
with the manufacturer's specifications and quality control
for the measurement of Iodine-131. All supplies for preparation and administration
of the BEXXAR therapeutic regimen should be sterile. Use
appropriate aseptic technique and radiation precautions for the preparation
of the components of the BEXXAR therapeutic regimen. Waterproof gloves should be utilized in the preparation and administration
of the product. Iodine I 131 Tositumomab doses should be prepared,
assayed, and administered by personnel who are licensed to handle
and/or administer radionuclides. Appropriate shielding should be used
during preparation and administration of the product. Restrictions on patient contact with others and release
from the hospital must follow all applicable federal, state, and institutional
regulations. Preparation for the Dosimetric Step Tositumomab Dose Required materials not supplied: A. One 50 mL syringe with attached 18-gauge
needle (to withdraw 450 mg of Tositumomab from two vials each containing
225 mg Tositumomab) B. One 50 mL bag of
sterile 0.9% Sodium Chloride for Injection, USP C. One 50 mL syringe for drawing up 32 mL of saline for disposal
from the 50 mL bag of sterile 0.9% Sodium Chloride for Injection,
USP Method: Note: Tositumomab
solution may contain particulates that are generally white in nature.
The product should appear clear to opalescent, colorless to slightly
yellow. Preparation
of Iodine I 131 Tositumomab Dosimetric Dose Required materials not supplied: A. Lead shielding for preparation vial
and syringe pump B. One 30 mL syringe with
18-gauge needle to withdraw the calculated volume of Iodine I 131
Tositumomab from the Iodine I 131 Tositumomab vial. One 60 mL syringe
with 18-gauge needle to withdraw the volume from the preparation vial
for administration C. One 20 mL syringe
with attached needle, filled with 0.9% Sodium Chloride for Injection,
USP D. One 3 mL syringe with attached needle
to withdraw Tositumomab from 35 mg vial E.
One sterile, 30 or 50 mL preparation vial F.
Two lead pots, both kept at room temperature. One pot is used to thaw
the labeled antibody and the second pot is used to hold the preparation
vial Method: Administration
of the Dosimetric Step Required materials not supplied: For questions
about required materials call the BEXXAR Service Center at 1-877-423-9927. A. IV Filter set (0.22 micron filter),
15 inch with injection site (port) and luer lock B. One Primary IV infusion set C. One
100 mL bag of sterile 0.9% Sodium Chloride for Injection, USP D. Two Secondary IV infusion sets E. One IV Extension set, 30 inch luer lock F. One 3-way stopcock G. One 50 mL
bag of sterile 0.9% Sodium Chloride for Injection, USP H. One Infusion pump for Tositumomab infusion I. One Syringe Pump for Iodine I 131 Tositumomab infusion J. Lead shielding for use in the administration of
the dosimetric dose Tositumomab Infusion: (See Figure
1 in the���Workbook for Dosimetry
Methodology and Administration Set-Up���for diagrammatic
illustration of the configuration of the infusion set components.) Iodine I 131 Tositumomab
Dosimetric Infusion: (See Figure
2 in the���Workbook for Dosimetry
Methodology and Administration Set-Up���for diagrammatic
illustration of the configuration of the infusion set components.) Determination of Dose
for the Therapeutic Step (see Calculation of Iodine-131 Activity for
Therapeutic Dose): The method for determining and calculating
the patient-specific dose of Iodine-131 activity (mCi) to be administered
in the therapeutic step is described below. The derived values obtained
in steps 3 and 4 and calculation of the therapeutic dose as described
in step 6 may be determined manually [see���Workbook for Dosimetry Methodology and Administration Set-Up���] or calculated automatically using the GlaxoSmithKline proprietary
software program [BEXXAR Patient Management Templates]. To receive
training and to obtain the���BEXXAR Patient Management Templates���call the BEXXAR Service Center at 1-877-423-9927. For assistance with
either manual or automated calculations call the BEXXAR Service Center
at 1-877-423-9927. The following equation is used to calculate
the activity of Iodine-131 required for delivery of the desired total
body dose of radiation. Preparation for the Therapeutic
Step Tositumomab
Dose Required materials not supplied: A. One 50 mL syringe with attached 18-gauge needle (to withdraw
450 mg of Tositumomab from two vials each containing 225 mg Tositumomab) B. One 50 mL bag of sterile 0.9% Sodium Chloride for
Injection, USP C. One 50 mL syringe for
drawing up 32 mL of saline for disposal from the 50 mL bag of sterile
0.9% Sodium Chloride for Injection, USP Method: Note: Tositumomab
solution may contain particulates that are generally white in nature.
The product should appear clear to opalescent, colorless to slightly
yellow. Preparation
of Iodine I 131 Tositumomab Therapeutic Dose Required materials not
supplied: A.Lead shielding for
preparation vial and syringe pump B.One
or two 30 mL syringes with 18-gauge needles to withdraw the calculated
volume of Iodine I 131 Tositumomab from the Iodine I 131 Tositumomab
vial(s). One or two 60 mL syringes with 18-gauge needles to withdraw
the volume from the preparation vial for administration C. One 20 mL syringe with attached needle filled with
0.9% Sodium Chloride for Injection, USP D. One
3 mL sterile syringe with attached needle to draw up Tositumomab from
the 35 mg vial E. One sterile, 30 or 50 mL preparation
vial F.Two lead pots both kept at room temperature.
One pot is used to thaw the labeled antibody, and the second pot is
used to hold the preparation vial Method: Administration
of the Therapeutic Step Note: Restrictions on patient contact
with others and release from the hospital must follow all applicable
federal, state, and institutional regulations. Required materials not supplied: For
questions about required materials call the BEXXAR Service Center
at 1-877-423-9927. A. One IV Filter
set (0.22 micron, filter), 15 inch with injection site (port) and
luer lock B. One Primary IV infusion set C. One 100 mL bag of sterile 0.9% Sodium Chloride for
Injection, USP D. Two Secondary IV infusion
sets E. One IV extension set, 30 inch luer
lock F. One 3-way stopcock G. One 50 mL bag of sterile 0.9% Sodium Chloride for Injection, USP H. One Infusion pump for Tositumomab infusion I. One Syringe Pump for Iodine I 131 Tositumomab infusion J. Lead shielding for use in the administration of the
therapeutic dose Tositumomab
Infusion: (See Figure 1 in the���Workbook for Dosimetry Methodology and Administration
Set-Up���for diagrammatic illustration of the configuration
of the infusion set components.) Iodine I 131 Tositumomab
Therapeutic Infusion: (See Figure
2 in the���Workbook for Dosimetry
Methodology and Administration Set-Up���for diagrammatic
illustration of the configuration of the infusion set components.) DOSIMETRY The following sections describe the procedures for
image acquisition for collection of dosimetry data, interpretation
of biodistribution images, calculation of residence time, and calculation
of activity hours. Please read all sections carefully. IMAGE ACQUISITION AND INTERPRETATION Gamma Camera and Dose Calibrator Procedures Manufacturer-specific quality control
procedures should be followed for the gamma camera/computer system,
the collimator, and the dose calibrator. Less than 20% variance between
maximum and minimum pixel count values in the useful field of view
is acceptable on Iodine-131 intrinsic flood fields and variability<10% is preferable. Iodine-131-specific camera uniformity corrections
are strongly recommended, rather than applying lower energy correction
to the Iodine-131 window. Camera extrinsic uniformity should be assessed
at least monthly usingTc orCo as a source
with imaging at the appropriate window. Additional
(non-routine) quality control procedures are required. To assure the
accuracy and precision of the patient total body counts, the gamma
camera must undergo validation and daily quality control on each day
it is used to collect patient images. Use
the same setup and region of interest (ROI) for calibration, determination
of background, and whole body patient studies. Gamma Camera Set-Up The same camera,
collimator, scanning speed, energy window, and setup must be used
for all studies. The gamma camera must be capable of whole body imaging
and have a large or extra large field of view with a digital interface.
It must be equipped with a parallel-hole collimator rated to at least364 keV by the manufacturer with a septal penetration for Iodine-131
of<7%. The camera and computer must be
set up for scanning as follows: Counts from Calibrated
Source for Quality Control Camera
sensitivity for Iodine-131 must be determined each day. Determination
of the gamma camera's sensitivity is obtained by scanning a
calibrated activity of Iodine-131 (e.g., 200���250��Ci
in at least 20 mL of saline within a sealed pharmaceutical vial).
The radioactivity of the Iodine-131 source is first determined using
a NIST-traceable-calibrated clinical dose calibrator at the Iodine-131
setting. Background
Counts The background count is
obtained from a scan with no radioactive source. This should be obtained
following the count of the calibrated source and just prior to obtaining
the patient count. If abnormally high background
counts are measured, the source should be identified and, if possible,
removed. If abnormally low background counts are measured, the camera
energy window setting and collimator should be verified before repeating
the background counts. The counts per��Ci
are obtained by dividing the background-corrected source count by
the calibrated activity for that day. For a specific camera and collimator,
the counts per��Ci should be relatively constant. When values
vary more than 10% from the established ratio, the reason for the
discrepancy should be ascertained and corrected and the source countrepeated. Patient
Total Body Counts The source
and background counts are obtained first and the camera sensitivity
(i.e., constant counting efficiency) is established prior to obtaining
the patient count. The same rectangular region of interest (ROI) must
be used for the whole body counts, the quality control counts of the
radioactive source, and the background counts. Acquire anterior and posterior whole body images for gamma camera
counts. For any particular patient, the same gamma camera must be
used for all scans. To obtain proper counts, extremities must be included
in the images, and arms should not cross over the body. The scans
should be centered on the midline of the patient. Record the time
of the start of the radiolabeled dosimetric infusion and the time
of the start of each count acquisition. Gamma
camera counts will be obtained at the three imaging timepoints: Assessment of Biodistribution
of Iodine I 131 Tositumomab The
biodistribution of Iodine I 131 Tositumomab should be assessed by
determination of total body residence time and by visual examination
of whole body camera images from the first image taken at the time
of Count 1 (within an hour of the end of the infusion) and from the
second image taken at the time of Count 2 (at 2 to 4 days after administration).
To resolve ambiguities, an evaluation of the third image at the time
of Count 3 (6 to 7 days after administration) may be necessary. If
either of these methods indicates that the biodistribution is altered,
the Iodine I 131 Tositumomab therapeutic dose should not be administered. Expected Biodistribution Results Indicating Altered Biodistribution CALCULATION OF IODINE-131
ACTIVITY FOR THE THERAPEUTIC DOSE There are two options for calculation of the Iodine-131 activity
for the therapeutic dose. The derived values and calculation of the
therapeutic dose may be determined manually [see���Workbook for Dosimetry Methodology and Administration
Set-Up���] or calculated automatically using the GlaxoSmithKline
proprietary software program [BEXXAR Patient Management Templates].
The following describes in greater detail the stepwise method for
manual determination of the Iodine-131 activity for the therapeutic
dose. Residence Time
(hr) For each timepoint, calculate
the background corrected total body count at each timepoint (defined
as the geometric mean). The following equation is used: In this equation, C= the anterior counts, C= the anterior background
counts, C= the posterior counts, and C=
the posterior background counts. Once the
geometric mean of the counts has been calculated for each of the 3
timepoints, the % injected activity remaining for each timepoint is
calculated by dividing the geometric mean of the counts from that
timepoint by the geometric mean of the counts from Day 0 and multiplying
by 100. The residence time (h) is then determined
by plotting the time from the start of infusion
and the % injected activity values for the 3 imaging timepoints on Graph 1 (see Worksheet���Determination
of Residence Time���in the���Workbook for Dosimetry Methodology and Administration Set-Up���supplied with Dosimetric Dose Packaging). A best-fit line is then
drawn from 100% (the pre-plotted Day 0 value) through the other 2
plotted points (if the line does not intersect the two points, one
point must lie above the best-fit line and one point must lie below
the best-fit line). The residence time (h) is read from the x-axis
of the graph at the point where the fitted line intersects with the
horizontal 37% injected activity line. Activity Hours (mCi hr) In order to determine the activity hours (mCi hr), look up the
patient's maximum effective mass derived from the patient's
sex and height (see Worksheet���Determination
of Maximum Effective Mass���in the���Workbook for Dosimetry Methodology and Administration
Set-Up���supplied with Dosimetric Dose Packaging).
If the patient's actual weight is less than the maximum effective
mass, the actual weight should be used in the activity hours table
(see Worksheet���Determination of
Activity Hours���in the���Workbook for Dosimetry Methodology and Administration Set-Up���supplied with Dosimetric Dose Packaging). If the patient's
actual weight is greater than the maximum effective mass, the mass
from the worksheet for���Determination
of Maximum Effective Mass���should be used. Calculation of Iodine-131 Activity
for the Therapeutic Dose The following
equation is used to calculate the activity of Iodine-131 required
for delivery of the desired total body dose of radiation.
|
| dailymed-drugs:197 |
OSMITROL Injection (Mannitol Injection, USP) should be administered only by intravenous infusion. The total dosage, concentration,
and rate of administration should be governed by the nature and severity of the condition being treated, fluid requirement, and urinary output. The usual adult dosage ranges from 20 to
100 g in a 24 hour period, but in most instances an adequate response will be achieved at a dosage of approximately 50 to 100 g in a 24 hour period. The rate of administration is usually
adjusted to maintain a urine flow of at least 30 to 50 mL/hour. This outline of administration and dosage is only a general guide to therapy. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever
solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible. Test Dose: A test dose of mannitol should be given prior to instituting OSMITROL Injection (Mannitol Injection, USP) therapy for
patients with marked oliguria, or those believed to have inadequate renal function. Such a test dose may be approximately 0.2 g/kg body weight (about 75 mL of a 20% solution or 100 mL of
a 15% solution) infused in a period of three to five minutes to produce a urine flow of at least 30 to 50 mL/hour. If urine flow does not increase, a second test dose may be given; if
there is an inadequate response, the patient should be reevaluated. Prevention of Acute Renal Failure (Oliguria): When used during cardiovascular and other types of surgery, 50 to 100 g of mannitol
as a 5, 10, or 15% solution may be given. The concentration will depend upon the fluid requirements of the patient. Treatment of Oliguria: The usual dose for treatment of oliguria is 100 g administered as a 15 or 20% solution. Reduction of Intraocular Pressure: A dose of 1.5 to 2.0 g/kg as a 20% solution (7.5 to 10 mL/kg) or as a 15% solution (10 to 13
mL/kg) may be given over a period as short as 30 minutes in order to obtain a prompt and maximal effect. When used preoperatively the dose should be given one to one and one-half hours
before surgery to achieve maximal reduction of intraocular pressure before operation. Reduction of Intracranial Pressure: Usually a maximum reduction in intracranial pressure in adults can be achieved with a dose of
0.25 g/kg given not more frequently than every six to eight hours. An osmotic gradient between the blood and cerebrospinal fluid of approximately 10 mOsmol will yield a satisfactory
reduction in intracranial pressure. Adjunctive Therapy for Intoxications: As an agent to promote diuresis in intoxications, 5%, 10%, 15% or 20% mannitol is indicated.
The concentration will depend upon the fluid requirement and urinary output of the patient. Measurement of glomerular filtration rate by creatinine clearance may be useful for determination of dosage. All injections in VIAFLEX containers are intended for intravenous administration using sterile equipment. The use of supplemental additive medication is not recommended.
|
| dailymed-drugs:198 |
Patients should use Fluticasone Propionate Nasal Spray at regular intervals for optimal effect.<br/>Adults: The recommended starting dosage in adults is two sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg). The same dosage divided into 100 mcg given twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able to reduce their dosage to 100 mcg (one spray in each nostril) once daily for maintenance therapy.<br/>Adolescents and Children (4 Years of Age and Older): Patients should be started with 100 mcg (one spray in each nostril once daily). Patients not adequately responding to 100 mcg may use 200 mcg (two sprays in each nostril). Once adequate control is achieved, the dosage should be decreased to 100 mcg (one spray in each nostril) daily. The maximum total daily dosage should not exceed two sprays in each nostril (200 mcg/day). (See Individualization of Dosage and Clinical Trials sections.) Fluticasone Propionate Nasal Spray is not recommended for children under 4 years of age.<br/>Directions for Use: Illustrated patient's instructions for proper use accompany each package of Fluticasone Propionate Nasal Spray.
|
| dailymed-drugs:200 |
The recommended starting dose of Diovan is 80 mg once daily when used as monotherapy in patients who are not volume-depleted. Diovan may be used over a dose range of 80 mg to 320 mg daily, administered once-a-day. The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required, the dosage may be increased to 160 mg or 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg. No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of Diovan in patients with hepatic or severe renal impairment. Diovan may be administered with other antihypertensive agents. Diovan may be administered with or without food.
|
| dailymed-drugs:201 |
Zarontin is administered by the oral route. The initial dose for patients 3 to 6 years of age is one capsule (250 mg) per day; for patients 6 years of age and older, 2 capsules (500 mg) per day. The dose thereafter must be individualized according to the patient's response. Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels withinthe accepted therapeutic range of 40 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations. Zarontin may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20mg/kg/day.
|
| dailymed-drugs:202 |
The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin and should continue on this diet during treatment with lovastatin (see NCEP Treatment Guidelines for details on dietary therapy). Lovastatin should be given with meals.<br/>Adult Patients: The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range is 10 to 80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Guidelines and CLINICAL PHARMACOLOGY). Patients requiring reductions in LDL-C of 20% or more to achieve their goal (see INDICATIONS AND USAGE) should be started on 20 mg/day of lovastatin. A starting dose of 10 mg may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more. Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin if cholesterol levels fall significantly below the targeted range.<br/>Dosage in Patients Taking Cyclosporine or Danazol: In patients taking cyclosporine or danazol concomitantly with lovastatin (see WARNINGS, Myopathy/Rhabdomyolysis), therapy should begin with 10 mg of lovastatin and should not exceed 20 mg/day.<br/>Dosage in Patients Taking Amiodarone or Verapamil: In patients taking amiodarone or verapamil concomitantly with lovastatin, the dose should not exceed 40 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, DrugInteractions, Other Drug Interactions).<br/>Adolescent Patients (10 to 17 years of age) with Heterozygous Familial Hypercholesterolemia: The recommended dosing range is 10 to 40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Pediatric Panel Guidelines, CLINICAL PHARMACOLOGY, and INDICATIONS AND USAGE). Patients requiring reductions in LDL-C of 20% or more to achieve their goal should be started on 20 mg/day of lovastatin. A starting dose of 10 mg may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.<br/>Concomitant Lipid-Lowering Therapy: Lovastatin is effective alone or when used concomitantly with bile-acid sequestrants. If lovastatin is used in combination with gemfibrozil, other fibrates or lipid-lowering doses (���1g/day) of niacin, the dose of lovastatin should not exceed 20 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions).<br/>Dosage in Patients with Renal Insufficiency: In patients with severe renal insufficiency (creatinine clearance<30 mL/min), dosage increases above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS, Myopathy/Rhabdomyolysis).
|
| dailymed-drugs:203 |
Fluticasone Propionate Cream, 0.05% may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of Fluticasone Propionate Cream, 0.05% in pediatric patients for more than 4 weeks of use have not been established . The safety and efficacy of Fluticasone Propionate Cream, 0.05% in pediatric patients below 3 months of age have not been established. Geriatric Use: In studies where geriatric patients have been treated with fluticasone propionate cream 0.05%, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended. Atopic Dermatitis: Apply a thin film of Fluticasone Propionate Cream, 0.05% to the affected skin areas once or twice daily. Rub in gently. Other Corticosteroid-Responsive Dermatoses: Apply a thin film of Fluticasone Propionate Cream, 0.05% to the affected skin areas twice daily. Rub in gently. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Fluticasone Propionate Cream, 0.05% should not be used with occlusive dressings. Fluticasone Propionate Cream, 0.05% should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings.
|
| dailymed-drugs:204 |
SHAKE WELL BEFORE USING. Two drops should be instilled into the conjunctival sac every four hours during the day and at bedtime. Not more than 20 milliliters should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above. BLEPHAMIDE dosage may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application. If signs and symptoms fail to improve after two days, the patient should be re-evaluated .
|
| dailymed-drugs:205 |
Hypertension:<br/>Heart Failure:<br/>Acute Myocardial Infarction:<br/>Use in Elderly:<br/>Pediatric Hypertensive Patients���6 years of age:<br/>Preparation of Suspension (for 200 mL of a 1 mg/mL suspension):
|
| dailymed-drugs:206 |
Instill one drop in the affected eye 3 times a day for 7 days.
|
| dailymed-drugs:207 |
BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE TABLETS SHOULD BE ADMINISTERED ONLY BY PHYSICIANS WHO ARE EXPERIENCED IN THE TREATMENT OF LIFE-THREATENING ARRHYTHMIAS WHO ARE THOROUGHLY FAMILIAR WITH THE RISKS AND BENEFITS OF AMIODARONE THERAPY, AND WHO HAVE ACCESS TO LABORATORY FACILITIES CAPABLE OF ADEQUATELY MONITORING THE EFFECTIVENESS AND SIDE EFFECTS OF TREATMENT. In order to insure that an antiarrhythmic effect will be observed without waiting several months, loading doses are required. A uniform, optimal dosage schedule for administration of amiodarone hydrochloride tablets has not been determined. Because of the food effect on absorption, amiodarone hydrochloride tablets should be administered consistently with regard to meals (see CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:<br/>For Life-Threatening Ventricular Arrhythmias, Such as Ventricular Fibrillation or Hemodynamically Unstable Ventricular Tachycardia: Close monitoring of the patients is indicated during the loading phase, particularly until risk of recurrent ventricular tachycardia or fibrillation has abated. Because of the serious nature of the arrhythmia and the lack of predictable time course of effect, loading should be performed in a hospital setting. Loading doses of 800 to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of amiodarone hydrochloride tablets in divided doses with meals is suggested for total daily doses of 1,000 mg or higher, or when gastrointestinal intolerance occurs.) If side effects become excessive, the dose should be reduced. Elimination of recurrence of ventricular fibrillation and tachycardia usually occurs within 1 to 3 weeks, along with reduction in complex and total ventricular ectopic beats. Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, grapefruit juice should not be taken during treatment with oral amiodarone (see PRECAUTIONS, Drug Interactions). Upon starting amiodarone hydrochloride tablet therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see PRECAUTIONS, Drug Interactions). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride tablet dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see CLINICAL PHARMACOLOGY, Monitoring Effectiveness). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone hydrochloride tablets may be administered as a single daily dose, or in patients with severe gastrointestinal intolerance, as a b.i.d. dose. In each patient, the chronic maintenance dose should be determined according to antiarrhythmic effect as assessed by symptoms, Holter recordings, and/or programmed electrical stimulation and by patienttolerance. Plasma concentrations may be helpful in evaluating nonresponsiveness or unexpectedly severe toxicity (see CLINICAL PHARMACOLOGY). The lowest effective dose should be used to prevent the occurrence of side effects. In all instances, the physician must be guided by the severity of the individual patient's arrhythmia and response to therapy. When dosage adjustments are necessary, the patient should be closely monitored for an extended period of time because of the long and variable half-life of amiodarone and the difficulty in predicting the time required to attain a new steady state level of drug. Dosage suggestions are summarized below:
|
| dailymed-drugs:209 |
AEROSPAN Inhalation Aerosol should be administered by the orally inhaled route in asthmatic patients aged 6 years and older. The onset and degree of symptom relief with orally inhaled corticosteroids is usually apparent within 2-4 weeks after the start of treatment, and varies with individual patients. The time to improvement in asthma control was not evaluated in clinical studies with AEROSPAN Inhalation Aerosol. For patients who do not respond adequately to the starting dose after 3-4 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of AEROSPAN Inhalation Aerosol when administered in excess of recommended doses have not been established. Note: In all patients it is desirable to titrate to the lowest effective dose once asthma stability is achieved. Adults (age 12 and older): The recommended starting dose is 160 mcg twice daily. The maximum dose should not exceed 320 mcg twice daily. Higher doses have not been studied. Children (age 6 to 11): The recommended starting dose is 80 mcg twice daily. The maximum dose should not exceed 160 mcg twice daily. Higher doses have not been studied. Pediatric patients should administer this product under adult supervision. The recommended dosage of AEROSPAN Inhalation Aerosol relative to flunisolide CFC inhalation aerosol is lower due to differences in delivery characteristics between the products. Recognizing that a definitive comparative therapeutic ratio between AEROSPAN Inhalation Aerosol and flunisolide CFC inhalation aerosol has not been demonstrated, any patient who is switched from flunisolide CFC inhalation aerosol to AEROSPAN Inhalation Aerosol should be dosed appropriately, taking into account the dosing recommendations above, and should be monitored to ensure that the dose of AEROSPAN Inhalation Aerosol selected is safe and efficacious. As with any inhaled corticosteroid, physicians are advised to select the dose of AEROSPAN Inhalation Aerosol that would be appropriate based upon the patient's disease severity and titrate the dose of AEROSPAN Inhalation Aerosol downward over time to the lowest level that maintains proper asthma control. Clinical studies with AEROSPAN Inhalation Aerosol did not evaluate patients on oral corticosteroids. However, clinical studies with therapeutic doses of flunisolide CFC inhalation aerosol did show efficacy in the management of asthmatics dependent or maintained on systemic corticosteroids. If a patient is already on a systemic corticosteroid for asthma control, AEROSPAN Inhalation Aerosol should be used concurrently with the patient's usual maintenance dose of oral corticosteroid before an attempt is made to withdraw systemic corticosteroid. The patient's asthma should be reasonably stable before withdrawal of oral corticosteroid is initiated. After approximately one week, gradual withdrawal of the systemic corticosteroid may be started by reducing the daily or alternate daily dose. The next reduction may be made after an interval of one or two weeks, depending on the response of the patients. In general, these decrements should not exceed 2.5 mg of prednisone orits equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral corticosteroids, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency . During their withdrawal from a systemic corticosteroid, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or musculoskeletal pain, lassitude and depression, despite maintenance or even improvements in pulmonary function. Such patients should be encouraged to continue with AEROSPAN Inhalation Aerosol and should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly. During periods of stress or a severe asthma attack, patients being transferred may require supplementary treatment with a systemic corticosteroid.
|
| dailymed-drugs:210 |
The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals. While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration. Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.
|
| dailymed-drugs:211 |
DOSAGE MUST BE INDIVIDUALIZED. Chlorthalidone is usually given at a dose of 25 mg daily; the usual initial dose of atenolol is 50 mg daily. Therefore, the initial dose should be one TENORETIC 50 tablet given once a day. If an optimal response is not achieved, the dosage should be increased to one TENORETIC 100 tablet given once a day. When necessary, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure. Since atenolol is excreted via the kidneys, dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73m(normal range is 100-150 mL/min/1.73m); therefore, the following maximum dosages are recommended for patients with renal impairment.
|
| dailymed-drugs:212 |
Carbinoxamine maleate is contraindicated in children younger than 2 years of age . Carbinoxamine maleate tablets should be taken on an empty stomach with water. DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Carbinoxamine maleate dosage should be based on the severity of the condition and the response of the patient. The drug is well tolerated in doses as high as 24 mg daily, in divided doses, over prolonged periods. On the other hand, some patients respond to as little as 4 mg daily. Clinical experience suggests the following dosage schedules:<br/>Tablets: Usual Adult Dosage: Usual Child's Dosage:<br/>Oral Solution: Usual Adult Dosage: Usual Child's Dosage (approximately 0.2���0.4 mg/kg/day):
|
| dailymed-drugs:213 |
CIPRODEX' OTIC SHOULD BE SHAKEN WELL IMMEDIATELY BEFORE USE CIPRODEX' Otic contains 3 mg/mL (3000��g/mL) ciprofloxacin and 1 mg/mL dexamethasone. Acute Otitis Media in pediatric patients with tympanostomy tubes: The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (age 6 months and older) through tympanostomy tubes is: Four drops (0.14 mL, 0.42 mg ciprofloxacin, 0.14 mg dexamethasone) instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragusshould then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed. Acute Otitis Externa: The recommended dosage regimen for the treatment of acute otitis externa is: For patients (age 6 months and older): Four drops (0.14 mL, 0.42 mg ciprofloxacin, 0.14 mg dexamethasone) instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.
|
| dailymed-drugs:214 |
Systemic evaluation of dose and/or interval between dose has not been done. However, on limited clinical experience, the recommended initial dose of SYPRINE is 500-750 mg/day for pediatric patients and 750-1250 mg/day for adults given in divided doses two, three or four times daily. This may be increased to a maximum of 2000 mg/day for adults or 1500 mg/day for pediatric patients age 12 or under. The daily dose of SYPRINE should be increased only when the clinical response is not adequate or the concentration of free serum copper is persistently above 20 mcg/dL. Optimal long-term maintenance dosage should be determined at 6-12 month intervals . It is important that SYPRINE be given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed.
|
| dailymed-drugs:215 |
The total daily dose of FOSRENOL' should be divided and
taken with meals. The recommended initial total daily dose of
FOSRENOL' is 750-1500 mg. The dose should be titrated every 2-3
weeks until an acceptable serum phosphate level is reached. Serum
phosphate levels should be monitored as needed during dose titration and
on a regular basis thereafter. In clinical studies of ESRD patients, FOSRENOL' doses up
to 3750 mg were evaluated. Most patients required a total daily dose
between 1500 mg and 3000 mg to reduce plasma phosphate levels to less
than 6.0 mg/dL. Doses were generally titrated in increments of 750
mg/day. Tablets should be chewed completely before
swallowing. Intact tablets should not be swallowed.
|
| dailymed-drugs:216 |
The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of lactulose) daily. The dose may be increased to 60 mL daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement. Note: Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water or milk.
|
| dailymed-drugs:217 |
Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.
|
| dailymed-drugs:2029 |
Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.
|
| dailymed-drugs:2326 |
Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.
|
| dailymed-drugs:219 |
CHC Monoinfection: The recommended dose of RIBASPHERE (ribavirin, USP) tablets is provided in Table 4. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks. The daily dose of RIBASPHERE (ribavirin, USP) is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 4). In the pivotal clinical trials, patients were instructed to take ribavirin with food; therefore, patients are advised to take RIBASPHERE (ribavirin, USP) with food.<br/>Dose Modifications: If severe adverse reactions or laboratory abnormalities develop during combination RIBASPHERE (ribavirin, USP)/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment,
RIBASPHERE (ribavirin, USP)/
peginterferon alfa-2a therapy should be discontinued. RIBASPHERE (ribavirin, USP) should be administered with caution to patients with pre-existing cardiac disease (see Table 5). Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped . Once RIBASPHERE (ribavirin, USP) has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart RIBASPHERE (ribavirin, USP) at 600 mg daily and further increase the dose to 800 mg daily depending upon the physician's judgment. However, it is not recommended that RIBASPHERE (ribavirin, USP) be increased to its original assigned dose (1000 mg to 1200 mg).<br/>Renal Impairment: RIBASPHERE (ribavirin, USP) should not be used in patients with creatinine clearance<50 mL/min .
|
| dailymed-drugs:220 |
Carefully consider the potential benefits and risks of oxaprozin and other treatment options before deciding to use oxaprozin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with oxaprozin, the dose and frequency should be adjusted to suit an individual patient's needs. Rheumatoid Arthritis For relief of the signs and symptoms of rheumatoid arthritis, the usual recommended dose is 1200 mg (two 600-mg tablets) given orally once a day (see Individualization of dosage). Osteoarthritis For relief of the signs and symptoms of osteoarthritis, the usual recommended dose is 1200 mg (two 600-mg tablets) given orally once a day (see Individualization of dosage). Juvenile Rheumatoid Arthritis For the relief of the signs and symptoms of JRA in patients 6-16 years of age, the recommended dose given orally once per day should be based on body weight of the patient as given in Table 3 (see also Individualization of dosage). (see CLINICAL PHARMACOLOGY: Special populations: Pediatric patients)<br/>INDIVIDUALIZATION OF DOSAGE: As with other NSAIDs, the lowest dose should be sought for each patient. Therefore, after observing the response to initial therapy with oxaprozin, the dose and frequency should be adjusted to suit an individual patient's needs. In osteoarthritis and rheumatoid arthritis and juvenile rheumatoid arthritis, the dosage should be individualized to the lowest effective dose of oxaprozin to minimize adverse effects. The maximum recommended total daily dose of oxaprozin in adults is 1800 mg (26 mg/kg, whichever is lower) in divided doses. In children, doses greater than 1200 mg have not been studied. Patients of low body weight should initiate therapy with 600 mg once daily. Patients with severe renal impairment or on dialysis should also initiate therapy with 600 mg once daily. If there is insufficient relief of symptoms in such patients, the dose may be cautiously increased to 1200 mg, but only with close monitoring (see CLINICAL PHARMACOLOGY: Special Populations). In adults, in cases where a quick onset of action is important, the pharmacokinetics of oxaprozin allow therapy to be started with a one-time loading dose of 1200 to 1800 mg (not to exceed 26 mg/kg). Doses larger than 1200 mg/day on a chronic basis should be reserved for patients who weigh more than 50 kg, have normal renal and hepatic function, are at low risk of peptic ulcer, and whose severity of disease justifies maximal therapy. Physicians should ensure that patients are tolerating doses in the 600 to 1200 mg/day range without gastroenterologic, renal, hepatic, or dermatologic adverse effects before advancing to the larger doses. Most patients will tolerate once-a-day dosing with oxaprozin, although divided doses may be tried in patients unable to tolerate single doses. SAFETY AND HANDLING Oxaprozin is supplied as a solid dosage form in closed containers, is not known to produce contact dermatitis, and poses no known risk to healthcare workers. It may be disposed of in accordance with applicable local regulations governing the disposal of pharmaceuticals.
|
| dailymed-drugs:221 |
Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (e.g., 3 to 6 month intervals) to determine if treatment is still necessary . For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Activella therapy consists of a single tablet to be taken once daily. 1. For the treatment of moderate to severe vasomotor symptoms associated with menopause, and the prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. 2. For the treatment of moderate to severe symptoms of vulvar and vaginal atrophy. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Patients should be started at the lowest dose.
|
| dailymed-drugs:222 |
Usual Dosage: Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating. Short corneal and conjunctival procedures: 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses. Note: OPHTHETIC should be clear to straw-color. If the solution becomes darker, discard the solution.
|
| dailymed-drugs:223 |
Active Duodenal Ulcer. The recommended adult oral dosage for duodenal ulcer is 1 g (10 mL/2 teaspoonfuls) four times per day. CARAFATE should be administered on an empty stomach. Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
|
| dailymed-drugs:225 |
Blood pressure decreases associated with any dose of ALTACE depend, in part, on the presence or absence of volume depletion (e.g., past and current diuretic use) or the presence or absence of renal artery stenosis. If such circumstances are suspected to be present, the initial starting dose should be 1.25 mg once daily.<br/>Reduction in Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes: ALTACE should be given at an initial dose of 2.5 mg, once a day for 1 week, 5 mg, once a day for the next 3 weeks, and then increased as tolerated, to a maintenance dose of 10 mg, once a day. If the patient is hypertensive or recently post myocardial infarction, it can also be given as a divided dose.<br/>Hypertension: The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Dosage should be adjusted according to the blood pressure response. The usual maintenance dosage range is 2.5 to 20 mg per day administered as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with ALTACE alone, a diuretic can be added.<br/>Heart Failure Post Myocardial Infarction: For the treatment of post-infarction patients who have shown signs of congestive failure, the recommended starting dose of ALTACE is 2.5 mg twice daily (5 mg per day). A patient who becomes hypotensive at this dose may be switched to 1.25 mg twice daily, and after one week at the starting dose, patients should then be titrated (if tolerated) toward a target dose of 5 mg twice daily, with dosage increases being about 3 weeks apart. After the initial dose of ALTACE, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS , Drug Interactions .) If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of ALTACE does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension. The ALTACE Capsule is usually swallowed whole. The ALTACE Capsule can also be opened and the contents sprinkled on a small amount (about 4 oz.) of apple sauce or mixed in 4 oz. (120 ml) of water or apple juice. To be sure that ramipril is not lost when such a mixture is used, the mixture should be consumed in its entirety. The described mixtures can be pre-prepared and stored for up to 24 hours at room temperature or up to 48 hours under refrigeration. Concomitant administration of ALTACE with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of ALTACE. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with ALTACE. Then, if blood pressure is not controlled with ALTACE alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 1.25 mg ALTACE should be used to avoid excess hypotension.<br/>Dosage Adjustment in Renal Impairment: In patients with creatinine clearance<40 ml/min/1.73m(serum creatinine approximately>2.5 mg/dl) doses only 25% of those normally used should be expected to induce full therapeutic levels of ramiprilat. Hypertension: For patients with hypertension and renal impairment, the recommended initial dose is 1.25 mg ALTACE once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 5 mg. Heart Failure Post Myocardial Infarction: For patients with heart failure and renal impairment, the recommended initial dose is 1.25 mg ALTACE once daily. The dose may be increased to 1.25 mg b.i.d. and up to a maximum dose of 2.5 mg b.i.d. depending upon clinical response and tolerability.
|
| dailymed-drugs:226 |
Primary hyperaldosteronism: Aldactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.<br/>Long test: Aldactone is administered at a daily dosage of 400 mg for three to four weeks. Correction of hypokalemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.<br/>Short test: Aldactone is administered at a daily dosage of 400 mg for four days. If serum potassium increases during Aldactone administration but drops when Aldactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered. After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, Aldactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, Aldactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.<br/>Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome): An initial daily dosage of 100 mg of Aldactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, Aldactone should be continued for at least five days at the initial dosage level, after which it may be adjusted to the optimal therapeutic or maintenance level administered in either single or divided daily doses. If, after five days, an adequate diuretic response to Aldactone has not occurred, a second diuretic which acts more proximally in the renal tubule may be added to the regimen. Because of the additive effect of Aldactone when administered concurrently with such diuretics, an enhanced diuresis usually begins on the first day of combined treatment; combined therapy is indicated when more rapid diuresis is desired. The dosage of Aldactone should remain unchanged when other diuretic therapy is added.<br/>Essential hypertension: For adults, an initial daily dosage of 50 to 100 mg of Aldactone administered in either single or divided doses is recommended. Aldactone may also be given with diuretics which act more proximally in the renal tubule or with other antihypertensive agents. Treatment with Aldactone should be continued for at least two weeks, since the maximum response may not occur before this time. Subsequently, dosage should be adjusted according to the response of the patient.<br/>Hypokalemia: Aldactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium-sparing regimens are considered inappropriate.
|
| dailymed-drugs:227 |
Ampicillin and
Sulbactam for Injection may be administered by either the IV or the IM
routes. For IV
administration, the dose can be given by slow intravenous injection over
at least 10-15 minutes or can also be delivered in greater dilutions
with 50-100 mL of a compatible diluent as an intravenous infusion over
15-30 minutes. Ampicillin and
Sulbactam for Injection may be administered by deep intramuscular
injection. (See Preparation for
Intramuscular Injection.) The recommended
adult dosage of ampicillin and sulbactam is 1.5 g (1 g ampicillin as the
sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g
ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt)
every six hours. This 1.5 to 3 g range represents the total of
ampicillin content plus the sulbactam content of Ampicillin and
Sulbactam for Injection, and corresponds to a range of 1 g
ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total
dose of sulbactam should not exceed 4 grams per day.<br/>Pediatric Patients
1 Year of Age or Older: The
recommended daily dose of Ampicillin and Sulbactam for Injection
in pediatric patients is 300 mg per kg of body weight
administered via intravenous infusion in equally divided doses
every 6 hours. This 300 mg/kg/day dosage represents the total
ampicillin content plus the sulbactam content of Ampicillin and
Sulbactam for Injection, and correspondsto 200 mg
ampicillin/100 mg sulbactam per kg per day. The safety and
efficacy of Ampicillin and Sulbactam for Injection administered via intramuscular injection in pediatric patients have not been
established. Pediatric
patients weighing 40 kg or more should be dosed according to
adult recommendations, and the total dose of sulbactam should
not exceed 4 grams per day. The course of intravenous therapy
should not routinely exceed 14 days. In clinical trials, most
children received a course of oral antimicrobials following
initial treatment with intravenous Ampicillin and Sulbactam for
Injection. (See CLINICAL
STUDIES section.)<br/>Impaired Renal
Function: In patients
with impairment of renal function the elimination kinetics of
ampicillin and sulbactam are similarly affected, hence the ratio
of one to the other will remain constant whatever the renal
function. The dose of Ampicillin and Sulbactam for Injection in
such patients should be administered less frequently in accordance with the usual practice for ampicillin and according
to the following recommendations: When only
serum creatinine is available, the following formula (based on
sex, weight, and age of the patient) may be used to convert this
value into creatinine clearance. The serum creatinine should
represent a steady state of renal function.<br/>Compatibility,
Reconstitution and Stability: Prior to
reconstitution store Ampicillin and Sulbactam for Injection
sterile dry powder at 20��-25��C (68��-77��F) [see USP Controlled
Room Temperature]. When
concomitant therapy with aminoglycosides is indicated,
ampicillin and sulbactam and aminoglycosides should be
reconstituted and administered separately, due to the in vitro inactivation of
aminoglycosides by any of the aminopenicillins.<br/>Directions for Use:<br/>General
Dissolution Procedures: Ampicillin and Sulbactam for Injection sterile powder
for intravenous and intramuscular use may be
reconstituted with any of the compatible diluents
described in this insert. Solutions should be allowed to
stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for
complete solubilization.<br/>Preparation
for Intravenous Use:<br/>Preparation
for Intramuscular Injection:
|
| dailymed-drugs:228 |
Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Oxycodone and acetaminophen tablets are given orally. The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. The maximal daily dose of oxycodone and acetaminophen 5 mg/325 mg is 12 tablets.<br/>Cessation of Therapy: In patients treated with oxycodone and acetaminophen tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.
|
| dailymed-drugs:229 |
This solution is for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride). There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. Dextrose may be administered to normal individuals at a rate of 0.5 g/kg/hour without producing glycosuria. At the maximum infusion rate of 0.8 g/kg/hour, approximately 95% of the dextrose is retained. This solution may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium ions in this solution should be considered when phosphate is present in the additive solution, in order to avoid precipitation. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|
| dailymed-drugs:230 |
SYSTEMIC SULFONAMIDES ARE CONTRAINDICATED IN INFANTS UNDER 2 MONTHS OF AGE except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis.<br/>Usual Dosage for Infants over 2 Months of Age and Children: Initially, one-half the 24-hour dose. Maintenance, 150 mg/kg or 4 g/m2, divided into 4 to 6 doses, every 24 hours, with a maximum of 6 g every 24 hours. Rheumatic fever prophylaxis, under 30 kg (66 pounds), 500 mg every 24 hours; over 30 kg (66 pounds), 1 g every 24 hours.<br/>Usual Adult Dosage: Initially, 2 to 4 g. Maintenance, 2 to 4 g, divided into 3 to 6 doses, every 24 hours.
|
| dailymed-drugs:232 |
Following suitable admixture of prescribed additive,
the dose is usually dependent upon the age, weight and clinical condition
of the patient.
|
| dailymed-drugs:1940 |
Following suitable admixture of prescribed additive,
the dose is usually dependent upon the age, weight and clinical condition
of the patient.
|
| dailymed-drugs:233 |
The same dosage schedule applies to children and adults. The tablet may be chewed, swallowed, or crushed and mixed with food. If the patient is not cured three weeks after treatment, a second course of treatment is advised. No special procedures, such as fasting or purging, are required.
|
| dailymed-drugs:234 |
BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE SHOULD BE ADMINISTERED ONLY BY PHYSICIANS WHO ARE EXPERIENCED IN THE TREATMENT OF LIFE-THREATENING ARRHYTHMIAS WHO ARE THOROUGHLY FAMILIAR WITH THE RISKS AND BENEFITS OF AMIODARONE THERAPY AND WHO HAVE ACCESS TO LABORATORY FACILITIES CAPABLE OF ADEQUATELY MONITORING THE EFFECTIVENESS AND SIDE EFFECTS OF TREATMENT. In order to insure that an antiarrhythmic effect will be observed without waiting several months, loading doses are required. A uniform, optimal dosage schedule for administration of amiodarone has not been determined. Because of the food effect on absorption, amiodarone should be administered consistently with regard to meals . Individual patient titration is suggested according to the following guidelines: For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia: Close monitoring of the patients is indicated during the loading phase, particularly until risk of recurrent ventricular tachycardia or fibrillation has abated. Because of the serious nature of the arrhythmia and the lack of predictable time course of effect, loading should be performed in a hospital setting. Loading doses of 800 mg/day to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of amiodarone hydrochloride in divided doses with meals is suggested for total daily doses of 1,000 mg or higher, or when gastrointestinal intolerance occurs.) If side effects become excessive, the dose should be reduced. Elimination of recurrence of ventricular fibrillation and tachycardiausually occurs within 1 to 3 weeks, along with reduction in complex and total ventricular ectopic beats. Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, grapefruit juice should not be taken during treatment with oral amiodarone . Upon starting amiodarone therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs . When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride dose should be reduced to 600 mg/day to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day . Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone may be administered as a single daily dose, or in patients with severe gastrointestinal intolerance, as a b.i.d. dose. In each patient, the chronic maintenancedose should be determined according to antiarrhythmic effect as assessed by symptoms, Holter recordings, and/or programmed electrical stimulation and by patient tolerance. Plasma concentrations may be helpful in evaluating nonresponsiveness or unexpectedly severe toxicity . The lowest effective dose should be used to prevent the occurrence of side effects. In all instances, the physician must be guided by the severity of the individual patient's arrhythmia and response to therapy. When dosage adjustments are necessary, the patient should be closely monitored for an extended period of time because of the long and variable half-life of amiodarone and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:
|
| dailymed-drugs:235 |
Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of RESTASIS ophthalmic emulsion twice a day in each eye approximately 12 hours apart. RESTASIS can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard vial immediately after use.
|
| dailymed-drugs:236 |
OPANA is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine and other opioids. OPANA, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. Selection of patients for treatment with OPANA should be governed by the same principles that apply to the use of similar opioid analgesics . Physicians should individualize treatment in every case , using non-opioid analgesics, prn opioids and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society. As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of OPANA, attention should be given to the following: The following dosing recommendations, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient. OPANA should be administered on an empty stomach, at least one hour prior to or two hours after eating .<br/>Initiation of Therapy:<br/>Opioid-Na��ve Patients: Patients who have not been receiving opioid analgesics should be started on OPANA in a dosing range of 10 to 20 mg every four to six hours depending on the initial pain intensity. If deemed necessary to initiate therapy at a lower dose, patients may be started with OPANA 5 mg. The dose should be titrated based upon the individual patient's response to their initial dose of OPANA. This dose can then be adjusted to an acceptable level of analgesia taking into account the pain intensity and side effects experienced by the patient. Initiation of therapy with doses higher than 20 mg is not recommended because of potential serious side effects (see Clinical Trials: Orthopedic Surgery).<br/>Conversion from Parenteral Oxymorphone to OPANA: Given the absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to OPANA by administering 10 times the patient's total daily parenteral oxymorphone dose as OPANA, in four or six equally divided doses (e.g. IV dose x 10/4). For example, approximately 10 mg of OPANA may be required to provide pain relief equivalent to a total daily IM doseof 4 mg oxymorphone. The dose can be titrated to optimal pain relief or combined with acetaminophen/NSAIDs for optimal pain relief. Due to patient variability with regard to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.<br/>Conversion from Other Oral Opioids to OPANA: For conversion from other opioids to OPANA, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to start the OPANA therapy by administering half of the calculated total daily dose of OPANA in 4 to 6 equallydivided doses, every 4-6 hours. The initial dose of OPANA can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.<br/>Individualization of Dose: Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate pain relief (generally mild or no pain). Patients who experience breakthrough pain may require dosage adjustment or non-opioid therapy such as acetaminophen or NSAIDs. If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences. If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control. During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family. Patients and family members should be advised of the potential common side effects to decrease fear of the use of opioids and promote their optimal use.<br/>Patients with Hepatic Impairment: OPANA is contraindicated in patients with moderate and severe hepatic dysfunction. OPANA should be used with caution in patients with mild hepatic impairment. These patients with mild hepatic impairment should be started with the lowest dose and titrated slowly while carefully monitoring side effects .<br/>Patients with Renal Impairment: There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate to severe renal impairment, respectively, treated with OPANA ER . Accordingly, OPANA should be administered cautiously and in reduced dosages to patients with creatinine clearance rate less than 50 mL/min.<br/>Use with CNS depressants: OPANA, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, because respiratory depression, hypotension and profound sedation or coma may result. No specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, but caution in the use of any opioid in patients taking this class of drugs is appropriate .<br/>Geriatrics: Caution should be exercised in the selection of the starting dose of OPANA for an elderly patient starting at the low end of the dosing range.<br/>Maintenance of Therapy: OPANA is intended as an opioid analgesic for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. During therapy, continual re-evaluation of the patient receiving OPANA is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose and/or using adjuvant analgesics such as acetaminophen or NSAIDs.<br/>Cessation of Therapy: When the patient no longer requires therapy with OPANA, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.
|
| dailymed-drugs:237 |
1. For Treatment of Moderate to Severe Vasomotor Symptoms, Vulval and Vaginal Atrophy Associated with the Menopause, the Lowest Dose and Regimen that Will Control Symptoms Should be Chosen and Medication Should be Discontinued as Promptly as Possible. Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals. The usual initial dosage range is 1 or 2 mg daily of estradiol adjusted as necessary to control presenting symptoms. The minimal effective dose for maintenance therapy should be determined by titration. Administration should be cyclic (e.g., 3 weeks on and 1 week off). 2. For Treatment of Female Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure. Treatment is usually initiated with a dose of 1 or 2 mg daily of estradiol, adjusted as necessary to control presenting symptoms; the minimal effective dose for maintenance therapy should be determined by titration. 3. For Treatment of Breast Cancer, for Palliation Only, in Appropriately Selected Women and Men With Metastatic Disease. Suggested dosage is 10 mg three times daily for a period of at least three months. 4. For Treatment of Advanced Androgen-Dependant Carcinoma of the Prostrate, for Palliation Only. Suggested dosage is 1 to 2 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient. 5. For Prevention of Osteoporosis. Therapy with Innofem���(Estradiol Tablets, USP) to prevent postmenopausal bone loss should be initiated as soon as possible after menopause. A daily dosage of 0.5 mg should be administered cyclically (e.g., 23 days on and 5 days off). The dosage may be adjusted if necessary to control concurrent menopausal symptoms. Discontinuation of estrogen replacement therapy may re-establish the natural rate of bone loss.
|
| dailymed-drugs:238 |
The dose is dependent on the age, weight and clinical
condition of the patient. As reported in
the literature, the dosage and constant infusion rate of intravenous
dextrose must be selected with caution in pediatric patients, particularly
neonates and low birth weight infants, because of the increased risk
of hyperglycemia/hypoglycemia. Parenteral
drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container
permit. See PRECAUTIONS.
|
| dailymed-drugs:239 |
The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg of prednisone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.
It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process,
the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of
PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.<br/>Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective.
(Dosage range is the same for prednisone and prednisolone.)<br/>ADT (Alternate Day Therapy): ADT is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises:
(a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion.
Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear,then, that a disturbance in the diurnal cycle with maintenance of elevated
corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when
pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1��to 1��days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy:
|
| dailymed-drugs:240 |
DOSAGE MUST BE INDIVIDUALIZED. The recommended initial dose is 100 mg twice daily whether used alone or added to a diuretic regimen. After 2 or 3 days, using standing blood pressure as an indicator, dosage may be titrated in increments of 100 mg b.i.d. every 2 or 3 days. The usual maintenance dosage of labetalol HCl is between 200 and 400 mg twice daily. Since the full antihypertensive effect of labetalol is usually seen within the first 1 to 3 hours of the initial dose or dose increment, the assurance of a lack of an exaggerated hypotensive response can be clinically established in the office setting. The antihypertensive effects of continued dosing can be measured at subsequent visits, approximately 12 hours after a dose, to determine whether further titration is necessary. Patients with severe hypertension may require from 1200 mg to 2400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered b.i.d., the same total daily dose administered t.i.d. may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg b.i.d. When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol HCl dosage adjustment. As with most antihypertensive drugs, optimal dosages of labetalol HCl tablets are usually lower in patients also receiving a diuretic. When transferring a patient from other antihypertensive drugs, labetalol HCl tablets, USP should be introduced as recommended and the dosage of the existing therapy progressively decreased.
|
| dailymed-drugs:241 |
Dihydroergotamine Mesylate Injection, USP should be administered in a dose of 1 mL intravenously, intramuscularly or subcutaneously. The dose can be repeated, as needed, at 1 hour intervals to a total dose of 3 mL for intramuscular or subcutaneous delivery or 2 mL for intravenous delivery in a 24 hour period. The total weekly dosage should not exceed 6 mL. Dihydroergotamine mesylate injection should not be used for chronic daily administration.
|
| dailymed-drugs:243 |
The dose of ARIMIDEX is one 1 mg tablet taken once a day. For patients with advanced breast cancer, ARIMIDEX should be continued until tumor progression. For adjuvant treatment of early breast cancer in postmenopausal women, the optimal duration of therapy is unknown. In the ATAC trial ARIMIDEX was administered for five years.<br/>Patients with Hepatic Impairment: (See CLINICAL PHARMACOLOGY) Hepatic metabolism accounts for approximately 85% of anastrozole elimination. Although clearance of anastrozole was decreased in patients with cirrhosis due to alcohol abuse, plasma anastrozole concentrations stayed in the usual range seen in patients without liver disease. Therefore, no changes in dose are recommended for patients with mild-to-moderate hepatic impairment, although patientsshould be monitored for side effects. ARIMIDEX has not been studied in patients with severe hepatic impairment.<br/>Patients with Renal Impairment: No changes in dose are necessary for patients with renal impairment.<br/>Use in the Elderly: No dosage adjustment is necessary.
|
| dailymed-drugs:245 |
Dosage Fat
emulsion coadministration should be considered when prolonged (more than 5
days) parenteral nutrition is required in order to prevent essential fatty
acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD
in patients maintained on fat-free TPN. Adults: The objective of nutritional management of renal decompensation
is to provide sufficient amino acid and caloric support for protein synthesis
without exceeding the renal capacity to excrete metabolic wastes. A
dosage of 2.4 to 4.7 grams of nitrogen per day (from essential amino acids)
with adequate calories will maintain nitrogen equilibrium in patients with
uremia. If more nitrogen and calories are required in severely stressed patients
in acute renal failure who cannot eat, higher dosages may be administered
provided great care is taken to avoid exceeding limits of fluid intake or
glucose tolerance. In general, dosage should be guided
by fluid, glucose and nitrogen tolerances, as well as the metabolic and clinical
response. The rate of rise in BUN generally diminishes with infusion of essential
amino acids. However, excessive intake of protein or increased protein catabolism
may alter this response. The usual daily dose ranges
from 300 to 600 mL of Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection���renal formula) equivalent to 2.4 to 4.7 grams of nitrogen in 15.7
to 31 grams of essential amino acids. Adequate calories should be administered
simultaneously. Each 500 mL of Aminosyn-RF 5.2% mixed under sterile conditions
with 832 mL of Dextrose 70% will provide a solution of 1.95% of Aminosyn-RF
5.2% in 44% dextrose. This mixture provides a calorie-to-nitrogen ratio of
504:1. Electrolyte supplementation may be required. Elevated
phosphorus, potassium and magnesium levels generally decrease during treatment
with Aminosyn-RF 5.2%. Particular care should be taken in the presence of
cardiac arrhythmias or digitalis toxicity to assure that sufficient quantities
of these electrolytes are provided when necessary. Compatibility
of electrolyte additives to the mixtures of Aminosyn-RF 5.2% and hypertonic
dextrose must be considered and potentially incompatible ions (calcium, phosphate)
may be added to alternate infusion bottles to avoid precipitation. Children: Pediatric requirements for Aminosyn-RF
5.2% vary greatly depending upon growth, nutritional state and degree of renal
insufficiency. A dosage of 0.5 to 1 gram of essential amino acids per kilogram
of body weight per day will meet the requirements of the majority of pediatric
patients. Initial daily dosage of Aminosyn-RF 5.2% should be low and increased
slowly; more than one gram of essential amino acids per kilogram of body weight
per day is not recommended. The total volume of nutritional solution and the
rate at which it is administered will vary with the child's age, nutritional
and growth state, as well as the degree of renal failure. See Special
Precautions in Pediatric Patients foradditional information. Administration Aminosyn-RF
5.2% admixed with sufficient dextrose to provide caloric energy requirements
may be safely administered via a central venous catheter with the tip located
in the vena cava. Initial infusion rates should be slow,
generally 20 to 30 mL/hour for the first 6 to 8 hours. Increments of 10 mL/hour
for each hour are suggested up to a maximum rate of 60 to 100 mL/hour. If
administration rates fall behind the scheduled 24 hour dosage, no attempt
should be made to catch up to the planned intake. The patient's fluid,
nitrogen and glucose tolerance should be the governing factor of the rate
of administration. Uremic patients are frequently glucose intolerant especially
in association with peritoneal dialysis; insulin may be required to prevent
hyperglycemia. When hypertonic dextrose infusion is abruptly discontinued,
rebound hypoglycemia may be prevented by administering 5% dextrose. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. WARNING: Do not use flexible container in series
connections.
|
| dailymed-drugs:246 |
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses and over 6 years, 50 to 100 mg daily in divided doses. For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses and over 6 years, 50 to 100 mg daily in divided doses. As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg in adults, and 0.6 mg/kg in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all medications, the dosage should be adjusted according to the patient's response to therapy.
|
| dailymed-drugs:248 |
Flumazenil injection, USP is recommended for intravenous use only. It is compatible with 5% dextrose in water, lactated Ringer's and normal saline solutions. If flumazenil injection is drawn into a syringe or mixed with any of these solutions, it should be discarded after 24 hours. For optimum sterility, flumazenil injection should remain in the vial until just before use. As with all parenteral drug products, flumazenil injection should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. To minimize the likelihood of pain at the injection site, flumazenil injection should be administered through a freely running intravenous infusion into a large vein.<br/>Reversal of Conscious Sedation:<br/>Adult Patients: For the reversal of the sedative effects of benzodiazepines administered for conscious sedation, the recommended initial dose of flumazenil injection is 0.2 mg (2 mL) administered intravenously over 15 seconds. If the desired level of consciousness is not obtained after waiting an additional 45 seconds, a second dose of 0.2 mg (2 mL) can be injected and repeated at 60 second intervals where necessary (up to a maximum of 4 additional times) to a maximum total dose of 1 mg (10 mL). The dosage should be individualized based on the patient's response, with most patients responding to doses of 0.6 mg to 1 mg . In the event of resedation, repeated doses may be administered at 20 minute intervals as needed. For repeat treatment, no more than 1 mg (given as 0.2 mg/min) should be administered at any one time, and no more than 3 mg should be given in any one hour. It is recommended that flumazenil be administered as the series of small injections described (not as a single bolus injection) to allow the practitioner to control the reversal of sedation to the approximate endpoint desired and to minimize the possibility of adverse effects .<br/>Pediatric Patients: For the reversal of the sedative effects of benzodiazepines administered for conscious sedation in pediatric patients greater than 1 year of age, the recommended initial dose is 0.01 mg/kg (up to 0.2 mg) administered intravenously over 15 seconds. If the desired level of consciousness is not obtained after waiting an additional 45 seconds, further injections of 0.01 mg/kg (up to 0.2 mg) can be administered and repeated at 60 second intervals where necessary (up to a maximum of 4 additional times) to a maximum total dose of 0.05 mg/kg or 1 mg, whichever is lower. The dose should be individualized based on the patient's response. The mean total dose administered in the pediatric clinical trial of flumazenil was 0.65 mg (range: 0.08 mg to 1.00 mg). Approximately one-half of patients required the maximum of five injections. Resedation occurred in 7 of 60 pediatric patients who were fully alert 10 minutes after the start of flumazenil injection administration . The safety and efficacy of repeated flumazenil administration in pediatric patients experiencing resedation have not been established. It is recommended that flumazenil be administered as the series of small injections described (not as a single bolus injection) to allow the practitioner to control the reversal of sedation to the approximate endpoint desired and to minimize the possibility of adverse effects . The safety and efficacy of flumazenil injection in the reversal of conscious sedation in pediatric patients below the age of 1 year have not been established.<br/>Reversal of General Anesthesia in Adult Patients: For the reversal of the sedative effects of benzodiazepines administered for general anesthesia, the recommended initial dose of flumazenil is 0.2 mg (2 mL) administered intravenously over 15 seconds. If the desired level of consciousness is not obtained after waiting an additional 45 seconds, a further dose of 0.2 mg (2 mL) can be injected and repeated at 60-second intervals where necessary (up to a maximum of 4 additional times) to a maximum total dose of 1 mg (10 mL). The dosage should be individualized based on the patient's response, with most patients responding to doses of 0.6 mg to 1 mg . In the event of resedation, repeated doses may be administered at 20-minute intervals as needed. For repeat treatment, no more than 1 mg (given as 0.2 mg/min) should be administered at any one time, and no more than 3 mg should be given in any one hour. It is recommended that flumazenil be administered as the series of small injections described (not as a single bolus injection) to allow the practitioner to control the reversal of sedation to the approximate endpoint desired and to minimize the possibility of adverse effects .<br/>Management of Suspected Benzodiazepine Overdose in Adult Patients: For initial management of a known or suspected benzodiazepine overdose, the recommended initial dose of flumazenil injection is 0.2 mg (2 mL) administered intravenously over 30 seconds. If the desired level of consciousness is not obtained after waiting 30 seconds, a further dose of 0.3 mg (3 mL) can be administered over another 30 seconds. Further doses of 0.5 mg (5 mL) can be administered over 30 seconds at 1 minute intervals up to a cumulative dose of 3 mg. Do not rush the administration of flumazenil injection. Patients should have a secure airway and intravenous access before administration of the drug and be awakened gradually . Most patients with a benzodiazepine overdose will respond to a cumulative dose of 1 mg to 3 mg of flumazenil injection, and doses beyond 3 mg do not reliably produce additional effects. On rare occasions, patients with a partial response at 3 mg may require additional titration up to a total dose of 5 mg (administered slowly in the same manner). If a patient has not responded 5 minutes after receiving a cumulative dose of 5 mg of flumazenil injection, the major cause of sedation is likely not to be due to benzodiazepines, and additional flumazenil is likely to have no effect. In the event of resedation, repeated doses may be given at 20-minute intervals if needed. For repeat treatment, no more than 1 mg (given as 0.5 mg/min) should be given at any one time and no more than 3 mg should be given in any one hour.<br/>Safety and Handling: Flumazenil injection is supplied in sealed dosage forms and poses no known risk to the healthcare provider. Routine care should be taken to avoid aerosol generation when preparing syringes for injection, and spilled medication should be rinsed from the skin with cool water.<br/>HOW SUPPLIED: Flumazenil Injection, USP is supplied in vials containing 0.1 mg/mL fulmazenil as follows: NDC 23360-031-05: 5 mL multi-dose vials in carton of 10. NDC 23360-031-10: 10 mL multi-dose vials in carton of 10.
|
| dailymed-drugs:249 |
The initial dosage of prednisolone sodium phosphate oral solution, 5 mg (base/5 mL) may vary from 5 mL to 60 mL (5 to 60 mg prednisolone base) per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time, there is a lack of satisfactory clinical response, prednisolone sodium phosphate oral solution should be discontinued and the patient placed on other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of prednisolone sodium phosphate oral solution for a period of time consistent with the patient's condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4 to 8 mg dexamethasone every other day for one month have been shown to be effective. In pediatric patients, the initial dose of prednisolone sodium phosphate oral solution may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/mbsa/day). The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m/day. The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone or methylprednisolone in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1���2 mg/kg/day in single or divided doses. It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent relapse. For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids: These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
|
| dailymed-drugs:250 |
The dosage of Disopyramide Phosphate must be individualized for each patient on the basis of response and tolerance. The usual adult dosage of Disopyramide Phosphate is 400 to 800 mg per day given in divided doses. The recommended dosage for most adults is 600 mg/day given in divided doses (150 mg every 6 hours). For patients whose body weight is less than 110 pounds (50 kg), the recommended dosage is 400 mg/day given in divided doses (100 mg every 6 hours). In the event of increased anticholinergic side effects, plasma levels of disopyramide should be monitored and the dose of the drug adjusted accordingly. A reduction of the dose by one third, from the recommended 600 mg/day to 400 mg/day, would be reasonable, without changing the dosing interval. For patients with cardiomyopathy or possible cardiac decompensation, a loading dose, as discussed below, should not be given, and initial dosage should be limited to 100 mg every 6 to 8 hours. Subsequent dosage adjustments should be made gradually, with close monitoring for the possible development of hypotension and/or congestive heart failure (see WARNINGS). For patients with moderate renal insufficiency (creatinine clearance greater than 40 mL/min) or hepatic insufficiency, the recommended dosage is 400 mg/day given in divided doses (100 mg every 6 hours). For patients with severe renal insufficiency (C40 mL/min or less), the recommended dosage regimen is 100 mg at intervals shown in the table below, with or without an initial loading dose of 150 mg. For patients in whom rapid control of ventricular arrhythmia is essential, an initial loading dose of 300 mg of Disopyramide Phosphate (200 mg for patients whose body weight is less than 110 pounds) is recommended, followed by the appropriate maintenance dosage. Therapeutic effects are usually attained 30 minutes to 3 hours after administration of a 300-mg loading dose. If there is no response or evidence of toxicity within 6 hours of the loading dose, 200 mg of Disopyramide Phosphate every 6 hours may be prescribed instead of the usual 150 mg. If there is no response to this dosage within 48 hours, either Disopyramide Phosphate should then be discontinued or the physician should consider hospitalizing the patient for careful monitoring while subsequent Disopyramide Phosphate doses of 250 mg or 300 mg every 6 hours are given. A limited number of patients with severe refractory ventricular tachycardia have tolerated daily doses of Disopyramide Phosphate up to 1600 mg per day (400 mg every 6 hours), resulting in disopyramide plasma levels up to 9 mcg/mL. If such treatment is warranted, it is essential that patients be hospitalized for close evaluation and continuous monitoring.<br/>Transferring to Disopyramide Phosphate: The following dosage schedule based on theoretical considerations rather than experimental data is suggested for transferring patients with normal renal function from either quinidine sulfate or procainamide therapy (Type 1 antiarrhythmic agents) to Disopyramide Phosphate therapy: Disopyramide Phosphate should be started using the regular maintenance schedule without a loading dose 6 to 12 hours after the last dose of quinidine sulfate or 3 to 6 hours after the last dose of procainamide. In patients in whom withdrawal of quinidine sulfate or procainamide is likely to produce life-threatening arrhythmias, the physician should consider hospitalization of the patient.<br/>Pediatric Dosage: Controlled clinical studies have not been conducted in pediatric patients; however, the following suggested dosage table is based on published clinical experience. Total daily dosage should be divided and equal doses administered orally every 6 hours or at intervals according to individual patient needs. Disopyramide plasma levels and therapeutic response must be monitored closely. Patients should be hospitalized during the initial treatment period, and dose titration should start at the lower end of the ranges provided below.
|
| dailymed-drugs:251 |
One drop of Diclofenac Sodium Ophthalmic Solution, 0.1% should be applied to the affected eye four times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the postoperative period.
|
| dailymed-drugs:253 |
The reconstituted solution should be used upon preparation and should not be stored.<br/>a. Intravenous:<br/>Preparation: The CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections should be reviewed. Sedatives, analgesics, and all other medications except those that might be deemed essential (such as digitalis and insulin) are withheld for at least 24 hours, and preferably 48 to 72 hours, prior to the test. Antihypertensive drugs are withheld until blood pressure returns to the untreated, hypertensive level. This test is not preformed on a patient who is normotensive.<br/>Procedure: The patient is kept at rest in a supine position throughout the test, preferably in a quiet, darkened room. Injection of phentolamine is delayed until blood pressure is stabilized, as evidenced by blood pressure readings taken every 10 minutes for at least 30 minutes. Five milligrams of phentolamine mesylate is dissolved in 1 mL of Sterile Water for Injection. The dose for adults is 5 mg; for children, 1 mg. The syringe needle is inserted into the vein, and injection is delayed until pressor response to venipuncture has subsided. Phentolamine is injected rapidly. Blood pressure is recorded immediately after injection, at 30-second intervals for the first 3 minutes, and at 60-second intervals for the next 7 minutes.<br/>Interpretation: A positive response, suggestive of pheochromocytoma, is indicated when the blood pressure is reduced more than 35 mm Hg systolic and 25 mm Hg diastolic. A typical positive response is a reduction in pressure of 60 mm Hg systolic and 25 mm Hg diastolic. Usually, maximal effect is evident within 2 minutes after injection. A return to preinjection pressure commonly occurs within 15 to 30 minutes but may occur more rapidly. If blood pressure decreases to a dangerous level, the patient should be treated as outlined under OVERDOSAGE. A positive response should always be confirmed by other diagnostic procedures, preferably by measurement of urinary catecholamines or their metabolites. A negative response is indicated when the blood pressure is elevated, unchanged, or reduced less than 35 mm Hg systolic and 25 mm Hg diastolic after injection of phentolamine. A negative response to this test does not exclude the diagnosis of pheochromocytoma, especially in patients with paroxysmal hypertension in whom the incidence of false-negative responses is high.<br/>b. Intramuscular: If the intramuscular test for pheochromocytoma is preferred, preparation is the same as for the intravenous test. Five milligrams of phentolamine mesylate is then dissolved in 1 mL of Sterile Water for Injection. The dose for adults is 5 mg intramuscularly; for children, 3 mg. Blood pressure is recorded every 5 minutes for 30 to 45 minutes following injection. A positive response is indicated when the blood pressure is reduced 35 mm Hg systolic and 25 mm Hg diastolic, or more, within 20 minutes following injection. Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|
| dailymed-drugs:254 |
A total of four (4) drops of flurbiprofen sodium ophthalmic solution should be administered by instilling 1 drop approximately every 1/2 hour beginning 2 hours before surgery.
|
| dailymed-drugs:255 |
LIDEX Cream is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of the occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
|
| dailymed-drugs:256 |
Gout: Therapy with probenecid should not be started until an acute gouty attack has subsided. However, if an acute attack is precipitated during therapy, probenecid may be continued without changing the dosage, and full therapeutic dosage of colchicine, or other appropriate therapy, should be given to control the acute attack. The recommended adult dosage is 250 mg (1/2 probenecid tablet), twice a day for one week, followed by 500 mg (1 tablet) twice a day thereafter. Some degree of renal impairment may be present in patients with gout. A daily dosage of 1000 mg may be adequate. However, if necessary, the daily dosage may be increased by 500 mg increments every 4 weeks within tolerance (and usually not above 2000 mg per day) if symptoms of gouty arthritis are not controlled or the 24 hour uric acid excretion is not above 700 mg. As noted, probenecid may not be effective in chronic renal insufficiency particularly when the glomerular filtration rate is 30 mL/minute or less. Gastric intolerance may be indicative of overdosage, and may be corrected by decreasing the dosage. As uric acid tends to crystallize out of an acid urine, a liberal fluid intake is recommended, as well as sufficient sodium bicarbonate (3 to 7.5 g daily), or potassium citrate (7.5 g daily) to maintain an alkaline urine . Alkalization of the urine is recommended until the serum urate level returns to normal limits and tophaceous deposits disappear, i.e., during the period when urinary excretion of uric acid is at a high level. Thereafter, alkalization of the urine and the usual restriction of purine-producing foods may be somewhat relaxed. Probenecid should be continued at the dosage that will maintain normal serum urate levels. When acute attacks have been absent for 6 months or more and serum urate levels remain within normal limits, the daily dosage may be decreased by 500 mg every 6 months. The maintenance dosage should not be reduced to the point where serum urate levels tend to rise.<br/>Probenecid and Penicillin Therapy (General):<br/>Adults: The recommended dosage is 2000 mg (4 tablets of probenecid) daily in divided doses. This dosage should be reduced in older patients in whom renal impairment may be present.<br/>Children: 2���14 years of age: Initial dose: 25 mg/kg body weight (or 0.7 g/square meter body surface). Maintenance Dose: 40 mg/kg body weight (or 1.2 g/square meter body surface) per day, divided into 4 doses. For children weighing more than 50 kg (110 lb) the adult dosage is recommended. Probenecid is contraindicated in children under 2 years of age. The PSP excretion test may be used to determine the effectiveness of probenecid in retarding penicillin excretion and maintaining therapeutic levels. The renal clearance of PSP is reduced to about one-fifth the normal rate when dosage of probenecid is adequate.<br/>Penicillin Therapy (Gonorrhea): In uncomplicated gonococcal infections in men and women (urethral, cervical, rectal), 1 g of probenecid should be given orally with 4.8 million units of aqueous procaine penicillin G(given IM), or 3 g of amoxicillin(given orally), or 3.5 g of ampicillin(given orally). For further guidance, see CDC recommendations for definition of regimens of choice, alternative regimens, treatment of hypersensitive patients, and other aspects of therapy.
|
| dailymed-drugs:257 |
As noted under���CLINICAL PHARMACOLOGY���multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for Isosorbide Dinitrate Extended-release Tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long. The necessary dose-free interval for Isosorbide Dinitrate Extended-release Tablets has not been clearly identified, but is presumably somewhat longer. As also noted under���CLINICAL PHARMACOLOGY���only one trial has ever studied the use of controlled-release isosorbide dinitrate for more than one dose. In that trial, 40 mg of a different formulation of controlled-release ISDN was administered twice daily in doses given 6 hours apart. After 4 weeks, active treatment could not be distinguished from placebo. Large controlled studies with other nitrates suggest that no dosing regimen with Isosorbide Dinitrate Extended-release Tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day. In clinical trials, immediate-release oral isosorbide dinitrate has been administered in a variety of regimens, with total daily doses ranging from 30 mg to 480 mg.
|
| dailymed-drugs:258 |
Initial Treatment:<br/>Dosage for Adults:<br/>Major Depressive Disorder-: Sertraline hydrochloride tablets treatment should be administered at a dose of 50 mg once daily. While a relationship between dose and effect has not been established for major depressive disorder patients were dosed in a range of 50-200 mg/day in the clinical trials demonstrating the effectiveness of sertraline hydrochloride tablets for the treatment of this indication. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day. Given the 24 hour elimination half-life of sertraline hydrochloride tablets, dose changes should not occur at intervals of less than 1 week. Sertraline should be administered once daily, either in the morning or evening.<br/>Maintenance/Continuation/Extended Treatment:<br/>Major Depressive Disorder-: It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of sertraline hydrochloride tablet has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50-200 mg/day (mean dose of 70 mg/day) . It is not known whether the dose of sertraline hydrochloride tablets needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.<br/>Switching Patients to or from a Monoamine Oxidase Inhibitor-: At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with sertraline hydrochloride tablets. In addition, at least 14 days should be allowed after stopping sertraline hydrochloride tablets before starting an MAOI .<br/>Special Populations:<br/>Dosage for Hepatically Impaired Patients-: The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used .<br/>Treatment of Pregnant Women During the Third Trimester-: Neonates exposed to sertraline hydrochloride tablets and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding . When treating pregnant women with sertraline hydrochloride tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering sertraline hydrochloride tablets in the third trimester.<br/>Discontinuation of Treatment with Sertraline Hydrochloride Tablets: Symptoms associated with discontinuation of sertraline hydrochloride tablets and other SSRIs and SNRIs, have been reported . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
|
| dailymed-drugs:259 |
It is advisable that CONRAY be at or close to body temperature when injected. The patient should be instructed to omit the meal that precedes the examination. Appropriate premedication, which may include a barbiturate, tranquilizer or analgesic drug, may be administered prior to the examination. A preliminary film is recommended to check the position of the patient and the x-ray exposure factors. If a minor reaction occurs during administration, the injection should be slowed or stopped until the reaction has subsided. If a major reaction occurs, the injection should be discontinued immediately. Under no circumstances should either corticosteroids or antihistamines be mixed in the same syringe with the contrast medium because of a potential for chemical incompatibility. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
|
| dailymed-drugs:260 |
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended. For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For children over 100 lb, the usual adult dose should be used. The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. When used in streptococcal infections, therapy should be continued for 10 days. Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration . If gastric irritation occurs, doxycycline may be given with food or milk. Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment. Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg by mouth, twice a day for 7 days. Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum: 100 mg, by mouth, twice a day for 7 days. Syphilis���early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice a day for 2 weeks. Syphilis of more than one year's duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice a day for 4 weeks. Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days. Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days. For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1-2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area. Inhalational anthrax (post-exposure): ADULTS: 100 mg, of doxycycline, by mouth, twice a day for 60 days. CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose. Sprinkling the Capsule Contents on Applesauce DORYX Capsules may also be administered by carefully opening the capsules and sprinkling the capsule contents on a spoonful of applesauce. However, any loss of pellets in the transfer would prevent using the dose. The applesauce should be swallowed immediately without chewing and followed with a cool 8-ounce glass of water to ensure complete swallowing of the capsule contents. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. In the event that a prepared dose of applesauce/DORYX pellets cannot be taken immediately, the mixture should be discarded and not stored for later use.
|
| dailymed-drugs:262 |
Not recommended for use in pediatric patients less than 2 months of age.<br/>Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children:<br/>Adults: The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS tablet every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.<br/>Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:<br/>For Patients With Impaired Renal Function: When renal function is impaired, a reduced dosage should be employed using the following table:<br/>Acute Exacerbations of Chronic Bronchitis in Adults: The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim double strength tablet every 12 hours for 14 days.<br/>Pneumocystis Carinii Pneumonia:<br/>Treatment:<br/>Prophylaxis:<br/>Adults: The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet daily.<br/>Children: For children, the recommended dose is 750 mg/m/day sulfamethoxazole with 150 mg/m/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.The following table is a guideline for the attainment of this dosage in children:<br/>Travelers' Diarrhea in Adults: For the treatment of traveler's diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim DS tablet every 12 hours for 5 days.
|
| dailymed-drugs:263 |
SEREVENT DISKUS should be administered by the orally
inhaled route only (see Instructions for Using SEREVENT DISKUS in
the Medication Guide accompanying the product). The patient must not
exhale into the DISKUS and the DISKUS should only be activated and
used in a level, horizontal position.<br/>Asthma: Long-acting beta-adrenergic agonists,
such as salmeterol, the active ingredient in SEREVENT DISKUS, may
increase the risk of asthma-related death (see WARNINGS). Therefore,
when treating patients with asthma, SEREVENT DISKUS should only be
used as additional therapy for patients not adequately controlled
on other asthma-controller medications (e.g., low- to medium-dose
inhaled corticosteroids) or whose disease severity clearly warrants
initiation of treatment with 2 maintenance therapies, including SEREVENT
DISKUS. It is not indicated for patients whose asthma can be managed
by occasional use of inhaled, short-acting beta-agonists
or for patients whose asthma can be successfully managed by inhaled
corticosteroids or other controller medications along with occasional
use of inhaled, short-acting beta-agonists. For maintenance of bronchodilatation and prevention of
symptoms of asthma, including the symptoms of nocturnal asthma, the
usual dosage for adults and children 4 years of age and older
is 1 inhalation (50 mcg) twice daily (morning and evening, approximately
12 hours apart). If a previously effective dosage regimen fails
to provide the usual response, medical advice should be sought immediately
as this is often a sign of destabilization of asthma. Under these
circumstances, the therapeutic regimen should be reevaluated. If symptoms
arise in the period between doses, an inhaled, short-acting beta-agonist should be taken for immediate relief.<br/>Chronic Obstructive Pulmonary Disease: For maintenance treatment of bronchospasm associated
with COPD (including chronic bronchitis and emphysema), the usual
dosage for adults is 1 inhalation (50 mcg) twice daily (morning
and evening, approximately 12 hours apart). For both asthma and COPD, adverse effects are more likely to occur
with higher doses of salmeterol, and more frequent administration
or administration of a larger number of inhalations is not recommended. To gain full therapeutic benefit, SEREVENT DISKUS should
be administered twice daily (morning and evening) in the treatment
of reversible airway obstruction.<br/>Geriatric Use: Based on available data for SEREVENT DISKUS, no
dosage adjustment is recommended.<br/>Prevention of Exercise-Induced Bronchospasm: One inhalation of SEREVENT DISKUS at least 30 minutes
before exercise has been shown to protect patients against EIB. When
used intermittently as needed for prevention of EIB, this protection
may last up to 9 hours in adolescents and adults and up to 12 hours
in patients 4 to 11 years of age. Additional doses of SEREVENT should not be used for 12 hours after
the administration of this drug. Patients who are receiving SEREVENT
DISKUS twice daily should not use additional SEREVENT for prevention
of EIB. If regular, twice-daily dosing is not effective
in preventing EIB, other appropriate therapy for EIB should be considered.
|
| dailymed-drugs:264 |
Allergic Rhinitis:<br/>Adults and Children 12 Years of Age and Older: The recommended dose for prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis and treatment of the nasal symptoms of perennial allergic rhinitis is two sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg). In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with NASONEX Nasal Spray, 50 mcg (200 mcg/day) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.<br/>Children 2 to 11 Years of Age: The recommended dose for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is one spray (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 100 mcg). Improvement in nasal symptoms of allergic rhinitis has been shown to occur within 11 hours after the first dose based on one single-dose, parallel-group study of patients in an outdoor "park" setting (park study) and one environmental exposure unit (EEU) study and within 2 days after the first dose in two randomized, double-blind, placebo-controlled, parallel-group seasonal allergic rhinitis studies. Maximum benefit is usually achieved within 1 to 2 weeks. Patients should use NASONEX Nasal Spray, 50 mcg only once daily for allergic rhinitis at a regular interval.<br/>Nasal Polyps:<br/>Adults 18 years of Age and Older: The recommended dose for nasal polyps is two sprays (50 mcg of mometasone furoate in each spray) in each nostril twice daily (total daily dose of 400 mcg). A dose of two sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg) is also effective in some patients. Prior to initial use of NASONEX Nasal Spray, 50 mcg, the pump must be primed by actuating ten times or until a fine spray appears. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by actuating two times, or until a fine spray appears.<br/>Directions for Use: Illustrated Patient's Instructions for Use accompany each package of NASONEX Nasal Spray, 50 mcg.<br/>Directions for Cleaning: Illustrated Applicator Cleaning Instructions accompany each package of NASONEX Nasal Spray, 50 mcg.
|
| dailymed-drugs:265 |
Acute Treatment of Herpes Zoster 800 mg every 4 hours orally, five times daily for 7 to 10 days. Genital Herpes TREATMENT OF INITIAL GENITAL HERPES 200 mg every 4 hours, five times daily for 10 days. CHRONIC SUPPRESSIVE THERAPY FOR RECURRENT DISEASE 400 mg two times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg three times daily to 200 mg five times daily. The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir. INTERMITTENT THERAPY 200 mg every 4 hours, five times daily for 5 days. Therapy should be initiated at the earliest sign or symptom prodrome) of recurrence. Treatment of Chickenpox CHILDREN (2 YEARS OF AGE AND OLDER) 20 mg/kg per dose orally four times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox. ADULTS AND CHILDREN OVER 40 KG 800 mg four times daily for 5 days. Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients. When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms. Patients With Acute or Chronic Renal Impairment In patients with renal impairment, the dose of Acyclovir Capsules or Tablets should be modified as shown in Table 3. Hemodialysis For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis. Peritoneal Dialysis No supplemental dose appears to be necessary after adjustment of the dosing interval. Bioequivalence of Dosage Forms Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n=20) and one acyclovir 800 mg tablet was shown to be bioequivalent to four acyclovir 200 mg capsules (n=24).
|
| dailymed-drugs:266 |
Alprazolam XR tablets may be administered once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken. The suggested total daily dose ranges between 3 to 6 mg/day. Dosage should be individualized for maximum beneficial effect. While the suggested total daily dosages given will meet the needs of most patients, there will be some patients who require doses greater than 6 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.<br/>Dosing in Special Populations: In elderly patients, in patients with advanced liver disease, or in patients with debilitating disease, the usual starting dose of Alprazolam XR is 0.5 mg once daily. This may be gradually increased if needed and tolerated (see Dose Titration). The elderly may be especially sensitive to the effects of benzodiazepines.<br/>Dose Titration: Treatment with Alprazolam XR may be initiated with a dose of 0.5 mg to 1 mg once daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. Slower titration to the dose levels may be advisable to allow full expression of the pharmacodynamic effect of Alprazolam XR. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.<br/>Dose Maintenance: In controlled trials conducted to establish the efficacy of Alprazolam XR tablets in panic disorder, doses in the range of 1 to 10 mg/day were used. Most patients showed efficacy in the dose range of 3 to 6 mg/day. Occasional patients required as much as 10 mg/day to achieve a successful response. The necessary duration of treatment for panic disorder patients responding to Alprazolam XR is unknown. However, periodic reassessment is advised. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.<br/>Dose Reduction: Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided . In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction. In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reducedby no more than 0.5 mg every three days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.<br/>Switch from alprazolam (immediate-release) tablets to Alprazolam XR (extended-release) tablets: Patients who are currently being treated with divided doses of alprazolam (immediate-release) tablets, for example 3 to 4 times a day, may be switched to Alprazolam XR tablets at the same total daily dose taken once daily. If the therapeutic response after switching is inadequate, the dosage may be titrated as outlined above.
|
| dailymed-drugs:267 |
Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food. Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for seven days.
|
| dailymed-drugs:269 |
ULTRAM ER should not be used in patients with: . ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split . Adults (18 years of age and over) Patients Not Currently on Tramadol Immediate-Release Products For patients not currently treated with tramadol immediate-release (IR) products, ULTRAM ER should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100-mg increments every five days to relief of pain and depending upon tolerability. ULTRAM ER should not be administered at a dose exceeding 300 mg per day. Patients Currently on Tramadol Immediate-Release Products For patients maintained on tramadol IR products, calculate the 24-hour tramadol IR dose and initiate a total daily dose of ULTRAM ER rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with ULTRAM ER, some patients maintained on tramadol IR products may not be able to convert to ULTRAM ER.
ULTRAM ER should not be administered at a dose exceeding 300 mg per day. The concomitant use of ULTRAM ER with other tramadol products is not recommended . Individualization of Dose Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of ULTRAM ER have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg. In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. ULTRAM ER should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
|
| dailymed-drugs:270 |
Dosage must be individualized, depending on the type and severity of the condition to be treated. Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur. The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour. If necessary, the effects of the drug can be abolished promptly by atropine .
|
| dailymed-drugs:2451 |
Dosage must be individualized, depending on the type and severity of the condition to be treated. Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur. The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour. If necessary, the effects of the drug can be abolished promptly by atropine .
|
| dailymed-drugs:271 |
Apply a thin layer of Dovonex ointment once or twice daily and rub in gently and completely.
|
| dailymed-drugs:272 |
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.<br/>Anxiety disorders and transient symptoms of anxiety: Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employedand the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration
of treatment. In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered. In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.<br/>Panic disorder: The successful treatment of many panic disorder patients has required the use of alprazolam at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about
300 received alprazolam in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to
achieve a successful response. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Thereafter, the dose can be increased at intervals equal to at least 5 times the elimination half-life (about 11 hours in young patients, about 16 hours in elderly patients). Longer titration intervals
should probably be used because the maximum therapeutic response may not occur until after the plasma
levels achieve steady state. Dose should be advanced until an acceptable therapeutic response (ie, a substantial
reduction in or total eliminationof panic attacks) is achieved, intolerance occurs, or the maximum recommended
dose is attained. For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration
of dosage reduction is advised. In a controlled postmarketing dose-response study, pat ients treated with doses of alprazolam greater than 4 mg/day for three months were able to taper to 50% of their total maintenance
dose without apparent loss of clinical benefit . Because of the danger of withdrawal, abrupt discontinuation
of treatment should be avoided. The following regimen is one that follows the principles outlined above: Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule. The necessary duration of treatment for panic disorder patients responding to alprazolam is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena. In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every three days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.
|
| dailymed-drugs:273 |
The Nutropin AQ [somatropin (rDNA origin) injection] dosage and administration schedule should be individualized for each patient. Response to GH therapy in pediatric patients tends to decrease with time. However, in pediatric patients failure to increase growth rate, particularly during the first year of therapy, suggests the need for close assessment of compliance and evaluation of other causes of growth failure, such as hypothyroidism, under���nutrition, and advanced bone age.<br/>Dosage:<br/>Pediatric Growth Hormone Deficiency (GHD): A weekly dosage of up to 0.3 mg/kg of body weight divided into daily subcutaneous injection is recommended. In pubertal patients, a weekly dosage of up to 0.7 mg/kg divided daily may be used.<br/>Adult Growth Hormone Deficiency (GHD): Based on the weight-based dosing utilized in the original pivotal studies described herein, the recommended dosage at the start of therapy is not more than 0.006 mg/kg given as a daily subcutaneous injection. The dose may be increased according to individual patient requirements to a maximum of 0.025 mg/kg daily in patients under 35 years old and to a maximum of 0.0125 mg/kg daily in patients over 35 years old. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-I levels may be used as guidance in dose titration. Alternatively, taking into account more recent literature, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day, according to individual patient requirements based on the clinical response and serum IGF-I concentrations. During therapy, the dose should be decreased if required by the occurrence of adverse events and/or serum IGF-I levels above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person. A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.<br/>Chronic Renal Insufficiency (CRI): A weekly dosage of up to 0.35 mg/kg of body weight divided into daily subcutaneous injection is recommended. Nutropin AQ therapy may be continued up to the time of renal transplantation. In order to optimize therapy for patients who require dialysis, the following guidelines for injection schedule are recommended:<br/>Turner Syndrome: A weekly dosage of up to 0.375 mg/kg of body weight divided into equal doses 3 to 7 times per week by subcutaneous injection is recommended.<br/>Idiopathic Short Stature (ISS): A weekly dosage of up to 0.3 mg/kg of body weight divided into daily subcutaneous injection has been shown to be safe and efficacious, and is recommended.<br/>Administration: The solution should be clear immediately after removal from the refrigerator. Occasionally, after refrigeration, you may notice that small colorless particles of protein are present in the solution. This is not unusual for solutions containing proteins. Allow the vial or pen cartridge to come to room temperature and gently swirl. If the solution is cloudy, the contents MUST NOT be injected.<br/>For Nutropin AQ Vial: Before needle insertion, wipe the septum of the Nutropin AQ vial with rubbing alcohol or an antiseptic solution to prevent contamination of the contents by microorganisms that may be introduced by repeated needle insertions. It is recommended that Nutropin AQ be administered using sterile, disposable syringes and needles. The syringes should be of small enough volume that the prescribed dose can be drawn from the vial with reasonable accuracy.<br/>For Nutropin AQ Pen Cartridge: The Nutropin AQ pen cartridge is intended for use only with the Nutropin AQ Pen. Wipe the septum of the Nutropin AQ pen cartridge with rubbing alcohol or an antiseptic solution to prevent contamination of the contents by microorganisms that may be introduced by repeated needle insertions. It is recommended that Nutropin AQ be administered using sterile, disposable needles. Follow the directions provided in the Nutropin AQ Pen Instructions for Use. The Nutropin AQ pen allows for administration of a minimum dose of 0.1 mg to a maximum dose of 4.0 mg, in 0.1 mg increments.
|
| dailymed-drugs:274 |
Usual Adult Dosage:<br/>Perioperative Prophylactic Use:: To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: a. 1 gram IV administered��hour to 1 hour prior to start of surgery. b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified
depending on the duration of the operative procedure). c. 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively. It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to start of surgery so that adequate
antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during
surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic
arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.<br/>Dosage Adjustment for Patients With Reduced Renal Function:: Cefazolin Injection, USP may be used in patients with reduced renal function with the following dosage adjustments: Patients
with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min.
or serum creatinine of 1.6 to 3.0 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34
mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given��the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of
4.6 mg % or greater should be given��the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the
infection. Patients undergoing peritoneal dialysis: See CLINICAL
PHARMACOLOGY.<br/>Pediatric Dosage:: In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided
into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe
infections. Since safetyfor use in premature infants and in neonates has not been established, the use of Cefazolin Injection, USP in these patients is not recommended. In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the
normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of
the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20to 5 mL/min.) may
be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.
|
| dailymed-drugs:275 |
NORVIR is administered orally.
It is recommended that NORVIR be taken with meals if possible. Patients
may improve the taste of NORVIR oral solution by mixing with chocolate
milk, Ensure, or Advera within one
hour of dosing. The effects of antacids on the absorption of ritonavir
have not been studied.<br/>Adults:<br/>Recommended Dosage: The recommended dosage of ritonavir is 600 mg twice
daily by mouth. Use of a dose titration schedule may help to reduce
treatment-emergent adverse events while maintaining appropriate ritonavir
plasma levels. Ritonavir should be started at no less than 300 mg
twice daily and increased at 2 to 3 day intervals by 100 mg twice
daily.<br/>Pediatric Patients: Ritonavir should
be used in combination with other antiretroviral agents (see General Dosing Guidelines ). The recommended
dosage of ritonavir in children>1 month is 350 to 400 mg/mtwice daily by mouth and should not exceed 600 mg twice daily.
Ritonavir should be started at 250 mg/mand increased
at 2 to 3 day intervals by 50 mg/mtwice daily. If patients
do not tolerate 400 mg/mtwice daily due to adverse events,
the highest tolerated dose may be used for maintenance therapy in
combination with other antiretroviral agents, however, alternative
therapy should be considered. When possible, dose should be administered
using a calibrated dosing syringe.<br/>General Dosing Guidelines: Patients should
be aware that frequently observed adverse events, such as mild to
moderate gastrointestinal disturbances and paraesthesias, may diminish
as therapy is continued. In addition, patients initiating combination
regimens with NORVIR and reverse transcriptase inhibitors may improve
gastrointestinal tolerance by initiating NORVIR alone and subsequently
adding reverse transcriptase inhibitors before completing two weeks
of NORVIR monotherapy.
|
| dailymed-drugs:277 |
Major Depressive Disorder:<br/>Initial Treatment: The recommended dose of Lexapro is 10 mg once daily. A fixed-dose trial of Lexapro demonstrated the effectiveness of both 10 mg and 20 mg of Lexapro, but failed to demonstrate a greater benefit of 20 mg over 10 mg . If the dose is increased to 20 mg, this should occur after a minimum of one week. Lexapro should be administered once daily, in the morning or evening, with or without food.<br/>Special Populations: 10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment. No dosage adjustment is necessary for patients with mild or moderate renal impairment. Lexapro should be used with caution in patients with severe renal impairment.<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to Lexapro and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding . When treating pregnant women with Lexapro during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Lexapro in the third trimester.<br/>Maintenance Treatment: It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of continuing Lexapro 10 or 20 mg/day for periods of up to 36 weeks in patients with major depressive disorder who responded while taking Lexapro during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment . Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.<br/>Generalized Anxiety Disorder:<br/>Initial Treatment: The recommended starting dose of Lexapro is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week. Lexapro should be administered once daily, in the morning or evening, with or without food.<br/>Maintenance Treatment: Generalized anxiety disorder is recognized as a chronic condition. The efficacy of Lexapro in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use Lexapro for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.<br/>Discontinuation of Treatment with Lexapro: Symptoms associated with discontinuation of Lexapro and other SSRIs and SNRIs have been reported . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.<br/>Switching Patients To or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of Lexapro therapy. Similarly, at least 14 days should be allowed after stopping Lexapro before starting an MAOI .
|
| dailymed-drugs:278 |
Capsules, tablets and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.<br/>Neonates and Infants Aged���12 Weeks (���3 Months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.<br/>Adults and Pediatric Patients>3 Months: After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety. All patients with gonorrhea should be evaluated for syphilis. Larger doses may be required for stubborn or severe infections.<br/>General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological followup for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.<br/>H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:<br/>Triple Therapy:<br/>Dual Therapy:<br/>Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of<30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. There are currently no dosing recommendations for pediatric patients with impaired renal function.<br/>Directions for Mixing Oral Suspension: Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously. NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.
|
| dailymed-drugs:279 |
Seromycin is
effective orally and is currently administered only by this route. The usual
dosage is 500 mg to 1 g daily in divided
doses monitored by blood levels.The
initial adult dosage most frequently given is 250 mg twice
daily at 12���hour intervals for the first 2 weeks. A
daily dosage of 1 g should not be exceeded.
|
| dailymed-drugs:280 |
Stroke: The recommended dose of ticlopidine hydrochloride tablets is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.<br/>Coronary Artery Stenting: The recommended dose of ticlopidine hydrochloride tablets is 250 mg bid taken with food together with antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation.
|
| dailymed-drugs:281 |
(See WARNINGS and PRECAUTIONS.) Dosage should be adjusted according to the indication
for therapy, severity of symptoms, and the response of the patient. Injectable���100 mg/mL (Not for use in pediatric patients.) Usual Adult Dosage. 2 mL (200
mg) t.i.d. or q.i.d. intramuscularly. Intramuscular
administration may cause pain, stinging, burning, redness, and swelling
at the site of injection. Such effects may be minimized by deep injection
into the upper outer quadrant of the gluteal region, and by avoiding
the escape of solution along the route. Note: The injectable form is intended for
intramuscular administration only; it is not recommended for intravenous
use. Parenteral drug
products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit.
|
| dailymed-drugs:282 |
Hypertension:<br/>Monotherapy: The recommended initial dose of quinapril tablets USP in patients not on diuretics is 10 or 20 mg once daily. Dosage should be adjusted according to blood pressure response measured at peak (2 to 6 hours after dosing) and trough (predosing). Generally, dosage adjustments should be made at intervals of at least 2 weeks. Most patients have required dosages of 20, 40, or 80 mg/day, given as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients an increase in dosage or twice daily administration may be warranted. In general, doses of 40 to 80 mg and divided doses give a somewhat greater effect at the end of the dosing interval.<br/>Concomitant Diuretics: If blood pressure is not adequately controlled with quinapril tablets USP monotherapy, a diuretic may be added. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of quinapril tablets USP. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued 2 to 3 days prior to beginning therapy with quinapril tablets USP . Then, if blood pressure is not controlled with quinapril tablets USP alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 5 mg quinapril tablets USP should be used with careful medical supervision for several hours and until blood pressure has stabilized. The dosage should subsequently be titrated (as described above) to the optimal response .<br/>Renal Impairment: Kinetic data indicate that the apparent elimination half-life of quinaprilat increases as creatinine clearance decreases. Recommended starting doses, based on clinical and pharmacokinetic data from patients with renal impairment, are as follows: Patients should subsequently have their dosage titrated (as described above) to the optimal response.<br/>Elderly (���65 years): The recommended initial dosage of quinapril tablets USP in elderly patients is 10 mg given once daily followed by titration (as described above) to the optimal response. Following the initial dose of quinapril tablets USP, the patient should be observed under medical supervision for at least two hours for the presence of hypotension or orthostatis and, if present, until blood pressure stabilizes. The appearance of hypotension, orthostatis, or azotemia early in dose titration should not preclude further careful dose titration. Consideration should be given to reducing the dose of concomitant diuretics.<br/>DOSE ADJUSTMENTS IN PATIENTS WITH RENAL IMPAIRMENT OR HYPONATREMIA: Pharmacokinetic data indicate that quinapril elimination is dependent on level of renal function. In patients with heart failure and renal impairment, the recommended initial dose of quinapril tablets USP is 5 mg in patients with a creatinine clearance above 30 mL/min and 2.5 mg in patients with a creatinine clearance of 10 to 30 mL/min. There is insufficient data for dosage recommendation in patients with a creatinine clearance less than 10 mL/min . If the initial dose is well tolerated, quinapril tablets USP may be administered the following day as a twice daily regimen. In the absence of excessive hypotension or significant deterioration of renal function, the dose may be increased at weekly intervals based on clinical and hemodynamic response.
|
| dailymed-drugs:283 |
Most patients will require only 1 ounce of Lindane Shampoo. Based on the length and density of hair, some patients may require 2 ounces of Lindane Shampoo. Apply shampoo directly to dry hair without adding water. Work thoroughly into the hair and allow to remain in place for 4 minutes only. Special attention should be given to the fine hairs along the neck. After 4 minutes, add small quantities of water to hair until a good lather forms. Immediately rinse all lather away. Avoid unnecessary contact oflather with other body surfaces. Do not prescribe more than 2 ounces for larger adults. Do not retreat. Patients should be provided specific information on use of product. A Lindane Shampoo Medication Guide must be given to the patient each time LINDANE Shampoo is dispensed as required by law. The Lindane Shampoo Medication Guide is an important part of the risk management program for the patient.
|
| dailymed-drugs:284 |
In controlled clinical trials, single doses of
1 and 2.5 mg of AMERGE Tablets taken with fluid were effective
for the acute treatment of migraines in adults. A greater proportion
of patients had headache response following a 2.5-mg dose than following
a 1-mg dose (see CLINICAL TRIALS). Individuals may vary in response
to doses of AMERGE Tablets. The choice of dose should therefore be
made on an individual basis, weighing the possible benefit of the
2.5-mg dose with the potential for a greater risk of adverse events.
If the headache returns or if the patient has only partial response,
the dose may be repeated once after 4 hours, for a maximum dose
of 5 mg in a 24-hour period. There is evidence that doses of
5 mg do not provide a greater effect than 2.5 mg. The safety of treating, on average, more than 4 headachesin a 30-day period has not been established.<br/>Renal Impairment: The use of AMERGE is contraindicated in patients
with severe renal impairment (creatinine clearance,<15 mL/min)
because of decreased clearance of the drug (see CONTRAINDICATIONS
and CLINICAL PHARMACOLOGY). In patients with mild to moderate renal
impairment, the maximum daily dose should not exceed 2.5 mg over
a 24-hour period and a lower starting dose should be considered.<br/>Hepatic Impairment: The use of AMERGE is contraindicated in patients
with severe hepatic impairment (Child-Pugh grade C) because of decreased
clearance (see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY). In patients
with mild or moderate hepatic impairment, the maximum daily dose should
not exceed 2.5 mg over a 24-hour period and a lower starting
dose should be considered (see CLINICAL PHARMACOLOGY).
|
| dailymed-drugs:286 |
Reconstitution and Storage: Sincalide for Injection may be stored at room temperature prior to reconstitution. To reconstitute, aseptically add 5 mL of Sterile Water for Injection USP to the vial. This
solution may be kept at room temperature and should be used within 8 hours of reconstitution,
after which time any unused portion should be discarded. Parenteral drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. For prompt contraction of the gallbladder, a dose of 0.02 mcg sincalide per kg (1.4 mcg/70
kg) is injected intravenously over a 30- to 60-second interval; if satisfactory contraction of the gallbladder does not occur in 15 minutes, a second dose, 0.04 mcg sincalide per kg, may be
administered. To reduce theintestinal side effects , an intravenous
infusion may be prepared at a dose of 0.12 mcg/kg in 100 mL of Sodium Chloride Injection
USP and given at a rate of 2 mL per minute; alternatively, an intramuscular dose of 0.1 mcg/kg
may be given. When Kinevac (Sincalide for Injection) is used in cholecystography,
roentgenograms are usually taken at five-minute intervals after the injection. For visualization
of the cystic duct, it may be necessary to take roentgenograms at one-minute intervals during
the first fiveminutes after the injection. For the Secretin-Kinevac test of pancreatic function, the patient receives a dose of 0.25 units
secretin per kg by intravenous infusion over a 60-minute period. Thirty minutes after the initiation
of the secretin infusion, a separate IV infusion of Kinevac at a total dose of 0.02 mcg per
kg is administered over a 30-minute interval. For example, the total dose for a 70 kg patient is
1.4 mcg of sincalide; therefore, dilute 1.4 mL of reconstituted Kinevac solution to 30 mL with
Sodium Chloride Injection USP and administer at a rate of 1 mL per minute. To accelerate the transit time of a barium meal through the small bowel, administer Kinevac
after the barium meal is beyond the proximal jejunum. (Sincalide, like cholecystokinin, may
cause pyloric contraction.) The recommended dose is 0.04 mcg sincalide per kg (2.8 mcg/70
kg) injected intravenously over a 30- to 60- second interval; if satisfactory transit of the barium
meal has not occurred in 30 minutes, a second dose of 0.04 mcg sincalide per kg may be
administered. For reduction of side effects, a 30-minute IV infusion of sincalide [0.12 mcg per
kg (8.4 mcg/70 kg) diluted to approximately 100 mL with Sodium Chloride Injection USP] may
be administered. Sodium Chloride Injection dilutions may be kept at room temperature and should be used
within one hour of dilution.
|
| dailymed-drugs:287 |
Because of the flexibility of this product and the range of emotional disturbances responsive to it, dosage should be individualized for maximum beneficial effects. This product is not indicated in pediatric patients under 6 years of age. Absolute dosage for pediatric patients 6 to 12 years of age is not established.
|
| dailymed-drugs:288 |
The dosage should be initiated at a low level and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. DESYREL should be taken shortly after a meal or light snack. Symptomatic relief may be seen during the first week, with optimal antidepressant effects typically evident within two weeks. Twenty-five percent of those who respond to DESYREL require more than two weeks (up to four weeks) of drug administration.<br/>Usual Adult Dosage: An initial dose of 150 mg/day in divided doses is suggested. The dose may be increased by 50 mg/day every three to four days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.<br/>Maintenance: Dosage during prolonged maintenance therapy should be kept at the lowest effective level. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response. Although there has been no systematic evaluation of the efficacy of DESYREL beyond six weeks, it is generally recommended that a course of antidepressant drug treatment should be continued for several months.
|
| dailymed-drugs:289 |
Major Depressive Disorder:<br/>Initial Treatment:<br/>Maintenance/Continuation/Extended Treatment: It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.<br/>Daily Dosing: Systematic evaluation of fluoxetine in adult patients has shown that its efficacy in major depressive disorder is maintained for periods of up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) at a dose of 20 mg/day .<br/>Switching Patients to a Tricyclic Antidepressant (TCA): Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued (see Other drugs effective in the treatment of major depressive disorder under PRECAUTIONS, Drug Interactions).<br/>Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI): At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with fluoxetine. In addition, at least 5 weeks, perhaps longer, should be allowed after stopping fluoxetine before starting an MAOI .<br/>Obsessive Compulsive Disorder:<br/>Initial Treatment:<br/>Maintenance/Continuation Treatment: While there are no systematic studies that answer the question of how long to continue fluoxetine, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine after 13 weeks has not been documented in controlled trials, adult patients have been continued in therapy under double-blind conditions for up to an additional 6 months without loss of benefit. However, dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for treatment.<br/>Bulimia Nervosa:<br/>Initial Treatment: In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of bulimia nervosa, patients were administered fixed daily fluoxetine doses of 20 or 60 mg, or placebo . Only the 60-mg dose was statistically significantly superior to placebo in reducing the frequency of binge-eating and vomiting. Consequently, the recommended dose is 60 mg/day, administered in the morning. For some patients it may be advisable to titrate up to this target dose over several days. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with bulimia. As with the use of fluoxetine in the treatment of major depressive disorder and OCD, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly , and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary .<br/>Maintenance/Continuation Treatment: Systematic evaluation of continuing fluoxetine 60 mg/day for periods of up to 52 weeks in patients with bulimia who have responded while taking fluoxetine 60 mg/day during an 8-week acute treatment phase has demonstrated a benefit of such maintenance treatment . Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.<br/>Panic Disorder:<br/>Initial Treatment: In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of panic disorder, patients were administered fluoxetine doses in the range of 10 to 60 mg/day . Treatment should be initiated with a dose of 10 mg/day. After 1 week, the dose should be increased to 20 mg/day. The most frequently administered dose in the 2 flexible-dose clinical trials was 20 mg/day. A dose increase may be considered after several weeks if no clinical improvement is observed. Fluoxetine doses above 60 mg/day have not been systematically evaluated in patients with panic disorder. As with the use of fluoxetine in other indications, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly , and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary .<br/>Maintenance/Continuation Treatment: While there are no systematic studies that answer the question of how long to continue fluoxetine, panic disorder is a chronic condition and it is reasonable to consider continuation for a responding patient. Nevertheless, patients should be periodically reassessed to determine the need for continued treatment.<br/>Special Populations:<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to fluoxetine and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding . When treating pregnant women with fluoxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering fluoxetine in the third trimester.<br/>Discontinuation of Treatment with Fluoxetine: Symptoms associated with discontinuation of fluoxetine and other SSRIs and SNRIs, have been reported . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. Plasma fluoxetine and norfluoxetine concentration decrease gradually at the conclusion of therapy which may minimizethe risk of discontinuation symptoms with this drug.
|
| dailymed-drugs:290 |
Clindamycin Injection,
USP can be administered by I.M. or I.V. injection (following dilution).
However, the intent of the ADD-VANTAGE vial is for the preparation
of solutions for I.V. infusion only. If diarrhea occurs during therapy, this antibiotic should be discontinued.
(See WARNING box.) Adults: Parenteral (I.M. or I.V.) Administration: Serious infections
due to aerobic gram-positive cocci and the more susceptible anaerobes
(NOT generally including Bacteroides
fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens): 600 to 1200 mg/day in 2, 3 or 4 equal doses More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens: 1200 to 2700 mg/day in 2, 3 or 4 equal doses For more serious infections, these doses may have to be
increased. In life threatening situations due to either aerobes or
anaerobes, these doses may be increased. Doses of as much as 4800
mg daily have been given intravenously to adults. See Dilution and Infusion Rates section below. Single intramuscular injections of greater than 600 mg
are not recommended. Alternatively, drug may
be administered in the form of a single rapid infusion of the first
dose followed by continuous I.V. infusion as follows: Neonates (less than 1
month): 15 to 20 mg/kg/day in three
to four equal doses. The lower dosage may be adequate for small prematures. Pediatric patients (1 month
of age to 16 years): Parenteral (I.M.
or I.V. Administration): 20 to 40 mg/kg/day
in 3 or 4 equal doses. The higher doses would be used for more severe
infections. As an alternative to dosing on a body weight basis, pediatric
patients may be dosed on the basis of square meters body surface:
350 mg/m/day for serious infections and 450 mg/m/day for more severe infections. Parenteral
therapy may be changed to clindamycin palmitate hydrochloride for
oral solution or clindamycin hydrochloride capsules when the condition
warrants and at the discretion of the physician. In cases of��-hemolytic streptococcal infections, treatment
should be continued for at least 10 days. Dilution and Infusion Rates: Clindamycin phosphate must be
diluted prior to I.V. administration with the ADD-VANTAGE Flexible
Diluent Container. The concentration of clindamycin in diluent for
infusion should not exceed 18 mg per mL. Infusion rates should not
exceed 30 mg per minute. The usual infusion dilutions and
rates are as follows: Administration of more than 1200 mg in a 1-hour
infusion is not recommended. Parenteral drug
products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. Dilution and Compatibility: Physical and biological compatibility studies
monitored for 24 hours at room temperature have demonstrated no inactivationor incompatibility with the use of clindamycin phosphate in IV solutions
containing sodium chloride, glucose, calcium or potassium, and solutions
containing vitamin B complex in concentrations usually used clinically.
No incompatibility has been demonstrated with the antibiotics cephalothin,
kanamycin, gentamicin, penicillin or carbenicillin. The following drugs are physically incompatible with clindamycin
phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline,
calcium gluconate, and magnesium sulfate. The compatibility and duration of stability of drug admixtures will
vary depending on concentration and other conditions. Physico-Chemical Stability of Diluted Solutions
of Clindamycin: Room temperature:
6, 9, and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose
Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer's
Injection in glass bottles or minibags, demonstrated physical and
chemical stability for at least 16 days at 25��C. Also 18 mg/mL
(equivalent to clindamycin base) in 5% Dextrose Injection, in minibags,
demonstrated physical and chemical stability for at least 16 days
at 25��C. Refrigeration: 6, 9 and 12 mg/mL
(equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium
Chloride Injection, or Lactated Ringer's Injection in glass
bottles or minibags, demonstrated physical and chemical stability
for at least 32 days at 4��C. IMPORTANT:
This chemical stability information in no way indicates that it would
be acceptable practice to use this product well after the preparation
time. Good professional practice suggests that compounded admixtures
should be administered as soon after preparation as is feasible. Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base)
in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated
Ringer's Injection in minibags demonstrated physical and chemical
stability for at least eight weeks at -10��C. Frozen solutions should be thawed at room temperature and not refrozen. INSTRUCTIONS FOR USE To Open Diluent Container: Peel overwrap from the corner and remove container. Some
opacity of the plastic due to moisture absorption during the sterilization
process may be observed. This is normal and does not affect the solution
quality or safety. The opacity will diminish gradually. To Assemble Vial and Flexible
Diluent Container: (Use Aseptic Technique) To Prepare Admixture: Preparation for Administration (Use Aseptic Technique) WARNING: Do not use flexible
container in series connections.
|
| dailymed-drugs:291 |
Carefully consider the potential benefits and risks of naproxen sodium extended-release tablets and other treatment options before deciding to use naproxen sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . After observing the response to initial therapy with naproxen sodium extended-release tablets, the dose and frequency should be adjusted to suit an individual patient's needs.<br/>For the relief of::<br/>Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis: The recommended starting dose of naproxen sodium extended-release tablets in adults is two naproxen sodium extended-release 375 mg tablets (750 mg) once daily, or two naproxen sodium extended-release 500 mg tablets (1000 mg) once daily. Patients already taking naproxen 250 mg, 375 mg or 500 mg twice daily (morning and evening) may have their total daily dose replaced with naproxen sodium extended-release tablets as a single daily dose. During long-term administration, the dose of naproxen sodium extended-release tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of naproxen sodium extended-release tablets well, the dose may be increased to three naproxen sodium extended-release 500 mg tablets (1500 mg) once daily for limited periods when a higher level of anti-inflammatory/analgesic activity is required. When treating patients,especially at the higher dose levels, the physician should observe sufficient increased clinical benefit to offset the potential increased risk. (See Clinical Pharmacology). The lowest effective dose should be sought and used in every patient. Symptomatic improvement in arthritis usually begins within one week; however, treatment for two weeks may be required to achieve a therapeutic benefit. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see Precautions). Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly it is prudent to use the lowest effective dose.<br/>Management of Pain, Primary Dysmenorrhea, and Acute Tendinitis and Bursitis: The recommended starting dose is two naproxen sodium extended-release 500 mg tablets (1000 mg) once daily. For patients requiring greater analgesic benefit, three naproxen sodium extended-release 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two naproxen sodium extended-release 500 mg tablets (1000 mg).<br/>Acute Gout: The recommended dose on the first day is two to three naproxen sodium extended-release 500 mg tablets (1000-1500 mg) once daily, followed by two naproxen sodium extended-release 500 mg tablets (1000 mg) once daily, until the attack has subsided.
|
| dailymed-drugs:293 |
Cefprozil tablets are administered orally.<br/>Renal Impairment:: Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.<br/>Hepatic Impairment:: No dosage adjustment is necessary for patients with impaired hepatic function.
|
| dailymed-drugs:294 |
One full applicator (5 g) of Zazole Vaginal Cream 0.4% (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of Zazole Vaginal Cream 0.4% is not affected by menstruation.
|
| dailymed-drugs:295 |
Dosage should be determined by individual titration (see INDICATIONS AND USAGE). Hydrochlorothiazide is usually given at a dosage of 12.5 to 50 mg per day. The usual initial dosage of Lopressor is 100 mg daily in single or divided doses. Dosage may be increased gradually until optimum blood pressure control is achieved. The effective dosage range is 100 to 450 mg per day. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring bloodpressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Betaselectivity diminishes as dosage of Lopressor is increased. The following dosage schedule may be used to administer from 100 to 200 mg of Lopressor per day and from 25 to 50 mg of hydrochlorothiazide per day: Dosing regimens that exceed 50 mg of hydrochlorothiazide per day are not recommended. When necessary, another antihypertensive agent may be added gradually, beginning with 50% of the usual recommended starting dose to avoid an excessive fall in blood pressure.
|
| dailymed-drugs:296 |
For Use in Chronic Spasticity: Prior to the administration of Dantrium, consideration should be given to the potential response to treatment. A decrease in spasticity sufficient to allow a daily function not otherwise attainable should be the therapeutic goal of treatment with Dantrium. Refer to INDICATIONS AND USAGE section for description of response to be anticipated. It is important to establish a therapeutic goal (regain and maintain a specific function such as therapeutic exercise program, utilization of braces, transfer maneuvers, etc.) before beginning Dantrium therapy. Dosage should be increased until the maximum performance compatible with the dysfunction due to underlying disease is achieved. No further increase in dosage is then indicated. Usual Dosage: It is important that the dosage be titrated and individualized for maximum effect. The lowest dose compatible with optimal response is recommended. In view of the potential for liver damage in long-termDantriumuse, therapy should be stopped if benefits are not evident within 45 days. Adults: The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose. Therapy with a dose four times daily may be necessary for some individuals. Doses higher than 100 mg four times daily should not be used. (See Box Warning.) Pediatric Patients: The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose. Therapy with a dose four times daily may be necessary for some individuals. Doses higher than 100 mg four times daily should not be used. (See Box Warning.)<br/>For Malignant Hyperthermia::
|
| dailymed-drugs:297 |
The recommended dose of
ALLEGRA-D 12 HOUR Extended-Release Tablets is one tablet twice daily
administered on an empty stomach with water for adults and children
12 years of age and older. It is recommended that the administration
of ALLEGRA-D 12 HOUR with food should be avoided. A dose of one tablet
once daily is recommended as the starting dose in patients with decreased
renal function. (See CLINICAL
PHARMACOLOGY and PRECAUTIONS.) ALLEGRA-D 12 HOUR
must be swallowed whole and never crushed or chewed. Occasionally,
the inactive ingredients of ALLEGRA-D 12 HOUR may be eliminated in
the feces in a form that may resemble the original tablet.
|
| dailymed-drugs:298 |
Epilepsy:<br/>Adjunctive Use: Lamotrigine tablets are indicated as adjunctive therapy for partial seizures and the generalized seizures of Lennox-Gastaut syndrome in adult and pediatric patients (���2 years of age).<br/>Monotherapy Use: Lamotrigine tablets are indicated for conversion to monotherapy in adults with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED. Safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy, (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.<br/>Bipolar Disorder: Lamotrigine tablets are indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.<br/>General Dosing Considerations for Epilepsy and Bipolar Disorder Patients: The risk of nonserious rash is increased when the recommended initial dose and/or the rate of dose escalation of lamotrigine tablets is exceeded. There are suggestions, yet to be proven, that the risk of severe, potentially life-threatening rash may be increased by (1) coadministration of lamotrigine tablets with valproate, (2) exceeding the recommended initial dose of lamotrigine tablets, or (3) exceeding the recommended dose escalation for lamotrigine tablets. However, cases have been reported in the absence of these factors (see BOX WARNING). Therefore, it is important that the dosing recommendations be followed closely. It is recommended that lamotrigine not be restarted in patients who discontinued due to rash associated with prior treatment with lamotrigine, unless the potential benefits clearly outweigh the risks. If the decision is made to restart a patient who has discontinued lamotrigine, the need to restart with the initial dosing recommendations should be assessed. The greater the interval of time since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations. If a patient has discontinued lamotrigine for a period of more than 5 half-lives, it is recommended that initial dosing recommendations and guidelines be followed.<br/>Lamotrigine Added to Drugs Known to Induce or Inhibit Glucuronidation: Drugs other than those listed in PRECAUTIONS, Drug Interactions have not been systematically evaluated in combination with lamotrigine. Since lamotrigine is metabolized predominantly by glucuronic acid conjugation, drugs that are known to induce or inhibit glucuronidation may affect the apparent clearance of lamotrigine, and doses of lamotrigine may require adjustment based on clinical response.<br/>Target Plasma Levels for Patients With Epilepsy or Bipolar Disorder: A therapeutic plasma concentration range has not been established for lamotrigine. Dosing of lamotrigine should be based on therapeutic response. The half-life of lamotrigine is affected by other concomitant medications (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Drug Metabolism). See also DOSAGE AND ADMINISTRATION, Special Populations.<br/>Special Populations:<br/>Patients With Hepatic Impairment: Experience in patients with hepatic impairment is limited. Based on a clinical pharmacology study in 24 patients with mild, moderate, and severe liver dysfunction (see CLINICAL PHARMACOLOGY), the following general recommendations can be made. No dosage adjustment is needed in patients with mild liver impairment. Initial, escalation, and maintenance doses should generally be reduced by approximately 25% in patients with moderate and severe liver impairment without ascites and 50% in patients with severe liver impairment with ascites. Escalation and maintenance doses may be adjusted according to clinical response.<br/>Patients With Renal Functional Impairment: Initial doses of lamotrigine should be based on patients' AED regimen (see above); reduced maintenance doses may be effective for patients with significant renal functional impairment (see CLINICAL PHARMACOLOGY). Few patients with severe renal impairment have been evaluated during chronic treatment with lamotrigine. Because there is inadequate experience in this population, lamotrigine should be used with caution in these patients.<br/>Epilepsy:<br/>Adjunctive Therapy With Lamotrigine for Epilepsy: This section provides specific dosing recommendations for patients 2 to 12 years of age and patients greater than 12 years of age. Within each of these age groups, specific dosing recommendations are provided depending upon concomitant AED (Table 9 for patients 2 to 12 years of age and Table 11 for patients greater than 12 years of age). A weight based dosing guide for pediatric patients on concomitant valproate is provided in Table 10.<br/>Conversion From Adjunctive Therapy With Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate as the Single AED to Monotherapy With Lamotrigine in Patients���16 Years of Age With Epilepsy: The goal of the transition regimen is to effect the conversion to monotherapy with lamotrigine under conditions that ensure adequate seizure control while mitigating the risk of serious rash associated with the rapid titration of lamotrigine. The recommended maintenance dose of lamotrigine as monotherapy is 500 mg/day given in 2 divided doses. To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of lamotrigine should not be exceeded (see BOX WARNING).<br/>Conversion From Adjunctive Therapy With Carbamazepine, Phenytoin, Phenobarbital, or Primidone to Monotherapy With Lamotrigine: After achieving a dose of 500 mg/day of lamotrigine according to Table 11, the concomitant AED should be withdrawn by 20% decrements each week over a 4 week period. The regimen for the withdrawal of the concomitant AED is based on experience gained in the controlled monotherapy clinical trial.<br/>Conversion From Adjunctive Therapy With Valproate to Monotherapy With Lamotrigine: The conversion regimen involves 4 steps (see Table 12).<br/>Conversion From Adjunctive Therapy With Antiepileptic Drugs Other Than Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate to Monotherapy With Lamotrigine: No specific dosing guidelines can be provided for conversion to monotherapy with lamotrigine with AEDs other than carbamazepine, phenobarbital, phenytoin, primidone, or valproate.<br/>Usual Maintenance Dose for Epilepsy: The usual maintenance doses identified in Tables 9 through 11 are derived from dosing regimens employed in the placebo-controlled adjunctive studies in which the efficacy of lamotrigine was established. In patients receiving multidrug regimens employing carbamazepine, phenytoin, phenobarbital, or primidone without valproate, maintenance doses of adjunctive lamotrigine as high as 700 mg/day have been used. In patients receiving valproate alone, maintenance doses of adjunctive lamotrigine as high as 200 mg/day have been used. The advantage of using doses above those recommended in Tables 9 through 12 has not been established in controlled trials.<br/>Discontinuation Strategy for Patients With Epilepsy: For patients receiving lamotrigine in combination with other AEDs, a reevaluation of all AEDs in the regimen should be considered if a change in seizure control or an appearance or worsening of adverse experiences is observed. If a decision is made to discontinue therapy with lamotrigine, a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) is recommended unless safety concerns require a more rapid withdrawal (see PRECAUTIONS). Discontinuing carbamazepine, phenytoin, phenobarbital, or primidone should prolong the half-life of lamotrigine; discontinuing valproate should shorten the half-life of lamotrigine.<br/>Bipolar Disorder: The goal of maintenance treatment with lamotrigine tablets is to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. The target dose of lamotrigine tablets is 200 mg/day (100 mg/day in patients taking valproate, which decreases the apparent clearance of lamotrigine, and 400 mg/day in patients not taking valproate and taking either carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, which increase the apparent clearance of lamotrigine). In the clinical trials, doses up to 400 mg/day as monotherapy were evaluated, however, no additional benefit was seen at 400 mg/day compared to 200 mg/day (see CLINICAL STUDIES, Bipolar Disorder). Accordingly, doses above 200 mg/day are not recommended. Treatment with lamotrigine tablets is introduced, based on concurrent medications, according to the regimen outlined in Table 13. If other psychotropic medications are withdrawn following stabilization, the dose of lamotrigine tablets should be adjusted. For patients discontinuing valproate, the dose of lamotrigine tablets should be doubled over a 2 week period in equal weekly increments (see Table 14). For patients discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, the dose of lamotrigine tablets should remain constant for the first week and then should be decreased by half over a 2 week period in equal weekly decrements (see Table 14). The dose of lamotrigine tablets may then be further adjusted to the target dose (200 mg) as clinically indicated. Dosage adjustments will be necessary in most patients who start or stop estrogen-containing oral contraceptives while taking lamotrigine (see DOSAGE AND ADMINISTRATION, Special Populations, Women and oral contraceptives, Adjustments to the maintenance dose of lamotrigine). If other drugs are subsequently introduced, the dose of lamotrigine tablets may need to be adjusted. In particular, the introduction of valproate requires reduction in the dose of lamotrigine tablets (see CLINICAL PHARMACOLOGY, Drug Interactions). To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of lamotrigine tablets should not be exceeded (see BOX WARNING). There is no body of evidence available to answer the question of how long the patient should remain on lamotrigine tablet therapy. Systematic evaluation of the efficacy of lamotrigine in patients with either depression or mania who responded to standard therapy during an acute 8 to 16 week treatment phase and were then randomized to lamotrigine or placebo for up to 76 weeks of observation for affective relapse demonstrated a benefit of such maintenance treatment (see CLINICAL STUDIES, Bipolar Disorder). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.<br/>Discontinuation Strategy in Bipolar Disorder: As with other AEDs, lamotrigine tablets should not be abruptly discontinued. In the controlled clinical trials, there was no increase in the incidence, type, or severity of adverse experiences following abrupt termination of lamotrigine. In clinical trials in patients with bipolar disorder, 2 patients experienced seizures shortly after abrupt withdrawal of lamotrigine. However, there were confounding factors that may have contributed to the occurrence of seizures in these bipolar patients. Discontinuation of lamotrigine tablets should involve a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) unless safety concerns require a more rapid withdrawal.
|
| dailymed-drugs:299 |
Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved. Vital signs and ECG should be monitored routinely. Adult Dosage: The maximum recommended initial dose of droperidol is 2.5 mg IM or slow IV. Additional 1.25 mg doses of droperidol may be administered to achieve the desired effect. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk. Children's Dosage: For children two to 12 years of age, the maximum recommended initial dose is 0.1 mg/kg, taking into account the patient's age and other clinical factors. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk. See WARNINGS and PRECAUTIONS for use of droperidol with other CNS depressants, and in patients with altered response. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If such abnormalities are observed, the drug should not be administered.
|
| dailymed-drugs:300 |
For oral administration The initial dosage varies from 0.75 to 9 mg
a day depending on the disease being treated. It Should Be Emphasized That Dosage
Requirements Are Variable And Must Be Individualized On The Basis
Of The Disease Under Treatment And The Response Of The Patient. After a favorable response is noted, the proper
maintenance dosage should be determined by decreasing the initial
drug dosage in small decrements at appropriate time intervals until
the lowest dosage that maintains an adequate clinical response is
reached. Situations which may make dosage adjustments
necessary are changes in clinical status secondary to remissions or
exacerbations in the disease process, the patient's individual
drug responsiveness, and the effect of patient exposure to stressful
situations not directly related to the disease entity under treatment.
In this latter situation it may be necessary to increase the dosage
of the corticosteroid for a period of time consistent with the patient's
condition. If after long-term therapy the drug is to bestopped, it
is recommended that it be withdrawn gradually rather than abruptly. In the treatment of acute exacerbations of multiple sclerosis,
daily doses of 30 mg of dexamethasone for a week followed by
4 to 12 mg every other day for one month have been shown to be
effective (see PRECAUTIONS,
Neuro-psychiatric). In pediatric
patients, the initial dose of dexamethasone may vary depending on
the specific disease entity being treated. The range of initial doses
is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6
to 9 mg/mbsa/day). For the purpose of comparison, the following is
the equivalent milligram dosage of the various corticosteroids: These dose relationships
apply only to oral or intravenous administration of these compounds.
When these substances or their derivatives are injected intramuscularly
or into joint spaces, their relative properties may be greatly altered. In acute, self-limited
allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy
is suggested: Dexamethasone Sodium Phosphate
injection, USP 4 mg per mL: First
Day 1 or 2 mL, intramuscularly DECADRON tablets, 0.75 mg: Second Day 4 tablets in two divided doses Third Day 4 tablets in two divided
doses Fourth Day 2 tablets
in two divided doses Fifth Day 1 tablet Sixth Day 1
tablet Seventh Day No
treatment Eighth Day Follow-up
visit This schedule is designed to ensure adequate
therapy during acute episodes, while minimizing the risk of overdosage
in chronic cases. In cerebral edema, Dexamethasone Sodium Phosphate injection,
USP is generally administered initially in a dosage of 10 mg
intravenously followed by 4 mg every six hours intramuscularly
until the symptoms of cerebral edema subside. Response is usually
noted within 12 to 24 hours and dosage may be reduced after two to
four days and gradually discontinued over a period of five to seven
days. For palliative management of patients with recurrent or inoperable
brain tumors, maintenance therapy with either Dexamethasone Sodium
Phosphate injection, USP or DECADRON tablets ina dosage of 2 mg
two or three times daily may be effective.<br/>Dexamethasone suppression tests:
|
| dailymed-drugs:301 |
Alcohol and Dextrose Injections USP are administered by intravenous infusion only. Total dosage and rate of infusion depend on the patient's response and tolerance. The average adult can metabolize approximately 10 mL of pure alcohol per hour, equivalent to the alcohol contained in 200 mL of a 5% solution or 100 mL of a 10% solution. The usual adult dosage is 1 to 2 liters and rarely exceeds 3 liters of a 5% solutionin a 24-hour period. Children may be given 40 mL per kg per 24 hours or from 350 mL to 1000 mL depending on size and clinical response. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
|
| dailymed-drugs:302 |
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.<br/>Clemastine Fumarate Tablets 1.34 mg: The recommended starting dose is one tablet twice daily. Dosage may be increased as required, but not to exceed six tablets daily.<br/>Clemastine Fumarate Tablets 2.68 mg: The maximum recommended dosage is one tablet three times daily. Many patients respond favorably to a single dose which may be repeated as required, but not to exceed three tablets daily.
|
| dailymed-drugs:303 |
MUTAMYCIN should be given intravenously only, using care to avoid extravasation of the compound. If extravasation occurs, cellulitis, ulceration, and slough may result. Each vial contains either mitomycin 5 mg and mannitol 10 mg, mitomycin 20 mg and mannitol 40 mg, or mitomycin 40 mg and mannitol 80 mg. To administer, add Sterile Water for Injection, 10 mL, 40 mL, or 80 mL respectively. Shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until solution is obtained. After full hematological recovery (see guide to dosage adjustment) from any previous chemotherapy, the following dosage schedule may be used at 6 to 8 week intervals: 20 mg/mintravenously as a single dose via a functioning intravenous catheter. Because of cumulative myelosuppression, patients should be fully reevaluated after each course of MUTAMYCIN, and the dose reduced if the patient has experienced any toxicities. Doses greater than 20 mg/mhave not been shown to be more effective, and are more toxic than lower doses. The following schedule is suggested as a guide to dosage adjustment: No repeat dosage should be given until leukocyte count has returned to 4000/mmand a platelet count to 100,000/mm. When MUTAMYCIN is used in combination with other myelosuppressive agents, the doses should be adjusted accordingly. If the disease continues to progress after two courses of MUTAMYCIN, the drug should be stopped since chances of response are minimal.<br/>STABILITY: Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
|
| dailymed-drugs:304 |
For safety reasons, only physicians who enroll in the Prometheus Prescribing Program for LOTRONEX should prescribe LOTRONEX (see PRECAUTIONS: Prescribing Program for LOTRONEX).<br/>Usual Dosage in Adults: To lower the risk of constipation, LOTRONEX should be started at a dosage of 0.5 mg twice a day. Patients well controlled on 0.5 mg twice a day may be maintained on this regimen. If, after 4 weeks, the 0.5-mg twice-daily dosage is well tolerated but does not adequately control IBS symptoms, then the dosage can be increased to up to 1 mg twice a day, the dose used in controlled clinical trials (see CLINICAL TRIALS). LOTRONEX should be discontinued in patients who have not had adequate control of IBS symptoms after 4 weeks of treatment with 1 mg twice a day. LOTRONEX can be taken with or without food (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Food Effects). LOTRONEX should be discontinued immediately in patients who develop constipation or signs of ischemic colitis. LOTRONEX should not be restarted in patients who develop ischemic colitis. Clinical trial and postmarketing experience suggest that debilitated patients or patients taking additional medications that decrease gastrointestinal motility may be at greater risk of serious complications of constipation. Therefore, appropriate caution and follow-up should be exercised if LOTRONEX is prescribed for these patients (see also Geriatric Patients).<br/>Pediatric Patients: Safety and effectiveness have not been established in pediatric patients.<br/>Geriatric Patients: Postmarketing experience suggests that elderly patients may be at greater risk for complications of constipation; therefore, appropriate caution and follow-up should be exercised if LOTRONEX is prescribed for these patients (see WARNINGS).<br/>Patients With Renal Impairment: There is insufficient data available on the biological activity of the metabolites of LOTRONEX. It is unknown if dosage adjustment is needed in patients with renal impairment (see CLINICAL PHARMACOLOGY: Population Subgroups: Reduced Renal Function).<br/>Patients With Hepatic Impairment: LOTRONEX is extensively metabolized by the liver and increased exposure to LOTRONEX is likely to occur in patients with hepatic impairment. Increased drug exposure may increase the risk of serious adverse events. LOTRONEX should be used with caution in patients with mild or moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Population Subgroups: Reduced Hepatic Function, CONTRAINDICATIONS, and PRECAUTIONS: Hepatic Insufficiency).<br/>Information for Pharmacists: LOTRONEX may be dispensed only on presentation of a prescription for LOTRONEX with a sticker for the Prescribing Program for LOTRONEX attached. A Medication Guide for LOTRONEX must be given to the patient each time LOTRONEX is dispensed as required by law. No telephone, facsimile, or computerized prescriptions are permitted with this program. Refills are permitted to be written on prescriptions.
|
| dailymed-drugs:305 |
This solution is for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. Isolyte S pH 7.4 (Multi-Electrolyte Injection) may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of magnesium and phosphate ions in this solution should be considered when phosphate is present in the additive solution, in order to avoid precipitation. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|
| dailymed-drugs:306 |
The oral dose and interval of administration should be adjusted for the individual patient, based on clinical assessment of the degree of underlying myocardial diseased, the patient's age, and renal function. As a general guide, for younger adult patients with normal renal function, an initial total daily oral dose of up to 50 mg/kg of body weight of PRONESTYL Capsules or Tablets may be used, given in divided doses, every three hours, to maintain therapeutic blood levels. For older patients, especially thoseover 50 years of age, or for patients with renal, hepatic, or cardiac insufficiency, lesser amounts or longer intervals may produce adequate blood levels, and decrease the probability of occurrence of dose-related adverse reactions. The total daily dose should be administered in divided doses at three, four, or six hour intervals and adjusted according to the patient's response.
|
| dailymed-drugs:309 |
For most patients with illness of mild to moderate severity, a starting daily dose of 75 mg is recommended. Dosage may subsequently be increased or decreased at appropriate intervals and according to individual response. The usual optimum dose range is 75 mg/day to 150 mg/day. In more severely ill patients higher doses may be required with subsequent gradual increase to 300 mg/day if necessary. Additional therapeutic effect is rarely to be obtained by exceeding a dose of 300 mg/day. In patients with very mild symptomatology or emotional symptoms accompanying organic disease, lower doses may suffice. Some of these patients have been controlled on doses as low as 25 to 50 mg/day. The total daily dosage of doxepin (as the hydrochloride) may be given on a divided or once a day dosage schedule. If the once a day schedule is employed the maximum recommended dose is 150 mg/day. This dose may be given at bedtime. The 150 mg capsule strength is intended for maintenance therapy only and is not recommended for initiation of treatment. Antianxiety effect is apparent before the antidepressant effect. Optimal antidepressant effect may not be evident for two to three weeks.
|
| dailymed-drugs:310 |
: NOTE--For preventive therapy of tuberculous infection and treatment of tuberculosis, it is recommended that physicians be familiar with the following publications: (1) the recommendations of the Advisory Council for the Elimination of Tuberculosis, published in the MMWR: vol 42; RR-4, 1993 and (2)Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, American Journal of Respiratory and Critical Care Medicine: vol 149; 1359-1374, 1994.<br/>For Treatment of Tuberculosis: Isoniazid is used in conjunction with other effective anti-tuberculous agents. Drug susceptibility testing should be performed on the organisms initially isolated from all patients with newly diagnosed tuberculosis. If the bacilli becomes resistant, therapy must be changed to agents to which the bacilli are susceptible. Usual Oral Dosage (depending on the regimen used):<br/>Adults: 5 mg/kg up to 300 mg daily in a single dose; or15 mg/kg up to 900 mg/day, two or three times/week<br/>Children: 10-15 mg/kg up to 300 mg daily in a single dose; or20-40 mg/kg up to 900 mg/day, two or three times/week<br/>Patients with Pulmonary Tuberculosis Without HIV Infection: There are 3 regimen options for the initial treatment of tuberculosis in children and adults: Option 1: Daily isoniazid, rifampin, and pyrazinamide for 8 weeks followed by 16 weeks of isoniazid and rifampin daily or 2-3 times weekly. Ethambutol or streptomycin should be added to the initial regimen until sensitivity to isoniazid and rifampin is demonstrated. The addition of a fourth drug is optional if the relative prevalence of isoniazid-resistant Mycobacterium tuberculosis isolates in the community is less than or equal to four percent. Option 2: Daily isoniazid, rifampin, pyrazinamide, and streptomycin or ethambutol for 2 weeks followed by twice weekly administration of the same drugs for 6 weeks, subsequently twice weekly isoniazid and rifampin for 16 weeks. Option 3: Three times weekly with isoniazid, rifampin, pyrazinamide, and ethambutol or streptomycin for 6 months. *All regimens given twice weekly or 3 times weekly should be administered by directly observed therapy (see alsoDirectly Observed Therapy (DOT)). The above treatment guidelines apply only when the disease is caused by organisms that are susceptible to the standard antituberculous agents. Because of the impact of resistance to isoniazid and rifampin on the response to therapy, it is essential that physicians initiating therapy for tuberculosis be familiar with the prevalence of drug resistance in their communities. It is suggested that ethambutol not be used in children whose visual acuity cannot be monitored.<br/>Patients with Pulmonary Tuberculosis and HIV Infection: The response of the immunologically impaired host to treatment may not be as satisfactory as that of a person with normal host responsiveness. For this reason, therapeutic decisions for the impaired host must be individualized. Since patients co-infected with HIV may have problems with malabsorption, screening of antimycobacterial drug levels, especially in patients with advanced HIV disease, may be necessary to prevent the emergence of MDRTB.<br/>Patients with Extra pulmonary Tuberculosis: The basic principles that underlie the treatment of pulmonary tuberculosis also apply to Extra pulmonary forms of the disease. Although there have not been the same kinds of carefully conducted controlled trials of treatment of Extra pulmonary tuberculosis as for pulmonary disease, increasing clinical experience indicates that a 6 to 9 month short-course regimen is effective. Because of the insufficient data, miliary tuberculosis, bone/joint tuberculosis, and tuberculous meningitis in infants and children should receive 12 month therapy. Bacteriologic evaluation of Extra pulmonary tuberculosis may be limited by the relative inaccessibility of the sites of disease. Thus, response to treatment often must be judged on the basis of clinical and radiographic findings. The use of adjunctive therapies such as surgery and corticosteroids is more commonly required in Extra pulmonary tuberculosis than in pulmonary disease. Surgery may be necessary to obtain specimens for diagnosis and to treat such processes as constrictive pericarditis and spinal cord compression from Pott's Disease. Corticosteriods have been shown to be of benefit in preventing cardiac constriction from tuberculous pericarditis and in decreasing the neurologic sequelae of all stages of tuberculosis meningitis, especially when administered early in the course of the disease.<br/>Pregnant Women with Tuberculosis: The options listed above must be adjusted for the pregnant patient. Streptomycin interferes with in utero development of the ear and may cause congenital deafness. Routine use of pyrazinamide is also not recommended in pregnancy because of inadequate teratogenicity data. The initial treatment regimen should consist of isoniazid and rifampin. Ethambutol should be included unless primary isoniazid resistance is unlikely (isoniazid resistance rate documented to be less than 4%).<br/>Treatment of Patients with Multi-Drug Resistant Tuberculosis (MDRTB): Multiple-drug resistant tuberculosis (i.e., resistance to at least isoniazid and rifampin) presents difficult treatment problems. Treatment must be individualized and based on susceptibility studies. In such cases, consultation with an expert in tuberculosis is recommended.<br/>Directly Observed Therapy (DOT): A major cause of drug-resistant tuberculosis is patient noncompliance with treatment. The use of DOT can help assure patient compliance with drug therapy. DOT is the observation of the patient by a health care provider or other responsible person as the patient ingests anti-tuberculosis medications. DOT can be achieved with daily, twice weekly or thrice weekly regimens, and is recommended for all patients.<br/>For Preventative Therapy of Tuberculosis: Before isoniazid preventive therapy is initiated, bacteriologically positive or radiographically progressive tuberculosis must be excluded. Appropriate evaluations should be performed if Extra pulmonary tuberculosis is suspected.<br/>Adults over 30 Kg: 300 mg per day in a single dose.<br/>Infants and Children: 10 mg/kg (up to 300 mg daily) in a single dose. In situations where adherence with daily preventative therapy cannot be assured, 20-30 mg/kg (not to exceed 900 mg) twice weekly under the direct observation of a health care worker at the time of administration. Continuous administration of isoniazid for a sufficient period is an essential part of the regimen because relapse rates are higher if chemotherapy is stopped prematurely. In the treatment of tuberculosis, resistant organisms may multiply and the emergence of resistant organisms during the treatment may necessitate a change in the regimen. For following patient compliance: the Potts-Cozart test, a simple colorimetricmethod of checking for isoniazid in the urine, is a useful tool for assuring patient compliance, which is essential for effective tuberculosis control. Additionally, isoniazid test strips are also available to check patient compliance. Concomitant administration of pyridoxine (B) is recommended in the malnourished and in those predisposed to neuropathy (e.g., alcoholics and diabetics).
|
| dailymed-drugs:311 |
UNASYN may be administered by either the IV or the IM routes. For IV administration, the dose can be given by slow intravenous injection over at least 10���15 minutes or can also be delivered, in greater dilutions with 50���100 mL of a compatible diluent as an intravenous infusion over 15���30 minutes. UNASYN may be administered by deep intramuscular injection. (See Preparation for Intramuscular Injection.) The recommended adult dosage of UNASYN is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of UNASYN, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.<br/>Pediatric Patients 1 Year of Age or Older: The recommended daily dose of UNASYN in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of UNASYN, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of UNASYN administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according toadult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous UNASYN.<br/>Impaired Renal Function: In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of UNASYN in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations: When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function. Males weight (kg)��(140���age)72��serum creatinine Females 0.85��above value
|
| dailymed-drugs:312 |
Concentrated Dextrose in Water is administered by
slow intravenous infusion (a) After admixture with amino acid solutions
or (b) After dilution with other compatible I.V. fluids. Dosage should
be adjusted to meet the requirements of each individual patient. The maximum rate at which dextrose can be infused
without producing glycosuria is 0.5 g/kg of body weight /hr. About
95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr. As reported in the literature, the dosage and constant
infusion rate of intravenous dextrose must be selected with caution
in pediatric patients, particularly neonates and low birth weight
infants, because of the increased risk of hyperglycemia/hypoglycemia. Clinical evaluation and periodic laboratory determinations
are necessary to monitor changes in fluid balance, electrolyte concentrations,
and acid-base balance during prolonged parenteral therapy or whenever
the condition of the patient warrants such evaluation. A list of nutritional admixture values is appended. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration,
whenever solution and container permit. See PRECAUTIONS. Drug Interaction Additives may be incompatible. Consult with pharmacist,
if available. When introducing additives, use aseptic technique, mix
thoroughly and do not store. Some opacity
of the plastic due to moisture absorption during sterilization process
may be observed. This is normal and does not affect the solution quality
or safety. The opacity will diminish gradually. WARNING: Do not use flexible container
in series connections.
|
| dailymed-drugs:313 |
Carefully consider the potential benefits and risks of Cataflam (diclofenac potassium immediate-release tablets) and other treatment options before deciding to use Cataflam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with Cataflam, the dose and frequency should be adjusted to suit an individual patient's needs. For treatment of pain or primary dysmenorrhea the recommended dosage is 50 mg t.i.d. With experience, physicians may find that in some patients an initial dose of 100 mg of Cataflam, followed by 50-mg doses, will provide better relief. For the relief of osteoarthritis the recommended dosage is 100-150 mg/day in divided doses, 50 mg b.i.d. or t.i.d. For the relief of rheumatoid arthritis the recommended dosage is 150-200 mg/day in divided doses, 50 mg t.i.d. or q.i.d. Different formulations of diclofenac [Voltaren (diclofenac sodium enteric-coated tablets); Voltaren-XR (diclofenac sodium extended-release tablets); Cataflam (diclofenac potassium immediate-release tablets)] are not necessarily bioequivalent even if the milligram strength is the same.
|
| dailymed-drugs:315 |
Maintenance Therapy: Once a complete hematologic remission is obtained, maintenance therapy is considered essential. Maintenance doses will vary from patient to patient. The usual daily maintenance dose of mercaptopurine tablets is 1.5 to 2.5 mg/kg/day as a single dose. It is to be emphasized that in pediatric patients with acute lymphatic leukemia in remission, superior results have been obtained when mercaptopurine tablets have been combined with other agents (most frequently with methotrexate) for remission maintenance. Mercaptopurine tablets should rarely be relied upon as a single agent for the maintenance of remissions induced in acute leukemia. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.<br/>Dosage with Concomitant Allopurinol: When allopurinol and mercaptopurine are administered concomitantly, the dose of mercaptopurine must be reduced to one third to one quarter of the usual dose to avoid severe toxicity.<br/>Dosage in TPMT-deficient Patients: Patients with inherited little or no thiopurine S-methyltransferase (TPMT) activity are at increased risk for severe mercaptopurine toxicity from conventional doses of mercaptopurine and generally require substantial dose reduction. The optimal starting dose for homozygous deficient patients has not been established. Most patients with heterozygous TPMT deficiency tolerated recommended mercaptopurine doses, but some require dose reduction. Genotypic and phenotypic testing of TPMT status are available.<br/>Dosage in Renal and Hepatic Impairment: It is probably advisable to start with lower dosages in patients with impaired renal function, due to slower elimination of the drug and metabolites and a greater cumulative effect. Consideration should be given to reducing the dosage in patients with impaired hepatic function.
|
| dailymed-drugs:316 |
Duodenal Ulcer: ACUTE THERAPYThe recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective. MAINTENANCE THERAPY The recommended adult oral dose is 20 mg once a day at bedtime.<br/>Benign Gastric Ulcer: ACUTE THERAPY The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.<br/>Gastroesophageal Reflux Disease (GERD): The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). DOSAGE FOR PEDIATRIC PATIENTS<1 YEAR OF AGE GASTROESOPHAGEAL REFLUX DISEASE(GERD) See PRECAUTIONS, Pediatric Patients<1 year of age. The studies described in PRECAUTIONS, Pediatric Patients<1 year of age suggest that the following starting doses in pediatric patients<1 year of age: GASTROESOPHAGEAL REFLUX DISEASE (GERD) 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients<3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to<1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients<1 year of age with GERD has not been adequately studied. DOSAGE FOR PEDIATRIC PATIENTS 1 TO 16 YEARS OF AGE See PRECAUTIONS, Pediatric Patients 1 to 16 years of age. The studies described in PRECAUTIONS, Pediatric Patients 1 to 16 Years of Age suggest the following starting doses in pediatric patients 1 to 16 years of age. PEPTIC ULCER 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day. GASTROESOPHAGEAL REFLUX DISEASE WITH OR WITHOUT ESOPHAGITIS INCLUDING EROSIONS AND ULCERATIONS 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d. While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1 to 16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.<br/>Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine: The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.<br/>Concomitant Use of Antacids: Antacids may be given concomitantly if needed.<br/>Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency: In adult patients with moderate (creatinine clearance<50 mL/min) or severe (creatinine clearance<10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response. Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
|
| dailymed-drugs:319 |
ZANOSAR sterile powder should be administered intravenously by rapid injection or short/prolonged infusion. It is not active orally. Although it has been administered intraarterially, this is not recommended pending further evaluation of the possibility that adverse renal effects may be evoked more rapidly by this route of administration. Two different dosage schedules have been employed successfully with ZANOSAR. Daily Schedule���The recommended dose for daily intravenous administration is 500 mg/mof body surface area for five consecutive days every six weeks until maximum benefit or until treatment-limiting toxicity is observed. Dose escalation on this schedule is not recommended. Weekly Schedule���The recommended initial dose for weekly intravenous administration is 1000 mg/mof body surface area at weekly intervals for the first two courses (weeks). In subsequent courses, drug doses may be escalated in patients who have not achieved a therapeutic response and who have not experienced significant toxicity with the previous course of treatment. However, A SINGLE DOSE OF 1500 mg/mBODY SURFACE AREA SHOULD NOT BE EXCEEDED as a greater dose may cause azotemia. When administered on this schedule, the median time to onset of response is about 17 days and the median time to maximum response is about 35 days. The median total dose to onset of response is about 2000 mg/mbody surface area and the median total dose to maximum response is about 4000 mg/mbody surface area. The ideal duration of maintenance therapy with ZANOSAR has not yet been clearly established for either of the above schedules. For patients with functional tumors, serial monitoring of fasting insulin levels allows a determination of biochemical response to therapy. For patients with either functional or nonfunctional tumors, response to therapy can be determined by measurable reductions of tumor size (reduction of organomegaly, masses, or lymph nodes). Reconstitute ZANOSAR with 9.5 mL of dextrose injection USP, or 0.9% sodium chloride injection USP. The resulting pale-gold solution will contain 100 mg of streptozocin and 22 mg of citric acid per mL. Where more dilute infusion solutions are desirable, further dilution in the above vehicles is recommended. The total storage time for streptozocin after it has been placed in solution should not exceed 12 hours. This product contains no preservatives and is not intended as a multiple-dose vial. Caution in the handling and preparation of the powder and solution should be exercised, and the use of gloves is recommended. If the sterile powder of ZANOSAR or a solution prepared from ZANOSAR contacts the skin or mucosae, immediately wash the affected area with soap and water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
|
| dailymed-drugs:320 |
Note: Rapid administration is to be avoided. Parenteral therapy is indicated only when oral therapy is not indicated. Oral therapy should be instituted as soon as possible. If intravenous therapy is given over prolonged periods of time, thrombophlebitis may result. THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF INTRAVENOUS DOXYCYCLINE (100 TO 200 MG/DAY) DIFFERS FROM THAT OF THE OTHER TETRACYCLINES (1 TO 2 G/DAY). EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Studies to date have indicated that doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment.<br/>Adults: The usual dosage of intravenous doxycycline is 200 mg on the first day of treatment administered in one or two infusions. Subsequent daily dosage is 100 to 200 mg depending upon the severity of infection, with 200 mg administered in one or two infusions. In the treatment of primary and secondary syphilis, the recommended dosage is 300 mg daily for at least 10 days. In the treatment of inhalational anthrax (post-exposure) the recommended dose is 100 mg of doxycycline, twice a day. Parenteral therapy is only indicated when oral therapy is not indicated and should not be continued over a prolonged period of time. Oral therapy should be instituted as soon as possible. Therapy must continue for a total of 60 days.<br/>For Children Above Eight Years of Age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight on the first day of treatment, administered in one or two infusions. Subsequent daily dosage is 1 to 2 mg/lb of body weight given as one or two infusions, depending on the severity of the infection. For children over 100 pounds the usual adult dose should be used. . In the treatment of inhalational anthrax (post-exposure) the recommended dose is 1 mg/lb (2.2 mg/kg) of body weight, twice a day in the children weighing less than 100 lb (45 kg). Parenteral therapy is only indicated when oral therapy is not indicated and should not be continued over a prolonged period of time. Oral therapy should be instituted as soon as possible. Therapy must continue for a total of 60 days.<br/>General: The duration of infusion may vary with the dose (100 to 200 mg per day), but is usually one to four hours. A recommended minimum infusion time for 100 mg of a 0.5 mg/mL solution is one hour. Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided. The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. Intravenous solutions should not be injected intramuscularly or subcutaneously. Caution should be taken to avoid the inadvertent introduction of the intravenous solution into the adjacent soft tissue.<br/>Preparation of Solution: To prepare a solution containing 10 mg/mL, the contents of the vial should be reconstituted with 10 mL of Sterile Water for Injection, or any of the ten intravenous infusion solutions listed below. Each 100 mg of doxycycline (i.e., withdraw entire solution from the 100 mg vial) is further diluted with 100 to 1000 mL of the intravenous solutions listed below: This will result in desired concentrations of 0.1 to 1 mg/mL. Concentrations lower than 0.1 mg/mL or higher than 1 mg/mL are not recommended.<br/>Stability: Doxycycline is stable for 48 hours in solution when diluted with Sodium Chloride Injection, or 5% Dextrose Injection, to concentrations between 1 mg/mL and 0.1 mg/mL and stored at 25��C. Doxycycline in these solutions is stable under fluorescent light for 48 hours, but must be protected from direct sunlight during storage and infusion. Reconstituted solutions (1 to 0.1 mg/mL) may be stored up to 72 hours prior to start of infusion if refrigerated and protected from sunlight and artificial light. Infusion must then be completed within 12 hours. Solutions must be used within these time periods or discarded. Doxycycline, when diluted with Ringer's Injection, or Invert Sugar, 10% in Water, or Normosol-M' in D5-W (Abbott), or Normosol-R' in D5-W (Abbott), or Plasma-Lyte' 56 in 5% Dextrose (Travenol), or Plasma-Lyte' 148 in 5% Dextrose (Travenol) to a concentration between 1 mg/mL and 0.1 mg/mL, must be completely infused within 12 hours after reconstitution to ensure adequate stability. During infusion, the solution must be protected from direct sunlight. Reconstituted solutions (1 to 0.1 mg/mL) may be stored up to 72 hours prior to start of infusion, if refrigerated and protected from sunlight and artificial light. Infusion must then be completed within 12 hours. Solutions must be used within these time periods or discarded. When diluted with Lactated Ringer's Injection, or Dextrose 5% in Lactated Ringer's, infusion of the solution (ca. 1 mg/mL) or lower concentrations (not less than 0.1 mg/mL) must be completed within six hours after reconstitution to ensure adequate stability. During infusion, the solution must be protected from direct sunlight. Solutions must be used within this time period or discarded. Solutions of doxycycline hyclate at a concentration of 10 mg/mL in Sterile Water for Injection, when frozen immediately after reconstitution are stable for 8 weeks when stored at���20��C. If the product is warmed, care should be taken to avoid heating it after the thawing is complete. Once thawed the solution should not be refrozen. Parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.
|
| dailymed-drugs:321 |
The suggested dose range employed in the average adult patient (70kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70��Ci/kg) to 5.2 MBq/kg (140��Ci/kg) with a minimum dose of 37 MBq (1 mCi). The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.
|
| dailymed-drugs:322 |
Therapy should be initiated with the lowest possible dose. This dose should be titrated according to individual patient response to gain maximal therapeutic benefit while maintaining lowest dosage possible. A single dose given in the morning with food is recommended; divided daily doses are unnecessary.<br/>Hypertension: Initiation: Therapy, in most patients, should be initiated with a single daily dose of 25 mg. If the response is insufficient after a suitable trial, the dosage may be increased to a single daily dose of 50 mg. If additional control is required, the dosage of chlorthalidone may be increased to 100 mg once daily or a second antihypertensive drug (step 2 therapy) may be added. Dosage above 100 mg daily usually does not increase effectiveness. Increases in serum uric acid and decreases in serum potassium are dose-related over the 25���100 mg/day range. Maintenance: Maintenance doses may be lower than initial doses and should be adjusted according to individual patient response. Effectiveness is well sustained during continued use.<br/>Edema: Initiation: Adults, initially 50 to 100 mg daily, or 100 mg on alternate days. Some patients may require 150 to 200 mg at these intervals or up to 200 mg daily. Dosages above this level, however, do not usually produce a greater response. Maintenance: Maintenance doses may often be lower than initial doses and should be adjusted according to individual patient response. Effectiveness is well sustained during continued use.
|
| dailymed-drugs:323 |
Essential Hypertension: Verapamil capsules (PM) should be administered once daily at bedtime. Clinical trials studied doses of 100 mg, 200 mg, 300 mg and 400 mg. The usual daily dose of verapamil capsules (PM) in clinical trials has been 200 mg given by mouth once daily at bedtime. In rare instances, initial doses of 100 mg a day may be warranted in patients who have an increased response to verapamil [e.g. patients with impaired renal function , impaired hepatic function, elderly, small people, etc.]. Upward titration should be based on therapeutic efficacy and safety evaluated approximately 24 hours after dosing. The antihypertensive effects of verapamil capsules (PM) are evident within the first week of therapy. If an adequate response is not obtained with 200 mg of verapamil capsules (PM), the dose may be titrated upward in the following manner: When verapamil capsules (PM) are administered at bedtime, office evaluation of blood pressure during morning and early afternoon hours is essentially a measure of peak effect. The usual evaluation of trough effect, which sometimes might be needed to evaluate the appropriateness of any given dose of verapamil capsules (PM) would be just prior to bedtime. As with immediate-release and sustained-release verapamil, dosages of verapamil capsules (PM) should be individualized and titration may be needed in some patients.<br/>Sprinkling the Capsule Contents on Food: Verapamil capsules (PM) may also be administered by carefully opening the capsule and sprinkling the beads onto one tablespoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the beads. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any beads /applesauce mixture should be used immediately and not stored for future use. Absorption of the beads sprinkled onto other foods has not been tested. This method of administration may be beneficial for patients who have difficulty swallowing whole capsules or tablets. Subdividing the contents of a verapamil capsule (PM) is not recommended.
|
| dailymed-drugs:324 |
Effective dosage of ZAROXOLYN should be individualized according to indication and patient response. A single daily dose is recommended. Therapy with ZAROXOLYN should be titrated to gain an initial therapeutic response and to determine the minimal dose possible to maintain the desired therapeutic response.<br/>Usual Single Daily Dosage Schedules: Suitable initial dosages will usually fall in the ranges given. Edema of cardiac failure: ZAROXOLYN 5 to 20 mg once daily. Edema of renal disease: ZAROXOLYN 5 to 20 mg once daily. Mild to moderate essential hypertension: ZAROXOLYN 2��to 5 mg once daily. New patients���MYKROX Tablets (metolazone tablets, USP) (see MYKROX package circular). If considered desirable to switch patients currently on ZAROXOLYN to MYKROX, the dose should be determined by titration starting at one tablet (1/2 mg) once daily and increasing to two tablets (1 mg) once daily if needed.<br/>Treatment Of Edematous States: The time interval required for the initial dosage to produce an effect may vary. Diuresis and saluresis usually begin within one hour and persist for 24 hours or longer. When a desired therapeutic effect has been obtained, it may be advisable to reduce the dose if possible. The daily dose depends on the severity of the patient's condition, sodium intake, and responsiveness. A decision to change the daily dose should be based on the results of thorough clinical and laboratory evaluations. If antihypertensive drugs or diuretics are given concurrently with ZAROXOLYN, more careful dosage adjustment may be necessary. For patients who tend to experience paroxysmal nocturnal dyspnea, it may be advisable to employ a larger dose to ensure prolongation of diuresis and saluresis for a full 24-hour period.<br/>Treatment Of Hypertension: The time interval required for the initial dosage regimen to show effect may vary from three or four days to three to six weeks in the treatment of elevated blood pressure. Doses should be adjusted at appropriate intervals to achieve maximum therapeutic effect.
|
| dailymed-drugs:325 |
Shake well before using. Instill one drop into the conjunctival sac up to every four hours.
|
| dailymed-drugs:326 |
Seizure Disorders:<br/>Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg. The use of multiple anticonvulsants may result in an increase of depressant adverse effects. This should be considered before adding clonazepam to an existing anticonvulsant regimen.<br/>Pediatric Patients: Clonazepam is administered orally. In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses. Dosage should be increased by no more than 0.25 to 0.5 mg every third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase. Whenever possible, the daily dose should be divided into three equal doses. If doses are not equally divided, the largest dose should be given before retiring.<br/>Geriatric Patients: There is no clinical experience with clonazepam in seizure disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS:Geriatric Use).<br/>Panic Disorder:<br/>Adults: The initial dose for adults with panic disorder is 0.25 mg bid. An increase to the target dose for most patients of 1 mg/day may be made after 3 days. The recommended dose of 1 mg/day is based on the results from a fixed dose study in which the optimal effect was seen at 1 mg/day. Higher doses of 2, 3, and 4 mg/day in that study were less effective than the 1 mg/day dose and were associated with more adverse effects. Nevertheless, it is possible that some individual patients may benefit from doses of up to a maximum dose of 4 mg/day, and in those instances, the dose may be increased in increments of 0.125 to 0.25 mg bid every 3 days until panic disorder is controlled or until side effects make further increases undesired. To reduce the inconvenience of somnolence, administration of one dose at bedtime may be desirable. Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every 3 days, until the drug is completely withdrawn. There is no body of evidence available to answer the question of how long the patient treated with clonazepam should remain on it. Therefore, the physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.<br/>Pediatric Patients: There is no clinical trial experience with clonazepam in panic disorder patients under 18 years of age.<br/>Geriatric Patients: There is no clinical experience with clonazepam in panic disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS: Geriatric Use).
|
| dailymed-drugs:327 |
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy: The recommended adult oral dosage of ondansetron hydrochloride tablet is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin���50 mg/m. Multiday, single-dose administration of a 24 mg dosage has not been studied.<br/>Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.<br/>Geriatric Use: The dosage recommendation is the same as for the general population.<br/>Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is one 8 mg ondansetron hydrochloride tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron hydrochloride tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.<br/>Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron hydrochloride tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron hydrochloride tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.<br/>Geriatric Use: The dosage is the same as for the general population.<br/>Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: The recommended oral dosage is one 8 mg ondansetron hydrochloride tablet given 3 times a day. For total body irradiation, one 8 mg ondansetron hydrochloride tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day. For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron hydrochloride tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy. For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron hydrochloride tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.<br/>Pediatric Use: There is no experience with the use of ondansetron hydrochloride tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.<br/>Geriatric Use: The dosage recommendation is the same as for the general population.<br/>Postoperative Nausea and Vomiting: The recommended dosage is 16 mg given as two 8 mg ondansetron hydrochloride tablets 1 hour before induction of anesthesia.<br/>Pediatric Use: There is no experience with the use of ondansetron hydrochloride tablets in the prevention of postoperative nausea and vomiting in pediatric patients.<br/>Geriatric Use: The dosage is the same as for the general population.<br/>Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.<br/>Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pughscore of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
|
| dailymed-drugs:1081 |
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy: The recommended adult oral dosage of ondansetron hydrochloride tablet is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin���50 mg/m. Multiday, single-dose administration of a 24 mg dosage has not been studied.<br/>Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.<br/>Geriatric Use: The dosage recommendation is the same as for the general population.<br/>Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is one 8 mg ondansetron hydrochloride tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron hydrochloride tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.<br/>Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron hydrochloride tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron hydrochloride tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.<br/>Geriatric Use: The dosage is the same as for the general population.<br/>Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: The recommended oral dosage is one 8 mg ondansetron hydrochloride tablet given 3 times a day. For total body irradiation, one 8 mg ondansetron hydrochloride tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day. For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron hydrochloride tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy. For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron hydrochloride tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.<br/>Pediatric Use: There is no experience with the use of ondansetron hydrochloride tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.<br/>Geriatric Use: The dosage recommendation is the same as for the general population.<br/>Postoperative Nausea and Vomiting: The recommended dosage is 16 mg given as two 8 mg ondansetron hydrochloride tablets 1 hour before induction of anesthesia.<br/>Pediatric Use: There is no experience with the use of ondansetron hydrochloride tablets in the prevention of postoperative nausea and vomiting in pediatric patients.<br/>Geriatric Use: The dosage is the same as for the general population.<br/>Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.<br/>Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pughscore of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
|
| dailymed-drugs:328 |
THE COMBINED
DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC
TROMETHAMINE TABLETS IS NOT TO EXCEED FIVE (5) DAYS. THE USE OF
KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY
TO KETOROLAC TROMETHAMINE INJECTION.<br/>Ketorolac
Tromethamine Injection: Ketorolac
Tromethamine Injection may be used as a single or multiple dose
on a regular or���prn���schedule for the management of moderately
severe acute pain that requires analgesia at the opioid level,
usually in a postoperative setting. Hypovolemia should be
corrected prior to the administration of ketorolac tromethamine
. Patients should be switched to
alternative analgesics as soon as possible, but ketorolac
tromethamine therapy is not to exceed five (5) days. When
administering Ketorolac Tromethamine Injection, the IV bolus
must be given over no less than 15 seconds. The IM
administration should be given slowly and deeply into the
muscle. The analgesic effect begins in ~30 minutes with maximum
effect in 1 to 2 hours after dosing IV or IM. Duration of
analgesic effect is usually 4 to 6 hours.<br/>Single-Dose
Treatment: The Following Regimen Should Be Limited to Single
Administration Use Only:<br/>IM Dosing::<br/>IV Dosing::<br/>Multiple-Dose
Treatment (IV or IM):<br/>Patients<65 Years of Age:: The
recommended dose is 30 mg Ketorolac Tromethamine
Injection every 6 hours. The maximum daily dose should
not exceed 120 mg.<br/>For
Patients���65 Years of Age, Renally Impaired Patients (see
WARNINGS) and Patients Less Than 50 Kg (110 lbs):: The
recommended dose is 15 mg Ketorolac Tromethamine
Injection every 6 hours. The maximum daily dose for
these populations should not exceed 60 mg. For
breakthrough pain do not increase the dose or the
frequency of ketorolac tromethamine. Consideration
should be given to supplementing these regimens with low
doses of opioids���prn���unless otherwise
contraindicated.<br/>Pharmaceutical
Information for Ketorolac Tromethamine Injection: Parenteral
drug products should be inspected visually for particulate
matter and discoloration prior to administration, whenever solution and container permit. Ketorolac
Tromethamine Injection should not be mixed in a small volume
(e.g., in a syringe) with morphine sulfate, meperidine
hydrochloride, promethazine hydrochloride or hydroxyzine
hydrochloride; this will result in precipitation of ketorolac
from solution.
|
| dailymed-drugs:330 |
General Dosing Considerations for Parkinson's Disease and RLS: Ropinirole hydrochloride tablets can be taken with or without food. Patients may be advised that taking ropinirole hydrochloride tablets with food may reduce the occurrence of nausea. However, this has not been established in controlled clinical trials. If a significant interruption in therapy with ropinirole hydrochloride has occurred, retitration of therapy may be warranted.<br/>Geriatric Use: Pharmacokinetic studies demonstrated a reduced clearance of ropinirole in the elderly (see CLINICAL PHARMACOLOGY). Dose adjustment is not necessary since the dose is individually titrated to clinical response.<br/>Renal Impairment: The pharmacokinetics of ropinirole were not altered in patients with moderate renal impairment (see CLINICAL PHARMACOLOGY). Therefore, no dosage adjustment is necessary in patients with moderate renal impairment. The use of ropinirole hydrochloride in patients with severe renal impairment has not been studied.<br/>Hepatic Impairment: The pharmacokinetics of ropinirole have not been studied in patients with hepatic impairment. Since patients with hepatic impairment may have higher plasma levels and lower clearance, ropinirole hydrochloride should be titrated with caution in these patients.<br/>Dosing for Parkinson's Disease: In all clinical studies, dosage was initiated at a subtherapeutic level and gradually titrated to therapeutic response. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of nausea, dizziness, somnolence, and dyskinesia. The recommended starting dose for Parkinson's Disease is 0.25 mg 3 times daily. Based on individual patient response, dosage should then be titrated with weekly increments as described in Table 5. After week 4, if necessary, daily dosage may be increased by 1.5 mg/day on a weekly basis up to a dose of 9 mg/day, and then by up to 3 mg/day weekly to a total dose of 24 mg/day. Doses greater than 24 mg/day have not been tested in clinical trials. When ropinirole hydrochloride tablets are administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be decreased gradually as tolerated. L-dopa dosage reduction was allowed during the advanced Parkinson's disease (with L-dopa) study if dyskinesias or other dopaminergic effects occurred. Overall, reduction of L-dopa dose was sustained in 87% of patients treated with ropinirole hydrochloride and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with ropinirole hydrochloride. Ropinirole hydrochloride tablets for Parkinson's disease patients should be discontinued gradually over a 7 day period. The frequency of administration should be reduced from 3 times daily to twice daily for 4 days. For the remaining 3 days, the frequency should be reduced to once daily prior to complete withdrawal of ropinirole hydrochloride tablets.<br/>Dosing for Restless Legs Syndrome: In all clinical trials, the dose for ropinirole was initiated at 0.25 mg once daily, 1 to 3 hours before bedtime. Patients were titrated based on clinical response and tolerability. The recommended adult starting dosage for RLS is 0.25 mg once daily, 1 to 3 hours before bedtime. After 2 days, the dosage can be increased to 0.5 mg once daily and to 1 mg once daily at the end of the first week of dosing, then shown as in Tablet 6 as needed to achieve efficacy. For RLS, the safety and effectiveness of doses greater than 4 mg once daily have not been established In clinical trials of patients being treated for RLS with doses up to 4 mg once daily, ropinirole was discontinued without a taper.
|
| dailymed-drugs:331 |
If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box). Adults: Parenteral (IV Administration) Serious infections: 600 to 1200 mg/day in 2, 3, or 4 equal doses. More severe infections: 1200 to 2700 mg/day in 2, 3, or 4 equal doses. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution and Infusion Rates section below. Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows: Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures. Pediatric patients (1 month of age to 16 years): Parenteral (IV) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m/day for serious infections and 450 mg/m/day for more severe infections. Parenteral therapy may be changed to oral clindamycin palmitate hydrochloride or clindamycin hydrochloride capsules when the condition warrants and at the discretion of the physician. In cases of��-hemolytic streptococcal infections, treatment should be continued for at least 10 days.<br/>Dilution and Infusion Rates: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute. The usual infusion dilutions and rates are as follows: Administration of more than 1200 mg in a single 1-hour infusion is not recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin injection in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin. The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate. The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.<br/>Physico-Chemical Stability of diluted solutions of Clindamycin Injection: Room temperature: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25��C. Also, 18 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, in minibags, demonstrated physical and chemical stability for at least 16 days at 25��C. Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4��C. IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible. Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringers Injection in minibags demonstrated physical and chemical stability for at least eight weeks at���10��C. Frozen solutions should be thawed at room temperature and not refrozen.<br/>DIRECTIONS FOR DISPENSING: Pharmacy Bulk Vial���Not for Direct Infusion The Pharmacy Bulk Vial is for use in a Pharmacy Admixture Service only under a laminar flow hood. Entry into the vial should be made with a small diameter sterile transfer set or other small diameter sterile dispensing device, and contents dispensed in aliquots using aseptic technique. Use of a syringe with needle is not recommended. Multiple entries increase the potential of microbial and particulate contamination. AFTER ENTRY USE ENTIRE CONTENTS OF VIAL PROMPTLY. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS AFTER INITIAL ENTRY. NOTE: Parenteral drug products should be inspected visually for particulates and discoloration whenever solution and container permit.
|
| dailymed-drugs:332 |
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one or two capsules every four to six hours as needed for pain. The total daily dosage should not exceed 8 capsules.
|
| dailymed-drugs:1542 |
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one or two capsules every four to six hours as needed for pain. The total daily dosage should not exceed 8 capsules.
|
| dailymed-drugs:1556 |
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one or two capsules every four to six hours as needed for pain. The total daily dosage should not exceed 8 capsules.
|
| dailymed-drugs:1875 |
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one or two capsules every four to six hours as needed for pain. The total daily dosage should not exceed 8 capsules.
|
| dailymed-drugs:333 |
Patients with tinea (pityriasis) versicolor should apply Mentax Cream, 1%, once daily for two weeks. Sufficient Mentax Cream should be applied to cover affected areas and immediately surrounding skin of patients with tinea versicolor. If a patient shows no clinical improvement after the treatment period, the diagnosis and therapy should be reviewed.
|
| dailymed-drugs:334 |
The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. The average effective dose for adults (6 years of age and over) is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
|
| dailymed-drugs:335 |
Apply a thin film of fluticasone propionate ointment, 0.005% to the affected skin areas twice daily. Rub in gently. Fluticasone propionate ointment, 0.005% should not be used with occlusive dressings.<br/>Geriatric Use: In studies where geriatric patients have been treated with fluticasone propionate ointment, 0.005%, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
|
| dailymed-drugs:336 |
Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the PRECAUTIONS section of this label for definitions of mild, moderate and severe hepatic impairment.<br/>Head&Neck Cancer Patients: The recommended initial dose of pilocarpine hydrochloride tablets is one tablet (5 mg) taken three times a day. Dosage should be adjusted according to therapeutic response and tolerability. The usual dosage range is 15 to 30 mg per day. (Not to exceed 10 mg per dose.) Although early improvement may be realized, at least 12 weeks of uninterrupted therapy with pilocarpine hydrochloride tablets may be necessary to assess whether a beneficial response will be achieved. The incidence of the most common adverse events increases with dose. The lowest dose that is tolerated and effective should be used for maintenance.<br/>Sjogren's Syndrome Patients: The recommended dose of pilocarpine hydrochloride tablets is one tablet (5 mg) taken four times a day. Efficacy was established by 6 weeks of use.
|
| dailymed-drugs:337 |
Hypertension:<br/>Initial Therapy: In patients with uncomplicated essential hypertension not on diuretic therapy, the recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours. If it is not, an increase in dose should be considered. Doses up to 80 mg have been used but do not appear to give greater effect. If blood pressure is not controlled with lisinopril tablets alone, a low dose of a diuretic may be added. Hydrochlorothiazide 12.5 mg has been shown to provide an additive effect. After the addition of a diuretic, it may be possible to reduce the dose of lisinopril tablets.<br/>Diuretic Treated Patients: In hypertensive patients who are currently being treated with a diuretic, symptomatic hypotension may occur occasionally following the initial dose of lisinopril tablets. The diuretic should be discontinued, if possible, for two to three days before beginning therapy with lisinopril tablets to reduce the likelihood of hypotension (see WARNINGS). The dosage of lisinopril tablets should be adjusted according to blood pressure response. If the patient's blood pressure is not controlled with lisinopril tablets alone, diuretic therapy may be resumed as described above. If the diuretic cannot be discontinued, an initial dose of 5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions). Concomitant administration of lisinopril tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see PRECAUTIONS).<br/>Dosage Adjustment in Renal Impairment: The usual dose of lisinopril tablets (10 mg) is recommended for patients with creatinine clearance>30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance���10 mL/min���30 mL/min (serum creatinine���3 mg/dL), the first dose is 5 mg once daily. For patients with creatinine clearance<10 mL/min (usually on hemodialysis) the recommended initial dose is 2.5 mg. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.<br/>Heart Failure: Lisinopril tablets are indicated as adjunctive therapy with diuretics and (usually) digitalis. The recommended starting dose is 5 mg once a day. When initiating treatment with lisinopril in patients with heart failure, the initial dose should be administered under medical observation, especially in those patients with low blood pressure (systolic blood pressure below 100 mmHg). The mean peak blood pressure lowering occurs six to eight hours after dosing. Observation should continue until blood pressure is stable. The concomitant diuretic dose should be reduced, if possible, to help minimize hypovolemia which may contribute to hypotension (see WARNINGS and PRECAUTIONS, Drug Interactions). The appearance of hypotension after the initial dose of lisinopril tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension. The usual effective dosage range is 5 to 40 mg per day administered as a single daily dose. The dose of lisinopril tablets can be increased by increments of no greater than 10 mg, at intervals of no less than 2 weeks to the highest tolerated dose, up to a maximum of 40 mg daily. Dose adjustment should be based on the clinical response of individual patients.<br/>Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia: In patients with heart failure who have hyponatremia (serum sodium<130 mEq/L) or moderate to severe renal impairment (creatinine clearance���30 mL/min or serum creatinine>3 mg/dL), therapy with lisinopril tablets should be initiated at a dose of 2.5 mg once a day under close medical supervision (see WARNINGS and PRECAUTIONS, Drug Interactions).<br/>Acute Myocardial Infarction: In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, the first dose of lisinopril tablets is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg of lisinopril tablets once daily. Dosing should continue for six weeks. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers. Patients with a low systolic blood pressure (���120 mmHg) when treatment is started or during the first 3 days after the infarct should be given a lower 2.5 mg oral dose of lisinopril tablets (see WARNINGS). If hypotension occurs (systolic blood pressure���100 mmHg), a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure<90 mmHg for more than 1 hour) lisinopril tablets should be withdrawn. For patients who develop symptoms of heart failure, see DOSAGE AND ADMINISTRATION, Heart Failure.<br/>Dosage Adjustment in Patients with Myocardial Infarction with Renal Impairment: In acute myocardial infarction, treatment with lisinopril tablets should be initiated with caution in patients with evidence of renal dysfunction, defined as serum creatinine concentration exceeding 2 mg/dL. No evaluation of dosing adjustments in myocardial infarction patients with severe renal impairment has been performed.<br/>Use in Elderly: In general, the clinical response was similar in younger and older patients given similar doses of lisinopril tablets. Pharmacokinetic studies, however, indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients, so that dosage adjustments should be made with particular caution.<br/>Pediatric Hypertensive Patients���6 years of age: The usual recommended starting dose is 0.07 mg/kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism and Pharmacodynamics and Clinical Effects). Lisinopril tablets are not recommended in pediatric patients<6 years or in pediatric patients with glomerular filtration rate<30 mL/min/1.73 min(see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism, and Pharmacodynamics and Clinical Effects and PRECAUTIONS).<br/>Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension): Add 10 mL of Purified Water USP to a polyethylene terephthalate (PET) bottle containing ten 20 mg tablets of lisinopril and shake for at least one minute. Add 30 mL of Bicitra* diluent and 160 mL of Ora-Sweet SF���** to the concentrate in the PET bottle and gently shake for several seconds to disperse the ingredients. The suspension should be stored at or below 25��C (77��F) and can be stored for up to four weeks. Shake the suspension before each use. *Bicitra is a registered trademark of Alza Corporation ** Ora-Sweet SF is a trademark of Paddock Laboratories, Inc.
|
| dailymed-drugs:338 |
Usual Adult Dosage:<br/>Perioperative Prophylactic Use: To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.<br/>Dosage Adjustment for Patients with Reduced Renal Function: Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3.0 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.<br/>DUPLEX' Drug Delivery System Directions for Use: Patient Labeling and Drug Powder/Diluent Inspection Reconstitution (Activation) Administration Precautions
|
| dailymed-drugs:339 |
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
|
| dailymed-drugs:2553 |
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
|
| dailymed-drugs:2827 |
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
|
| dailymed-drugs:3900 |
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
|
| dailymed-drugs:4019 |
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
|
| dailymed-drugs:4080 |
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
|
| dailymed-drugs:340 |
Patients should be instructed on the proper use of their inhaler (see Patient's Instructions for Use). Patients should be advised that although Atrovent' HFA (ipratropium bromide HFA) Inhalation Aerosol may have a slightly different taste and inhalation sensation than that of an inhaler containing Atrovent' (ipratropium bromide) Inhalation Aerosol CFC, they are comparable in terms of the safety and efficacy. ATROVENT HFA Inhalation Aerosol is a solution aerosol that does not require shaking. However, as with any other metered dose inhaler, some coordination is required between actuating the canister and inhaling the medication. Patients should "prime" or actuate ATROVENT HFA Inhalation Aerosol before using for the first time by releasing 2 test sprays into the air away from the face. In cases where the inhaler has not been used for more than 3 days, prime the inhaler again by releasing 2 test sprays into the air away from the face. Patients should avoid spraying ATROVENT HFA Inhalation Aerosol into their eyes. The usual starting dose of ATROVENT HFA Inhalation Aerosol is two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours. Each actuation of ATROVENT HFA Inhalation Aerosol delivers 17 mcg of ipratropium bromide from the mouthpiece.
|
| dailymed-drugs:342 |
Dosage must be regulated carefully
to prevent a more rapid or substantial loss of fluid or electrolyte than is
indicated or necessary. The magnitude of diuresis and natriuresis
is largely dependent on the degree of fluid accumulation present in the patient.
Similarly, the extent of potassium excretion is determined in large measure
by the presence and magnitude of aldosteronism.<br/>Oral Use: EDECRIN is available for oral use as 25 mg tablets.<br/>Dosage: To Initiate Diuresis: In Adults: The smallest
dose required to produce gradual weight loss (about 1 to 2 pounds per day)
is recommended. Onset of diuresis usually occurs at 50 to 100 mg for adults.After diuresis has been achieved, the minimally effective dose (usually from
50 to 200 mg daily) may be given on a continuous or intermittent dosage schedule.
Dosage adjustments are usually in 25 to 50 mg increments to avoid derangement
of water and electrolyte excretion. The patient should
be weighed under standard conditions before and during the institution of
diuretic therapy with this compound. Small alterations in dose should effectively
prevent a massive diuretic response. The following schedule may be helpful
in determining the smallest effective dose. Day 1���50 mg once daily after a meal Day 2���50 mg twice
daily after meals, if necessary Day 3���100 mg
in the morning and 50 to 100 mg following the afternoon or evening meal, depending
upon response to the morning dose. A few patients may
require initial and maintenance doses as high as 200 mg twice daily. These
higher doses, which should be achieved gradually, are most often required
in patients with severe, refractory edema. In Pediatric Patients : The initial dose
should be 25 mg. Careful stepwise increments in dosage of 25 mg should be
made to achieve effective maintenance.<br/>Maintenance Therapy: It is usually possible to reduce the dosage and frequency
of administration once dry weight has been achieved. EDECRIN (Ethacrynic Acid) may be given intermittently
after an effective diuresis is obtained with the regimen outlined above. Dosage may be on an alternate daily schedule or more prolongedperiods of diuretic therapy may be interspersed with rest periods. Such an
intermittent dosage schedule allows time for correction of any electrolyte
imbalance and may provide a more efficient diuretic response. The
chloruretic effect of this agent may give rise to retention of bicarbonate
and a metabolic alkalosis. This may be corrected by giving chloride (ammonium
chloride or arginine chloride). Ammonium chloride should not be given to cirrhotic
patients. EDECRIN has additive effects when used with
other diuretics. For example, a patient who is on maintenance dosage of an
oral diuretic may require additional intermittent diuretic therapy, such as
an organomercurial, for the maintenance of basal weight. The intermittent
use of EDECRIN orally may eliminate the need for injections of organomercurials.
Small doses of EDECRIN may be added to existing diuretic regimens to maintain
basal weight. This drug may potentiate the action of carbonic anhydrase inhibitors,
with augmentation of natriuresis and kaliuresis. Therefore, when adding EDECRIN
the initial dose and changes of dose should be in 25 mg increments, to avoid
electrolyte depletion. Rarely, patients who failed to respond to ethacrynic
acid have responded to older established agents. While
many patients do not require supplemental potassium, the use of potassium
chloride or potassium-sparing agents, or both, during treatment with EDECRIN
is advisable, especially in cirrhotic or nephrotic patients and in patients
receiving digitalis. Salt liberalization usually prevents
the development of hyponatremia and hypochloremia. During treatment with EDECRIN,
salt may be liberalized to a greater extent than with other diuretics. Cirrhotic
patients, however, usually require at least moderate salt restriction concomitant
with diuretic therapy.<br/>Intravenous Use: Intravenous SODIUM EDECRIN is for intravenous use when oral
intake is impractical or in urgent conditions, such as acute pulmonary edema. The
usual intravenous dose for the average sized adult is 50 mg, or 0.5 to 1.0mg per kg of body weight. Usually only one dose has been necessary; occasionally
a second dose at a new injection site, to avoid possible thrombophlebitis,
may be required. A single intravenous dose not exceeding 100 mg has been used
in critical situations. Insufficient
pediatric experience precludes recommendation for this age group. To
reconstitute the dry material, add 50 mL of 5 percent Dextrose Injection,
or Sodium Chloride Injection to the vial. Occasionally, some 5 percent Dextrose
Injection solutions may have a low pH (below 5). The resulting solution with
such a diluent may be hazy or opalescent. Intravenous use of such a solution
is not recommended. Inspect the vial containing Intravenous SODIUM EDECRIN
for particulate matter and discoloration before use. The
solution may be given slowly through the tubing of a running infusion or by
direct intravenous injection over a period of several minutes. Do not mix
this solution with whole blood or its derivatives. Discard unused reconstituted
solution after 24 hours. SODIUM EDECRIN should not be
given subcutaneously or intramuscularly because of local pain and irritation.
|
| dailymed-drugs:343 |
When there is urgent need, therapy in the hospitalized patient may be initiated intramuscularly or as a rapid intravenous bolus injection directly into the vein. Hydralazine hydrochloride injection should be used only when the drug cannot be given orally. The usual dose is 20-40 mg, repeated as necessary. Certain patients (especially those with marked renal damage) may require a lower dose. Blood pressure should be checked frequently. It may begin to fall within a few minutes after injection, with the average maximal decrease occurring in 10-80 minutes. In cases where there has been increased intracranial pressure, lowering the blood pressure may increase cerebral ischemia. Most patients can be transferred to oral hydralazine hydrochloride within 24-48 hours. The product should be used immediately after the vial is opened. It should not be added to infusion solutions. Hydralazine hydrochloride injection may discolor upon contact with metal; discolored solutions should be discarded. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|
| dailymed-drugs:344 |
Recommended Doses:<br/>Adults and Adolescents 12 years of age and older: The recommended starting dose of Nasacort HFA Nasal Aerosol is 220 mcg per day given as 2 sprays (55 mcg/spray) in each nostril once daily. If needed, the dose may be increased to 440 mcg per day given as 4 sprays (55 mcg/spray) in each nostril once daily. Once the maximal effect has been achieved, it is always desirable to titrate the patient to the minimum effective dose.<br/>Children 6 through 11 years of age: The recommended dose of Nasacort HFA Nasal Aerosol is 220 mcg per day given as 2 sprays (55 mcg/spray) in each nostril once daily. Once the maximal effect has been achieved, it is always desirable to titrate the patient to the minimum effective dose. Safety and effectiveness have not been established in pediatric patients below the age of 6 years .<br/>Directions for Use: Illustrated PATIENT'S INSTRUCTIONS FOR USE accompanies each package.
|
| dailymed-drugs:345 |
For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS section. Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery from any toxicity.<br/>VePesid Capsules: In small cell lung cancer, the recommended dose of VePesid Capsules is two times the IV dose rounded to the nearest 50 mg (i.e., two times 35 mg/m/day for 4 days to 50 mg/m/day for 5 days). The dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior x-ray therapy or chemotherapy which may have compromised bone marrow reserve.<br/>Administration Precautions: To minimize the risk of dermal exposure, always wear impervious gloves when handling blisterpacks of individually labeled blisters containing VePesid capsules. This includes all handling activities in clinical settings, pharmacies, storerooms, and home healthcare settings, including during unpacking and inspection, transport within a facility, and dose preparation and administration.<br/>Stability: VePesid Capsules must be stored under refrigeration 2�����8��C (36�����46��F). The capsules are stable for 24 months under such refrigeration conditions. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
|
| dailymed-drugs:346 |
There is no fixed dosage regimen for the management of diabetes mellitus with Dia��eta or any other hypoglycemic agent. The patient's fasting blood glucose must be measured periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Periodic glycosylated hemoglobin determinations should be performed. Short-term administration of Dia��eta may be sufficient during periods of transient loss of control in patients usually controlled well on diet. In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions.
|
| dailymed-drugs:347 |
Maxaquin (lomefloxacin HCl) may be taken without regard to meals. Sucralfate and antacids containing magnesium or aluminum, or Videx (didanosine), chewable/buffered tablets or the pediatric powder for oral solution should not be taken within 4 hours before or 2 hours after taking lomefloxacin. Risk of reaction to solar UVA light may be reduced by taking Maxaquin at least 12 hours before exposure to the sun (eg, in the evening). (See Clinical Pharmacology.) See Indications and Usage for information on appropriate pathogens and patient populations.<br/>Treatment:<br/>Patients with normal renal function: The recommended daily dose of Maxaquin is described in the following chart:<br/>Elderly patients: No dosage adjustment is needed for elderly patients with normal renal function (Cl���40 mL/min/1.73 m).<br/>Patients with impaired renal function: Lomefloxacin is primarily eliminated by renal excretion. (See Clinical Pharmacology.) Modification of dosage is recommended in patients with renal dysfunction. In patients with a creatinine clearance>10 mL/min/1.73 mbut<40 mL/min/1.73 m, the recommended dosage is an initial loading dose of 400 mg followed by daily maintenance doses of 200 mg (1/2 tablet) once daily for the duration of treatment. It is suggested that serial determinations of lomefloxacin levels be performed to determine any necessary alteration in the appropriate next dosing interval. If only the serum creatinine is known, the following formula may be used to estimate creatinine clearance. Men: (weight in kg)��(140���age)(72)��serum creatinine (mg/dL) Women: (0.85)��(calculated value for men)<br/>Dialysis patients: Hemodialysis removes only a negligible amount of lomefloxacin (3% in 4 hours). Hemodialysis patients should receive an initial loading dose of 400 mg followed by daily maintenance doses of 200 mg (1/2 tablet) once daily for the duration of treatment.<br/>Patients with cirrhosis: Cirrhosis does not reduce the nonrenal clearance of lomefloxacin. The need for a dosage reduction in this population should be based on the degree of renal function of the patient and on the plasma concentrations. (See Clinical Pharmacology and Dosage and Administration���Patients with impaired renal function.)<br/>Prevention / prophylaxis: The recommended dose of Maxaquin is described in the following chart:
|
| dailymed-drugs:348 |
MINIZIDE (prazosin hydrochloride/polythiazide): Dosage: as determined by individual titration of MINIPRESS (prazosin hydrochloride) and RENESE (polythiazide). (See box warning.) Usual MINIZIDE dosage is one capsule two or three times daily, the strength depending upon individual requirement following titration. The following is a general guide to the administration of the individual components of MINIZIDE:<br/>MINIPRESS (prazosin hydrochloride):<br/>Initial Dose: 1 mg two or three times a day.<br/>Maintenance Dose: Dosage may be slowly increased to a total daily dose of 20 mg given in divided doses. The therapeutic dosages most commonly employed have ranged from 6 mg to 15 mg daily given in divided doses. Doses higher than 20 mg usually do not increase efficacy, however a few patients may benefit from further increases up to a daily dose of 40 mg given in divided doses. After initial titration some patients can be maintained adequately on a twice daily dosage regimen.<br/>Use With Other Drugs: When adding a diuretic or other antihypertensive agent, the dose of MINIPRESS should be reduced to 1 mg or 2 mg three times a day and retitration then carried out.<br/>RENESE (polythiazide): The usual dose of RENESE for antihypertensive therapy is 2 to 4 mg daily.
|
| dailymed-drugs:350 |
Hypercalcemia of Malignancy: Consideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hemotologic malignancies, the use of glucocorticoid therapy may be helpful.<br/>Moderate Hypercalcemia: The recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e.,>2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency.<br/>Severe Hypercalcemia: The recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium*>13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e.,>2 hours) may reduce the risk of renal toxicity, particularly in patients with preexisting renal insufficiency. *Albumin-corrected serum calcium (CCa, mg/dL) = serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL).<br/>Retreatment: A limited number of patients have received more than one treatment with pamidronate disodium for hypercalcemia. Retreatment with pamidronate disodium, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.<br/>Paget's Disease: The recommended dose of pamidronate disodium in patients with moderate to severe Paget's disease of bone is 30 mg daily, administered as a 4 hour infusion on 3 consecutive days for a total dose of 90 mg.<br/>Retreatment: A limited number of patients with Paget's disease have received more than one treatment of pamidronate disodium in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.<br/>Osteolytic Bone Lesions of Multiple Myeloma: The recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4 hour infusion given on a monthly basis. Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to pamidronate disodium infusion. Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine���3.0 mg/dL. Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows: In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value. The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials section).<br/>Osteolytic Bone Metastases of Breast Cancer: The recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2 hour infusion given every 3 to 4 weeks. Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide. Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows: In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value. The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefit (see Clinical Trials section).<br/>Calcium and Vitamin D Supplementation: In the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget's disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.<br/>Method of Administration: DUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG. There must be strict adherence to the intravenous administration recommendations for pamidronate disodium in order to decrease the risk of deterioration in renal function.<br/>Hypercalcemia of Malignancy: The daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60 mg and 90 mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP. This infusion solution is stable for up to 24 hours at room temperature.<br/>Paget's Disease: The recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period for 3 consecutive days.<br/>Osteolytic Bone Metastases of Breast Cancer: The recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 2 hour period every 3 to 4 weeks.<br/>Osteolytic Bone Lesions of Multiple Myeloma: The recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period on a monthly basis. Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer's solution, and should be given in a single intravenous solution and line separate from all other drugs. Note : Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|
| dailymed-drugs:352 |
Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with naproxen tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Different dose strengths and formulations (i.e., tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation. Although naproxen tablets, naproxen suspension, naproxen delayed-release tablets, and naproxen sodium tablets all circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 30 minutes in patients taking naproxen sodium and within 1 hour in patients taking naproxen. Because naproxen delayed-release tablets dissolve in the small intestine rather than in the stomach, the absorption of the drug is delayed compared to the other naproxen formulations (see CLINICAL PHARMACOLOGY). The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS and PRECAUTIONS).<br/>Geriatric Patients: Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.<br/>Patients with Moderate to Severe Renal Impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance<30 mL/min) (see WARNINGS, Renal Effects).<br/>Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis: During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary. In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see CLINICAL PHARMACOLOGY).<br/>Juvenile Arthritis: The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (i.e., 5 mg/kg given twice a day). Naproxen tablets are not well suited to this dosage so use of naproxen oral suspension is recommended for this indication.<br/>Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis: Because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium is recommended for the management of acute painful conditions when prompt onset of pain relief is desired. Naproxen tablets may also be used. For the relief of mild to moderate pain, primary dysmenorrhea, and acute tendonitis and bursitis, the recommended starting dose of naproxen is 500 mg given orally, followed by 500 mg given orally every 12 hours or 250 mg given orally every 6 to 8 hours as required. The initial total daily dose should not exceed 1250 mg of naproxen. Thereafter, the total daily dose should not exceed 1000 mg of naproxen (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE).<br/>Acute Gout: The recommended starting dose is 750 mg of naproxen followed by 250 mg every 8 hours until the attack has subsided (see CLINICAL PHARMACOLOGY).
|
| dailymed-drugs:353 |
The recommended dose of CeeNU in adult and pediatric patients as a single agent in previously untreated patients is 130 mg/mas a single oral dose every 6 weeks. In individuals with compromised bone marrow function, the dose should be reduced to 100 mg/mevery 6 weeks. When CeeNU is used in combination with other myelosuppressive drugs, the doses should be adjusted accordingly. Doses subsequent to the initial dose should be adjusted according to the hematologic response of the patient to the preceding dose. The following schedule is suggested as a guide to dosage adjustment: A repeat course of CeeNU should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000/mm; leukocytes above 4000/mm), and this is usually in 6 weeks. Adequate number of neutrophils should be present on a peripheral blood smear. Blood counts should be monitored weekly and repeat courses should not be given before 6 weeks because the hematologic toxicity is delayed and cumulative.
|
| dailymed-drugs:354 |
Single-Agent Vinorelbine Injection USP: The usual initial dose of single-agent Vinorelbine Injection USP is 30 mg/madministered weekly. The recommended method of administration is an intravenous injection over 6 to 10 minutes. In controlled trials, single-agent Vinorelbine Injection USP was given weekly until progression or dose-limiting toxicity.<br/>Vinorelbine Injection USP in Combination with Cisplatin: Vinorelbine Injection USP may be administered weekly at a dose of 25 mg/min combination with cisplatin given every 4 weeks at a dose of 100 mg/m. Blood counts should be checked weekly to determine whether dose reductions of Vinorelbine Injection USP and/or cisplatin are necessary. In the SWOG study, most patients required a 50% dose reduction of Vinorelbine Injection USP at day 15 of each cycle and a 50% dose reduction of cisplatin by cycle 3. Vinorelbine Injection USP may also be administered weekly at a dose of 30 mg/min combination with cisplatin, given on days 1 and 29, then every 6 weeks at a dose of 120 mg/m.<br/>Dose Modifications for Vinorelbine Injection USP: The dosage should be adjusted according to hematologic toxicity or hepatic insufficiency, whichever results in the lower dose for the corresponding starting dose of Vinorelbine Injection USP (see Table 5).<br/>Dose Modifications for Hematologic Toxicity: Granulocyte counts should be���1,000 cells/mmprior to the administration of Vinorelbine Injection USP. Adjustments in the dosage of Vinorelbine Injection USP should be based on granulocyte counts obtained on the day of treatment according to Table 5.<br/>Dose Modifications for Hepatic Insufficiency: Vinorelbine Injection USP should be administered with caution to patients with hepatic insufficiency. In patients who develop hyperbilirubinemia during treatment with Vinorelbine Injection USP, the dose should be adjusted for total bilirubin according to Table 6.<br/>Dose Modifications for Concurrent Hematologic Toxicity and Hepatic Insufficiency: In patients with both hematologic toxicity and hepatic insufficiency, the lower of the doses based on the corresponding starting dose of Vinorelbine Injection USP determined from Table 5 and Table 6 should be administered.<br/>Dose Modifications for Renal Insufficiency: No dose adjustments for Vinorelbine Injection USP are required for renal insufficiency. Appropriate dose reductions for cisplatin should be made when Vinorelbine Injection USP is used in combination.<br/>Dose Modifications for Neurotoxicity: If Grade���2 neurotoxicity develops, Vinorelbine Injection USP should be discontinued.<br/>Administration Precautions: Caution - Vinorelbine Injection USP must be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any Vinorelbine Injection USP is injected. Leakage into surrounding tissue during intravenous administration of Vinorelbine Injection USP may cause considerable irritation, local tissue necrosis, and/or thrombophlebitis. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Since there are no established guidelines for the treatment of extravasation injuries with Vinorelbine Injection USP, institutional guidelines may be used. The ONS Chemotherapy Guidelines provide additional recommendations for the prevention of extravasation injuries. As with other toxic compounds, caution should be exercised in handling and preparing the solution of Vinorelbine Injection USP. Skin reactions may occur with accidental exposure. The use of gloves is recommended. If the solution of Vinorelbine Injection USP contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water. Severe irritation of the eye has been reported with accidental contamination of the eye with another vinca alkaloid. If this happens with Vinorelbine Injection USP, the eye should be flushed with water immediately and thoroughly. Procedures for proper handling and disposal of anticancer drugs should be used. Several guidelines on this subject have been published.There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Vinorelbine Injection USP is a clear, colorless to pale yellow solution. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. If particulate matter is seen, Vinorelbine Injection USP should not be administered.<br/>Preparation for Administration: Vinorelbine Injection USP must be diluted in either a syringe or IV bag using one of the recommended solutions. The diluted Vinorelbine Injection USP should be administered over 6 to 10 minutes into the side port of a free-flowing IV closest to the IV bag followed by flushing with at least 75 to 125 mL of one of the solutions. Diluted Vinorelbine Injection USP may be used for up to 24 hours under normal room light when stored in polypropylene syringes or polyvinyl chloride bags at 5��to 30��C (41��to 86��F).<br/>Syringe: The calculated dose of Vinorelbine Injection USP should be diluted to a concentration between 1.5 and 3.0 mg/mL. The following solutions may be used for dilution:5% Dextrose Injection, USP0.9% Sodium Chloride Injection, USP<br/>IV Bag: The calculated dose of Vinorelbine Injection USP should be diluted to a concentration between 0.5 and 2 mg/mL. The following solutions may be used for dilution:5% Dextrose Injection, USP0.9% Sodium Chloride Injection, USP0.45% Sodium Chloride Injection, USP5% Dextrose and 0.45% Sodium Chloride Injection, USPRinger's Injection, USPLactated Ringer's Injection, USP<br/>Stability: Unopened vials of Vinorelbine Injection USP are stable until the date indicated on the package when stored under refrigeration at 2��to 8��C (36��to 46��F) and protected from light in the carton. Unopened vials of Vinorelbine Injection USP are stable at temperatures up to 25��C (77��F) for up to 72 hours. This product should not be frozen.
|
| dailymed-drugs:355 |
Terbinafine hydrochloride tablets, one 250 mg tablet, should be taken once daily for 6 weeks by patients with fingernail onychomycosis. Terbinafine hydrochloride tablets, one 250 mg tablet, should be taken once daily for 12 weeks by patients with toenail onychomycosis. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.
|
| dailymed-drugs:1866 |
Terbinafine hydrochloride tablets, one 250 mg tablet, should be taken once daily for 6 weeks by patients with fingernail onychomycosis. Terbinafine hydrochloride tablets, one 250 mg tablet, should be taken once daily for 12 weeks by patients with toenail onychomycosis. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.
|
| dailymed-drugs:356 |
Methadone differs from many other opioid agonists in several important ways. Methadone's pharmacokinetic properties, coupled with high interpatient variability in its absorption, metabolism, and relative analgesic potency, necessitate a cautious and highly individualized approach to prescribing. Particular vigilance is necessary during treatment initiation, during conversion from one opioid to another, and during dose titration. While methadone's duration of analgesic action (typically 4 to 8 hours) in the setting of single-dose studies approximates that of morphine, methadone's plasma elimination half-life is substantially longer than that of morphine (typically 8 to 59 hours vs. 1 to 5 hours). Methadone's peak respiratory depressant effects typically occur later, and persist longer than its peak analgesic effects. Also, with repeated dosing, methadone may be retained in the liver and then slowly released, prolonging the duration of action despite low plasma concentrations. For these reasons, steady-state plasma concentrations, and full analgesic effects, are usually not attained until 3 to 5 days of dosing. Additionally, incomplete cross-tolerance between mu-opioid agonists makes determination of dosing during opioid conversion complex. The complexities associated with methadone dosing can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration. A high degree of���opioid tolerance���does not eliminate the possibility of methadone overdose, iatrogenic or otherwise. Deaths have been reported during conversion to methadone from chronic, high-dose treatment with other opioid agonists and during initiation of methadone treatment of addiction in subjects previously abusing high doses of other agonists.<br/>Treatment of Pain: Optimal methadone initiation and dose titration strategies for the treatment of pain have not been determined. Published equianalgesic conversion ratios between methadone and other opioids are imprecise, providing at best, only population averages that cannot be applied consistently to all patients. It should be noted that many commonly cited equianalgesia tables only present relative analgesic potencies of single opioid doses in non-tolerant patients, thus greatly underestimating methadone's analgesic potency, and its potential for adverse effects in repeated-dose settings. Regardless of the dose determination strategy employed, methadone is most safely initiated and titrated using small initial doses and gradual dose adjustments. As with all opioid drugs, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. The following dosing recommendations should only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient. Prescribers should always follow appropriate pain management principles of careful assessment and ongoing monitoring. In the selection of an initial dose of Methadone Hydrochloride Oral Solution, attention should be given to the following:<br/>Initiation of Therapy in Opioid Non-Tolerant Patients: When oral methadone is used as the first analgesic in patients who are not already being treated with, and tolerant to, opioids, the usual oral methadone starting dose is 2.5 mg to 10 mg every 8 to 12 hours, slowly titrated to effect. More frequent administration may be required during methadone initiation in order to maintain adequate analgesia, and extreme caution is necessary to avoid overdosage, taking into account methadone's long elimination half-life.<br/>Conversion from Parenteral Methadone to Oral Methadone: Conversion from parenteral methadone to oral methadone should initially use a 1:2 dose ratio (e.g., 5 mg parenteral methadone to 10 mg oral methadone).<br/>Switching Patients to Methadone from other Chronic Opioids: Switching a patient from another chronically administered opioid to methadone requires caution due to the uncertainty of dose conversion ratios and incomplete cross-tolerance. Deaths have occurred in opioid tolerant patients during conversion to methadone. Conversion ratios in many commonly used equianalgesic dosing tables do not apply in the setting of repeated methadone dosing. Although with single-dose administration the onset and duration of analgesic action, as well as the analgesic potency of methadone and morphine, are similar methadone's potency increases over time with repeated dosing. Furthermore, the conversion ratio between methadone and other opiates varies dramatically depending on baseline opiate (morphine equivalent) use as shown in the table below. The dose conversion scheme below is derived from various consensus guidelines for converting chronic pain patients to methadone from morphine. Clinicians should consult published conversion guidelines to determine the equivalent morphine dose for patients converting from other opioids.<br/>Table 1: The total daily methadone dose derived from the table above may then be divided to reflect the intended dosing schedule (i.e., for administration every 8 hours, divide total daily methadone dose by 3). Note: Equianalgesic methadone dosing varies not only between patients, but also within the same patient, depending on baseline morphine (or other opioid) dose. Table 1 has been included in order to illustrate this concept and to provide a safe starting point for opioid conversion. Methadone dosing should not be based solely on these tables. Methadone conversion and dose titration methods should always be individualized to account for the patient's prior opioid exposure, general medical condition, concomitant medication, and anticipated breakthrough medication use. The endpoint of titration is achievement of adequate pain relief, balanced against tolerability of opioid side effects. If a patient develops intolerable opioid related side effects, the methadone dose, or dosing interval, may need to be adjusted.<br/>Dosage Adjustment During Pregnancy: Methadone clearance may be increased during pregnancy. Several small studies have demonstrated significantly lower trough methadone plasma concentrations and shorter methadone half-lives in women during their pregnancy compared to after their delivery. During pregnancy a woman's methadone dose may need to be increased, or their dosing interval decreased. Methadone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. For detoxification and maintenance of opiate dependence methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8.12, including limitations on unsupervised administration.<br/>Induction/Initial Dosing: The initial methadone dose should be administered, under supervision, when there are no signs of sedation or intoxication, and the patient shows symptoms of withdrawal. Initially, a single dose of 20 to 30 mg of methadone will often be sufficient to suppress withdrawal symptoms. The initial dose should not exceed 30 mg. If same-day dosing adjustments are to be made, the patient should be asked to wait 2 to 4 hours for further evaluation, when peak levels have been reached. An additional 5 to 10 mg of methadone may be provided if withdrawal symptoms have not been suppressed or if symptoms reappear. The total daily dose of methadone on the first day of treatment should not ordinarily exceed 40 mg. Dose adjustments should be made over the first week of treatment based on control of withdrawal symptoms at the time of expected peak activity (e.g., 2 to 4 hours after dosing). Dose adjustment should be cautious; deaths have occurred in early treatment due to the cumulative effects of the first several days' dosing. Patients should be reminded that the dose will���hold���for a longer period of time as tissue stores of methadone accumulate. Initial doses should be lower for patients whose tolerance is expected to be low at treatment entry. Loss of tolerance should be considered in any patient who has not taken opioids for more than 5 days. Initial doses should not be determined by previous treatment episodes or dollars spent per day on illicit drug use.<br/>For Short-term Detoxification: For patients preferring a brief course of stabilization followed by a period of medically supervised withdrawal, it is generally recommended that the patient be titrated to a total daily dose of about 40 mg in divided doses to achieve an adequate stabilizing level. Stabilization can be continued for 2 to 3 days, after which the dose of methadone should be gradually decreased. The rate at which methadone is decreased should be determined separately for each patient. The dose of methadone can be decreased on a daily basis or at 2-day intervals, but the amount of intake should remain sufficient to keep withdrawal symptoms at a tolerable level. In hospitalized patients, a daily reduction of 20% of the total daily dose may be tolerated. In ambulatory patients, a somewhat slower schedule may be needed.<br/>For Maintenance Treatment: Patients in maintenance treatment should be titrated to a dose at which opioid symptoms are prevented for 24 hours, drug hunger or craving is reduced, the euphoric effects of self-administered opioids are blocked or attenuated, and the patient is tolerant to the sedative effects of methadone. Most commonly, clinical stability is achieved at doses between 80 to 120 mg/day.<br/>For Medically Supervised Withdrawal After a Period of Maintenance Treatment: There is considerable variability in the appropriate rate of methadone taper in patients choosing medically supervised withdrawal from methadone treatment. It is generally suggested that dose reductions should be less than 10% of the established tolerance or maintenance dose, and that 10 to 14-day intervals should elapse between dose reductions. Patients should be apprised of the high risk of relapse to illicit drug use associated with discontinuation of methadone maintenance treatment.
|
| dailymed-drugs:357 |
DOSAGE MUST BE INDIVIDUALIZED.The initial dosage of doxazosin mesylate tablets in patients with hypertension and/or BPH is 1 mg given once daily in the a.m. or p.m. This starting dose is intended to minimize the frequency of postural hypotension and first dose syncope associated with doxazosin mesylate tablets. Postural effects are most likely to occur between 2 and 6 hours after a dose. Therefore blood pressure measurements should be taken during this time period after the first dose and with each increase in dose. If doxazosin mesylate tablet administration is discontinued for several days, therapy should be restarted using the initial dosing regimen. A. BENIGN PROSTATIC HYPERPLASIA 1-8 mg once daily. The initial dosage of doxazosin mesylate tablets is 1 mg, given once daily in the a.m. or p.m. Depending on the individual patient's urodynamics and BPH symptomatology, dosage may then be increased to 2 mg and thereafter to 4 mg and 8 mg once daily, the maximum recommended dose for BPH. The recommended titration interval is 1-2 weeks. Blood pressure should be evaluated routinely in these patients. B. HYPERTENSION 1-16 mg once daily The initial dosage of doxazosin mesylate tablet is 1 mg given once daily. Depending on the individual patient's standing blood pressure response (based on measurements taken at 2-6 hours post-dose and 24 hours post-dose), dosage may then be increased to 2 mg and thereafter if necessary to 4 mg, 8 mg and 16 mg to achieve the desired reduction in blood pressure. Increases in dose beyond 4 mg increase the likelihood of excessive postural effects including syncope, postural dizziness/vertigo and postural hypotension. At a titrated dose of 16 mg once daily the frequency of postural effects is about 12% compared to 3% for placebo.
|
| dailymed-drugs:358 |
Adults: The usual dose is one teaspoonful (5 mg/5 mL) syrup two to three times a day. The maximum recommended dose is one teaspoonful (5 mg/5 mL) syrup four times a day.<br/>Children over 5 years of age: The usual dose is one teaspoonful (5 mg/5 mL) two times a day. The maximum recommended dose is one teaspoonful (5 mg/5 mL) three times a day.
|
| dailymed-drugs:359 |
Procainamide Hydrochloride Injection is useful for arrhythmias
which require immediate suppression and for maintenance of arrhythmia control.
Intravenous therapy allows most rapid control of serious arrhythmias, including
those following myocardial infarction; it should be carried out in circumstances
where close observation and monitoring of the patient are possible, such as
in hospital or emergency facilities. Intramuscular administration is less
apt to produce temporary high plasma levels buttherapeutic plasma levels
are not obtained as rapidly as with intravenous administration. Oral procainamide
dosage forms are preferable for less urgent arrhythmias as well as for long-term
maintenance after initial parenteral PA therapy. Intramuscular
administration may be used as an alternative to the oral route for patients
with less threatening arrhythmias but who are nauseated or vomiting, who are
ordered to receive nothing by mouth preoperatively, or who may have malabsorptive
problems. An initial daily dose of 50 mg per kg body weight may be estimated.
This amount should be divided into fractional doses of one-eighth to one-quarter
to be injected intramuscularly every three to six hours until oral therapy
is possible. If more than three injections are given, the physician may wish
to assess patient factors such as age and renal function (see below), clinical
response and, if available, blood levels of PA and NAPA in adjusting further
doses for that individual. For treatment of arrhythmias associated with anesthesia
or surgical operation, the suggested dose is 100 to 500 mg by intramuscular
injection. Intravenous administration of Procainamide
Hydrochloride Injection should be done cautiously to avoid a possible hypotensive
response (see PRECAUTIONS and OVERDOSAGE). Initial arrhythmia control, under
ECG monitoring, may usually be accomplished safely within a half-hour by either
of the two methods which follows: a) Direct injection
into a vein or into tubing of an established infusion line should be done
slowly at a rate not to exceed 50 mg per minute. It is advisable to dilute
either the 100 mg/mL or the 500 mg/mL concentrations of procainamide
hydrochloride prior to intravenous injection to facilitate control of dosage
rate. Doses of 100 mg may be administered every 5 minutes at this rate until
the arrhythmia is suppressed or until 500 mg has been administered, after
which it is advisable to wait 10 minutes or longer to allow for more distribution
into tissues before resuming. b) Alternatively, a loading
infusion containing 20 mg of Procainamide Hydrochloride per mL (1 g diluted
to 50 mL with 5% Dextrose Injection, USP) may be administered at a constant
rate of 1 mL per minute for 25 to 30 minutes to deliver 500 to 600 mg of PA.
Some effects may be seen after infusion of the first 100 or
200 mg; it is unusual to require more than 600 mg to achieve satisfactory
antiarrhythmic effects. The maximum advisable dosage
to be given either by repeated bolus injections or such loading infusion is
1 g. To maintain therapeutic levels, a more dilute
intravenous infusion at a concentration of 2 mg/mL is convenient (1000 mg
procainamide HCl in 500 mL of 5% Dextrose Injection, USP), and may be administered
at 1 to 3 mL/minute. If daily total fluid intake must be limited, a 4 mg/mL
concentration (1 g of Procainamide Hydrochloride Injection in 250 mL of 5%
Dextrose Injection, USP) administeredat 0.5 to 1.5 mL/minute will deliver
an equivalent 2 to 6 mg per minute. The amount needed in a given patient to
maintain the therapeutic level should be assessed principally from the clinical
response, and will depend upon the patient's weight and age, renal
elimination, hepatic acetylation rate, and cardiac status, but should be adjusted
for each patient based upon close observation. A maintenance infusion rate
of 50 mcg/min/kg body weight to a person with a normal renal PA elimination
half-time of threehours may be expected to produce a plasma level of approximately
6.5 mcg/mL. Since the principal route for elimination
of PA and NAPA is renal excretion, reduced excretion will prolong the half-life
of elimination and lower the dose rate needed to maintain therapeutic levels.
Advancing age reduces the renal excretion of PA and NAPA independently of
reductions in creatinine clearance; compared to normal young adults, there is approximately
25 percent reduction at age 50 and 50 percentat age 75. Intravenous
therapy should be terminated if persistent conduction disturbances or hypotension
develop. As soon as the patient's basic cardiac rhythm appears to be
stabilized, oral antiarrhythmic maintenance therapy is preferable, if indicated
and possible. A period of about three to four hours (one half-time for renal
elimination, ordinarily) should elapse after the last intravenous dose before
administering the first dose of Procainamide Hydrochloride tablets or capsules. Parenteral drug products should be examined visually for
particulate matter and discoloration (see HOW SUPPLIED) prior to administration.
|
| dailymed-drugs:360 |
Adults: The usual initial antihypertensive oral dose of amlodipine besylate tablets is 5 mg once daily with a maximum dose of 10 mg once daily. Small, fragile, or elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablets to other antihypertensive therapy. Dosage should be adjusted according to each patient's need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient's response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently. The recommended dose for chronic stable or vasospastic angina is 5���10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect. See ADVERSE REACTIONS section for information related to dosage and side effects. The recommended dose range for patients with coronary artery disease is 5���10 mg once daily. In clinical studies the majority of patients required 10 mg .<br/>Children: The effective antihypertensive oral dose in pediatric patients ages 6���17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients. See CLINICAL PHARMACOLOGY.<br/>Co-administration with Other Antihypertensive and/or Antianginal Drugs: Amlodipine besylate tablets have been safely administered with thiazides, ACE inhibitors, beta-blockers, long-acting nitrates, and/or sublingual nitroglycerin.
|
| dailymed-drugs:361 |
As directed by a
physician. Dosage is dependent upon the age, weight, and clinical
condition of the patient as well as laboratory determinations. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. Use of a final filter is recommended during administration of
all parenteral solutions, where possible. All injections in
VIAFLEX plastic containers are intended for intravenous administration
using sterile equipment. Additives may be
incompatible. Complete information is not available. Those additives
known to be incompatible should not be used. Consult with pharmacist, if
available. If, in the informed judgment of the physician, it is deemed
advisable to introduce additives, use aseptic technique. Mix thoroughly
when additives have been introduced. Do not store solutions containing
additives.
|
| dailymed-drugs:362 |
Depression: Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time, at the lowest dose that will maintain remission.<br/>Usual Adult Dose:<br/>Childhood Enuresis: Initially, an oral dose of 25 mg/day should be tried in children aged 6 and older. Medication should be given one hour before bedtime. If a satisfactory response does not occur within one week, increase the dose to 50 mg nightly in children under 12 years; children over 12 may receive up to 75 mg nightly. A daily dose greater than 75 mg does not enhance efficacy and tends to increase side effects. Evidence suggests that in early night bedwetters, the drug is more effective given earlier and in divided amounts, i.e.,25 mg in midafternoon, repeated at bedtime. Consideration should be given to instituting a drug free period following an adequate therapeutic trial with a favorable response. Dosage should be tapered off gradually rather than abruptly discontinued; this may reduce the tendency to relapse. Children who relapse when the drug is discontinued do not always respond to a subsequent course of treatment. A dose of 2.5 mg/kg/day should not be exceeded. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount. The safety and effectiveness of Tofranil as temporary adjunctive therapy for nocturnal enuresis in children less than 6 years of age has not been established.
|
| dailymed-drugs:363 |
The adhesive side of the Vivelle system should be placed on a clean, dry area of the trunk of the body (including the abdomen or buttocks). The Vivelle system should not be applied to the breasts. The Vivelle system should be replaced twice weekly. The sites of application must be rotated, with an interval of at least one week allowed between applications to a particular site. The area selected should not be oily, damaged, or irritated. The waistline should be avoided since tight clothing may rub the system off. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges. In the event that a system should fall off, the same system may be reapplied. If necessary, a new system may be applied. In either case, the original treatment schedule should be continued. If a woman has forgotten to apply a patch, she should apply a new patch as soon as possible. The new patch should be applied on the original treatment schedule. The interruption of treatment in women taking Vivelle might increase the likelihood of breakthrough bleeding, spotting and recurrence of symptoms.<br/>Initiation of Therapy: When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine whether treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Patients should be started at the lowest dose. The lowest effective dose of Vivelle has not been determined for any indication. For treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy associated with the menopause, start therapy with Vivelle estradiol transdermal system 0.0375 mg/day applied to the skin twice weekly. For the prevention of postmenopausal osteoporosis, start therapy with Vivelle 0.025 mg/day applied to the skin twice weekly. The dosage may be adjusted as necessary. Reproductive system-associated adverse events were encountered more frequently in the highest dose group (0.1 mg/day) than in other active treatment groups or in placebo-treated patients. In women not currently taking oral estrogens or in women switching from another estradiol transdermal therapy, treatment with the Vivelle estradiol transdermal system may be initiated at once. In women who are currently taking oral estrogens, treatment with the Vivelle estradiol transdermal system should be initiated one week after withdrawal of oral hormone therapy, or sooner if menopausal symptoms reappear in less than one week.<br/>Therapeutic Regimen: Vivelle may be given continuously in patients who do not have an intact uterus. In those patients with an intact uterus, Vivelle may be given continuously or on a cyclic schedule (e.g., three weeks on drug followed by one week off drug) with a progestin.
|
| dailymed-drugs:364 |
When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose andfor the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. One Climara Pro transdermal system is available for use. Climara Pro delivers 0.045 mg of estradiol per day and 0.015 mg of levonorgestrel per day. The lowest effective dose of Climara Pro has not been determined.<br/>Initiation of Therapy:: Women not currently using continuous estrogen or combination estrogen/progestin therapy may start therapy with Climara Pro at any time. However, women currently using continuous estrogen or combination estrogen/progestin therapy should complete the current cycle of therapy, before initiating Climara Pro therapy. Women often experience withdrawal bleeding at the completion of the cycle. The first day of this bleeding would be an appropriate time to begin Climara Pro therapy.<br/>Therapeutic Regimen:: A Climara Pro 0.045 mg / 0.015 mg (22 sq cm) matrix transdermal system is worn continuously on the lower abdomen. A new system should be applied weekly during a 28-day cycle.<br/>Application of the System:: Site Selection: Climara Pro should be placed on a smooth (fold free), clean, dry area of the skin on the lower abdomen. Climara Pro should not be applied to or near the breasts. The area selected should not be oily (which can impair adherence of the system), damaged, or irritated. The waistline should be avoided, since tight clothing may rub the system off or modify drug delivery. The sites of application must be rotated, with an interval of at least one week allowed between applications to the same site. Application of the system: After opening the pouch, remove one side of the protective liner, taking care not to touch the adhesive part of the transdermal delivery system with the fingers. Immediately apply the transdermal delivery system to a smooth (fold free) area of skin on the lower abdomen. Remove the second side of the protective liner and press the system firmly in place with the hand for at least 10 seconds, making sure there is good contact, especially around the edges. Care should be taken that the system does not become dislodged during bathing and other activities. If a system should fall off, the same system may be reapplied to another area of the lower abdomen. If necessary, a new transdermal system may be applied, in which case, the original treatment schedule should be continued. Only one system should be worn at any one time during one week dosing interval. Once in place, the transdermal system should not be exposed to the sun for prolonged periods of time.<br/>Removal of the System: Removal of the system should be done carefully and slowly to avoid irritation of the skin. Should any adhesive remain on the skin after removal of the system, allow the area to dry for 15 minutes. Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue. Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it away.
|
| dailymed-drugs:365 |
General: Fixed ratio insulins are typically dosed on a twice daily basis, i.e. before breakfast and supper, with each dose intended to cover two meals or a meal and snack. NovoLog Mix 70/30 is intended only for subcutaneous injection (into the abdominal wall, thigh, or upper arm). NovoLog Mix 70/30 should not be administered intravenously. The absorption rate of NovoLog Mix 70/30 from the subcutaneous tissue allows dosing within 15 minutes of meal initiation. Dose regimens of NovoLog Mix 70/30 will vary among patients and should be determined by the health care professional familiar with the patient's metabolic needs, eating habits, and other lifestyle variables. As with all insulins, the duration of action may vary according to the dose, injection site, blood flow, temperature, and level of physical activity and conditioning.<br/>Administration using NovoLog Mix 70/30 FlexPen Prefilled Syringes or vials:: Disposable NovoLog Mix 70/30 FlexPenPrefilled Syringes: NovoLog Mix 70/30 suspension should be visually inspected and resuspended immediately before use. The resuspended NovoLog Mix 70/30 must appear uniformly white and cloudy. Before use, roll the disposable NovoLog Mix 70/30 FlexPen prefilled syringe between your palms 10 times. This procedure should be carried out with the FlexPen cartridge in a horizontal position. Thereafter, turn the disposable NovoLog Mix 70/30 FlexPen prefilled syringe upside down so that the glass ball moves from one end of the reservoir to the other. Do this at least 10 times. The rolling and turning procedure must be repeated until the suspension appears uniformly white and cloudy. Mixing is easier when the insulin has reached room temperature. Inject immediately. Before each subsequent injection, turn the disposable NovoLog Mix 70/30 FlexPen prefilled syringe upside down so that the glass ball moves from one end of the reservoir to the other at least 10 times and until the suspension appears uniformly white and cloudy. Inject immediately. After use, needles on the disposable NovoLog Mix 70/30 FlexPen prefilled syringes should not be recapped. Used syringes, needles, or lancets should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly. Vial: NovoLog Mix 70/30 vial must be resuspended immediately before use. Roll the vial gently 10 times in your hand to mix it. This procedure should be carried out with the vial in a horizontal position. The rolling procedure must be repeated until the suspension appears uniformly white and cloudy. Inject immediately.
|
| dailymed-drugs:366 |
Parenteral Administration: In some hospitalized patients with pathological
hypersecretory conditions or intractable duodenal ulcers, or in patients
who are unable to take oral medication, ZANTAC may be administered
parenterally according to the following recommendations:<br/>Intramuscular Injection: 50 mg (2 mL) every 6 to 8 hours.
(No dilution necessary.)<br/>Intermittent Intravenous Injection:<br/>Continuous Intravenous Infusion: Add ZANTAC Injection to 5% dextrose injection or
other compatible IV solution (see Stability). Deliver at a rate of
6.25 mg/h (e.g., 150 mg [6 mL] of ZANTAC Injection
in 250 mL of 5% dextrose injection at10.7 mL/h). For Zollinger-Ellison patients, dilute ZANTAC Injection
in 5% dextrose injection or other compatible IV solution (see Stability)
to a concentration no greater than 2.5 mg/mL. Start the infusion
at a rate of 1.0 mg/kg per hour. If after 4 hours either
a measured gastric acid output is>10 mEq/h or the patient becomes
symptomatic, the dose should be adjusted upward in 0.5-mg/kg per hour
increments, and the acid output should be remeasured. Dosages up to
2.5 mg/kg per hour and infusion rates as high as 220 mg/h
have been used.<br/>Pediatric Use: While limited data exist on the administration of
IV ranitidine to children, the recommended dose in pediatric patients
is for a total daily dose of 2 to 4 mg/kg, to be divided and
administered every 6 to 8 hours, up to a maximum of 50 mg
given every 6 to 8 hours. This recommendation is derived from
adult clinical studies and pharmacokinetic data in pediatric patients.
Limited data in neonatal patients (less than one month of age) receiving
ECMO have shown that a dose of 2 mg/kg is usually sufficient
to increase gastric pH to>4 for at least 15 hours. Therefore,
doses of 2 mg/kg given every 12 to 24 hours or as a continuous
infusion should be considered.<br/>ZANTAC Injection Premixed
in Flexible Plastic Containers:<br/>Instructions for Use:<br/>Preparation for Administration: Use aseptic technique.<br/>Caution: ZANTAC Injection Premixed in flexible plastic containers
is to be administered by slow IV drip infusion only. Additives should not be introduced into this solution. If used with a primary IV fluid system, the primary solution should
be discontinued during ZANTAC Injection Premixed infusion. Do not administer unless solution is clear and container
is undamaged.<br/>Warning: Do not use flexible plastic container in series
connections.<br/>Dosage Adjustment for Patients
With Impaired Renal Function: The administration of ranitidine as a continuous
infusion has not been evaluated in patients with impaired renal function.
On the basis of experience with a group of subjects with severely
impaired renal function treated with ZANTAC, the recommended dosage
in patients with a creatinine clearance<50 mL/min is 50 mg
every 18 to 24 hours. Should the patient's condition require,
the frequency of dosing may be increased to every 12 hours or
even further with caution. Hemodialysis reduces the level of circulating
ranitidine. Ideally, the dosing schedule should be adjusted so that
the timing of a scheduled dose coincides with the end of hemodialysis. Elderly patients are more likely to have decreased
renal function, therefore caution should be exercised in dose selection,
and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY:
Pharmacokinetics: Geriatric Use and PRECAUTIONS: Geriatric Use).<br/>Stability: Undiluted, ZANTAC Injection tends to exhibit a yellow
color that may intensify over time without adversely affecting potency.
ZANTAC Injection is stable for 48 hours at room temperature when
added to or diluted with most commonly used IV solutions, e.g., 0.9%
sodium chloride injection, 5% dextrose injection, 10% dextrose injection,
lactated ringer's injection, or 5% sodium bicarbonate injection. ZANTAC Injection Premixed in flexible plastic containers
is sterile through the expiration date on the label when stored under
recommended conditions. Note: Parenteral drug products should be inspected visually
for particulate matter and discoloration before administration whenever
solution and container permit.
|
| dailymed-drugs:367 |
Dosage should be individualized
for maximum beneficial effect. The usual recommended dose in older children and adults
ranges from 2 mg to 20 mg IM or IV, depending on the indication and its severity. In
some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific
indications.) In acute conditions the injection may be repeated within one hour
although an interval of 3 to4 hours is usually satisfactory. Lower doses (usually 2
mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated
patients and when other sedative drugs are administered. For dosage in infants above the
age of 30 days and children, see the specific indications below. When intravenous use
is indicated, facilities for respiratory assistance should be readily
available.<br/>Intramuscular: Diazepam Injection should
be injected deeply into the muscle.<br/>Intravenous Use: (See WARNINGS,
particularly for use in children.) The solution should be injected slowly, taking
at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as
those on the dorsum of the hand or wrist. Extreme care should be taken to avoid
intra-arterial administration or extravasation. Do not mix or dilute diazepam with
other solutions or drugs in syringe or infusion flask. If it is not feasible to
administer diazepam directly IV, it may be injected slowly through the infusion
tubing as close as possible to the vein insertion. Once the acute
symptomatology has been properly controlled with Diazepam Injection, the patient
may be placed on oral therapy with diazepam if further treatment is required. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration, whenever
solution and container permit. NOTE: Solution may appear colorless to light yellow.
|
| dailymed-drugs:368 |
Adults: Parenteral therapy with furosemide injection should be used only in patients unable to take oral medication or in emergency situations and should be replaced with oral therapy as soon as practical.<br/>Edema: The usual initial dose of furosemide is 20 to 40 mg given as a single dose, injected intramuscularly or intravenously. The intravenous dose should be given slowly (1 to 2 minutes). Ordinarily a prompt diuresis ensues. If needed, another dose may be administered in the same manner 2 hours later or the dose may be increased. The dose may be raised by 20 mg and given not sooner than 2 hours after the previous dose until the desired diuretic effect has been obtained. This individually determined single dose should then be given once or twicedaily. Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. Close medical supervision is necessary. If the physician elects to use high dose parenteral therapy, add the furosemide to either Sodium Chloride Injection USP, Lactated Ringer's Injection USP, or Dextrose (5%) Injection USP after pH has been adjusted to above 5.5, and administer as a controlled intravenous infusion at a rate not greater than 4 mg/min. Furosemide injection is a buffered alkaline solution with a pH of about 9 and drug may precipitate at pH values below 7. Care must be taken to ensure that the pH of the prepared infusion solution is in the weakly alkaline to neutral range. Acid solutions, including other parenteral medications (e.g., labetalol, ciprofloxacin, amrinone, and milrinone) must not be administered concurrently in the same infusion because they may cause precipitation of the furosemide. Inaddition, furosemide injection should not be added to a running intravenous line containing any of these acidic products.<br/>Acute Pulmonary Edema: The usual initial dose of furosemide is 40 mg injected slowly intravenously (over 1 to 2 minutes). If a satisfactory response does not occur within 1 hour, the dose may be increased to 80 mg injected slowly intravenously (over 1 to 2 minutes). If necessary, additional therapy (eg., digitalis, oxygen) may be administered concomitantly.<br/>Pediatric Patients: Parenteral therapy should be used only in patients unable to take oral medication or in emergency situations and should be replaced with oral therapy as soon as practical. The usual initial dose of Furosemide Injection (intravenously or intramuscularly) in infants and children is 1 mg/kg body weight and should be given slowly under close medical supervision. If the diuretic response to the initial dose is not satisfactory, dosage may be increased by 1 mg/kg not sooner than 2 hours after the previous dose, until the desired diuretic effect has been obtained. Doses greater than 6 mg/kg body weight are not recommended. Literature reports suggest that the maximum dose for premature infants should not exceed 1 mg/kg/day . NOTE: Furosemide Injection should be inspected visually for particulate matter and discoloration before administration. Do not use if solution is discolored.
|
| dailymed-drugs:369 |
The recommended dose is one to two drops in each affected eye four times daily. Symptomatic response to therapy (decreased itching) may be evident within a few days, but frequently requires longer treatment (up to four weeks).
|
| dailymed-drugs:370 |
Osteoarthritis: Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with meloxicam, the dose should be adjusted to suit an individual patient's needs. For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam tablets is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily. The maximum recommended daily oral dose of meloxicam tablets is 15 mg. Meloxicam tablets may be taken without regard to timing of meals.
|
| dailymed-drugs:371 |
Intralipid 30% (A 30% I.V. Fat Emulsion) Pharmacy Bulk Package should be administered only as a part of a three-in-one or total nutrient admixture via peripheral vein or by central venous infusion.<br/>Directions For Proper Use of Pharmacy Bulk Package: Intralipid 30% (A 30% I.V. Fat Emulsion) PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INFUSION. The container closure may be penetrated only once using a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Once the closure is penetrated, the contents should be dispensed as soon as possible; the transfer of contents to suitable TPN admixture containers must be completed within 4 hours of closure penetration. The bag should be stored below 25��C (77��F) after the closure has been entered. Date and time of container entry should be noted in the area designated on the container label. Admixtures made using Intralipid 30% should be used promptly. See MIXING GUIDELINES AND LIMITATIONS section for admixture storage recommendations.<br/>Adult Patients: The initial infusion rate of the nutrient admixture in adults should be the equivalent of 0.1 g fat/minute for the first 15 to 30 minutes of infusion. If no untoward reactions occur (see ADVERSE REACTIONS section), the infusion rate of the nutrient admixture can be increased to 0.2 g fat/minute. For adults, the admixture should not contain more than 330 mL of Intralipid 30% on the first day of therapy. If the patient has no untoward reactions, the dose can be increased on the following day. The daily dosage should not exceed 2.5 g of fat/kg of body weight (8.3 mL of Intralipid 30% per kg). Intralipid should make up no more than 60% of the total caloric input to the patient. Carbohydrate and a source of amino acids should comprise the remaining caloric input.<br/>Pediatric Patients: The dosage for premature infants starts at 0.5 g fat/kg body weight/24 hours (1.7 mL) Intralipid 30% and may be increased in relation to the infant's ability to eliminate fat. The maximum dosage recommended by the American Academy of Pediatrics is 3 g fat/kg/24 hours The initial rate of infusion of the nutrient admixture in older pediatric patients should be no more than 0.01 g fat/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.1 g of fat/kg/hour. The daily dosage should not exceed 3 g of fat/kg of body weightIntralipid should make up no more than 60% of the total caloric input to the patient. Carbohydrate and a source of amino acids should comprise the remaining caloric input.<br/>Essential Fatty Acid Deficiency: When Intralipid is administered to correct essential fatty acid deficiency, eight to ten percent of the caloric input should be supplied by Intralipid in order to provide adequate amounts of linoleic and linolenic acids. When EFAD occurs together with stress, the amount of Intralipid needed to correct the deficiency may be increased.<br/>Administration: See MIXING GUIDELINES AND LIMITATIONS section for information regarding mixing this fat emulsion with other parenteral fluids. INTRALIPID 30% (A 30% I.V. Fat Emulsion) is not for direct infusion. It must be infused as part of an admixture into a central or peripheral vein. The flow rate of the admixture should be controlled with an infusion pump. Filters of less than 1.2 micron pore size must not be used with admixtures containing Intralipid 30%. Conventional administration sets and TPN pooling bags contain polyvinyl chloride (PVC) components that have DEHP (diethyl hexyl phthalate) as a plasticizer. Fat-containing fluids such as Intralipid extract DEHP from these PVC components. Therefore it may be advisable to use a non-DEHP administration set for infusing admixtures which contain Intralipid. Do not use any bag in which there appears to be an oiling out on the surface of the emulsion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. whenever solution and container permit.<br/>MIXING GUIDELINES AND LIMITATIONS: INTRALIPID 30% PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INFUSION. It must be combined with total parenteral nutrition (TPN) fluids so that the resulting admixture has a final concentration of not more than 20% fat (0.2 g fat per mL of admixture). The following table may be used as a guide: Investigations have been conducted which demonstrate the compatibility of Intralipid 30% when properly mixed with either Novamine (8.5%, 11.4% or 15%) or 8.5% Travasol or 10% Travasol Amino Acid Injections for use in Total Parenteral Nutrition (TPN) therapy. Because of the potential for life threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrition mixture. Perform all manipulations in a suitable work area, such as a laminar flow hood. Failure to follow the Mixing Guidelines and Limitations below, including recommended storage temperature, storage time. order of mixing, etc., may result in an unstable admixture. The following proper mixing sequence must be followed to minimize pH related problems by ensuring that typically acidic Dextrose Injections are not mixed with lipid emulsions alone: Note: Amino Acid Injection, Dextrose Injection and Intralipid may be simultaneously transferred to the admixture container. Admixing should be accompanied by gentle agitation to avoid localized concentration effects. These admixtures should be used promptly with storage under refrigeration (2-8��C) not to exceed 24 hours and must be completely used within 24 hours after removal from refrigeration. It is essential that the admixture be prepared using strict aseptic techniques as this nutrient mixture is a good growth medium for microorganisms. Additives other than those named above may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist. If in the informed judgement of the prescribing physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives (e.g., vitamins and minerals). Additives must not be added directly to Intralipid and in no case should Intralipid 30% be added to the TPN container first. Bags should be shaken gently after each addition to minimize localized concentration. Supplemental electrolytes, trace metals or multivitamins may be required in accordance with the prescription of the attending physician. The prime destabilizers of emulsions are excessive acidity (low pH) and inappropriate electrolyte content. Careful consideration should be given to additions of divalent cations (Caand Mg) which have been shown to cause emulsion instability. Amino acid solutions exert a buffering effect protecting the emulsion. The admixture should be inspected carefully for���breaking or oiling out���of the emulsion.���Breaking or oiling out���is described as the separation of the emulsion and can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion. The admixture should also be examined for particulates. The admixture must be discarded if any of the above is observed.
|
| dailymed-drugs:372 |
Amphetamines should be administered at the lowest
effective dosage and dosage should be individually adjusted. Late
evening doses���particularly with the SPANSULE capsule form���should
be avoided because of the resulting insomnia.<br/>Narcolepsy:: Usual dose is 5 to 60 mg per day in divided
doses, depending on the individual patient response. Narcolepsy seldom occurs in children under 12 years of age;
however, when it does, DEXEDRINE may be used. The suggested initial
dose for patients aged 6 to 12 is 5 mg daily; daily dose may
be raised in increments of 5 mg at weekly intervals until an
optimal response is obtained. In patients 12 years of age and
older, start with 10 mg daily; daily dosage may be raised in
increments of 10 mg at weekly intervals until an optimal response
is obtained. If bothersome adverse reactions appear (e.g., insomnia
or anorexia), dosage should be reduced. SPANSULE capsules may be used
for once-a-day dosage wherever appropriate. With tablets, give first
dose on awakening; additional doses (1 or 2) at intervals of 4 to
6 hours.<br/>Attention Deficit Disorder
with Hyperactivity:: Not recommended for pediatric patients under 3 years
of age. In pediatric
patients from 3 to 5 years
of age, start with 2.5 mg daily, by tablet; daily dosage
may be raised in increments of 2.5 mg at weekly intervals until
optimal response is obtained. In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised
in increments of 5 mg at weekly intervals until optimal response
is obtained. Only in rare cases will it be necessary to exceed a total
of 40 mg per day. SPANSULE capsules may be used for once-a-day dosage wherever
appropriate. With tablets, give first dose on
awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. Where possible, drug administration should be interrupted
occasionally to determine if there is a recurrence of behavioral symptoms
sufficient to require continued therapy.
|
| dailymed-drugs:373 |
Apply a thin film of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% to the affected skin areas twice daily. Rub in gently. DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1 % may be used in pediatric patients 1 year of age or older. Safety and efficacy of DERMATOP Emollient Cream 0.1% in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. DERMATOP Emollient Cream 0.1% should not be used with occlusive dressings unless directed by the physician. DERMATOP Emollient Cream 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
|
| dailymed-drugs:374 |
Administration of pergolide mesylate should be initiated with a daily dosage of 0.05 mg for the first 2 days. The dosage should then be gradually increased by 0.1 or 0.15 mg/day every third day over the next 12 days of therapy. The dosage may then be increased by 0.25 mg/day every third day until an optimal therapeutic dosage is achieved. Pergolide mesylate is usually administered in divided doses 3 times per day. During dosage titration, the dosage of concurrent l -dopa/carbidopa may be cautiously decreased. In clinical studies, the mean therapeutic daily dosage of pergolide mesylate was 3 mg/day. The average concurrent daily dosage of l -dopa/carbidopa (expressed as l -dopa) was approximately 650 mg/day. The efficacy of pergolide mesylate at doses above 5 mg/day has not been systematically evaluated.
|
| dailymed-drugs:375 |
For Reduction of Cumulative Renal Toxicity with Chemotherapy:: The recommended starting dose of ETHYOL is 910 mg/madministered once daily as a 15-minute i.v. infusion, starting 30 minutes prior to chemotherapy. The 15-minute infusion is better tolerated than more extended infusions. Further reductions in infusion times for chemotherapy regimens have not been systematically investigated. Patients should be adequately hydrated prior to ETHYOL infusion and kept in a supine position during the infusion. Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated. The infusion of ETHYOL should be interrupted if the systolic blood pressure decreases significantly from the baseline value as listed in the guideline below: If the blood pressure returns to normal within 5 minutes and the patient is asymptomatic, the infusion may be restarted so that the full dose of ETHYOL may be administered. If the full dose of ETHYOL cannot be administered, the dose of ETHYOL for subsequent chemotherapy cycles should be 740 mg/m. It is recommended that antiemetic medication, including dexamethasone 20 mg i.v. and a serotonin 5HTreceptor antagonist, be administered prior to and in conjunction with ETHYOL. Additional antiemetics may be required based on the chemotherapy drugs administered.<br/>For Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck:: The recommended dose of ETHYOL is 200 mg/madministered once daily as a 3-minute i.v. infusion, starting 15-30 minutes prior to standard fraction radiation therapy (1.8-2.0 Gy). Patients should be adequately hydrated prior to ETHYOL infusion. Blood pressure should be monitored at least before and immediately after the infusion, and thereafter as clinically indicated. It is recommended that antiemetic medication be administered prior to and in conjunction with ETHYOL. Oral 5HTreceptor antagonists, alone or in combination with other antiemetics, have been used effectively in the radiotherapy setting.<br/>Reconstitution: ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder requiring reconstitution for intravenous infusion. Each single-use vial contains 500 mg of amifostine on the anhydrous basis. Prior to intravenous injection, ETHYOL is reconstituted with 9.7 mL of sterile 0.9% Sodium Chloride Injection, USP. The reconstituted solution (500 mg amifostine/10 mL) is chemically stable for up to 5 hours at room temperature (approximately 25��C) or up to 24 hours under refrigeration (2��C to 8��C). ETHYOL prepared in polyvinylchloride (PVC) bags at concentrations ranging from 5 mg/mL to 40 mg/mL is chemically stable for up to 5 hours when stored at room temperature (approximately 25��C) or up to 24 hours when stored under refrigeration (2��C to 8��C). CAUTION: Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if cloudiness or precipitate is observed.<br/>Incompatibilities: The compatibility of ETHYOL with solutions other than 0.9% Sodium Chloride for Injection, or Sodium Chloride solutions with other additives, has not been examined. The use of other solutions is not recommended.
|
| dailymed-drugs:376 |
There is no fixed dosage regimen for the management of diabetes mellitus with glimepiride or any other hypoglycemic agent. The patient's fasting blood glucose and HbAmust be measured periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels should be performed to monitor the patient's response to therapy. Short-term administration of glimepiride may be sufficient during periods of transient loss of control in patients usually controlled well on diet and exercise. Usual Starting Dose The usual starting dose of glimepiride as initial therapy is 1-2 mg once daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1 mg once daily, and should be titrated carefully. (SeePRECAUTIONSSection for patients at increased risk.) No exact dosage relationship exists between glimepiride and the other oral hypoglycemic agents. The maximum starting dose of glimepiride should be no more than 2 mg. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy. Usual Maintenance Dose The usual maintenance dose is 1 to 4 mg once daily. The maximum recommended dose is 8 mg once daily. After reaching a dose of 2 mg, dosage increases should be made in increments of no more than 2 mg at 1-2 week intervals based upon the patient's blood glucose response. Long-term efficacy should be monitored by measurement of HbAlevels, for example, every 3 to 6 months. Glimepiride-Metformin Combination Therapy If patients do not respond adequately to the maximal dose of glimepiride monotherapy, addition of metformin may be considered. Published clinical information exists for the use of other sulfonylureas including glyburide, glipizide, chlorpropamide, and tolbutamide in combination with metformin. With concomitant glimepiride and metformin therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant glimepiride and metformin therapy, the risk of hypoglycemia associated with glimepiride therapy continues and may be increased. Appropriate precautions should be taken. Glimepiride-Insulin Combination Therapy Combination therapy with glimepiride and insulin may also be used in secondary failure patients. The fasting glucose level for instituting combination therapy is in the range of>150 mg/dL in plasma or serum depending on the patient. The recommended glimepiride dose is 8 mg once daily administered with the first main meal. After starting with low-dose insulin, upward adjustments of insulin can be done approximately weekly as guided by frequent measurements of fasting blood glucose. Once stable, combination-therapy patients should monitor their capillary blood glucose on an ongoing basis, preferably daily. Periodic adjustments of insulin may also be necessary during maintenance as guided by glucose and HbAlevels. Specific Patient Populations Glimepiride tablets are not recommended for use in pregnancy, nursing mothers, or children. In elderly, debilitated, or malnourished patients, or in patients with renal or hepatic insufficiency, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions (seeCLINICAL PHARMACOLOGY, Special PopulationsandPRECAUTIONS, General). Patients Receiving Other Oral Hypoglycemic Agents As with other sulfonylurea hypoglycemic agents, no transition period is necessary when transferring patients to glimepiride. Patients should be observed carefully (1-2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to glimepiride due to potential overlapping of drug effect.
|
| dailymed-drugs:377 |
This solution is for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. The presence of calcium ions in this solution should be considered when phosphate is present in additive solutions, in order to avoid precipitation. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.<br/>Pediatric Use: There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. See WARNINGS and PRECAUTIONS.
|
| dailymed-drugs:378 |
General Instructions: Fluorouracil Injection, USP should be administered only intravenously, using care to avoid extravasation. No dilution is required. All dosages are based on the patient's actual weight. However, the estimated lean body mass (dry weight) is used if the patient is obese or if there has been a spurious weight gain due to edema, ascites or other forms of abnormal fluid retention. It is recommended that prior to treatment each patient be carefully evaluated in order to estimate as accurately as possible the optimum initial dosage of Fluorouracil.<br/>Dosage: 12 mg/kg are given intravenously once daily for 4 successive days. The daily dose should not exceed 800 mg. If no toxicity is observed, 6 mg/kg are given on the 6, 8, 10and 12days unless toxicity occurs. No therapy is given on the 5, 7, 9or 11days. Therapy is to be discontinued at the end of the 12day, even if no toxicity has become apparent. (See
WARNINGS
and
PRECAUTIONS
sections.) Poor risk patients or those who are not in an adequate nutritional state (see
CONTRAINDICATIONS
and
WARNINGS
sections) should receive 6 mg/kg/day for 3 days. If no toxicity is observed, 3 mg/kg may be given on the 5, 7and 9days unless toxicity occurs. No therapy is given on the 4, 6or 8days. The daily dose should not exceed 400 mg. A sequence of injections on either schedule constitutes a"course of therapy."<br/>Maintenance Therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules: The patient's reaction to the previous course of therapy should be taken into account in determining the amount of the drug to be used, and the dosage should be adjusted accordingly. Some patients have received from 9 to 45 courses of treatment during periods which ranged from 12 to 60 months.<br/>Handling and Disposal: Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Although the Fluorouracil solution may discolor slightly during storage, the potency and safety are not adversely affected. If a precipitate occurs due to exposure to lowtemperatures, resolubilize by heating to 140��F and shaking vigorously; allow to cool to body temperature before using.
|
| dailymed-drugs:379 |
Rubramin PC (Cyanocobalamin Injection) should be visually inspected for particulate matter and color prior to administration; the solution is clear red. Do not administer intravenously.<br/>Schilling Test*: The flushing dose is 1000 mcg injected intramuscularly. For procedure see the insert packaged with Rubratope-57 (Cyanocobalamin Co 57) capsules or diagnostic kit .
|
| dailymed-drugs:380 |
Cephalexin is administered orally.<br/>Adults: The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.<br/>Pediatric Patients: The usual recommended daily dosage for children is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours. In severe infections, the dosage may be doubled. In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required. In the treatment of��-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
|
| dailymed-drugs:381 |
Procedure: For the best results, dosage should start at the first sign of an attack. Adults: Take 2 tablets at the start of attack; 1 additional tablet every��hour, if needed for full relief (maximum 6 tablets per attack, 10 per week). Early Administration Gives Maximum Effectiveness. Maximum Adult Dosage: Six tablets is the maximum dose for an individual attack. Total weekly dosage should not exceed 10 tablets. Ergotamine tartrate and caffeine-tablets should not be used for chronic daily administration. In carefully selected patients, with due consideration of maximum dosage recommendations, administration of the drug at bedtime may be an appropriate short-term preventive measure.
|
| dailymed-drugs:382 |
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.<br/>Recommended Dosage: Adults and Children 12 years of age and older: 2 mg (1 teaspoonful)Children 6 to 11 years: 1 mg (1/2 teaspoonful)Children 2 to 5 years: 0.5 mg (1/4 teaspoonful) Doses are generally given every 4 to 6 hours.
|
| dailymed-drugs:383 |
Dosage should be adjusted according to each patient's needs. It is recommended that nifedipine extended-release tablets be administered orally once daily on an empty stomach. Nifedipine extended-release tablets are an extended release dosage form and tablets should be swallowed whole, not bitten or divided. In general, titration should proceed over a 7-14 day period starting with 30 mg once daily. Upward titration should be based on therapeutic efficacy and safety. The usual maintenance dose is 30 mg to 60 mg once daily. Titration to doses above 90 mg daily is not recommended. If discontinuation of nifedipine extended-release tablets is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision. Co-administration of nifedipine with grapefruit juice is to be avoided . Care should be taken when dispensing nifedipine extended-release tablets to assure that the extended release dosage form has been prescribed.
|
| dailymed-drugs:384 |
One tablet of 200 mg of hydroxychloroquine sulfate is equivalent to 155 mg base. Malaria<br/>Suppression: In adults, 400 mg (=310 mg base) on exactly the same day of each week. In infants and children, the weekly suppressive dosage is 5 mg, calculated as base, per kg of body weight, but should not exceed the adult dose regardless of weight. If circumstances permit, suppressive therapy should begin two weeks prior to exposure. However, failing this, in adults an initial double (loading) dose of 800 mg (=620 mg base), or in children 10 mg base/kg may be taken in two divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after leaving the endemic area.<br/>Treatment of the acute attack: In adults, an initial dose of 800 mg (= 620 mg base) followed by 400 mg (=310 mg base) in six to eight hours and 400 mg (=310 mg base) on each of two consecutive days (total 2 g hydroxychloroquine sulfate or 1.55 g base). An alternative method, employing a single dose of 800 mg (=620 mg base), has also proved effective. The dosage for adults may also be calculated on the basis of body weight; this method is preferred for infants and children. A total dose representing 25 mg of base per kg of body weight is administered in three days, as follows: First dose: 10 mg base per kg (but not exceeding a single dose of 620 mg base). Second dose: 5 mg base per kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose. Third dose: 5 mg base per kg 18 hours after second dose. Fourth dose: 5 mg base per kg 24 hours after third dose. For radical cure of vivax and malariae malaria concomitant therapy with an 8-aminoquinoline compound is necessary.
|
| dailymed-drugs:386 |
Carefully consider the potential benefits and risks of a ketoprofen immediate-release capsules and ketoprofen extended-release capsules and other treatment options before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . After observing the response to initial therapy with ketoprofen immediate-release capsules and ketoprofen extended-release capsules, the dose and frequency should be adjusted to suit an individual patient's needs. Concomitant use of ketoprofen immediate-release capsules and ketoprofen extended-release capsules is not recommended. If minor side effects appear, they may disappear at a lower dose which may still have an adequate therapeutic effect. If well tolerated but not optimally effective, the dosage may be increased. Individual patients may show a better response to 300 mg of ketoprofen immediate-release capsules daily as compared to 200 mg, although in well controlled clinical trials patients on 300 mg did not show greater mean effectiveness. They did, however, show an increased frequency of upper and lower GI distress and headaches. It is of interest that women also had an increased frequency of these adverse effects compared to men. When treating patients with 300 mg/day, the physician should observe sufficient increased clinical benefit to offset potential increased risk. In patients with mildly impaired renal function, the maximum recommended total daily dose of ketoprofen immediate-release capsules or ketoprofen extended-release capsules is 150 mg. In patients with a more severe renal impairment (GFR less than 25 mL/min/1.73 mor end-stage renal impairment), the maximum total daily dose of ketoprofen immediate-release capsules or ketoprofen extended-release capsules should not exceed 100 mg. In elderly patients, renal function may be reduced with apparently normal serum creatinine and/or BUN levels. Therefore, it is recommended that the initial dosage of ketoprofen immediate-release capsules or ketoprofen extended-release capsules should be reduced for patients over 75 years of age . It is recommended that for patients with impaired liver function and serum albumin concentration less than 3.5 g/dL, the maximum initial total daily dose of ketoprofen immediate-release capsules or ketoprofen extended-release capsules should be 100 mg. All patients with metabolic impairment, particularly those with both hypoalbuminemia and reduced renal function,may have increased levels of free (biologically active) ketoprofen and should be closely monitored. The dosage may be increased to the range recommended for the general population, if necessary, only after good individual tolerance has been ascertained. Because hypoalbuminemia and reduced renal function both increase the fraction of free drug (biologically active form), patients who have both conditions may be at greater risk of adverse effects. Therefore, it is recommended that such patients also be started on lower doses of ketoprofen immediate-release capsules or ketoprofen extended-release capsules and closely monitored.<br/>Rheumatoid Arthritis and Osteoarthritis: The recommended starting dose of ketoprofen in otherwise healthy patients is for ketoprofen immediate-release capsules 75 mg three times or 50 mg four times a day, or for ketoprofen extended-release capsules 200 mg administered once a day. Smaller doses of ketoprofen immediate-release capsules or ketoprofen extended-release capsules should be utilized initially in small individuals, or in debilitated or elderly patients. The recommended maximum daily dose of ketoprofen is 300 mg/day for ketoprofen immediate-release capsules or 200 mg/day for ketoprofen extended-release capsules. Dosages higher than 300 mg/day of ketoprofen immediate-release capsules or 200 mg/day of ketoprofen extended-release capsules are not recommended because they have not been studied. Concomitant use of ketoprofen immediate-release capsules and ketoprofen extended-release capsules is not recommended. Relatively smaller people may need smaller doses. As with other non-steroidal anti-inflammatory drugs, the predominant adverse effects of ketoprofen are gastrointestinal. To attempt to minimize these effects, physicians may wish to prescribe that ketoprofen immediate-release capsules or ketoprofen extended-release capsules be taken with antacids, food, or milk. Although food delays the absorption of both formulations in most of the clinical trials ketoprofen was taken with food or milk. Physicians may want to make specific recommendations to patients about when they should take ketoprofen immediate-release capsules or ketoprofen extended-release capsules in relation to food and/or what patients should do if they experience minor GI symptoms associated with either formulation.<br/>Management of Pain and Dysmenorrhea: The usual dose of ketoprofen immediate-release capsules recommended for mild to moderate pain and dysmenorrhea is 25 to 50 mg every 6 to 8 hours as necessary. A smaller dose should be utilized initially in small individuals, in debilitated or elderly patients, or in patients with renal or liver disease . A larger dose may be tried if the patient's response to a previous dose was less than satisfactory, but doses above 75 mg have not been shown to give addedanalgesia. Daily doses above 300 mg are not recommended because they have not been adequately studied. Because of its typical non-steroidal anti-inflammatory drug-side effect profile, including as its principal adverse effect GI side effects , higher doses of ketoprofen immediate-release capsules should be used with caution and patients receiving them observed carefully. Ketoprofen extended-release capsules are not recommended for use in treating acute pain because of its extended-release characteristics.
|
| dailymed-drugs:388 |
Treatment of P. falciparum malaria: Quinidine sulfate tablets are used in one of the approved regimens for the treatment of life-threatening P. falciparum malaria. The central component of the regimen is Quinidine Gluconate Injection, and the regimen is described in the package insert of Quinidine Gluconate Injection.<br/>Conversion of atrial fibrillation/flutter to sinus rhythm: Especially in patients with known structural heart disease or other risk factors for toxicity, initiation or dose-adjustment of treatment with quinidine sulfate should generally be performed in a setting where facilities and personnel for monitoring and resuscitation are continuously available. Patients with symptomatic atrial fibrillation/flutter should be treated with quinidine sulfate only after ventricular rate control (e.g., with digitalis or��-blockers) has failed to provide satisfactory control of symptoms. Adequate trials have not identified an optimal regimen of quinidine sulfate for conversion of atrial fibrillation/flutter to sinus rhythm. In one reported regimen, the patient first receives two tablets (400 mg; 332 mg of quinidine base) of quinidine sulfate every six hours. If this regimen has not resulted in conversion after 4 or 5 doses, then the dose is cautiously increased. If, at any point during administration, the QRS complex widens to 130% of its pre-treatment duration; the QTinterval widens to 130% of its pre-treatment duration and is then longer than 500 ms; P waves disappear; or the patient develops significant tachycardia, symptomatic bradycardia, or hypotension, then quinidine sulfate is discontinued, and other means of conversion (e.g., direct-current cardioversion) are considered.<br/>Reduction of frequency of release into atrial fibrillation/flutter: In a patient with a history of frequent symptomatic episodes of atrial fibrillation/flutter, the goal of therapy with quinidine sulfate should be an increase in the average time between episodes. In most patients, the tachyarrhythmia will recur during therapy with quinidine sulfate, and a single recurrence should not be interpreted as therapeutic failure. Especially in patients with known structural heart disease or other risk factors for toxicity, initiation or dose-adjustment of treatment with quinidine sulfate should generally be performed in a setting where facilities and personnel for monitoring and resuscitation are continuously available. Monitoring should be continued for two or three days after initiation of the regimen on which the patient will be discharged. Therapy with quinidine sulfate should be begun with 200 mg (equivalent to 166 mg of quinidine base) every six hours. If this regimen is well tolerated, if the serum quinidine level is still well within the laboratory's therapeutic range, and if the average time between arrhythmic episodes has not been satisfactorily increased, then the dose may be cautiously raised. The total daily dosage should be reduced if the QRS complex widens to 130% of its pre-treatment duration; the QTinterval widens to 130% of its pre-treatment duration and is then longer than 500 ms; P waves disappear; or the patient develops significant tachycardia, symptomatic bradycardia, or hypotension.<br/>Suppression of ventricular arrhythmias: Dosing regimens for the use of quinidine sulfate in suppressing life-threatening ventricular arrhythmias have not been adequately studied. Described regimens have generally been similar to the regimen described just above for the prophylaxis of symptomatic atrial fibrillation/flutter. Where possible, therapy should be guided by the results of programmed electrical stimulation and/or Holter monitoring with exercise.
|
| dailymed-drugs:389 |
One capsule daily, before breakfast or 10-14 hours before retiring. For individuals exhibiting greater drug responsiveness, IONAMIN���15' will usually suffice. IONAMIN���30' is recommended for less responsive patients. IONAMIN is not recommended for use in pediatric patients under 16 years of age. IONAMIN Capsules should be swallowed whole.
|
| dailymed-drugs:390 |
The dosage and administration of Jantoven' Tablets (Warfarin Sodium Tablets, USP) must be individualized for each patient according to the particular patient's PT/INR response to the drug. The dosage should be adjusted based upon the patient's PT/INR.The best available information supports the following recommendations for dosing of Jantoven' Tablets.<br/>Venous Thromboembolism (including deep venous thrombosis [DVT] and pulmonary embolism [PE]): For patients with a first episode of DVT or PE secondary to a transient (reversible) risk factor, treatment with warfarin for 3 months is recommended. For patients with a first episode of idiopathic DVT or PE, warfarin is recommended for at least 6 to 12 months. For patients with two or more episodes of documented DVT or PE, indefinite treatment with warfarin is suggested. For patients with a first episode of DVT or PEwho have documented antiphospholipid antibodies or who have two or more thrombophilic conditions, treatment for 12 months is recommended and indefinite therapy is suggested. For patients with a first episode of DVT or PE who have documented deficiency of antithrombin, deficiency of protein C or protein S, or the Factor V Leiden or prothrombin 20210 gene mutation, homocystinemia, or high Factor VIII levels (>90th percentile of normal), treatment for 6 to 12 months is recommended and indefinite therapy is suggested for idiopathic thrombosis. The risk-benefit should be reassessed periodically in patients who receive indefinite anticoagulant treatment.The dose of warfarin should be adjusted to maintain a target INR of 2.5 (INR range, 2.0 to 3.0) for all treatment durations. These recommendations are supported by the 7th ACCP guidelines.<br/>Atrial Fibrillation: Five recent clinical trials evaluated the effects of warfarin in patients with non-valvular atrial fibrillation (AF). Meta-analysis findings of these studies revealed that the effects of warfarin in reducing thromboembolic events including stroke were similar at either moderately high INR (2.0 - 4.5) or low INR (1.4 - 3.0). There was a significant reduction in minor bleeds at the low INR. There are no adequate and well-controlled studies in populations with atrial fibrillation and valvular heart disease. Similar data from clinical studies in valvular atrial fibrillation patients are not available. The trials in non-valvular atrial fibrillation support the American College of Chest Physicians' (7th ACCP) recommendation that an INR of 2.0 - 3.0 be used for warfarin therapy in appropriate AF patients. Oral anticoagulation therapy with warfarin is recommended in patients with persistent or paroxysmal AF (PAF) (intermittent AF) at high risk of stroke (i.e., having any of the following features: prior ischemic stroke, transient ischemic attack, or systemic embolism, age>75 years, moderately or severely impaired left ventricular systolic function and/or congestive heart failure, history of hypertension, or diabetes mellitus). In patients with persistent AF or PAF, age 65 to 75 years, in the absence of other risk factors, but who are at intermediate risk of stroke, antithrombotic therapy with either oral warfarin or aspirin, 325 mg/day, is recommended. For patients with AF and mitral stenosis, anticoagulation with oral warfarin is recommended (7th ACCP). For patients with AF and prosthetic heart valves, anticoagulation with oral warfarin should be used; the target INR may be increased and aspirin added depending on valve type and position, and on patient factors.<br/>Post-Myocardial Infarction: The results of the WARIS II study and 7th ACCP guidelines suggest that in most healthcare settings, moderate- and low-risk patients with a myocardial infarction should be treated with aspirin alone over oral vitamin-K antagonist (VKA) therapy plus aspirin. In healthcare settings in which meticulous INR monitoring is standard and routinely accessible, for both high- and low-risk patients after myocardial infarction (MI), long-term (up to 4 years) high-intensity oral warfarin (target INR, 3.5; range, 3.0 to 4.0) without concomitant aspirin or moderate-intensity oral warfarin (target INR, 2.5; range, 2.0 to 3.0) with aspirin is recommended. For high-risk patients with MI, including those with a large anterior MI, those with significant heart failure, those with intracardiac thrombus visibleon echocardiography, and those with a history of a thromboembolic event, therapy with combined moderate-intensity (INR, 2.0 to 3.0) oral warfarin plus low-dose aspirin (���100 mg/day) for 3 months after the MI is suggested.<br/>Mechanical and Bioprosthetic Heart Valves: For all patients with mechanical prosthetic heart valves, warfarin is recommended. For patients with a St. Jude Medical (St. Paul, MN) bileaflet valve in the aortic position, a target INR of 2.5 (range, 2.0 to 3.0) is recommended. For patients with tilting disk valves and bileaflet mechanical valves in the mitral position, the 7th ACCP recommends a target INR of 3.0 (range, 2.5 to 3.5). For patients with caged ball or caged disk valves, a target INR of 3.0 (range, 2.5 to 3.5) incombination with aspirin, 75 to 100 mg/day is recommended. For patients with bioprosthetic valves, warfarin therapy with a target INR of 2.5 (range, 2.0 to 3.0) is recommended for valves in the mitral position and is suggested for valves in the aortic position for the first 3 months after valve insertion.<br/>Recurrent Systemic Embolism and Other Indications: Oral anticoagulation therapy has not been evaluated by properly designed clinical trials in patients with valvular disease associated with atrial fibrillation, patients with mitral stenosis, and patients with recurrent systemic embolism of unknown etiology. A moderate dose regimen (INR 2.0 to 3.0) is recommended for these patients. An INR of greater than 4.0 appears to provide no additional therapeutic benefit in most patients and is associated with a higher risk of bleeding.<br/>Initial Dosage: The dosing of Jantoven' Tablets must be individualized according to patient's sensitivity to the drug as indicated by the PT/INR. Use of a large loading dose may increase the incidence of hemorrhagic and other complications, does not offer more rapid protection against thrombi formation, and is not recommended. It is recommended that Jantoven' Tablets therapy be initiated with a dose of 2 to 5 mg per day with dosage adjustments based on the results of PT/INR determinations.The lower initiation doses should be considered for patients with certain genetic variations in CYP2C9 and VKORC1 enxymes as well as for elderly and / or debilitated patients and patients with potential to exhibit greater than expected PT/INR responses to Jantoven .<br/>Maintenance: Most patients are satisfactorily maintained at a dose of 2 to 10 mg daily. Flexibility of dosage is provided by breaking scored tablets in half. The individual dose and interval should be gauged by the patient's prothrombin response. Acquired or inherited warfarin resistance is rare, but should be suspected if large daily doses of warfarin are required to maintain a patient's PT/INR within a normal therapeutic range. Lower maintenance doses are recommended for elderly and/or debilitated patients and patients with a potential to exhibit greater thatn expected PT/INR response to warfarin sodium .<br/>Duration of Therapy: The duration of therapy in each patient should be individualized. In general, anticoagulant therapy should be continued until the danger of thrombosis and embolism has passed.<br/>Missed Dose: The anticoagulant effect of Jantoven' Tablets persists beyond 24 hours. If the patient forgets to take the prescribed dose of Jantoven' Tablets at the scheduled time, the dose should be taken as soon as possible on the same day. The patient should not take the missed dose by doubling the daily dose to make up for missed doses, but should refer back to his or her physician.<br/>Laboratory Control: The PT reflects the depression of vitamin K dependent Factors VII, X and II. A system of standardizing the PT in oral anticoagulant control was introduced by the World Health Organization in 1983. It is based upon the determination of an International Normalized Ratio (INR) which provides a common basis for communication of PT results and interpretations of therapeutic ranges.The PT should be determined daily after the administration of the initial dose until PT/INR results stabilize in the therapeutic range. Intervals between subsequent PT/INR determinations should be based upon the physician's judgment of the patient's reliability and response to Jantoven' Tablets inorder to maintain the individual within the therapeutic range. Acceptable intervals for PT/INR determinations are normally within the range of one to four weeks after a stable dosage has been determined. To ensure adequate control, it is recommended that additional PT tests be done when other warfarin products are interchanged with warfarin sodium tablets, USP, as well as whenever other medications are initiated, discontinued, or taken irregularly . Safety and efficacy of warfarin therapy can be improvedby increasing the quality of laboratory control. Reports suggest that in usual care monitoring, patients are in therapeutic range only 33%-64% of the time. Time in therapeutic range is significantly greater (56%-93%) in patients managed by anticoagulation clinics, among self-testing and self-monitoring patients, and in patients managed with the help of computer programs.Self-testing patients had fewer bleeding events than patients in usual care. Treatment During Dentistry And Surgery The management of patients who undergo dental and surgical procedures requires close liaison between attending physicians, surgeons and dentists.PT/INR determination is recommended just prior to any dental or surgical procedure. In patients undergoing minimal invasive procedures who must be anticoagulated prior to, during, or immediately following these procedures, adjusting the dosage of Jantoven' Tablets to maintain the PT/INR at the low end of the therapeutic range may safely allow for continued anticoagulation. The operative site should be sufficiently limited and accessible to permit the effective use of local procedures for hemostasis. Under these conditions, dental and minor surgical procedures may be performed without undue risk of hemorrhage. Some dental or surgical procedures may necessitate the interruption of Jantoven' Tablets therapy. When discontinuing Jantoven' Tablets even for a short period of time, the benefits and risks should be strongly considered. Conversion From Heparin Therapy Since the anticoagulant effect of Jantoven' Tablets is delayed, heparin is preferred initially for rapid anticoagulation. Conversion to Jantoven' Tablets may begin concomitantly with heparin therapy or may be delayed 3 to 6 days. To ensure continuous anticoagulation, it is advisable to continue full dose heparin therapy and that Jantoven' Tablets therapy be overlapped with heparin for 4 to 5 days, until Jantoven' Tablets has produced the desired therapeutic response as determined by PT/INR. When Jantoven' Tabletshas produced the desired PT/INR or prothrombin activity, heparin may be discontinued. Jantoven' Tablets may increase the activated partial thromboplastin time (aPTT) test, even in the absence of heparin. A severe elevation (>50 seconds) in activated partial thromboplstin time (aPTT) with a PT/INR in the desired range has been identified as an indication of increased risk of postoperative hemorrhage. During initial therapy with Jantoven' Tablets, the interference with heparin anticoagulation is of minimal clinical significance. As heparin may affect the PT/INR, patients receiving both heparin and Jantoven' Tablets should have blood for PT/INR determination drawn at least:
|
| dailymed-drugs:391 |
After preparation with oxidant-free sodium pertechnetate Tc99m injection the suggested dose range of technetium Tc99m medronate injection in the average patient (70 kg) is 370-740 MBq (10-20 mCi) given intravenously. Imaging post injection is optimal at 1 to 4 hours. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Shielding should be utilized when preparing the technetium Tc99m medronate injection. Slow administration of the drug over a period of 30 seconds is recommended.<br/>Radiation Dosimetry: The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed dosesto an average patient (70 kg) for an intravenous injection of a maximum dose of 740 MBq (20 mCi) of technetium Tc99m medronate injection are shown in Table 4. The typical total body exposure to a person administering a maximum dose of 740 MBq (20 mCi) of technetium Tc99m to a patient is about 0.2��Sv, 0.02 mR.
|
| dailymed-drugs:392 |
As required for irrigation. The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the directions of the additive's manufacturer should be followed. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
|
| dailymed-drugs:393 |
The usual dose of Triamterene/Hydrochlorothiazide Capsules, USP 37.5 mg/25 mg is one or two capsules given once daily, with appropriate monitoring of serum potassium and of the clinical effect. (See WARNINGS, Hyperkalemia.)
|
| dailymed-drugs:394 |
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin���50 mg/m. Multiday, single-dose administration of a 24 mg dosage has not been studied.<br/>Pediatric Use:: There is no experience with the use of a 24 mg dosage in pediatric patients.<br/>Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.<br/>Pediatric Use:: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of Ondansetron Oral Solution, USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of Ondansetron Oral Solution, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.<br/>Geriatric Use:: The dosage is the same as for the general population.<br/>Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: The recommended oral dosage is 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP given 3 times a day. For total body irradiation, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day. For single high-dose fraction radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy. For daily fractionated radiotherapy to the abdomen, 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of Ondansetron Oral Solution, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.<br/>Pediatric Use:: There is no experience with the use of Ondansetron Oral Solution, USP in the prevention of radiation-induced nausea and vomiting in pediatric patients.<br/>Geriatric Use:: The dosage recommendation is the same as for the general population.<br/>Postoperative Nausea and Vomiting: The recommended dosage is 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of Ondansetron Oral Solution, USP 1 hour before induction of anesthesia.<br/>Pediatric Use:: There is no experience with the use of Ondansetron Oral Solution, USP in the prevention of postoperative nausea and vomiting in pediatric patients.<br/>Geriatric Use:: The dosage is the same as for the general population.<br/>Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.<br/>Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pughscore of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
|
| dailymed-drugs:395 |
Apply a thin film of Topicort LP (desoximetasone) Cream 0.05%, Topicort (desoximetasone) Cream 0.25%, and Topicort (desoximetasone) Gel 0.05% to the affected skin areas twice daily. Rub in gently.
|
| dailymed-drugs:396 |
Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules is for oral administration once daily in the morning. Focalin XR may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Focalin XR and/or their contents should not be crushed, chewed, or divided. The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.<br/>Dosing Recommendations: Dosage should be individualized according to the needs and responses of the patients.<br/>Patients New to Methylphenidate: The recommended starting dose of Focalin XR for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day for pediatric patients and 10 mg/day for adult patients. Dosage may be adjusted in 5 mg increments to a maximum of 20 mg/day for pediatric patients and in 10 mg increments to a maximum of 20 mg/day for adult patients. In general, dosage adjustments may proceed at approximately weekly intervals. The patient should be observed for a sufficient duration at a given dose to ensure that a maximal benefit has been achieved before a dose increase is considered.<br/>Patients Currently Using Methylphenidate: For patients currently using methylphenidate, the recommended starting dose of Focalin XR is half the total daily dose of racemic methylphenidate. Patients currently using Focalin (dexmethylphenidate) may be switched to the same daily dose of Focalin XR. The maximum recommended dose is 20 mg/day for pediatric and adult patients.<br/>Maintenance/Extended Treatment: There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Focalin XR. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use Focalin XR for extended periods in patients with ADHD should periodically reevaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient's functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.<br/>Dose Reduction and Discontinuation: If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued. If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued.
|
| dailymed-drugs:397 |
There is no fixed dosage regimen for the management of diabetes mellitus with glimepiride or any other hypoglycemic agent. The patient's fasting blood glucose and HbAmust be measured periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels should be performed to monitor the patient's response to therapy. Short-term administration of glimepiride may be sufficient during periods of transient loss of control in patients usually controlled well on diet and exercise.<br/>Usual Starting Dose: The usual starting dose of glimepiride tablets as initial therapy is 1 to 2 mg once daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1 mg once daily, and should be titrated carefully. (See PRECAUTIONS Section for patients at increased risk.) No exact dosage relationship exists between glimepiride and the other oral hypoglycemic agents. The maximum starting dose of glimepiride tablets should be no more than 2 mg. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.<br/>Usual Maintenance Dose: The usual maintenance dose is 1 to 4 mg once daily. The maximum recommended dose is 8 mg once daily. After reaching a dose of 2 mg, dosage increases should be made in increments of no more than 2 mg at 1 to 2 week intervals based upon the patient's blood glucose response. Long-term efficacy should be monitored by measurement of HbAlevels, for example, every 3 to 6 months.<br/>Glimepiride-Metformin Combination Therapy: If patients do not respond adequately to the maximal dose of glimepiride tablets monotherapy, addition of metformin may be considered. Published clinical information exists for the use of other sulfonylureas including glyburide, glipizide, chlorpropamide, and tolbutamide in combination with metformin. With concomitant glimepiride tablets and metformin therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant glimepiride tablets and metformin therapy, the risk of hypoglycemia associated with glimepiride therapy continues and may be increased. Appropriate precautions should be taken.<br/>Glimepiride-Insulin Combination Therapy: Combination therapy with glimepiride tablets and insulin may also be used in secondary failure patients. The fasting glucose level for instituting combination therapy is in the range of>150 mg/dL in plasma or serum depending on the patient. The recommended glimepiride tablets dose is 8 mg once daily administered with the first main meal. After starting with low-dose insulin, upward adjustments of insulin can be done approximately weekly as guided by frequent measurements of fasting blood glucose. Once stable, combination-therapy patients should monitor their capillary blood glucose on an ongoing basis, preferably daily. Periodic adjustments of insulin may also be necessary during maintenance as guided by glucose and HbAlevels.<br/>Specific Patient Populations: Glimepiride tablets are not recommended for use in pregnancy or nursing mothers. Data are insufficient to recommend pediatric use of glimepiride. In elderly, debilitated, or malnourished patients, or in patients with renal or hepatic insufficiency, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions (see CLINICAL PHARMACOLOGY, Special Populations and PRECAUTIONS, General).<br/>Patients Receiving Other Oral Hypoglycemic Agents: As with other sulfonylurea hypoglycemic agents, no transition period is necessary when transferring patients to glimepiride tablets. Patients should be observed carefully (1 to 2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to glimepiride tablets due to potential overlapping of drug effect.
|
| dailymed-drugs:398 |
DO NOT EXCEED RECOMMENDED DOSAGE.<br/>Adults: The recommended initial dosage is two diphenoxylate HCl and atropine sulfate tablets four times daily (20 mg per day). Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (two tablets) daily. Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of diphenoxylate hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration.<br/>Children: Diphenoxylate HCl and atropine sulfate tablets are not recommended in children under 2 years of age and should be used with special caution in young children . The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use the oral solution. Do not use diphenoxylate HCl and atropine sulfate tablets for this age group. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
|
| dailymed-drugs:399 |
MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE TAKEN WHOLE, AND ARE NOT
TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED MORPHINE SULFATE EXTENDED-RELEASE TABLETS COULD LEAD TO THE RAPID RELEASE AND ABSORPTION OF A POTENTIALLY TOXIC DOSE OF MORPHINE. Morphine sulfate extended-release tablets are intended for use in patients who require more than several days continuous treatment with a potent opioid analgesic. The controlled-release nature of the formulation allows it to be administered on a more convenient schedule than conventional immediate-release oral morphine products. However, morphine sulfate extended-release tablets do not release morphine continuously over the course of a dosing interval. The administration of single doses of morphine sulfate extended-release tablets on a q12h dosing schedule will result in higher peak and lower trough plasma levels than those that occur when an identical daily dose of morphine is administered using conventional oral formulations on a q4h regimen. The clinical significance of greater fluctuations in morphine plasma level has not been systematically evaluated. As with any potent opioid drug product, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Although it is clearly impossible to enumerate every consideration that is important to the selection of initial dose and dosing interval of morphine sulfate extended-release tablets, attention should be given to 1) the daily dose, potency, and precise characteristics of the opioid the patient has been taking previously (e.g., whether it is a pure agonist or mixed agonist/antagonist), 2) the reliability of the relative potency estimate used to calculate the dose of morphine needed [N.B. potency estimates may vary with the route of administration], 3) the degree of opioid tolerance, if any, and 4) the general condition and medical status of the patient. The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions in the management of the pain of an individual patient.<br/>Conversion from Conventional Oral Morphine to Morphine Sulfate Extended-Release Tablets: A patient's daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to morphine sulfate extended-release tablets in either of two ways: 1) by administering one-half of the patient's 24-hour requirement as morphine sulfate extended-release tablets on an every12-hour schedule; or, 2) by administering one-third of the patient's daily requirement as morphine sulfate extended-release tablets on an every eight hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.<br/>Conversion from Parenteral Morphine or Other Opioids (Parenteral or Oral) to Morphine Sulfate Extended-Release Tablets: Morphine sulfate extended-release tablets can be administered as the initial oral morphine drug product; in this case, however, particular care must be exercised in the conversion process. Because of uncertainty about, and intersubject variation in, relative estimates of opioid potency and cross tolerance, initial dosing regimens should be conservative; that is, an underestimation of the 24-hour oral morphine requirement is preferred to an overestimate. To this end, initial individual doses of morphine sulfate extended-release tablets should be estimated conservatively. In patients whose daily morphine requirements are expected to be less than or equal to 120 mg per day, the 30 mg tablet strength is recommended for the initial titration period. Once a stable dose regimen is reached, the patient can be converted to the 60 mg or 100 mg tablet strength, or an appropriate combination of tablet strengths, if desired. Estimates of the relative potency of opioids are only approximate and are influenced by route of administration, individual patient differences, and possibly, by an individual's medical condition. Consequently, it is difficult to recommend any fixed rule for converting a patient to morphine sulfate extended-release tablets directly. The following general points should be considered, however. 1. Parenteral to oral morphine ratio: Estimates of the oral to parenteral potency of morphine vary. Some authorities suggest that a dose of oral morphine only three times the daily parenteral morphine requirement may be sufficient in chronic use settings. 2. Other parenteral or oral opioids to oral morphine: Because there is lack of systematic evidence bearing on these types of analgesic substitutions, specific recommendations are not possible. Physicians are advised to refer to published relative potency data, keeping in mind that such ratios are only approximate. In general, it is safer to underestimate the daily dose of morphine sulfate extended-release tablets required and rely upon ad hoc supplementation to deal with inadequate analgesia. (See discussion which follows.)<br/>Use of Morphine Sulfate Extended-Release Tablets as the First Opioid Analgesic: There has been no systematic evaluation of morphine sulfate extended-release tablets as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient using a controlled-release morphine, it is ordinarily advisable to begin treatment using an immediate-release formulation.<br/>Considerations in the Adjustment of Dosing Regimens: Whatever the approach, if signs of excessive opioid effects are observed early in a dosing interval, the next dose should be reduced. If this adjustment leads to inadequate analgesia, that is, "breakthrough" pain occurs late in the dosing interval, the dosing interval may be shortened. Alternatively, a supplemental dose of a short-acting analgesic may be given. As experience is gained, adjustments can be made to obtain an appropriate balance between pain relief, opioid side effects, and the convenience of the dosing schedule. In adjusting dosing requirements, it is recommended that the dosing interval never be extended beyond 12 hours because the administration of very large single doses may lead to acute overdose. (N.B. Morphine sulfate extended-release tablets are a controlled-release formulation; it does not release morphine continuously over the dosing interval.) For patients with low daily morphine requirements, the 15 mg tablet should be used.<br/>Conversion from Morphine Sulfate Extended-Release Tablets to Parenteral Opioids: When converting a patient from morphine sulfate extended-release tablets to parenteral opioids, it is best to assume that the parenteral to oral potency is high. NOTE THAT THIS IS THE CONVERSE OF THE STRATEGY USED WHEN THE DIRECTION OF CONVERSION IS FROM THE PARENTERAL TO ORAL FORMULATIONS. IN BOTH CASES, HOWEVER, THE AIM IS TO ESTIMATE THE NEW DOSE CONSERVATIVELY. For example, to estimate the required 24-hour dose of morphine for IM use, one could employ a conversion of 1 mg of morphine IM for every 6 mg of morphine as morphine sulfate extended-release tablets. Of course, the IM 24-hour dose would have to be divided by six and administered on a q4h regimen. This approach is recommended because it is least likely to cause overdose.
|
| dailymed-drugs:401 |
The recommended starting dose is one to two drops of
BETAGAN ophthalmic solution 0.5% in the
affected eye(s) once a day. Typical dosing with
BETAGAN 0.25% is one to two drops twice daily. In
patients with more severe or uncontrolled glaucoma,
BETAGAN 0.5% can be administered b.i.d. As with
any new medication, careful monitoring of patients is advised. Dosages
above one drop of BETAGAN 0.5% b.i.d. are not
generally more effective. If the patient's IOP is not at a
satisfactory level on this regimen, concomitant therapy with dipivefrin
and/or epinephrine, and/or pilocarpine and other miotics, and/or
systemically administered carbonic anhydrase inhibitors, such as
acetazolamide, can be instituted. Patients should not typically use two
or more topical ophthalmic beta-adrenergic blocking agents
simultaneously.
|
| dailymed-drugs:402 |
Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The physician should review the Patient Package Insert. Tretinoin Cream, USP (Emollient) should be applied to the face once a day in the evening, using only enough to cover the entire affected area lightly. Patients should gently wash their faces with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying Tretinoin Cream, USP (Emollient). The patient should apply a pea-sized amount of cream to cover the entire affected face lightly. Caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth. Application of Tretinoin Cream, USP (Emollient) may cause a transitory feeling of warmth or slight stinging. Mitigation (palliation) of facial fine wrinkling, mottled hyperpigmentation, and tactile roughness may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen. Most of the improvement noted with Tretinoin Cream, USP (Emollient) 0.05% is seen during the first 24 weeks of therapy. Thereafter, therapy primarily maintains the improvement realized during the first 24 weeks. With discontinuation of Tretinoin Cream, USP (Emollient) 0.05% therapy, a majority of patients will lose most mitigating effects of Tretinoin Cream, USP (Emollient) 0.05% on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using Tretinoin Cream, USP (Emollient) 0.05% daily for greater than 48 weeks have not been established. Application of larger amounts of medication than recommended may not lead to more rapid results or better results, and marked redness, peeling, or discomfort may occur. Patients treated with Tretinoin Cream, USP (Emollient) 0.05% may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.
|
| dailymed-drugs:403 |
Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided. Concomitant therapy: Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and by iron-containing preparations. Foods and some dairy products also interfere with absorption. Oral forms of tetracycline should be given at least 1 hour before or 2 hours after meals. In patients with renal impairment: Tetracyclines should be used cautiously in patients with impaired renal function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses. In patients with liver impairment: Tetracyclines should be used cautiously in patients with impaired liver function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses. Administration of adequate amounts of fluid with the oral formulations of tetracyclines is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. Adults: Usual daily dose - Four divided doses of 150 mg each or two divided doses of 300 mg each. For pediatric patients above eight years of age: Usual daily dose, 7 to 13 mg per kg body weight per day, depending upon the severity of the disease, divided into two to four doses not to exceed adult dosage of 600 mg per day. Gonorrhea patients sensitive to penicillin may be treated with demeclocycline administered as an initial oral dose of 600 mg followed by 300 mg every 12 hours for four days to a total of 3 grams.
|
| dailymed-drugs:404 |
Dosing and Administration in Adults:<br/>Initiation of Sotalol Hydrochloride Tablets (AF) Therapy: Step 1. Electrocardiographic assessment: Prior to administration of the first dose, the QT interval must be determined using an average of 5 beats. If the baseline QT is greater than 450 msec (JT���330 msec if QRS over 100 msec), sotalol hydrochloride tablets (AF) are contraindicated. Step 2. Calculation of creatinine clearance: Prior to the administration of the first dose, the patient's creatinine clearance should be calculated using the following formula: When serum creatinine is given in��mol/L, divide the value by 88.4 (1 mg/dL = 88.4��mol/L). Step 3. Starting Dose: The starting dose of sotalol hydrochloride tablets (AF) is 80 mg twice daily (BID) if the creatinine clearance is>60 mL/min, and 80 mg once daily (QD) if the creatinine clearance is 40-60 mL/min. If the creatinine clearance is<40 mL/min sotalol hydrochloride tablets (AF) are contraindicated. Step 4. Administer the appropriate daily dose of sotalol hydrochloride tablets (AF) and begin continuous ECG monitoring with QT interval measurements 2-4 hours after each dose. Step 5. If the 80 mg dose level is tolerated and the QT interval remains<500 msec after at least 3 days (after 5 or 6 doses if patient receiving QD dosing), the patient can be discharged. Alternatively, during hospitalization, the dose can be increased to 120 mg bid and the patient followed for 3 days on this dose (followed for 5 or 6 doses if patient receiving QD doses). The steps described above are summarized in the following diagram: Place Patient on Telemetry Check Baseline QT If QT>450 msec sotalol hydrochloride tablets (AF) are CONTRAINDICATED If QT���450 msec, proceed Calculate Creatine Clearance (Clcr) If Clcr is<40 mL/min sotalol hydrochloride tablets (AF) are CONTRAINDICATED If Clcr is 40-60 mL/min start sotalol hydrochloride tablets (AF) 80 mg QD If Clcr is>60 mL/min start sotalol hydrochloride tablets (AF) 80 mg BID Monitor QT 2-4 hours after each dose. If QT���500 msec discontinue sotalol hydrochloride tablets (AF) If QT<500 msec after 3 days (after 5th or 6th dose if patient receiving QD dosing) discharge patient on current treatment. Alternatively, during hospitalization, the dose can be increased to 120 mg BID and the patient followed for 3 days on this dose (followed for 5 or 6 doses if patient receiving QD doses).<br/>Upward Titration of Dose: In patients with Cl>60mL/min, if the 80 mg dose level (given BID or QD depending upon the creatinine clearance) does not reduce the frequency of relapses of AFIB/AFL and is tolerated without excessive QT interval prolongation (i.e.,���520 msec), the dose level may be increased to 120 mg (BID or QD depending upon the creatinine clearance). As proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment, Steps 2 through 5 used during initiation of sotalol hydrochloride tablets (AF) therapy should be followed when increasing the dose level. In the U.S. multicenter dose-response study, the 120 mg dose (BID or QD) was found to be the most effective in prolonging the time to ECG documented symptomatic recurrence of AFIB/AFL. If the 120 mg dose does not reduce the frequency of early relapse of AFIB/AFL and is tolerated without excessive QT interval prolongation (���520 msec), an increase to 160 mg (BID or QD depending upon the creatinine clearance), can be considered. Steps 2 through 5 used during the initiation of therapy should be used again to introduce such an increase.<br/>Maintenance of Sotalol Hydrochloride Tablets (AF) Therapy: Renal function and QT should be re-evaluated regularly if medically warranted. If QT is 520 msec or greater (JT 430 msec or greater if QRS is>100 msec), the dose of sotalol hydrochloride tablets (AF) therapy should be reduced and patients should be carefully monitored until QT returns to less than 520 msec. If the QT interval is���520 msec while on the lowest maintenance dose level (80 mg) the drug should be discontinued. If renal function deteriorates, reduce the daily dose in half by administering the drug once daily as described in Initiation of Sotalol Hydrochloride Tablets (AF) Therapy, Step 3. If the creatinine clearance decreases to<40 mL/min, treatment with sotalol hydrochloride tablets (AF) should be discontinued.<br/>Special Considerations: The maximum recommended dose in patients with a calculated creatinine clearance greater than 60 mL/min is 160 mg BID, doses greater than 160 mg BID have been associated with an increased incidence of Torsade de Pointes and are not recommended. A patient who misses a dose should NOT double the next dose. The next dose should be taken at the usual time.<br/>Dosing and Administration in Pediatric Patients: As in adults the following precautionary measures should be considered when initiating sotalol treatment in pediatric patients: initiation of treatment in the hospital after appropriate clinical assessment; individualized regimen as appropriate; gradual increase of doses if required; careful assessment of therapeutic response and tolerability; and frequent monitoring of the QTinterval and heart rate. For pediatric patients aged about 2 years and greater, with normal renal function, doses normalized for body surface area are appropriate for both initial and incremental dosing. Since the Class III potency in pediatric patients is not very different from that in adults, reaching plasma concentrations that occur within the adult dose range is an appropriate guide. From pediatric pharmacokinetic data the following is recommended. For initiation of treatment, 30 mg/mthree times a day (90 mg/mtotal daily dose) is approximately equivalent to the initial 160 mg total daily dose for adults. Subsequent titration to a maximum of 60 mg/m(approximately equivalent to the 360 mg total daily dose for adults) can then occur. Titration should be guided by clinical response, heart rate and QT, with increased dosing being preferably carried out in-hospital. At least 36 hours should be allowed between dose increments to attain steady-state plasma concentrations of sotalol in patients with age-adjusted normal renal function. For pediatric patients aged about 2 years or younger, the above pediatric dosage should be reduced by a factor that depends heavily upon age, as shown in the following graph, age plotted on a logarithmic scale in months. For a pediatric patient aged 20 months, the dosing suggested for pediatic patients with normal renal function aged 2 years or greater should be multiplied by about 0.97; the initial starting dose would be (30 X 0.97)=29.1 mg/m, administered three times daily. For a pediatric patient aged 1 month, the starting dose should be multiplied by 0.68; the initial starting dose would be (30 X 0.68)=20 mg/m, administered three times daily. For a pediatric patient aged about 1 week, the initial starting dose should be multiplied by 0.3; the starting dose would be (30 X 0.3)=9 mg/m. Similar calculations should be made for increased doses as titration proceeds. Since the half-life of sotalol decreases with decreasing age (below about 2 years), time to steady-state will also increase. Thus, in neonates the time to steady-state may be as long as a week or longer. In all pediatric patients, individualization of dosage is required. As in adults sotalol hydrochloride should be used with particular caution in pediatric patients if the QTis greater than 500 msec on therapy and serious consideration should be given to reducing the dose or discontinuing therapy when QTexceeds 550 msec. The use of sotalol hydrochloride tablets (AF) in pediatric patients with renal impairment has not been investigated. Sotalol elimination is predominantly via the kidney in the unchanged form. Use of sotalol in any age group with decreased renal function should be at lower doses or at increased intervals between doses. Monitoring of heart rate and QTis more important and it will take much longer to reach steady-state with any dose and/or frequency of administration.<br/>Transfer to Sotalol Hydrochloride Tablets (AF) from Sotalol Hydrochloride Tablets: Patients with a history of symptomatic AFIB/AFL who are currently receiving sotalol hydrochloride for the maintenance of normal sinus should be transferred to sotalol hydrochloride tablets (AF) because of the significant differences in labeling (i.e., patient package insert, dosing administration, and safety information).<br/>Transfer to Sotalol Hydrochloride Tablets (AF) from Other Antiarrhythmic Agents: Before starting sotalol hydrochloride tablets (AF), previous antiarrhythmic therapy should generally be withdrawn under careful monitoring for a minimum of 2-3 plasma half-lives if the patient's clinical condition permits . Treatment has been initiated in some patients receiving I.V. lidocaine without ill effect. After discontinuation of amiodarone, sotalol hydrochloride tablets (AF) should not be initiated until the QT interval is normalized (see
WARNINGS
).
|
| dailymed-drugs:405 |
Initial Treatment:<br/>Dosage for Adults:<br/>Dosage for Pediatric Population (Children and Adolescents):<br/>Maintenance/Continuation/Extended Treatment:<br/>Special Populations:<br/>Discontinuation of Treatment with sertraline hydrochloride: Symptoms associated with discontinuation of sertraline hydrochloride and other SSRIs and SNRIs, have been reported . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.<br/>Sertraline hydrochloride Oral Concentrate: Sertraline hydrochloride Oral Concentrate contains 20 mg/mL of sertraline (as the hydrochloride) as the active ingredient and 12% alcohol. Sertraline hydrochloride Oral Concentrate must be diluted before use. Just before taking, use the dropper provided to remove the required amount of sertraline hydrochloride Oral Concentrate and mix with 4 oz (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice ONLY. Do not mix sertraline hydrochloride Oral Concentrate with anything other than the liquids listed. The dose should be taken immediately after mixing. Do not mix in advance. At times,a slight haze may appear after mixing; this is normal. Note that caution should be exercised for patients with latex sensitivity, as the dropper dispenser contains dry natural rubber. Sertraline hydrochloride Oral Concentrate is contraindicated with ANTABUSE (disulfiram) due to the alcohol content of the concentrate.
|
| dailymed-drugs:406 |
IN ADULTS, THE
COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND
KETOROLAC TROMETHAMINE TABLETS IS NOT TO EXCEED FIVE (5) DAYS. IN
ADULTS, THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS
CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.<br/>Ketorolac
Tromethamine Injection:<br/>Adult
Patients: Ketorolac Tromethamine Injection may be used as a
single or multiple dose on a regular or���prn���schedule
for the management of moderately severe acute pain that
requires analgesia at the opioid level, usually in a
postoperative setting. Hypovolemia should be corrected
prior to the administration of ketorolac tromethamine
. Patients
should be switched to alternative analgesics as soon as
possible, but ketorolac tromethamine therapy is not to
exceed five (5) days. When administering Ketorolac Tromethamine Injection,
the IV bolus must be given over no less than 15 seconds.
The IM administration should be given slowly and deeply
into the muscle. The analgesic effect begins in ~30
minutes with maximum effect in 1 to 2 hours after dosing
IV or IM. Duration of analgesic effect is usually 4 to 6
hours.<br/>Single-Dose
Treatment: The Following Regimen Should Be Limited to Single
Administration Use Only:<br/>Adult
Patients:<br/>Pediatric
Patients (2 to 16 Years of Age): The
pediatric population should receive only a single dose
of Ketorolac Tromethamine Injection, as
follows:<br/>Multiple-Dose
Treatment (IV or IM) in Adults:<br/>Patients<65 Years of Age: The
recommended dose is 30 mg Ketorolac Tromethamine
Injection every 6 hours. The maximum daily dose should
not exceed 120 mg.<br/>For
Patients���65 Years of Age, Renally Impaired Patients and
Patients Less Than 50 Kg (110 lbs): The
recommended dose is 15 mg Ketorolac Tromethamine
Injection every 6 hours. The maximum daily dose for
these populations should not exceed 60 mg. For
breakthrough pain do not increase the dose or the
frequency of ketorolac tromethamine. Consideration
should be given to supplementing these regimens with low
doses of opioids prn unless otherwise
contraindicated.<br/>Pharmaceutical
Information for Ketorolac Tromethamine Injection: Parenteral
drug products should be inspected visually for particulate
matter and discoloration prior to administration, whenever
solution and container permit. Ketorolac
Tromethamine Injection should not be mixed in a small volume
(e.g., in a syringe) with morphine sulfate, meperidine
hydrochloride, promethazine hydrochloride or hydroxyzine
hydrochloride; this will result in precipitation of ketorolac
from solution. Shortening
the recommended dosing intervals may result in increased
frequency and severity of adverse reactions.
|
| dailymed-drugs:407 |
Carefully consider the potential benefits and risks of oxaprozin tablet, USP and other treatment options before deciding to use oxaprozin tablet, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . After observing the response to initial therapy with oxaprozin tablet, USP, the dose and frequency should be adjusted to suit an individual patient's needs. Rheumatoid arthritis: For relief of the signs and symptoms of rheumatoid arthritis, the usual recommended dose is 1200 mg (two 600-mg tablets) given orally once a day (see Individualization of dosage). Osteoarthritis: For relief of the signs and symptoms of osteoarthritis, the usual recommended dose is 1200 mg (two 600-mg tablets) given orally once a day (see Individualization of dosage). Juvenile rheumatoid arthritis: For the relief of the signs and symptoms of JRA in patients 6-16 years of age, the recommended dose given orally once per day should be based on body weight of the patient as given in Table 3 (see also Individualization of dosage). Individualization of dosage: As with other NSAIDs, the lowest dose should be sought for each patient. Therefore, after observing the response to initial therapy with oxaprozin tablet, USP, the dose and frequency should be adjusted to suit an individual patient's needs. In osteoarthritis and rheumatoid arthritis and juvenile rheumatoid arthritis, the dosage should be individualized to the lowest effective dose of oxaprozin tablet, USP to minimize adverse effects. The maximum recommended total daily dose of oxaprozin tablet, USP in adults is 1800 mg (26 mg/kg, whichever is lower) in divided doses. In children, doses greater than1200 mg have not been studied. Patients of low body weight should initiate therapy with 600 mg once daily. Patients with severe renal impairment or on dialysis should also initiate therapy with 600 mg once daily. If there is insufficient relief of symptoms in such patients, the dose may be cautiously increased to 1200 mg, but only with close monitoring . In adults, in cases where a quick onset of action is important, the pharmacokinetics of oxaprozin allow therapy to be started with aone-time loading dose of 1200 to 1800 mg (not to exceed 26 mg/kg). Doses larger than 1200 mg/day on a chronic basis should be reserved for patients who weigh more than 50 kg, have normal renal and hepatic function, are at low risk of peptic ulcer, and whose severity of disease justifies maximal therapy. Physicians should ensure that patients are tolerating doses in the 600 to 1200 mg/day range without gastroenterologic, renal, hepatic, or dermatologic adverse effects before advancing to the larger doses. Most patients will tolerate once-a-day dosing with oxaprozin tablet, USP, although divided doses may be tried in patients unable to tolerate single doses.<br/>SAFETY AND HANDLING: Oxaprozin tablet, USP is supplied as a solid dosage form in closed containers, is not known to produce contact dermatitis, and poses no known risk to healthcare workers. It may be disposed of in accordance with applicable local regulations governing the disposal of pharmaceuticals.
|
| dailymed-drugs:408 |
Gently massage ciclopirox olamine cream, USP into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream, USP the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
|
| dailymed-drugs:409 |
Apply the 0.1% triamcinolone acetonide lotion to the affected area two to three times daily. Rub in gently.<br/>Occlusive Dressing Technique: Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of lotion into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply triamcinolone acetonide lotion under an occlusive dressing in the evening and to remove the dressing in the morning (i.e.,12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional lotion should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
|
| dailymed-drugs:410 |
This preparation is specifically designed for use with���three-way���catheters or with other catheter systems permitting continuous irrigation of the urinary bladder. The usual irrigation dose is
one 1-mL ampul a day for up to 10 days. Using strict
aseptic techniques, the contents of one 1-mL ampul of NEOSPORIN G.U. Irrigant
Sterile (neomycin sulfate-polymyxin B sulfate solution for irrigation) should
be added to a 1,000-mL container of isotonic saline solution. This container
should then be connected to the inflow lumen of the���three-way���catheter which has been inserted with full aseptic precautions; use of a sterile
lubricant is recommended during insertion of the catheter. The outflow lumen
should be connected, via a sterile disposable plastic tube, to a disposable
plastic collection bag. Stringent procedures, such as taping the inflow and
outflow junction at the catheter, should be observed when necessary to insure
the junctional integrity of the system. For most patients,
the inflow rate of the 1,000-mL saline solution of neomycin and polymyxin
B should be adjusted to a slow drip to deliver about 1,000 mL every 24 hours.
If the patient's urine output exceeds 2 liters per day, it is recommendedthat the inflow rate be adjusted to deliver 2,000 mL of the solution in a
24-hour period. It is important that the rinse of the
bladder be continuous; the inflow or rinse
solution should not be interrupted for more than a few minutes. Preparation
of the irrigation solution should be performed with strict aseptic techniques.
The prepared solution should be stored at 4��C, and should be used within
48 hours following preparation to reduce the risk of contamination with resistant
microorganisms.
|
| dailymed-drugs:411 |
Apply a thin film to affected areas twice daily.
|
| dailymed-drugs:622 |
Apply a thin film to affected areas twice daily.
|
| dailymed-drugs:3987 |
Apply a thin film to affected areas twice daily.
|
| dailymed-drugs:412 |
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.<br/>Proper Use of an Intensol���: An Intensol is a concentrated oral solution as compared to standard oral liquid medications. It is recommended that an Intensol be mixed with liquid or semi-solid food such as water, juices, soda or soda-like beverages, applesauce and puddings. Use only the calibrated dropper provided with this product. Draw into the dropper the amount prescribed for a single dose. Then squeeze the dropper contents into a liquid or semi-solid food. Stir the liquid or food gently for a few seconds. The Intensol formulation blends quickly and completely. The entire amount of the mixture, of drug and liquid or drug and food, should be consumed immediately. Do not store for future use.
|
| dailymed-drugs:414 |
NOTE: This insert is
for a Pharmacy Bulk Package and is intended for preparing IV admixtures only.
Dosage recommendations for intramuscular or intravenous injection and intraperitoneal
use are for informational purposes only. Dosage: The usual adult dosage is 1 gram administered intravenously every
8 or 12 hours. The dosage and route should be determined by the susceptibility
of the causative organisms, the severity of infection and the condition and
renal function of the patient. The guidelines for dosage
of Tazicef (ceftazidime for injection, USP) are listed in Table 3. The following
dosage schedule is recommended. Impaired Hepatic Function: No adjustment in dosage is
required for patients with hepatic dysfunction. Impaired Renal Function: Ceftazidime is
excreted by the kidneys, almost exclusively by glomerular filtration. Therefore,
in patients with impaired renal function (glomerular filtration rate [GFR]<50 mL/min.), it is recommended that the dosage of ceftazidime be reduced
to compensate for its slower excretion. In patients with suspected renal insufficiency,
an initial loading dose of 1 gram of ceftazidime may be given. An estimate
of GFR should be made to determine the appropriate maintenance dose. The recommended
dosage is presented in Table 4. When only serum creatinine is available, the following
formula (Cockcroft's equation)may be used to estimate
creatinine clearance. The serum creatinine should represent a steady state
of renal function: In patients with severe infections who would normally receive
6 grams of Tazicef daily were it not
for renal insufficiency, the unit dose given in the table above may be increased
by 50% or the dosing frequency increased appropriately. Further dosing should
be determined by therapeutic monitoring, severity of the infection and susceptibility
of the causative organism. In pediatric patients as
for adults, the creatinine clearance should be adjusted for body surface area
or lean body mass and the dosing frequency reduced in cases of renal insufficiency. In
patients undergoing hemodialysis, a loading dose of 1 gram is recommended,
followed by 1 gram after each hemodialysis period. Tazicef
(ceftazidime for injection, USP) can also be used in patients undergoing intra-peritoneal
dialysis and continuous ambulatory peritoneal dialysis. In such patients,
a loading dose of 1 gram of Tazicef may
be given, followed by 500 mg every 24 hours. In addition to IV use, Tazicef can be incorporated in the dialysis
fluid at a concentration of 250 mg for 2 liters of dialysis fluid. Note: Generally Tazicef should be continued for 2 days after the signs and symptoms of
infection have disappeared, but in complicated infections longer therapy may
be required. Administration: See above NOTE concerning the proper use of Pharmacy Bulk Packages. Intravenous Administration: The IV route
is preferable for patients with bacterial septicemia, bacterial meningitis,
peritonitis, or other severe or life-threatening infections, or for patients
who may be poor risks because of lowered resistance resulting from such debilitating
conditions as malnutrition, trauma, surgery, diabetes, heart failure or malignancy,
particularly if shock is present or pending. Intermittent intravenous infusion with a Y-type administration
set can be accomplished with compatible solutions. However, during
infusion of a solution containing ceftazidime it is desirable to discontinue
the other solution. All vials of Tazicef as supplied are under reduced pressure. When Tazicef is dissolved, carbon dioxide is released and a positive pressure
develops. See RECONSTITUTION. Solutions of Tazicef, like those of most beta-lactam antibiotics,
should not be added to solutions of aminoglycoside antibiotics because of
potential interaction. However, if concurrent therapy
with Tazicef and an aminoglycoside
is indicated, each of these antibiotics can be administered separately to
the same patient. RECONSTITUTION Directions for
Proper Use of Pharmacy Bulk Packages: Note: The Pharmacy Bulk Package is for use in a
pharmacy admixture service only. Using aseptic technique, the closure should
be penetrated only 1 time after reconstitution using a sterile dispensing
set which allows measured dispensing of the contents. Use of a syringe and
needle is not recommended as it may cause leakage. The withdrawal of container
contents should be accomplished without delay. THE ENTIRE CONTENTS OF THE
VIAL SHOULD BE DISPENSED WITHIN 4 HOURS OF INITIAL ENTRY. A
plastic bail attached to the Pharmacy Bulk Package provides a suitable hanging
device while dispensing in the pharmacy. Reconstitute
with Sterile Water for Injection according to the following table. The vacuum may assist entry of the diluent. SHAKE WELL. Insert
a gas relief needle through the vial closure to relieve the internal pressure.
Remove the gas relief needle before extracting any solution. COMPATIBILITY AND STABILITY IMPORTANT:
The following chemical stability information in no way indicates that it would
be acceptable practice to use this product well after the preparation time.
Good professional practice suggests that compounded admixtures should be administered
as soon after preparation as is feasible. Intravenous:Tazicef (ceftazidime for injection, USP) when reconstituted as
directed with Sterile Water for Injection, maintains satisfactory potency
for 24 hours at room temperature or for 7 days under refrigeration (5��C).
Solutions in 0.9% Sodium Chloride Injection in Viaflex small
volume containers that are frozen immediately after reconstitution are stable
for 3 months when stored at -20��C. Components of the solution may precipitate
in the frozen state and will dissolve upon reaching room temperature with
little or no agitation. Potency is not affected. Frozen solutions should only
be thawed at room temperature. Do not force thaw by immersion in water baths
or by microwave irradiation. For larger volumes where it may be necessary
to warm the frozen product (to a maximum of 40��C), care should be taken
to avoid heating after thawing is complete. Once thawed, solutions should
not be refrozen. Thawed solutions may be stored for up to 8 hours at room
temperature or for 4 days in a refrigerator (5��C). Tazicef
(ceftazidime for injection, USP) is compatible with the more commonly used
IV infusion fluids. Solutions at concentrations between 1 mg/mL and 40 mg/mL
in the following infusion fluids may be stored for up to 24 hours at room
temperature or 7 days if refrigerated: 0.9% Sodium Chloride Injection; Ringer's
Injection USP; Lactated Ringer's Injection USP; 5% Dextrose Injection;
5% Dextrose and 0.225% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium
Chloride Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 10% Dextrose
Injection. Tazicef is
less stable in Sodium Bicarbonate Injection than in other IV fluids. It is
not recommended as a diluent. Solutions of Tazicef in 5% Dextrose and 0.9% Sodium Chloride Injection are stable for
at least 6 hours at room temperature in plastic tubing, drip chambers and
volume control devices of common IV infusion sets. Ceftazidime
at a concentration of 20 mg/mL has been found physically compatible for 24
hours at room temperature or 7 days under refrigeration in Sterile Water for
Injection when admixed with: cefazolin sodium 330 mg/mL; heparin 1000 units/mL;
and cimetidine HCl 150 mg/mL. Ceftazidime at a concentration
of 20 mg/mL has been found physically compatible for 24 hours at room temperature
or 7 days under refrigeration in 5% Dextrose Injection when admixed with potassium
chloride 40 mEq/L. Vancomycin solution exhibits a physical
incompatibility when mixed with a number of drugs, including ceftazidime.
The likelihood of precipitation with ceftazidime is dependent on the concentrations
of vancomycin and ceftazidime present. It is therefore recommended, when both
drugs are to be administered by intermittent IV infusion, that they be given
separately, flushing the IV lines (with one of the compatible IV fluids) between
the administration of these two agents. Note: Parenteral drug products should be inspected visually for particulate
matter prior to administration whenever solution and container permit. As
with other cephalosporins, Tazicef (ceftazidime for injection, USP) powder,
as well as solutions, tends to darken depending on storage conditions; within
the stated recommendations, however, product potency is not adversely affected.
|
| dailymed-drugs:415 |
Midazolam hydrochloride injection
is a potent sedative agent that requires slow administration and individualization
of dosage. Clinical experience has shown midazolam hydrochloride to be 3 to
4 times as potent per mg as diazepam. BECAUSE SERIOUS AND LIFE-THREATENING
CARDIORESPIRATORY ADVERSE EVENTS HAVE BEEN REPORTED, PROVISION FOR MONITORING,
DETECTION AND CORRECTION OF THESE REACTIONS MUST BE MADE FOR EVERY PATIENT
T0 WHOM MIDAZOLAM HYDROCHLORIDE INJECTION IS ADMINISTERED, REGARDLESS OF AGE
OR HEALTH STATUS. Excessive single doses or rapid intravenous administration
may result in respiratory depression, airway obstruction and/or arrest. The
potential for these latter effects is increased in debilitated patients, those
receiving concomitant medications capable of depressing the CNS, and patients
without an endotracheal tube but undergoing a procedure involving the upper
airway such as endoscopy or dental (see Boxed WARNING and WARNINGS). Reactions
such as agitation, involuntary movements, hyperactivity and combativeness
have been reported in adult and pediatric patients. Should such reactions
occur, caution should be exercised before continuing administration of midazolam
hydrochloride (see WARNINGS). Midazolam
hydrochloride injection should only be administered IM or IV (see WARNINGS). Care should be
taken to avoid intra-arterial injection or extravasation (see WARNINGS). Midazolam Hydrochloride Injection may
be mixed in the same syringe with the following frequently used premedications:
morphine sulfate, meperidine, atropine sulfate or scopolamine. Midazolam,
at a concentration of 0.5 mg/mL, is compatible with 5% dextrose in water and
0.9% sodium chloride for up to 24 hours and with lactated Ringer's
solution for up to 4 hours. Both the 1 mg/mL and 5 mg/mL formulations of midazolam
may be diluted with 0.9% sodium chloride or 5% dextrose in water. Monitoring: Patient response to sedative
agents, and resultant respiratory status, is variable. Regardless of the intended
level of sedation or route of administration, sedation is a continuum; a patient
may move easily from light to deep sedation, with potential loss of protective
reflexes. This is especially true in pediatric patients. Sedative doses should
be individually titrated, taking into account patient age, clinical status
and concomitant use of other CNS depressants. Continuous monitoring of respiratory
and cardiac function is required (i.e., pulse oximetry). Adults and Pediatrics: Sedation guidelines recommend
a careful presedation history to determine how a patient's underlying
medical conditions or concomitant medications might affect their response
to sedation/analgesia as well as a physical examination including a focused
examination of the airway for abnormalities. Further recommendations include
appropriate presedation fasting. Titration to effect
with multiple small doses is essential for safe administration. It should
be noted that adequate time to achieve peak central nervous system effect
(3 to 5 minutes) for midazolam should be allowed between doses to minimize
the potential for oversedation. Sufficient time must elapse between doses
of concomitant sedative medications to allow the effect of each dose to be
assessed before subsequent drug administration. This is an important consideration
for all patients who receive intravenous midazolam. Immediate
availability of resuscitative drugs and age-
and size-appropriate equipment and personnel trained in their use
and skilled in airway management should be assured (see WARNINGS). Pediatrics: For deeply sedated pediatric patients a dedicated individual,
other than the practitioner performing the procedure, should monitor the patient
throughout the procedure. Intravenous access is not
thought to be necessary for all pediatric patients sedated for a diagnostic
or therapeutic procedure because in some cases the difficulty of gaining IV
access would defeat the purpose of sedating the child; rather, emphasis should
be placed upon having the intravenous equipment available and a practitioner
skilled in establishing vascular access in pediatric patients immediately
available.
|
| dailymed-drugs:416 |
Simulect (basiliximab) is used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids. Simulect is for central or peripheral intravenous administration only. Reconstituted Simulect should be given either as a bolus injection or diluted to a volume of 25 mL (10-mg vial) or 50 mL (20-mg vial) with normal saline or dextrose 5% and administered as an intravenous infusion over 20 to 30 minutes. Bolus administration may be associated with nausea, vomiting and local reactions, including pain. Simulect should only be administered once it has been determined that the patient will receive the graft and concomitant immunosuppression. Patients previously administered Simulect should only be re-exposed to a subsequent course of therapy with extreme caution due to the potential risk of hypersensitivity (see WARNINGS). Parenteral drug products should be inspected visually for particulate matter and discoloration before administration. After reconstitution, Simulect should be a clear-to-opalescent, colorless solution. If particulate matter is present or the solution is colored, do not use. Care must be taken to assure sterility of the prepared solution because the drug product does not contain any antimicrobial preservatives or bacteriostatic agents. It is recommended that after reconstitution, the solution should be used immediately. If not used immediately, it can be stored at 2��C to 8��C for 24 hours or at room temperature for 4 hours. Discard the reconstituted solution if not used within 24 hours. No incompatibility between Simulect and polyvinyl chloride bags or infusion sets has been observed. No data are available on the compatibility of Simulect with other intravenous substances. Other drug substances should not be added or infused simultaneously through the same intravenous line.<br/>Adults: In adult patients, the recommended regimen is two doses of 20 mg each. The first 20-mg dose should be given within 2 hours prior to transplantation surgery. The recommended second 20-mg dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Simulect or graft loss occur.<br/>Pediatric: In pediatric patients weighing less than 35 kg, the recommended regimen is two doses of 10 mg each. In pediatric patients weighing 35 kg or more, the recommended regimen is two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery. The recommended second dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Simulect or graft loss occur.<br/>Reconstitution of 10 mg Simulect Vial: To prepare the reconstituted solution, add 2.5 mL of Sterile Water for Injection, USP, using aseptic technique, to the vial containing the Simulect powder. Shake the vial gently to dissolve the powder. The reconstituted solution is isotonic and may be given either as a bolus injection or diluted to a volume of 25 mL with normal saline or dextrose 5% for infusion. When mixing the solution, gently invert the bag in order to avoid foaming; DO NOT SHAKE.<br/>Reconstitution of 20 mg Simulect Vial: To prepare the reconstituted solution, add 5 mL of Sterile Water for Injection, USP, using aseptic technique, to the vial containing the Simulect powder. Shake the vial gently to dissolve the powder. The reconstituted solution is isotonic and may be given either as a bolus injection or diluted to a volume of 50 mL with normal saline or dextrose 5% for infusion. When mixing the solution, gently invert the bag in order to avoid foaming; DO NOT SHAKE.
|
| dailymed-drugs:417 |
Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP: Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.<br/>Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy: The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin���50 mg/m��. Multiday, single-dose administration of a 24 mg dosage has not been studied.<br/>Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.<br/>Geriatric Use: The dosage recommendation is the same as for the general population.<br/>Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.<br/>Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.<br/>Geriatric Use: The dosage is the same as for the general population.<br/>Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day. For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day. For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy. For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.<br/>Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.<br/>Geriatric Use: The dosage recommendation is the same as for the general population.<br/>Postoperative Nausea and Vomiting: The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.<br/>Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.<br/>Geriatric Use: The dosage is the same as for the general population.<br/>Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.<br/>Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pughscore of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
|
| dailymed-drugs:418 |
DOSAGE MUST BE INDIVIDUALIZED ACCORDING TO PATIENT'S RESPONSE. CAPOZIDE may be substituted for the previously titrated individual components. Alternatively, therapy may be instituted with a single tablet of CAPOZIDE 25 mg/15 mg taken once daily. For patients insufficiently responsive to the initial dose, additional captopril or hydrochlorothiazide may be added as individual components or by using CAPOZIDE 50 mg/15 mg, 25 mg/25 mg or 50 mg/25 mg, or divided doses may be used. Because the full effect of a given dose may not be attained for six to eight weeks, dosage adjustments should generally be made at six-week intervals, unless the clinical situation demands more rapid adjustment. In general, daily doses of captopril should not exceed 150 mg and of hydrochlorothiazide should not exceed 50 mg. CAPOZIDE should be taken one hour before meals. Dosage Adjustment in Renal Impairment: Because captopril and hydrochlorothiazide are excreted primarily by the kidneys, excretion rates are reduced in patients with impaired renal function. These patients will take longer to reach steady-state captopril levels and will reach higher steady-state levels for a given daily dose than patients with normal renal function. Therefore, these patients may respond to smaller or less frequent doses of CAPOZIDE. After the desired therapeutic effect has been achieved, the dose intervals should be increased or the total daily dose reduced until the minimal effective dose is achieved. When concomitant diuretic therapy is required in patients with severe renal impairment, a loop diuretic (eg, furosemide), rather than a thiazide diuretic is preferred for use with captopril; therefore, for patients with severe renal dysfunction the captopril and hydrochlorothiazide combination tablet isnot usually recommended.
|
| dailymed-drugs:419 |
Zemplar Capsules may be administered daily or three
times a week. When dosing three times weekly, the dose should be administered
no more frequently than every other day. The average weekly doses for both
daily and three times a week dosage regimens are similar (see CLINICAL
STUDIES). Zemplar Capsules may be taken
without regard to food. No dosing adjustment is required in patients with
mild and moderate hepatic impairment.<br/>Initial Dose: The initial dose of Zemplar Capsules is based on
baseline intact parathyroid hormone (iPTH) levels.<br/>Dose Titration: Dosing must be individualized and based on serum
or plasma iPTH levels, with monitoring of serum calcium and serum phosphorus.
The following is a suggested approach in titration. If a patient is taking the lowest dose
on the daily regimen and a dose reduction is needed, the dose can be decreased
to 1 mcg three times a week. If a further dose reduction is required, the
drug should be withheld as needed and can be restarted at a lower dose. If
a patient is on a calcium-based phosphate binder, the binder dose may be decreased
or withheld, or the patient may be switched to a non-calcium-based phosphate
binder. If hypercalcemia or an elevated Ca x P is observed, the dose of Zemplar
should be reduced or interrupted until these parameters are normalized. Serum calcium and phosphorus levels should be closely monitored
after initiation of Zemplar Capsules and during dose titration periods and
coadministration with strong P450 3A inhibitors (see CLINICAL
PHARMACOLOGY and PRECAUTIONS).
|
| dailymed-drugs:420 |
When fluorouracil is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion and reepithelialization. Fluorouracil should be applied preferably with a nonmetal applicator or suitable glove. If fluorouracil is applied with the fingers, the hands should be washed immediately afterward.<br/>Actinic or Solar Keratosis: Apply solution twice daily in an amount sufficient to cover the lesions. Medication should be continued until the inflammatory response reaches the erosion stage, at which time use of the drug should be terminated. The usual duration of therapy is from 2 to 4 weeks. Complete healing of the lesions may not be evident for 1 to 2 months following cessation of fluorouracil therapy.<br/>Superficial Basal Cell Carcinomas: Only the 5% strength is recommended. Apply solution twice daily in an amount sufficient to cover the lesions. Treatment should be continued for at least 3 to 6 weeks. Therapy may be required for as long as 10 to 12 weeks before the lesions are obliterated. As in any neoplastic condition, the patient should be followed for a reasonable period of time to determine if a cure has been obtained.
|
| dailymed-drugs:421 |
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection. FOR OPHTHALMIC USE ONLY.
|
| dailymed-drugs:422 |
In elderly patients, the pharmacokinetics of metronidazole may be altered, and, therefore, monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly.<br/>Trichomoniasis:<br/>In the Female:<br/>In the Male: Treatment should be individualized as for the female.<br/>Amebiasis:<br/>Adults:<br/>Pediatric Patients: 35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days.<br/>Anaerobic Bacterial Infections: In the treatment of most serious anaerobic infections, the intravenous form of metronidazole is usually administered initially. The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70-kg adult). A maximum of 4 g should not be exceeded during a 24-hour period. The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment. Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Close monitoring of plasma metronidazole levelsand toxicity is recommended. The dose of metronidazole should not be specifically reduced in anuric patients since accumulated metabolites may be rapidly removed by dialysis.
|
| dailymed-drugs:423 |
Apply a thin layer of Halobetasol Propionate Ointment to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely. Halobetasol Propionate Ointment is a high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Halobetasol Propionate Ointment should not be used with occlusive dressings.
|
| dailymed-drugs:424 |
When the DentiPatch system is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind. Isolate the procedure area with cotton rolls and use suction as appropriate. Dry the tissue with air or gauze. Remove the DentiPatch system from its packaging and peel off the clear protective liner. Immediately apply the DentiPatch' system using firm pressure. Allow the patch to remain in place until the desired anesthetic effect is produced but not for longer than 15 minutes. Experience in children is inadequate to recommend a pediatric dose at this time.
|
| dailymed-drugs:425 |
Because the pharmacokinetics of digoxin are complex, and because toxic levels of digoxin are only slightly higher than therapeutic levels, digoxin dosing can be difficult. The recommended approach is to<br/>Table 2: These doses will, in uncomplicated patients, tend to produce steady-state post-absorptive levels of 1 to 2 ng/mL, but the confidence limits around this range are wide.<br/>Adjust the Estimated Dose: As noted in CLINICAL PHARMACOLOGY, Pharmacokinetics and in WARNINGS: Drug Interactions, the body's handling of digoxin can be affected by many different patient-specific factors. Some of the possible effects are usually small, so anticipatory dose adjustment might not be required, but others shouldbe considered before initial dosing. Patients with abnormal renal function need to have their doses of digoxin proportionately reduced. Normal developmental changes in pediatric renal function were factored into the table given in the previous subsection, but age-related (or other) changes in adult renal function were not. The effects of renal function on recommended digoxin doses in adults is shown in Table 3 below. For children with known or suspected renal dysfunction, lower starting doses should be considered combined with frequent monitoring of digoxin levels. Digoxin's volume of distribution is proportional to lean body weight, and the table in the previous section assumes that patients are of average composition. The dose of digoxin must be reduced in patients whose lean body weight is���typically because of obesity or edema���an abnormally small fraction of their total body mass. Concomitant drug use should be considered when adjusting the estimated digoxin dose . NOTE: The calibrated dropper supplied with the 60 mL bottle of digoxin oral solution is not appropriate to measure doses below 0.2 mL. Doses less than 0.2 mL require appropriate methods or measuring devices designed to administer an accurate amount to the patient. Table 3 provides average daily maintenance dose requirements of digoxin for patients with heart failure based upon lean body weight and renal function.<br/>Table 3:<br/>Table 4: On the left side of the chart, locate the patient's weight in kilograms. At the top of the chart, identify which dose in mcg/kg/day will be used for this patient. The block on the chart at which the two rows (weight and target dose) intersect is the milliliter amount that should be given to the patient.<br/>Patient Monitoring: Dosing as described above may need to be increased or decreased, depending upon the patient's response, so patients must be monitored for signs of efficacy and toxicity. When the purpose of digoxin therapy is reduction of resting ventricular response to atrial tachyarrhythmia, a therapeutic digoxin effect may be obvious. In other settings, however, the therapeutic effect of digoxin may be difficult to separate from other developments in the course of the underlying disease. Similarly, digoxin toxicity may be easily identified when there are pathognomonic findings of new atrioventricular block, or of yellow/green discoloration of vision. Other manifestations of digoxin toxicity (e.g., nausea) might have alternative explanations, and symptoms of toxicity may be difficult to evaluate in small children and other inarticulate patients. It will therefore often be necessary to monitor digoxin therapy by means of serum digoxin levels. Because hypokalemia or hypomagnesia can greatly increase the risk of digoxin toxicity, it is appropriate to monitor these levels whenever digoxin levels are measured. These assays are widely available. Digoxin should be allowed to distribute into its volume of distribution before measurement, so specimens for these assays should not be collected until 6 to 8 hours after the time of administration. In general, serum levels below 0.5 ng/mL are unlikely to be beneficial, while levels above 2 ng/mL are associated with increased toxicity without increased benefit. Within the 0.5 to 2 ng/mL range, the inotropic effects of digoxin tend to appear at lower concentrations than the electrophysiological effects. When decision-making is to be guided by serum digoxin levels, the clinician must consider the possibility of reported concentrations that have been falsely elevated by endogenous digoxin-like immunoreactive substances . If the assay being used is sensitive to these substances, it may be prudent to obtain a baseline measurement before digoxin therapy is started, and correct later values by the reported baselinelevel.<br/>Dose Adjustment: The monitoring described above may suggest increases or decreases in digoxin doses. Additional monitoring, and in some cases anticipatory dose adjustment, may be indicated around the time of various changes in the patient's internal milieu, including
|
| dailymed-drugs:426 |
Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement: The recommended dose is 75 to 100 mg four times daily as an adjunct to the usual warfarin therapy. Please note that aspirin is not to be administered concomitantly with coumarin anticoagulants.
|
| dailymed-drugs:427 |
The dose for adults and children greater than two years of age is one to two drops in each affected eye four times daily for up to 3 months.
|
| dailymed-drugs:428 |
SOLODYN���is a once-daily tablet to be prescribed based on the patient's weight to achieve approximately a 1 mg/kg dosage without any loading dose. The following table shows tablet strength and body weight to achieve approximately 1 mg/kg. SOLODYN���tablets may be taken with or without food . Ingestion of food along with SOLODYN���may help reduce the risk of esophageal irritation and ulceration. The recommended dosage of SOLODYN���per clinical trials is 1 mg/kg daily for 12 weeks. Higher doses have not shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular side effects. In patients with renal impairment , the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses.
|
| dailymed-drugs:429 |
Not recommended for use in pediatric patients less than 2 months of age.<br/>Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children:<br/>Adults: The usual adult dosage in the treatment of urinary tract infections is 1 BACTRIM DS (double strength) tablet or 2 BACTRIM tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.<br/>Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:<br/>For Patients with Impaired Renal Function: When renal function is impaired, a reduced dosage should be employed using the following table:<br/>Acute Exacerbations of Chronic Bronchitis in Adults: The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 BACTRIM DS (double strength) tablet or 2 BACTRIM tablets every 12 hours for 14 days.<br/>Pneumocystis Carinii Pneumonia:<br/>Treatment: Adults and Children: The recommended dosage for patients with documented Pneumocystis carinii pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.The following table is a guideline for the upper limit of this dosage. For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.<br/>Prophylaxis:<br/>Adults: The recommended dosage for prophylaxis in adults is 1 BACTRIM DS (double strength) tablet daily.<br/>Children: For children, the recommended dose is 750 mg/m/day sulfamethoxazole with 150 mg/m/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.The following table is a guideline for the attainment of this dosage in children:<br/>Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea, the usual adult dosage is 1 BACTRIM DS (double strength) tablet or 2 BACTRIM tablets every 12 hours for 5 days.
|
| dailymed-drugs:430 |
Central Diabetes Insipidus: The dosage of DDAVP Tablets must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients previously on intranasal DDAVP therapy should begin tablet therapy twelve hours after the last intranasal dose. During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response. Patients should be monitored at regular intervals during the course of DDAVP Tablet therapy to assure adequate antidiuretic response. Modifications in dosage regimen should be implemented as necessary to assure adequate water turnover. Fluid restriction should be observed.<br/>Adults and Children: It is recommended that patients be started on doses of 0.05 mg (1/2 of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose. Most patients in clinical trials found that the optimal dosage range is 0.1 mg to 0.8 mg daily, administered in divided doses. Each dose should be separately adjusted for an adequate diurnalrhythm of water turnover. Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuresis. See Pediatric Use subsection for special considerations when administering desmopressin acetate to pediatric diabetes insipidus patients.<br/>Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.<br/>Primary Nocturnal Enuresis: The dosage of DDAVP Tablets must be determined for each individual patient and adjusted according to response. Patients previously on intranasal DDAVP therapy can begin tablet therapy the night following (24 hours after) the last intranasal dose. The recommended initial dose for patients age 6 years and older is 0.2 mg at bedtime. The dose may be titrated up to 0.6 mg to achieve the desired response. Fluid restriction should be observed, and fluid intake should be limited to a minimum from 1 hour before desmopressin administration, until the next morning, or at least 8 hours after administration.
|
| dailymed-drugs:432 |
Clinical studies
have shown that stressed patients can safely utilize up to 1.4 g/kg/day
of a 50% branched chain amino acid supplemented solution. However, the
total daily dose of the branched chain amino acid supplemented solutions
depends upon the judgement of the physician based upon the patient's
metabolic requirement, branched chain amino acid deficits and clinical
response. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. Use of a final filter is recommended during administration of
all parenteral solutions where possible. Do not administer unless solution is clear and
seal is intact. For dosage and
administration of concomitantly administered solutions, reference should
be made to the specific product information pertinent to that drug. Care should be
exercised to insure the maintenance of proper levels of serum potassium.
Quantities of 60 to 180 mEq of potassium per day have been used with
adequate clinical effect. All serum electrolytes should be monitored
frequently and electrolyte requirements individualized. Usual
administration of 4% BranchAmin' (Branched Chain Amino Acid) Injection
is as a supplement to parenteral nutrition solutions to achieve an amino
acid solution which is approximately 50% w/w branched chain amino acid.
(One method for achieving this ratio is the admixture of two volumes of
4% BranchAmin' (Branched Chain Amino Acid) Injection at 4 g/100 mL
concentration with one volume of an amino acid solution of 8 to 10 g/100
mL concentration.) The supplemental amino acid mixture is administered
in combination with energy substrates to provide at least 35 kcal/kg
ideal body weight as nonprotein calories. The treatment
regimen should be discontinued when the patient exhibits a marked
reduction in the clinical manifestations of metabolic stress, usually 7
to 14 days. 4% BranchAmin'
(Branched Chain Amino Acid) Injection in the Pharmacy Bulk Package is
intended for use in the preparation of sterile, intravenous admixtures.
Additives may be incompatible with the fluid withdrawn from this
container. Complete information is not available. Those additives known
to be incompatible should not be used. Consult with pharmacist, if
available. When compounding admixtures, use aseptic technique. Mix
thoroughly. Do not store any unused portion of 4% BranchAmin' (Branched
Chain Amino Acid) Injection.<br/>Directions for Use
of Viaflex' plastic Pharmacy
Bulk Package container:<br/>To Open: Tear overpouch down side at slit and remove solution
container. Some opacity of the plastic due to moisture
absorption during the sterilization process may be
observed. This is normal and does not affect the
solution quality or safety. The opacity will diminish
gradually. Check for minute leaks by squeezing inner bag
firmly. If leaks are found, discard solution as
sterility may be impaired. For
compounding only, not for direct infusion.<br/>Preparation
for Admixing:
|
| dailymed-drugs:433 |
Treatment of Malignant Diseases:<br/>Adults and Children:: Oral cyclophosphamide dosing is usually in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing. Many other regimens of intravenous and oral cyclophosphamide have been reported. Dosages must be adjusted in accord with evidence of antitumor activity and/or leukopenia. The total leukocyte count is a good, objective guide for regulating dosage. Transient decreases in the total white blood cell count to 2000 cells/mm(following short courses) or more persistent reduction to 3000 cells/mm(with continuing therapy) are tolerated without serious risk of infection if there is no marked granulocytopenia. When cyclophosphamide is included in combined cytotoxic regimens, it may be necessary to reduce the dose of cyclophosphamide, as well as that of the other drugs. Cyclophosphamide and its metabolites are dialyzable although there are probably quantitative differences depending upon the dialysis system being used. Patients with compromised renal function may show some measurable changes in pharmacokinetic parameters of cyclophosphamide metabolism, but there is no consistent evidence indicating a need for cyclophosphamide dosage modification in patients with renal function impairment.<br/>Treatment of Nonmalignant Diseases:<br/>Biopsy Proven���Minimal Change���Nephrotic Syndrome in Children:: An oral dose of 2.5 to 3 mg/kg daily for a period of 60 to 90 days is recommended. In males, the incidence of oligospermia and azoospermia increases if the duration of cyclophosphamide treatment exceeds 60 days. Treatment beyond 90 days increases the probability of sterility. Adrenocorticosteroid therapy may be tapered and discontinued during the course of cyclophosphamide therapy .<br/>Preparation and Handling of Solutions: Extemporaneous liquid preparations of cyclophosphamide for oral administration may be prepared by dissolving cyclophosphamide for injection in Aromatic Elixir, N.F. Such preparations should be stored under refrigeration in glass containers and used within 14 days.
|
| dailymed-drugs:434 |
Doses of extended-release tablets are usually given b.i.d. (approximately 12-hour intervals). When initiating therapy with extended-release lithium, dosage must be individualized according to serum levels and clinical response. When switching a patient from immediate-release capsules to the lithium carbonate extended-release tablets, give the same total daily dose when possible. Most patients on maintenance therapy are stabilized on 900 mg daily, e.g., 450 mg lithium carbonate extended-release b.i.d. When the previous dosage of immediate-release lithium is not a multiple of 450 mg, for example, 1500 mg, initiate lithium extended-release tablet at the multiple of 450 mg nearest to, but below, the original daily dosage, i.e., 1350 mg. When the two doses are unequal, give the larger dose in the evening. In the above example, with a total daily dosage of 1350 mg, generally 450 mg lithium carbonate extended-release should be given in the morning and 900 mg lithium carbonate extended-release in the evening. If desired, the total daily dosage of 1350 mg can be given in three equal 450 mg lithium carbonate extended-release doses. These patients should be monitored at 1 to 2 week intervals, and dosage adjusted if necessary, until stable and satisfactory serum levels and clinical state are achieved. When patients require closer titration than that available with doses of lithium carbonate extended-release in increments of 450 mg, immediate-release capsules should be used. Acute Mania - Optimal patient response to lithium carbonate can usually be established and maintained with 1800 mg per day in divided doses. Such doses will normally produce the desired serum lithium level ranging between 1 and 1.5 mEq/L. Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient's clinical state and serum lithium levels is necessary. Serum levels should be determined twice per week during the acute phase, and until the serum level and clinical condition of the patient have been stabilized. Long-Term Control - The desirable serum lithium levels are 0.6 to 1.2 mEq/L. Dosage will vary from one individual to another, but usually 900 mg to 1200 mg per day in divided doses will maintain this level. Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months. Patients unusually sensitive to lithium may exhibit toxic signs at serum levels below 1 mEq/L. N.B. - Blood samples for serum lithium determinations should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i.e., 8 to 12 hours after the previous dose). Total reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and laboratory analysis. Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by younger patients.
|
| dailymed-drugs:436 |
Primaquine phosphate is recommended only for the radical cure of vivax malaria, the prevention of relapse in vivax malaria, or following the termination of chloroquine phosphate suppressive therapy in an area where vivax malaria is endemic. Patients suffering from an attack of vivax malaria or having parasitized red blood cells should receive a course of chloroquine phosphate, which quickly destroys the erythrocytic parasites and terminates the paroxysm. Primaquine phosphate should be administered concurrently in order to eradicate the exoerythrocytic parasites in a dosage of 1 tablet (equivalent to 15 mg base) daily for 14 days.
|
| dailymed-drugs:437 |
The usual dose of triamterene and hydrochlorothiazide capsules is one or two capsules given once daily, with appropriate monitoring of serum potassium and of the clinical effect.
|
| dailymed-drugs:438 |
Liposyn II (Intravenous Fat Emulsion) should be administered
as part of an intravenous total nutrition program via peripheral vein
or central venous catheter. Adult Patients Liposyn II can provide up to 60% of daily calories at
a dose not to exceed 3 g/kg of body weight per day. The other 40%
should be provided by carbohydrate and amino acids. For the prevention of essential fatty acid deficiency, the recommended
daily requirement is approximately 4% of the caloric intake as linoleate.
In most adult patients, this can be supplied as 500 mL of Liposyn
II 10% or 250 mL of Liposyn II 20% administered twice weekly. The initial infusion rate for the first 15 minutes should
be 1 mL/minute for Liposyn II 10% and 0.5 mL/minute for Liposyn II
20%. If no adverse effects are observed during this initial infusion,
the rate can be increased to allow no more than 500 mL of Liposyn
II 10% or 250 mL of Liposyn II 20% to be given over a period of four
to six hours. Pediatric Patients Liposyn II can provide up to 60% of daily calories at
a dose not to exceed 4 g/kg of body weight per day. The other 40%
should be provided by carbohydrate and amino acids. For the prevention of essential fatty acid deficiency, the recommended
daily requirement is approximately 4% of the caloric intake as linoleate.
The daily dosage of Liposyn II ranges from 5 mL to 10 mL per
kilogram for the 10% emulsion and 2.5 mL to 5 mL per kilogram for
the 20% emulsion, depending upon the size and maturity of the patient. The infusion should be started at a rate of 0.1 mL/minute
for the first 15 minutes. If no adverse effects are observed during
this initial infusion, the rate can be increased to allow no more
than 100 mL of Liposyn II 10% or 50 mL of Liposyn II 20% per
hour. Administration With
the exception of heparin at 1 to 2 units/mL of fat emulsion, additives
to the Liposyn II bottle are contraindicated. Partly used containers must not be stored for later use. Filters
of less than 1.2 micron porosity must not be used with Liposyn II.
Do not use any bottle in which there appears to be an oiling out of
the emulsion. See CONTRAINDICATIONS regarding
mixing this emulsion with other I.V. fluids or additives. Liposyn II can be infused into the same central or peripheral
vein as the carbohydrate/amino acid solutions by means of a short
Y-connector near the infusion site. This allows for mixing of the
solutions immediately before entering the vein or for alternation
of each solution. Flow rates of each solution should be controlled
separately by infusion pumps, if these are used. Fat emulsion may
also be infused through a separate peripheral site. If desired, heparin
may be added to Liposyn II at a concentration of 1 to 2 units per
mL prior to administration. Alternatively, studies have documented
the stability of Liposyn II 10% and 20%, necessary
Hospira electrolytes, Hospira trace metals, and Hospira 10% through
70% Dextrose Injection, USP ina TPN admixture container with the
following Hospira amino acid solutions: Admixtures were compounded in either a nonphthalate
polyvinylchloride (PVC) or an ethylene vinyl acetate (EVA) container.
(See NOTE). SEE MIXING INSTRUCTIONS FOR COMBINED ADMINISTRATION. Compounded
admixtures may be stored under refrigeration for up to 24 hours.
Administration of admixtures should be completed within 24 hours after
removal from refrigeration. Conventional administration
sets contain polyvinyl chloride (PVC) components that have DEHP (diethylhexyl
phthalate) as a plasticizer. Fat-containing fluids such as Liposyn
II extract DEHP from this PVC component, and it may be advisable to
consider infusion of Liposyn II or the 3-in-1 admixture through a
non-DEHP administration set. A 1.2 micron air-eliminating
filter can be used to deliver either a stable 3-in-1 admixture containing
Liposyn II or the emulsion alone. Parenteral drug products should
be inspected visually for particulate matter and discoloration prior
to administration, whenever solution and container permit. MIXING INSTRUCTIONS FOR COMBINED
ADMINISTRATION Caution should be exercised
when admixing Liposyn II (Intravenous Fat Emulsion). It is absolutely essential that the admixture be prepared using strict
aseptic techniques as this nutrient mixture is a good growth media
for microorganisms. Studies have documented
the stability of LiposynII 10% and 20% with necessary
Hospira electrolytes, Hospira trace metals, and Hospira 10% through
70% Dextrose Injection, USP in a TPN admixture container with the
following Hospira amino acid solutions: NOTE: The TPN
admixture containers used in the stability studies were formulated
to minimize lipid/container interactions. The principal bag materials
were a nonphthalate polyvinylchloride (PVC) or ethylene vinyl acetate
(EVA). The only significant leachable from EVA is acetate. Acetate
is found in total parenteral nutrition (TPN) admixtures as acetic
acid, used for adjusting the pH of amino acid solutions, and as lysine
acetate. The level of leachable acetate from EVA is not sufficient
to alter the final acetate concentration significantly. Compounded
admixtures may be stored under refrigeration for up to 24 hours. Administration
of admixtures should be completed within 24 hours after removal from
refrigeration. Reference should be made to the individual package
inserts for detailed information on each component. The prime destabilizers of emulsions are excessive acidity (low pH)
and inappropriate electrolyte content. Careful consideration should
be given to the dosage levels of the divalent cations (Caand Mg) administered, as these have been shown to cause
emulsion instability. Amino acid solutions exert a buffering effect,
protecting the emulsion. The following proper
mixing sequence must be followed to minimize pH-related problems by
ensuring that typically acidic dextrose injections are not mixed with
lipid emulsion alone: Admixing should be accompanied by gentle agitation
to avoid localized concentration effects. Simultaneous or sequential
mixing of Liposyn II with other nutritional substrates using an automated,
gravimetric pumping system is considered an acceptable method for
admixture compounding, especially for institutions with a high volume
of 3-in-1 admixtures.
|
| dailymed-drugs:439 |
The following dosages of albuterol tablets are expressed in terms of albuterol base.<br/>Usual Dosage:<br/>Adults and Children Over 12 Years of Age: The usual starting dosage for adults and children 12 years and older is 2 or 4 mg three or four times a day.<br/>Children 6 to 12 Years of Age: The usual starting dosage for children 6 to 12 years of age is 2 mg three or four times a day.<br/>Dosage Adjustment:<br/>Adults and Children Over 12 Years of Age: For adults and children 12 years and older, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4 mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.<br/>Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg
Four Times a Day: For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).<br/>Elderly Patients and Those Sensitive to Beta-adrenergic Stimulators: An initial dosage of 2 mg three or four times a day is recommended for elderly patients
and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day. The total daily dose should not exceed 32 mg in adults and children 12 years and older.
|
| dailymed-drugs:440 |
Apply a 1/2" ribbon into the conjunctival sac three times a day on the first two days, then apply a 1/2" ribbon two times a day for the next five days.
|
| dailymed-drugs:441 |
Diclofenac may be administered as 25 mg, 50 mg, and 75 mg diclofenac sodium delayed-release tablets. The dosage of diclofenac sodium should be individualized to the lowest effective dose to minimize adverse effects (see INDIVIDUALIZATION OF DOSAGE).<br/>Osteoarthritis:: The recommended dosage is 100 to 150 mg/day in divided doses, 50 mg b.i.d. or t.i.d. or 75 mg b.i.d. Dosages above 200 mg/day have not been studied in patients with osteoarthritis.<br/>Rheumatoid Arthritis:: The recommended dosage is 150 to 200 mg/day in divided doses, 50 mg t.i.d. or g.i.d. or 75 mg b.i.d. Dosages above 225 mg/day are not recommended in patients with rheumatoid arthritis.<br/>Ankylosing Spondylitis:: The recommended dosage is 100 to 125 mg/day administered as 25 mg q.i.d. with an extra 25 mg dose at bedtime if necessary. Dosages above 125 mg/day have not been studied in patients with ankylosing spondylitis.
|
| dailymed-drugs:442 |
The recommended dose of CAMPRAL is two 333 mg tablets (each dose should total 666 mg) taken three times daily. Although dosing may be done without regard to meals, dosing with meals was employed during clinical trials and is suggested as an aid to compliance in those patients who regularly eat three meals daily. A lower dose may be effective in some patients. Treatment with CAMPRAL should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be maintained if the patient relapses. CAMPRAL should be used as part of a comprehensive psychosocial treatment program. Dosage in Renal Impairment: For patients with moderate renal impairment (creatinine clearance of 30-50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended. Patients with severe renal impairment (creatinine clearance of���30 mL/min) should not be given CAMPRAL.
|
| dailymed-drugs:443 |
Intravenous Aminocaproic
Acid Injection, USP is administered by infusion, utilizing the usual compatible
intravenous vehicles (e.g., Sterile Water for Injection, Sodium Chloride for
Injection, 5% Dextrose or Ringer's Injection). Although Sterile Water
for Injection is compatible for intravenous injection the resultant solution
is hypo-osmolar. RAPID INJECTION OF AMINOCAPROIC ACID INJECTION UNDILUTED
INTO A VEIN IS NOT RECOMMENDED. For the treatment of
acute bleeding syndromes due to elevated fibrinolytic activity, it is suggestedthat 16 to 20 mL (4 to 5 g) of aminocaproic acid in 250 mL of diluent be administered
by infusion during the first hour of treatment, followed by a continuing infusion
at the rate of 4 mL (1 g) per hour in 50 mL of diluent. This method of treatment
would ordinarily be continued for about 8 hours or until the bleeding
situation has been controlled. Parenteral drug products
should be inspected visually for particulate matter and discoloration prior
to administration, whenever solution and container permit. Do not administer
unless the solution is clear and seal is intact. Discard unused portion.
|
| dailymed-drugs:444 |
Patients should be retitrated when transferred from nonmicronized glyburide tablets or other oral hypoglycemic agents . There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient's blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient's response to therapy. Short-term administration of glyburide may be sufficient during periods of transient loss of control in patients usually controlled well on diet.<br/>Usual Starting Dose: The usual starting dose of glyburide tablets is 2.5 to 5 mg daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1.25 mg daily. (see PRECAUTIONS section for patients at increased risk.) Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy. Transfer From Other Hypoglycemic Therapy; Patients Receiving Other Oral Antidiabetic Therapy: Transfer of patients from other oral antidiabetic regimens to glyburide should be done conservatively and the initial daily dose should be 2.5 to 5 mg. When transferring patients from oral hypoglycemic agents other than chlorpropamide to glyburide, no transition period and no initial or priming dose are necessary. When transferring patients from chlorpropamide, particular care should be exercised during the first two weeks because the prolonged retention of chlorpropamide in the body and subsequent overlapping drug effects may provoke hypoglycemia. Patients Receiving Insulin: Some Type II diabetic patients being treated with insulin may respond satisfactorily to glyburide. If the insulin dose is less than 20 units daily, substitution of glyburide tablets 2.5 to 5 mg as a single daily dose may be tried. If the insulin dose is between 20 and 40 units daily, the patient may be placed directly on glyburide tablets 5 mg daily as a single dose. If the insulin dose is more than 40 units daily, a transition period is required for conversion to glyburide. In these patients, insulin dosage is decreased by 50% and glyburide tablets 5 mg daily is started. Please refer to Titration to Maintenance Dose for further explanation. Titration to Maintenance Dose: The usual maintenance dose is in the range of 1.25 to 20 mg daily, which may be given as a single dose or in divided doses (see Dosage Interval section). Dosage increases should be made in increments of no more than 2.5 mg at weekly intervals based upon the patient's blood glucose response. No exact dosage relationship exists between glyburide and the other oral hypoglycemic agents. Although patients may be transferred from the maximum dose of other sulfonylureas, the maximum starting dose of 5 mg glyburide tablets should be observed. A maintenance dose of 5 mg of glyburide tablets provides approximately the same degree of blood glucose control as 250 to 375 mg chlorpropamide, 250 to 375 mg tolazamide, 500 to 750 mg acetohexamide, or 1000 to 1500 mg tolbutamide. When transferring patients receiving more than 40 units of insulin daily, they may be started on a daily dose of glyburide tablets 5 mg concomitantly with a 50% reduction in insulin dose. Progressive withdrawal of insulin and increase of glyburide in increments of 1.25 to 2.5 mg every 2 to 10 days is then carried out. During this conversion period when both insulin and glyburide are being used, hypoglycemia may rarely occur. During insulin withdrawal, patients should test their urine for glucose and acetone at least three times daily and report results to their physician. The appearance of persistent acetonuria with glycosuria indicates that the patient is a Type I diabetic who requires insulin therapy. Concomitant Glyburide and Metformin Therapy: Glyburide tablets should be added gradually to the dosing regimen of patients who have not responded to the maximum dose of metformin monotherapy after four weeks (see Usual Starting Dose and Titration to Maintenance Dose). Refer to metformin package insert. With concomitant glyburide and metformin therapy, the desired control of glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the optimal dose of each drug needed to achieve this goal. With concomitant glyburide and metformin therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken . Maximum Dose: Daily doses of more than 20 mg are not recommended. Dosage Interval: Once-a-day therapy is usually satisfactory. Some patients, particularly those receiving more than 10 mg daily, may have a more satisfactory response with twice-a-day dosage. Specific Patient Populations: Glyburide is not recommended for use in pregnancy or for use in pediatric patients. In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions.
|
| dailymed-drugs:445 |
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT. The recommended starting dose is 1.34 mg (1/2 tablet) twice daily. Dosage may be increased as required. Clemastine fumarate tablets are recommended for the dermatologic indications at the 2.68 mg dosage level only. The maximum recommended dosage is 2.68 mg three times daily. Many patients respond favorably to a single dose which may be repeated as required, but not to exceed three tablets daily.
|
| dailymed-drugs:446 |
Adults: The usual dose is one teaspoonful (5 mg/5 mL) two to three times a day. The maximum recommended dose is one teaspoonful (5 mg/5 mL) four times a day. Pediatric patients over 5 years of age: The usual dose is one teaspoonful (5 mg/5 mL) two times a day. The maximum recommended dose is one teaspoonful (5 mg/5 mL) three times a day.
|
| dailymed-drugs:447 |
FOR INTRAVENOUS USE
ONLY. VERAPAMIL HYDROCHLORIDE INJECTION SHOULD BE GIVEN AS A SLOW INTRAVENOUS
INJECTION OVER AT LEAST A TWO-MINUTE PERIOD OF TIME UNDER CONTINUOUS ELECTROCARDIOGRAPHIC
(ECG) AND BLOOD PRESSURE MONITORING. The recommended intravenous
doses of verapamil hydrochloride injection are as follows: Adult: Initial
dose���5 to 10 mg (0.075 to 0.15 mg/kg body weight) given
as an intravenous bolus over at least 2 minutes. Repeat dose���10 mg (0.15 mg/kg
body weight) 30 minutes after the first dose if the initial response is not
adequate. An optimal interval for subsequent I.V. doses has not been determined,
and should be individualized for each patient. Older patients���The dose should
be administered over at least 3 minutes to minimize the risk of untoward drug
effects. Pediatric: Initial dose: 0 to 1 year: 0.1 to 0.2 mg/kg body weight (usual
single dose range: 0.75 to 2 mg) should be administered as an intravenous
bolus over at least 2 minutes under continuous ECG
monitoring. 1 to
15 years: 0.1 to 0.3 mg/kg body weight (usual single dose range:
2 to 5 mg) should be administered as an intravenous bolus over at least 2
minutes. Do not exceed 5 mg. Repeat dose: 0 to 1 year: 0.1 to 0.2 mg/kg body weight (usual
single dose range: 0.75 to 2 mg) 30 minutes after the first dose if the initial
response is not adequate (under continuous ECG monitoring). An optimal interval for subsequent I.V. doses has not been determined,
and should be individualized for each patient. 1 to 15 years: 0.1 to 0.3 mg/kg body weight (usual
single dose range: 2 to 5 mg) 30 minutes after the first dose if the initial
response is not adequate. Do not exceed 10 mg as
a single dose. An optimal interval for subsequent I.V. doses has
not been determined, and should be individualized for each patient. Note: Parenteral drug products should be inspected
visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. Use only if solution is clear and
vial seal is intact. Unused amount of solution should be discarded immediately
following withdrawal of any portion of contents. For
stability reasons this product is not recommended for dilution with Sodium
Lactate Injection, USP in polyvinyl chloride bags. Verapamil is physically
compatible and chemically stable for at least 24 hours at 25��C protected
from light in most common large volume parenteral solutions. Admixing verapamil
hydrochloride injection with albumin, amphotericin B, hydralazine hydrochloride
and trimethoprim with sulfamethoxazole should be avoided. Verapamil hydrochloride
injection will precipitate in any solution with a pH above 6.0.
|
| dailymed-drugs:448 |
A decrease in symptoms may occur as soon as 12 hours after starting steroid therapy and generally can be expected to occur within a few days of initiating therapy in allergic rhinitis. If improvement is not evident after 2 to 3 weeks, the patient should be re-evaluated. .<br/>Adults and Children 12 years of age and older: The recommended starting dose of Nasacort Nasal Inhaler is 220 mcg per day given as two sprays (55 mcg/spray) in each nostril once a day. If needed, the dose may be increased to 440 mcg per day (55 mcg/spray) either as once-a-day dosage or divided up to four times a day, i.e., twice a day (two sprays/nostril), or four times a day (one spray/nostril). After the desired effect is obtained, some patients may be maintained on a dose of as little as one spray (55 mcg) in each nostril once a day (total daily dose 110 mcg per day).<br/>Children 6 through 11 years of age: The recommended starting dose of Nasacort Nasal Inhaler is 220 mcg per day given as two sprays (55 mcg/spray) in each nostril once a day. Once the maximal effect has been achieved, it is always desirable to titrate the patient to the minimum effective dose. Nasacort Nasal Inhaler is not recommended for children below 6 years of age since adequate numbers of patients have not been studied in this age group.<br/>Directions for Use: Illustrated Patient's Instructions for use accompany each package of Nasacort Nasal Inhaler.
|
| dailymed-drugs:449 |
The dose of prazosin hydrochloride should be adjusted according to the patient's individual blood pressure response. The following is a guide to its administration:<br/>Initial Dose: 1 mg two or three times a day .<br/>Maintenance Dose: Dosage may be slowly increased to a total daily dose of 20 mg given in divided doses. The therapeutic dosages most commonly employed have ranged from 6 mg to 15 mg daily given in divided doses. Doses higher than 20 mg usually do not increase efficacy, however a few patients may benefit from further increases up to a daily dose of 40 mg given in divided doses. After initial titration some patients can be maintained adequately on a twice daily dosage regimen.<br/>Use With Other Drugs: When adding a diuretic or other antihypertensive agent, the dose of prazosin hydrochloride should be reduced to 1 mg or 2 mg three times a day and retitration then carried out.
|
| dailymed-drugs:450 |
As with other antiarrhythmic agents, sotalol hydrochloride should be initiated and doses increased in a hospital with facilities for cardiac rhythm monitoring and assessment . Sotalol should be administered only after appropriate clinical assessment , and the dosage of sotalol hydrochloride must be individualized for each patient on the basis of therapeutic response and tolerance. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment.<br/>Adults:: Dosage of sotalol hydrochloride should be adjusted gradually, allowing 3 days between dosing increments in order to attain steady-state plasma concentrations, and to allow monitoring of QT intervals. Graded dose adjustment will help prevent the usage of doses which are higher than necessary to control the arrhythmia. The recommended initial dose is 80 mg twice daily. This dose may be increased, if necessary, after appropriate evaluation to 240 or 320 mg/day (120���160 mg twice daily). In most patients, a therapeutic response is obtained at a total daily dose of 160 to 320 mg/day, given in two or three divided doses. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480���640 mg/day; however, these doses should only be prescribed when the potential benefit outweighs the increased risk of adverse events, in particular proarrhythmia. Because of the long terminal elimination half-life of sotalol, dosing on more than a BID regimen is usually not necessary.<br/>Children:: As in adults the following precautionary measures should be considered when initiating sotalol treatment in children: initiation of treatment in the hospital after appropriate clinical assessment; individualized regimen as appropriate; gradual increase of doses if required; careful assessment of therapeutic response and tolerability; and frequent monitoring of the QTinterval and heart rate. For children aged about 2 years and greater, with normal renal function, doses normalized for body surface area are appropriate for both initial and incremental dosing. Since the Class III potency in children is not very different from that in adults, reaching plasma concentrations that occur within the adult dose range is an appropriate guide. From pediatric pharmacokinetic data the following is recommended. For initiation of treatment, 30 mg/mthree times a day (90 mg/mtotal daily dose) is approximately equivalent to the initial 160 mg total daily dose for adults. Subsequent titration to a maximum of 60 mg/m(approximately equivalent to the 360 mg total daily dose for adults) can then occur. Titration should be guided by clinical response, heart rate and QT, with increased dosing being preferably carried out in-hospital. At least 36 hours should be allowed between dose increments to attain steady-state plasma concentrations of sotalol in patients with age-adjusted normal renal function. For children aged about 2 years or younger, the above pediatric dosage should be reduced by a factor that depends heavily upon age, as shown in the following graph, age plotted on a logarithmic scale in months. For a child aged 20 months, the dosing suggested for children with normal renal function aged 2 years or greater should be multiplied by about 0.97; the initial starting dose would be (30��0.97) = 29.1 mg/m, administered three times daily. For a child aged 1 month, the starting dose should be multiplied by 0.68; the initial starting dose would be (30��0.68) = 20 mg/m, administered three times daily. For a child aged about 1 week, the initial starting dose should be multiplied by 0.3; the starting dose would be (30��0.3) = 9 mg/m. Similar calculations should be made for increased doses as titration proceeds. Since the half-life of sotalol decreases with decreasing age (below about 2 years), time to steady-state will also increase. Thus, in neonates the time to steady-state may be as long as a week or longer. In all children, individualization of dosage is required. As in adults sotalol hydrochloride should be used with particular caution in children if the QTis greater than 500 msec on therapy, and serious consideration should be given to reducing the dose or discontinuing therapy when QTexceeds 550 msec.
|
| dailymed-drugs:451 |
Hypertension: ADULT: The recommended initial dose of fosinopril sodium tablet is 10 mg once a day, both as monotherapy and when the drug is added to a diuretic. Dosage should then be adjusted according to blood pressure response at peak (2 to 6 hours) and trough (about 24 hours after dosing) blood levels. The usual dosage range needed to maintain a response at trough is 20 to 40 mg but some patients appear to have a further response to 80 mg. In some patients treated with once daily dosing, the antihypertensive effect may diminish toward the end of the dosing interval. If trough response is inadequate, dividing the daily dose should be considered. If blood pressure is not adequately controlled with fosinopril sodium tablets alone, a diureticmay be added. Concomitant administration of fosinopril sodium tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium (see PRECAUTIONS). In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of fosinopril sodium tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with fosinopril sodium tablets (see WARNINGS). Then, if blood pressure is not controlled with fosinopril sodium tablets alone, diuretic therapy should be resumed. If diuretic therapy cannot be discontinued, an initial dose of 10 mg of fosinopril sodium tablets should be used with careful medical supervision for several hours and until blood pressure has stabilized. (See WARNINGS; PRECAUTIONS: Information for Patients and Drug Interactions.) Since concomitant administration of fosinopril sodium tablets with potassium supplements, or potassium-containing salt substitutes or potassium-sparing diuretics may lead to increases in serum potassium, they should be used with caution (see PRECAUTIONS). Pediatric Patients Information related to the dosing of fosinopril sodium in the treatment of hypertension in pediatric patients weighing more than 50 kg is available in the approved labeling for Bristol-Myers Squibb Company's fosinopril sodium drug product. However, due to Bristol-Myers Squibb's marketing exclusivity rights, this drug product, produced by Ranbaxy , is not labeled for pediatric use.<br/>Heart Failure: Digitalis is not required for fosinopril sodium tablets to manifest improvements in exercise tolerance and symptoms. Most placebo-controlled clinical trial experience has been with both digitalis and diuretics present as background therapy. The usual starting dose of fosinopril sodium tablets should be 10 mg once daily. Following the initial dose of fosinopril sodium tablets, the patient should be observed under medical supervision for at least two hours for the presence of hypotension or orthostasis and, if present, until blood pressure stabilizes. An initial dose of 5 mg is preferred in heart failure patients with moderate to severe renal failure or those who have been vigorously diuresed. Dosage should be increased, over a several week period, to a dose that is maximal and tolerated but not exceeding 40 mg once daily. The usual effective dosage range is 20 to 40 mg once daily. The appearance of hypotension, orthostasis, or azotemia early in dose titration should not preclude further careful dose titration. Consideration should be given to reducing the dose of concomitant diuretic. For Hypertensive or Heart Failure Patients With Renal Impairment: In patients with impaired renal function, the total body clearance of fosinoprilat is approximately 50% slower than in patients with normal renal function. Since hepatobiliary elimination partially compensates for diminished renal elimination, the total body clearance of fosinoprilat does not differ appreciably with any degree of renal insufficiency (creatinine clearances<80 mL/min/1.73m), including end-stage renal failure (creatinine clearance<10 mL/min/1.73m). This relative constancy of body clearance of active fosinoprilat, resulting from the dual route of elimination, permits use of the usual dose in patients with any degree of renal impairment. (See WARNINGS: Anaphylactoid reactions during membrane exposure and PRECAUTIONS: Hemodialysis.)
|
| dailymed-drugs:452 |
Adults: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days. Children: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary. Small Infants: A single instillation of one drop of 0.5% in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes. Observe infant closely for at least 30 minutes following instillation. Individuals with heavily pigmented irides may require higher strengths.
|
| dailymed-drugs:453 |
Preservative-free morphine
sulfate injection is intended for intravenous, epidural or intrathecal administration. Intravenous Administration Dosage: The initial dose of morphine sulfate should
be 2 mg to 10 mg/70 kg of body weight. Patients under the age of 18; no information
available. Epidural Administration PRESERVATIVE-FREE MORPHINE SULFATE INJECTION SHOULD BE ADMINISTERED EPIDURALLY ONLY
BY PHYSICIANS EXPERIENCED IN THE TECHNIQUES OF EPIDURAL ADMINISTRATION AND
WHO ARE THOROUGHLY FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY
IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT
AND A SPECIFIC ANTAGONIST (NALOXONE HYDROCHLORIDE INJECTION) SHOULD BE IMMEDIATELY
AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS
WHICH MIGHT RESULT FROM INADVERTENT INTRATHECAL OR INTRAVASCULAR INJECTION.
(NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE) PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS
AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR. Proper
placement of a needle or catheter in the epidural space should be verified
before preservative-free morphine sulfate
injection is injected. Acceptable techniques for verifying proper placement
include: a) aspiration to check for absence of blood or cerebrospinal fluid,
or b) administration of 5 mL (3 mL in obstetric patients) of UNPRESERVED
1.5% Lidocaine and Epinephrine (1:200,000) Injection and then observe the
patient for lack of tachycardia (this indicates that vascular injection has not been made) and lack of sudden onset of segmental
anesthesia (this indicates that intrathecal injection has not been made). Epidural
Adult Dosage: Initial injection of 5 mg in the lumbar region may
provide satisfactory pain relief for up to 24 hours. If adequate pain relief
is not achieved within one hour, careful administration of incremental doses
of 1 to 2 mg at intervals sufficient to assess effectiveness may be given.
No more than 10 mg/24 hr should be administered. Thoracic
administration has been shown to dramatically increase the incidence of early
and late respiratory depression even at doses of 1 to 2 mg. For
continuous infusion an initial dose of 2 to 4 mg/24 hours is recommended.
Further doses of 1 to 2 mg may be given if pain relief is not achieved initially. Aged
or debilitated patients���Administer with extreme caution (see PRECAUTIONS).
Doses of less than 5 mg may provide satisfactory pain relief for up to 24
hours. Epidural Pediatric
Use: No information on use in pediatric patients is available. Intrathecal Administration NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL
DOSAGE. PRESERVATIVE-FREE MORPHINE
SULFATE INJECTION SHOULD BE ADMINISTERED INTRATHECALLY ONLY BY PHYSICIANS
EXPERIENCED IN THE TECHNIQUES OF INTRATHECAL ADMINISTRATION AND WHO ARE THOROUGHLY
FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE
ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT AND A SPECIFIC
ANTAGONIST (NALOXONE HYDROCHLORIDE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE
FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH
MIGHT RESULT FROM INADVERTENT INTRAVASCULAR INJECTION. PATIENT
MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE
DELAYED RESPIRATORY DEPRESSION MAY OCCUR. RESPIRATORY DEPRESSION
(BOTH EARLY AND LATE ONSET) HAS OCCURRED MORE FREQUENTLY FOLLOWING INTRATHECAL
ADMINISTRATION. Intrathecal
Adult Dosage: A single injection of 0.2 to 1 mg may provide satisfactory
pain relief for up to 24 hours. (CAUTION: THIS IS ONLY 0.4 TO 2 ML OF THE
5 MG/10 ML CONTAINER OR 0.2 TO 1 ML OF THE 10 MG/10 ML CONTAINER OF PRESERVATIVE-FREE MORPHINE SULFATE INJECTION.)
DO NOT INJECT INTRATHECALLY MORE THAN 2 ML OF THE 5 MG/10 ML CONTAINER OR
1 ML OF THE 10 MG/10 ML CONTAINER. USE IN THE LUMBAR AREA ONLY IS RECOMMENDED.
Repeated intrathecal injections of preservative-free morphine sulfate injection are not recommended. A constant intravenous
infusion of naloxone hydrochloride, 0.6 mg/hr, for 24 hours after intrathecal
injection may be used to reduce the incidence of potential side effects. Aged
or debilitated patients���Administer with extreme caution (see PRECAUTIONS).
A lower dosage is usually satisfactory. Repeat
Dosage: If pain recurs, alternative routes of administration should
be considered, since experience with repeated doses of morphine by the intrathecal
route is limited. Intrathecal
Pediatric Use: No information on the use in pediatric patients is
available. Parenteral drug products should be inspected
for particulate matter and discoloration prior to administration, whenever
solution and container permit. Do not administer unless solution is clear
and container is undamaged. Discard unused portion.
|
| dailymed-drugs:454 |
Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-release and other treatment options before deciding to use Diclofenac Sodium Extended-release. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . After observing the response to initial therapy with Diclofenac Sodium Extended-release Tablets, the dose and frequency should be adjusted to suit an individual patient's needs. For the relief of osteoarthritis, the recommended dosage is 100 mg q.d. For the relief of rheumatoid arthritis, the recommended dosage is 100 mg q.d. in the rare patient where Diclofenac Sodium Extended-release Tablets 100 mg/day is unsatisfactory, the dose may be increased to 100 mg b.i.d. if the benefits outweigh the clinical risks of increased side effects. Different formulations of diclofenac [diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets; diclofenac potassium immediate-release tablets] are not necessarily bioequivalent even if the milligram strength is the same.
|
| dailymed-drugs:455 |
Before applying VUSION Ointment, gently cleanse the skin with lukewarm water and pat dry with a soft towel. Avoid using any scented soaps, shampoos, or lotions on the diaper area. VUSION Ointment should be applied to the affected area at each diaper change for 7 days. Treatment should be continued for the full 7 days, even if there is improvement. The safety of VUSION Ointment when used for longer than 7 days is not known. Gently apply a thin layer of VUSION Ointment to the diaper area with the fingertips. VUSION Ointment should not be rubbed into the skin as this may cause additional irritation. Thoroughly wash hands after applying VUSION Ointment. VUSION Ointment should be used for the adjunctive treatment of diaper dermatitis only when complicated by candidiasis, as documented by microscopic evidence of pseudohyphae and/or budding yeasts, in immunocompetent pediatric patients 4 weeks and older. VUSION Ointment should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes. VUSION Ointment should not be used as a substitute for frequent diaper changes. VUSION Ointment should not be used to prevent the occurrence of diaper dermatitis, since or preventative use may result in the development of drug resistance.
|
| dailymed-drugs:456 |
Adults: (For children's dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.<br/>Elderly Patients: In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.<br/>1. To Control Severe Nausea and Vomiting: Adjust dosage to the response of the individual. Begin with the lowest recommended dosage. Oral Dosage - Tablets Usually one 5 mg or 10 mg tablet 3 or 4 times daily. Daily dosages above 40 mg should be used only in resistant cases.<br/>2. In Adult Psychiatric Disorders: Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recommended dose. Although response ordinarily is seen within a day or 2, longer treatment is usually required before maximal improvement is seen. Oral Dosage Non-Psychotic Anxiety���Usual dosage is 5 mg 3 or 4 times daily. Do not administer in doses of more than 20 mg per day or for longer than 12 weeks. Psychotic Disorders including Schizophrenia���In relatively mild conditions, as seen in private psychiatric practice or in outpatient clinics, dosage is 5 or 10 mg 3 or 4 times daily. In moderate to severe conditions, for hospitalized or adequately supervised patients, usual starting dosage is 10 mg 3 or 4 times daily. Increase dosage gradually until symptoms are controlled or side effects become bothersome. When dosage is increased by small increments every 2 or 3 days, side effects either do not occur or are easily controlled. Some patients respond satisfactorily on 50 to 75 mg daily. In more severe disturbances, optimum dosage is usually 100 to 150 mg daily.<br/>Children: Do not use in pediatric surgery. Children seem more prone to develop extrapyramidal reactions, even on moderate doses. Therefore, use lowest effective dosage. Tell parents not to exceed prescribed dosage, since the possibility of adverse reactions increases as dosage rises. Occasionally the patient may react to the drug with signs of restlessness and excitement; if this occurs, do not administer additional doses. Take particular precaution in administering the drug to children with acute illnesses or dehydration (see under Dystonia).<br/>1. Severe Nausea and Vomiting in Children: Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or 2 years of age. It should not be used in conditions for which children's dosages have not been established. Dosage and frequency of administration should be adjusted according to the severity of the symptoms and the response of the patient. The duration of activity following intramuscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary. Oral Dosage More than 1 day's therapy is seldom necessary.<br/>2. In Children With Schizophrenia: Oral Dosage For children 2 to 12 years, starting dosage is 2.5 mg 2 or 3 times daily. Do not give more than 10 mg the first day. Then increase dosage according to patient's response. FOR AGES 2 to 5, total daily dosage usually does not exceed 20 mg. FOR AGES 6 to 12, total daily dosage usually does not exceed 25 mg.
|
| dailymed-drugs:457 |
Apply a few drops of Mometasone Furoate Lotion 0.1% (mometasone furoate topical solution USP) to the affected skin areas once daily and massage lightly until it disappears. For the most effective and economical use, hold the nozzle of the bottle very close to the affected areas and gently squeeze. Since safety and efficacy of Mometasone Furoate Lotion 0.1% have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended . As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Mometasone Furoate Lotion 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate Lotion 0.1% should not be applied in the diaper area if the patient still requires diapers or plastic pants as these garments may constitute occlusive dressing.
|
| dailymed-drugs:458 |
The objective of nutritional management of infants and young pediatric patients is the provision of sufficient amino acid and caloric support for protein synthesis and growth. The total daily dose of TrophAmine (Amino Acid Injections) depends on daily protein requirements and on the patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements. Dosage should also be guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response. Recommendations for allowances of protein in infant nutrition have ranged from 2 to 4 grams of protein per kilogram of body weight per day (2.0 to 4.0 g/kg/day).The recommended dosage of TrophAmine is 2.0 to 2.5 grams of amino acids per kilogram of body weight per day (2.0 to 2.5 g/kg/day) for infants up to 10 kilograms. For infants and young pediatric patients larger than 10 kilograms, the total dosage of amino acids should include the 20 to 25 grams/day for the first 10 kgof body weight plus 1.0 to 1.25 g/day for each kg of body weight over 10 kilograms. Typically, TrophAmine is admixed with B. Braun's 50% or 70% Dextrose Injection USP supplemented with electrolytes and vitamins and administered continuously over a 24 hour period. Total daily fluid intake should be appropriate for the patient's age and size. A fluid dose of 125 mL per kilogram body weight per day is appropriate for most infants on TPN. Although nitrogen requirements may be higher in severely hypercatabolic or depleted patients, provision of additional nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance. Cysteine is considered to be an essential amino acid in infants and young pediatric patients. An admixture of cysteine hydrochloride to the TPN solution is therefore recommended. Based on clinical studies, the recommended dosage is 1.0 mmole of L-cysteine hydrochloride monohydrate per kilogram of body weightper day. In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose solutions are abruptly discontinued. Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat free TPN. The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is required for optimum utilization of amino acids. In addition, sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given. In patients with hyperchloremic or other metabolic acidoses,sodium and potassium may be added as the acetate salts to provide bicarbonate precursor. The electrolyte content of TrophAmine must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently. Appropriate vitamins, minerals and trace elements should also be provided. Central Venous Nutrition. Hypertonic mixtures of amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, and gradually increased to the recommended 60���125 mL per kilogram body weight per day. If administration rate should fall behind schedule, no attempt to "catch up" to planned intake should be made. In addition to meeting protein needs, the rate of administration, particularly during the first few days of therapy, is governed by the patient's glucose tolerance. Daily intakeof amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of glucose levels in blood and urine. Peripheral Parenteral Nutrition. For patients in whom the central venous route is not indicated and who can consume adequate calories enterally, TrophAmine (Amino Acid Injections) may be administered by peripheral vein with or without parenteral carbohydrate calories. Such infusates can be prepared by dilution with B. Braun's Sterile Water for Injection or 5%���10% Dextrose Injection to prepare isotonic or slightly hypertonic solutions for peripheral infusion. It is essential that peripheral infusion be accompanied by adequate caloric intake. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. TrophAmine may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium and magnesium ions in an additive solution should be considered when phosphate is also present, in order to avoid precipitation. Care must be taken to avoid incompatible admixtures. Consult with pharmacist.
|
| dailymed-drugs:460 |
If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box). Adults: Serious infections���150 to 300 mg every 6 hours. More severe infections���300 to 450 mg every 6 hours. Pediatric Patients: Serious infections���8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections���16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses. To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water. Serious infections due to anaerobic bacteria are usually treated with clindamycin phosphate sterile solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules. In cases of��-hemolytic streptococcal infections, treatment should continue for at least 10 days.
|
| dailymed-drugs:461 |
Usual Adult Dosage:<br/>Perioperative Prophylactic Use: To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are; It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin for Injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection may be continued for 3 to 5 days following the completion of the surgery.<br/>Dosage Adjustment for Patients with Reduced Renal Function: Cefazolin for Injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses, Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3.0 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis; See Human Pharmacology.<br/>Pediatric Dosage: In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into three or four equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended. In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min,), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.<br/>RECONSTITITION:<br/>Preparation of Parenteral Solution: Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded. When reconstituted or diluted according to the instructions below, Cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5��C or 41��F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.<br/>Single dose vials: For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.<br/>Infusion bottles: Reconstitute with 50 to 100 mL of Sodium Chloride Injection or other IV solution listed under ADMINISTRATION. When adding diluent to vial, allow air to escape by using a small vent needle or by pumping the syringe. SHAKE WELL. Administer with primary IV fluids, as a single dose.<br/>ADMINISTRATION: Intramuscular Administration - Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin. Intravenous Administration - Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below). Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of one of the following solutions:
|
| dailymed-drugs:462 |
Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
|
| dailymed-drugs:463 |
OXISTAT Cream or Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. OXISTAT Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed. Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk that may extend to the neck, arms, and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea (pityriasis) versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.
|
| dailymed-drugs:464 |
General Principles: The goal of replacement
therapy is to achieve and maintain a clinical and biochemical euthyroid
state. The goal of suppressive therapy is to inhibit growth and/or
function of abnormal thyroid tissue. The dose of SYNTHROID that is
adequate to achieve these goals depends on a variety of factors including
the patient's age, body weight, cardiovascular status, concomitant
medical conditions, including pregnancy, concomitant medications,
and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve
only as dosing guidelines. Dosing must be individualized and adjustments
made based on periodic assessment of the patient's clinical response
and laboratory parameters (see PRECAUTIONS
- Laboratory Tests). SYNTHROID is administered as a single daily dose, preferably one-half
to one-hour before breakfast. SYNTHROID should be taken at least
4 hours apart from drugs that are known to interfere with its absorption
(see PRECAUTIONS - Drug Interactions). Due to
the long half-life of levothyroxine, the peak therapeutic effect at
a given dose of levothyroxine sodium may not be attained for 4-6 weeks. Caution should be exercised
when administering SYNTHROID to patients with underlying cardiovascular
disease, to the elderly, and to those with concomitant adrenal insufficiency
(see PRECAUTIONS ).<br/>Specific Patient Populations:<br/>Hypothyroidism in Adults and in Children in Whom Growth and
Puberty are Complete: (see WARNINGS and PRECAUTIONS - Laboratory Tests) Therapy
may begin at full replacement doses in otherwise healthy individuals
less than 50 years old and in those older than 50 years who have been
recently treated for hyperthyroidism or who have been hypothyroid
for only a short time (such as a few months). The average full replacement
dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Older
patients may require less than 1 mcg/kg/day. Levothyroxine sodium
doses greater than 200 mcg/day are seldom required. An inadequate
response to daily doses���300 mcg/day is rare and may indicate
poor compliance, malabsorption, and/or drug interactions. For most patients
older than 50 years or for patients under 50 years of age with underlying
cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended,
with gradual increments in dose at 6-8 week intervals, as needed.
The recommended starting dose of levothyroxine sodium in elderly
patients with cardiac disease is 12.5-25
mcg/day , with gradual dose increments at 4-6 week intervals.
The levothyroxine sodium dose is generally adjusted in 12.5-25 mcg
increments until the patient with primary hypothyroidism is clinically
euthyroid and the serum TSH has normalized. In patients with severe hypothyroidism, the recommended initial levothyroxine
sodium dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical
and laboratory assessment, until the TSH level is normalized. In patients with
secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the
levothyroxine sodium dose should be titrated until the patient is
clinically euthyroid and the serum free- Tlevel is restored
to the upper half of the normal range.<br/>Pediatric Dosage - Congenital or Acquired Hypothyroidism: (see PRECAUTIONS - Laboratory Tests)<br/>Pregnancy: Pregnancy may increase levothyroxine requirements (see PREGNANCY).<br/>Subclinical Hypothyroidism: If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement
may be adequate to normalize the serum TSH level. Patients who are
not treated should be monitored yearly for changes in clinical status
and thyroid laboratory parameters.<br/>TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid
Nodules: The target level for TSH suppression in these conditions has not
been established with controlled studies. In addition, the efficacy
of TSH suppression for benign nodular disease is controversial. Therefore,
the dose of SYNTHROID used for TSH suppression should be individualized
based on the specific disease and the patient being treated. In the treatment
of well-differentiated (papillary and follicular) thyroid cancer,
levothyroxine is used as an adjunct to surgery and radioiodine therapy.
Generally, TSH is suppressed to<0.1 mU/L, and this usually
requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk
tumors, the target level for TSH suppression may be<0.01
mU/L. In the treatment of benign nodules and nontoxic multinodular goiter,
TSH is generally suppressed to a higher target (e.g., 0.1 to either
0.5 or 1.0 mU/L) than that used for the treatment of thyroid cancer.
Levothyroxine sodium is contraindicated if the serum TSH is already
suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS - WARNINGS and PRECAUTIONS).<br/>Myxedema Coma: Myxedema coma is a life-threatening emergency characterized by poor
circulation and hypometabolism, and may result in unpredictable absorption
of levothyroxine sodium from the gastrointestinal tract. Therefore,
oral thyroid hormone drug products are not recommended to treat this
condition. Thyroid hormone products formulated for intravenous administration
should be administered.
|
| dailymed-drugs:465 |
Anticoagulant-Induced Prothrombin Deficiency in Adults: To correct excessively prolonged prothrombin times caused by oral anticoagulant therapy���2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required. Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition. If, in 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated.<br/>Hypoprothrombinemia Due to Other Causes in Adults: If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent MEPHYTON. The severity of the coagulation disorder should determine whether the immediate administration of MEPHYTON is required in addition to discontinuation or reductionof interfering drugs. A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained. The oral route should be avoided when the clinical disorder would prevent proper absorption. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.
|
| dailymed-drugs:467 |
The recommended dose of ipratropium bromide nasal solution 0.03% (Nasal Spray) is two sprays (42 mcg) per nostril two or three times daily (total dose 168 to 252 mcg/day) for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Optimum dosage varies with the response of the individual patient. Initial pump priming requires seven sprays of the pump. If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for more than seven days, the pump will require seven sprays to reprime. Avoid spraying into eyes.
|
| dailymed-drugs:468 |
When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (See Boxed Warnings and Warnings.) For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Patients should be started at the lowest dose. Six (6.5, 9.375, 12.5, 15, 18.75 and 25 cm) Climara systems are available. For the treatment of vasomotor symptoms, treatment should be initiated with the 6.5 cm(0.025 mg/day) Climara system applied to the skin once weekly. The dose should be adjusted as necessary to control symptoms. Clinical responses (relief of symptoms) at the lowest effective dose should be the guide for establishing administration of the Climara system, especially in women with an intact uterus. Attempts to taper or discontinue the medication should be made at 3- to 6-month intervals. In women who are not currently taking oral estrogens, treatment with the Climara system can be initiated at once. In women who are currently taking oral estrogen, treatment with the Climara system can be initiated 1-week after withdrawal of oral therapy or sooner if symptoms reappear in less than 1-week. For the prevention of postmenopausal osteoporosis, the minimum dose that has been shown to be effective is the 6.5 cm(0.025 mg/day) Climara system. Response to therapy can be assessed by biochemical markers and measurement of bone mineral density.<br/>Application of the System: The adhesive side of the Climara system should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock. The Climara system should not be applied to or near the breasts. The sites of application must be rotated, with an interval of at least 1-week allowed between applications to a particular site. The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub and remove the system. Application to areas where sitting would dislodge the system should also be avoided. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place with the fingers for about 10 seconds, making sure there is good contact, especially around the edges. If the system lifts, apply pressure to maintain adhesion. In the event that a system should fall off, a new system should be applied for the remainder of the 7-day dosing interval. Only one system should be worn at any one time during the 7-day dosing interval. Swimming, bathing, or using a sauna while using the Climara system has not been studied, and these activities may decrease the adhesion of the system and the delivery of estradiol.<br/>Removal of the System: Removal of the system should be done carefully and slowly to avoid irritation of the skin. Should any adhesive remain on the skin after removal of the system, allow the area to dry for 15 minutes. Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue. Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it away.
|
| dailymed-drugs:470 |
CNS (Central Nervous System): Adults: The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. An additional 0.4 mL/kg (0.2 mmol/kg) can be given within 20 minutes of the first dose. (See the Dosage Chart.) Pediatric Patients (2-16 years): The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. (See the Dosage Chart.)<br/>Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions): Adult and Pediatric Patients (2-16 years of age): For the kidney, the recommended dose of OMNISCAN is 0.1 mL/kg (0.05 mmol/kg). For the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg). (See the Dosage Chart.) To ensure complete injection of the contrast medium, the injection should be followed by a 5 mL flush of 0.9% sodium chloride, as provided in the Prefill Plus needle-free system. The imaging procedure should be completed within 1 hour of administration of OMNISCAN. Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the solution if it is discolored or particulate matter is present. Any unused portion must be discarded.
|
| dailymed-drugs:471 |
For Symptomatic Relief of Rhinorrhea Associated with the Common Cold The recommended dose of ATROVENT Nasal Spray 0.06% is two sprays (84 mcg) per nostril three or four times daily (total dose 504 to 672 mcg/day) in adults and children age 12 years and older. Optimum dosage varies with response of the individual patient. The recommended dose of ATROVENT Nasal Spray 0.06% for children age 5-11 years is two sprays (84 mcg) per nostril three times daily (total dose of 504 mcg/day). The safety and effectiveness of the use of ATROVENT Nasal Spray 0.06% beyond four days in patients with the common cold have not been established. For Symptomatic Relief of Rhinorrhea Associated with Seasonal Allergic Rhinitis The recommended dose of ATROVENT Nasal Spray 0.06% is two sprays (84 mcg) per nostril four times daily (total dose 672 mcg/day) in adults and children age 5 years and older. The safety and effectiveness of the use of ATROVENT Nasal Spray 0.06% beyond three weeks in patients with seasonal allergic rhinitis have not been established. Initial pump priming requires seven sprays of the pump. If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for more than seven days, the pump will require seven sprays to reprime. Avoid spraying into eyes.
|
| dailymed-drugs:472 |
General Principles: OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION. OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN, CHEWED OR CRUSHED. TAKING BROKEN, CHEWED OR CRUSHED OXYCODONE HYDROCHLORIDE EXTENDED-RELEASETABLETS LEADS TO THE RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE. In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment. Oxycodone hydrochloride extended-release tablets are an extended-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain requiring treatment with a strong opioid for continuous, around-the-clock analgesia for an extended period of time. The extended-release nature of the formulation allows the oxycodone hydrochloride extended-release tablets to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailoredto their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy. Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Health care professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring [See BOXED WARNING].<br/>Initiation of Therapy: It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to: Care should be taken to use low initial doses of oxycodone hydrochloride extended-release tablets in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions). For initiation of oxycodone hydrochloride extended-release tablet therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials. Experience indicated a reasonable starting dose of oxycodone hydrochloride extended-release tablets for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. Oxycodone hydrochloride extended-release tablets should be individually titrated to a dose that provides adequate analgesia and minimizes side effects. In all cases, supplemental analgesia (see below) should be made available in the form of a suitable short-acting analgesic. Oxycodone hydrochloride extended-release tablets can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).<br/>Conversion from Transdermal Fentanyl to Oxycodone Hydrochloride Extended-Release Tablets: Eighteen hours following the removal of the transdermal fentanyl patch, oxycodone hydrochloride extended-release tablet treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of oxycodone hydrochloride extended release tablets should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.<br/>Managing Expected Opioid Adverse Experiences: Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from oxycodone hydrochloride extended-release tablets are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids. Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with anti-emetics or other modalities may relieve these symptoms and should be considered.<br/>Individualization of Dosage: Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency.There is no clinical information on dosing intervals shorter than q12h. As a guideline, except for the increase from 10 mg to 20 mg q12h, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase. If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences. If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control. During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.<br/>Supplemental Analgesia: Most patients given around-the-clock therapy with extended-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).<br/>Maintenance of Therapy: The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control. During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.<br/>Cessation of Therapy: When the patient no longer requires therapy with oxycodone hydrochloride extended-release tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.<br/>Conversion from Oxycodone Hydrochloride Extended-Release Tablets to Parenteral Opioids: To avoid overdose, conservative dose conversion ratios should be followed.
|
| dailymed-drugs:473 |
Carefully consider the potential benefits and risks of MOTRIN Suspension and other treatment options before deciding to use MOTRIN Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . After observing the response to initial therapy with MOTRIN Suspension, the dose and frequency should be adjusted to suit an individual patient's needs.<br/>PEDIATRIC PATIENTS: Fever reduction: For reduction of fever in children, 6 months up to 2 years of age, the dosage should be adjusted on the basis of the initial temperature level . The recommended dose is 5 mg/kg if the baseline temperature is less than 102.5��F, or 10 mg/kg if the baseline temperature is 102.5��F or greater. The duration of fever reduction is generally 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg. Analgesia: For relief of mild to moderate pain in children 6 months up to 2 years of age, the recommended dosage is 10 mg/kg, every 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg. Doses should be given so as not to disturb the child's sleep pattern. Juvenile Arthritis: The recommended dose is 30 to 40 mg/kg/day divided into three to four doses (see Individualization of Dosage). Patients with milder disease may be adequately treated with 20 mg/kg/day. In patients with juvenile arthritis, doses above 50 mg/kg/day are not recommended because they have not been studied and doses exceeding the upper recommended dose of 40 mg/kg/day may increase the risk of causing serious adverse events. The therapeutic response may require from a few days to several weeks to be achieved. Once a clinical effectis obtained, the dosage should be lowered to the smallest dose of MOTRIN needed to maintain adequate control of symptoms. Pediatric patients receiving doses above 30 mg/kg/day or if abnormal liver function tests have occurred with previous NSAID treatments should be carefully followed for signs and symptoms of early liver dysfunction.<br/>ADULTS: Primary Dysmenorrhea: For the treatment of primary dysmenorrhea, beginning with the earliest onset of such pain, MOTRIN Suspension should be given in a dose of 400 mg every 4 hours, as necessary, for the relief of pain. Rheumatoid arthritis and osteoarthritis: Suggested dosage: 1200-3200 mg daily (300 mg q.i.d. or 400 mg, 600 mg or 800 mg t.i.d. or q.i.d.). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk. Individualization of Dosage: The dose of MOTRIN Suspension should be tailored to each patient, and may be lowered or raised from the suggested doses depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond. One fever study showed that, after the initial dose of MOTRIN Suspension, subsequent doses may be lowered and still provide adequate fever control. In a situation when low fever would require the MOTRIN Suspension 5 mg/kg dose in a child with pain, the dose that will effectively treat the predominant symptom should be chosen. In chronic conditions, a therapeutic response to MOTRIN Suspension therapy is sometimes seen in a few days to a week, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required. Patients with rheumatoid arthritis seem to require higher doses than do patients with osteoarthritis. The smallest dose of MOTRIN Suspension that yields acceptable control should be employed. MOTRIN Suspension may be used in combination with gold salts and/or corticosteroids.
|
| dailymed-drugs:475 |
Dosage in Adult Patients: AZACTAM (aztreonam injection), an intravenous solution in GALAXY
plastic containers (PL 2040), is intended for intravenous use only. Dosage
should be determined by susceptibility of the causative organisms, severity
and site of infection, and the condition of the patient. The intravenous route is recommended for patients with bacterial
septicemia, localized parenchymal abscess (eg, intra-abdominal abscess), peritonitis
or other severe systemic or life-threatening infections. The duration of therapy depends on the severity of infection. Generally,
AZACTAM should be continued for at least 48 hours after the patient becomes
asymptomatic or evidence of bacterial eradication has been obtained. Persistent
infections may require treatment for several weeks. Doses smaller than those
indicated should not be used.<br/>Renal Impairment in Adult Patients: Prolonged serum levels of aztreonam may occur in patients with
transient or persistent renal insufficiency. Therefore, the dosage of AZACTAM
should be halved in patients with estimated creatinine clearances between
10 mL/min/1.73 mand 30 mL/min/1.73 mafter
an initial loading dose of 1 g or 2 g. When only the serum creatinine concentration is available, the
following formula (based on sex, weight, and age of the patient) may be used
to approximate the creatinine clearance (Clcr). The serum creatinine should
represent a steady state of renal function. weight
(kg)��(140-age)Males:
Clcr =���������������������������������������������72��serum creatinine (mg/dL) Females:
0.85��above value In patients with severe renal failure (creatinine clearance less
than 10 mL/min/1.73 m), such as those supported
by hemodialysis, the usual dose of 500 mg, 1 g or 2 g should be given initially.
The maintenance dose should be one-fourth of the usual initial dose given
at the usual fixed interval of 6, 8 or 12 hours. For serious or life-threatening
infections, in addition to the maintenance doses, one-eighth of the initial
dose should be given after each hemodialysis session.<br/>Dosage in the Elderly: Renal status is a major determinant of dosage in the elderly; these
patients in particular may have diminished renal function. Serum creatinine
may not be an accurate determinant of renal status. Therefore, as with all
antibiotics eliminated by the kidneys, estimates of creatinine clearance should
be obtained, and appropriate dosage modifications made if necessary.<br/>Dosage in Pediatric Patients: AZACTAM should be administered intravenously to pediatric patients
with normal renal function. There are insufficient data regarding intramuscular
administration to pediatric patients or dosing in pediatric patients with
renal impairment. (See PRECAUTIONS: Pediatric
Use.) Because of the serious nature of infections due to Pseudomonas
aeruginosa, dosage of 2 g every 6 or 8 hours is recommended, at least
upon initiation of therapy, in systemic infections caused by this organism
in adults.<br/>CLINICAL STUDIES: A total of 612 pediatric patients aged 1 month to 12 years were
enrolled in uncontrolled clinical trials of aztreonam in the treatment of
serious gram-negative infections, including urinary tract, lower respiratory
tract, skin and skin-structure, and intra-abdominal infections.<br/>Directions for Use of AZACTAM (aztreonam injection) in GALAXY Plastic Container (PL 2040).: AZACTAM (aztreonam injection) in GALAXY plastic container (PL 2040)
is to be administered as an intermittent intravenous infusion only.<br/>Storage: Store in a freezer capable of maintaining a temperature of -20��C (-4��F).<br/>Thawing of Plastic Containers: Thaw frozen container at room temperature, 25��C (77��F) or in a refrigerator, 2��to 8��C (36��to 46��F). After
thawing is complete, invert the container to assure a well-mixed solution. (DO
NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.) Check for minute leaks by squeezing container firmly. If leaks
are detected, discard solution as sterility may be impaired. The container should be visually inspected. Thawed solutions should
not be used unless clear; solutions will be colorless to yellow. Components
of the solution may precipitate in the frozen state and will dissolve upon
reaching room temperature with little or no agitation. If after visual inspection
the solution remains discolored, cloudy, or if an insoluble precipitate is
noted or if any seals or outlet ports are not intact, the container should
be discarded. DO NOT ADD SUPPLEMENTARY MEDICATION. The thawed solution in GALAXY plastic container (PL 2040) remains
chemically stable for either 14 days under refrigeration (2��to 8��C/36��to 46��F) or for 48 hours at room temperature (25��C/77��F). DO NOT REFREEZE THAWED ANTIBIOTICS.<br/>Preparation for Intravenous Administration (Use aseptic technique): Additives or other medication should not be added to AZACTAM (aztreonam
injection) in GALAXY plastic container (PL 2040) or infused simultaneously
through the same intravenous line. If the same intravenous line is used for
sequential infusion of several different drugs, it should be flushed before
and after infusion of AZACTAM (aztreonam injection) in GALAXY plastic container
(PL 2040) with an infusion solution compatible with AZACTAM (aztreonam injection)
in GALAXY plastic container (PL 2040)* and any other drug(s) administered
via this common line. It is recommended that the intravenous administration apparatus
be replaced at least once every 48 hours. CAUTION: Do not use plastic containers in series connections.
Such use could result in an embolism due to residual air being drawn from
the primary container before administration of the fluid from the secondary
container is complete.<br/>Intravenous Administration: Infusion of AZACTAM (aztreonam injection) in GALAXY plastic container
(PL 2040) should be completed within a 20- to 60-minute period. The plastic
container is a single-dose unit; discard any unused portion remaining in the
container. *The following infusion solutions are compatible with AZACTAM (aztreonam
injection) in GALAXY plastic container (PL 2040):
|
| dailymed-drugs:476 |
If significant diarrhea occurs during therapy, this antibiotic should be discontinued . Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate HCl contained in CLEOCIN PEDIATRIC Flavored Granules. Serious infections: 8���12 mg/kg/day (4���6 mg/lb/day) divided into 3 or 4 equal doses. Severe infections: 13���16 mg/kg/day (6.5���8 mg/lb/day) divided into 3 or 4 equal doses. More severe infections: 17���25 mg/kg/day (8.5���12.5 mg/lb/day) divided into 3 or 4 equal doses. In pediatric patients weighing 10 kg or less,��teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose. Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with CLEOCIN PEDIATRIC. NOTE: In cases of��-hemolytic streptococcal infections, treatment should be continued for at least 10 days. Reconstitution Instructions: When reconstituted with water as follows, each 5 mL (teaspoon) of solution contains clindamycin palmitate HCl equivalent to 75 mg clindamycin. Reconstitute bottles of 100 mL with 75 mL of water. Add a large portion of the water and shake vigorously; add the remainder of the water and shake until the solution is uniform. Storage Conditions: Store at controlled room temperature 20��to 25��C (68��to 77��F) [see USP]. Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. The solution is stable for 2 weeks at room temperature.
|
| dailymed-drugs:477 |
After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Pyrophosphate Injection in the average ADULT patient (70 kg) is: Bone Imaging -185-555 megabecquerels (5-15 mCi) Cardiac Imaging - 370-555 megabecquerels (10-15 mCi) The suggested dose range of the non-radioactive reconstituted CIS-PYRO in the average ADULT patient (70 kg) is: Blood Imaging - Administer not less that one-third nor more than the total contents of one vial. [555-740 megabecquerels (15-20mCi) of Pertechnetate Tc 99m Injection].<br/>Bone and Cardiac Imaging: Technetium Tc 99m Pyrophosphate Injection is injected intravenously over a 10 to 20 second period. For optimal results, bone imaging should be done 1 to 6 hours following administration. Cardiac imaging should be done 30 to 90 minutes following administration. The acute myocardial infarct can be visualized from 24 hours to 6 days following onset of symptoms, with maximum localization at 48 to 72 hours. Cardiac imaging should be done with a gamma scintillation camera. It is recommended that images be made of the anterior, left anterior oblique and left lateral projections.<br/>Blood Pool Imaging: CIS-PYRO may be reconstituted with sterile, non-pyrogenic isotonic saline containing no preservatives. Administer not less than one-third nor more than the total contents of one vial 30 minutes prior to the intravenous administration of 555 to 740 megabecquerels (15-20 mCi) Sodium Pertechnetate Tc 99m Injection. The non-radioactive reconstituted CIS-PYRO should be injected by direct venipuncture. Heparinized catheter systems should be avoided. Cardiac imaging should be done 10 to 30 minutes following the administration of Sodium Pertechnetate Tc 99m Injection utilizing a scintillation camera interfaced to an electrocardiographic gating device. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.<br/>Radiation Dosimetry:<br/>Bone and Cardiac Imaging: The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average ADULT patient (70 kg) from an intravenous injection of a maximum of 555 megabecquerels (15 mCi) of Technetium Tc 99m Pyrophosphate Injection are shown in Table 4.<br/>Table 4.Estimated Absorbed Radiation Doses Bone and Cardiac Imaging*: *Based on the model in MIRD Dose Estimate Report No. 13 (J Nucl Med 30:1117-1122, 1989). Estimate calculated using phantoms of Cristy&Eckerman (Report ORNL/TM-8381/V1&V7). Bone and marrow model of Eckerman (Aspects of dosimetry of radionuclides within the skeleton with particular emphasis on the active marrow, In Fourth International Radiopharmaceutical Dosimetry Symposium; A.T. Schlafke-Stelson and E.E. Watson eds. CONF-851113, Oak Ridge Associated Universities, Oak Ridge, TN 37831, 1986. pp 514-534.) used. The effective dose equivalent is a quantity which may be suitable for comparing risks of different procedures in nuclear medicine, radiology, and other applications involving ionizing radiation, but should not be construed to give information about risks to individual patients and should not be applied to situations involving radiation therapy.<br/>Blood Pool Imaging: The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous injection of 740 megabecquerels (20 mCi) of Sodium Pertechnetate Tc 99m Injection, 30 minutes after the intravenous administration of the non-radioactive reconstituted CIS-PYRO are shown in Table 5.<br/>Table 5. Estimated Absorbed Radiation Doses:<br/>Blood Pool Imaging��: Assume 75% of the Sodium Pertechnetate Tc 99m labels red blood cells and the other 25% remains as pertechnetate. Method of calculation: MIRD Dose Estimate Report No. 8, J Nucl Med 17: 74-77, 1976. If 25% excreted with 1 hour T
|
| dailymed-drugs:478 |
Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container
permit. The usual dose is 1
to 3 mg administered under careful monitoring, such as
electrocardiography and central venous pressure. The rate of
administration should not exceed 1 mg (1 mL) per minute to diminish the
possibility of lowering blood pressure and causing cardiac standstill.
Sufficient time should be allowed for the drug to reach the site of
action even when a slow circulation is present. If necessary, a second
dose may be given after two minutes. Thereafter, additional drug should
not be given in less than four hours. Additional propranolol
hydrochloride should not be given when the desired alteration in rate or
rhythm is achieved. Transfer to oral
therapy as soon as possible.
|
| dailymed-drugs:480 |
The dosage of glycopyrrolate should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily dosage of glycopyrrolate is 8 mg. Glycopyrrolate Tablets 1 mg. The recommended initial dosage of glycopyrrolate for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to assure overnight control of symptoms. For maintenance, a dosage of one tablet twice a day is frequently adequate. Glycopyrrolate Tablets 2 mg. The recommended dosage of glycopyrrolate for adults is one tablet two or three times daily at equally spaced intervals. Glycopyrrolate tablets are not recommended for use in pediatric patients under the age of 12 years.
|
| dailymed-drugs:481 |
WARNING: This is a potent drug;
it must be diluted before administration to the patient. Dopamine
Hydrochloride Injection, USP is administered (only after dilution) by intravenous
infusion. Suggested
Dilution���For the 40 mg/mL preparation, transfer by aseptic
technique the contents containing either 5 mL, 200 mg or 10 mL, 400 mg of
Dopamine Hydrochloride to either a 250 mL or 500 mL bottle of one of the sterile
I.V. solutions listed below. For the 80 mg/mL preparation, transfer by aseptic
technique the contents containing 10 mL, 800 mg of Dopamine Hydrochloride
to a 250 mL, 500 mL or 1000 mL bottle of one of the following sterile I.V.
solutions: 0.9% Sodium Chloride Injection, USP 5%
Dextrose Injection, USP 5% Dextrose and 0.9% Sodium
Chloride Injection, USP 5% Dextrose and 0.45% Sodium
Chloride Injection, USP 5% Dextrose and Lactated Ringer's
Injection Sodium Lactate Injection, USP 1/6 Molar Lactated
Ringer's Injection, USP The resultant dilutions
are summarized in the following chart: Dopamine Hydrochloride Injection, USP has been found to
be stable for a minimum of 24 hours after dilution in the foregoing I.V.
solutions. However, as with all I.V. admixtures, dilution should be made just
prior to administration. Do NOT add Dopamine Hydrochloride
to Sodium Bicarbonate Injection, USP or other alkaline I.V. solutions, since
the drug is inactivated in alkaline solution. Rate of Administration���Dopamine
Hydrochloride Injection, USP after dilution, is administered intravenously
by infusion via a suitable I.V. catheter or needle. When administering Dopamine
Hydrochloride (or any potent medication) by continuous intravenous infusion,
it is advisable to use a precision volume control I.V. set. Each patient must
be individually titrated to the desired hemodynamic or renal response to dopamine. In
titrating to the desired increase in systolic blood pressure, the optimum
dosage rate for renal response may be exceeded, thus necessitating a reduction
in rate after the hemodynamic condition is stabilized. Administration
at rates greater than 50 mcg/kg/min have safely been used in advanced circulatory
decompensation states. If unnecessary fluid expansion is of concern, adjustment
of drug concentration may be preferred over increasing the flow rate of a
less concentrated dilution. Suggested
Regimen:
|
| dailymed-drugs:482 |
Spinal anesthesia with 5% Lidocaine Hydrochloride and 7.5%
Dextrose Injection, USP may be induced in the right or left lateral recumbent
or the sitting position. Since this is a hyperbaric solution, the anesthetic
will tend to move in the direction in which the table is tilted. After the
desired level of anesthesia is obtained and the anesthetic has become fixed,
usually in 5 to 10 minutes with lidocaine, the patient may be positioned according
to the requirement of the surgeon or obstetrician. In
clinical trials, the safety of hyperbaric lidocaine for single injection spinal
anesthesia was demonstrated using 22 or 25 gauge spinal needles. In these
studies, free flow of CSF was visible before injection of lidocaine. Neurologic
deficits have been reported with the use of small bore needles and microcatheters
for spinal anesthesia. It has been postulated, based on in
vitro models, that these deficits were caused by pooling and non-uniform
distribution of concentrated local anesthetic within the subarachnoid space.Animal
studies suggest mixing of 5% lidocaine hydrochloride with an equal volume
of CSF or preservative-free 0.9% saline solution may reduce the risk of nerve
injury due to pooling of concentrated local anesthetic.(See PRECAUTIONS). Intrathecal
distribution of anesthetic may be facilitated by using a spinal needle of
sufficient gauge to insure adequate withdrawal of CSF through the needle prior
to and after anesthetic administration. If the technique is properly placed
in the subarachnoid space, a separate injection is seldom necessary. An
incomplete or patchy block not responsive to patient repositioning may indicate
misplacement or inadequate distribution of drug. To avoid excessive drug pooling,
additional doses of lidocaine should not be administered with the same needle
placement. INJECTIONS SHOULD BE MADE SLOWLY. Consult
standard textbooks for specific techniques for spinal anesthetic procedures. Recommended dosages Normal
healthy adults: The following recommended dosages are for normal healthy adults
and serve only as a guide to the amount of anesthetic required for most routine
procedures. In all cases, the smallest dose that will produce the desired
result should be given. If the technique is properly
performed, and the needle is properly placed in the subarachnoid space, it
should not be necessary to administer more than one ampul (100 mg). Obstetrical low spinal or���saddle block���anesthesia: The dosage recommended for normal
vaginal delivery is approximately 1 mL (50 mg). For Caesarean section and
those deliveries requiring intrauterine manipulations, 1.5 mL (75 mg) is usually
adequate. Surgical
anesthesia: The dosage recommended for abdominal
anesthesia is 1.5 to 2 mL (75 to 100 mg). Pediatric Patients: The
dosage recommendations in healthy adolescents, 16 years of age and older,
is the same as for normal healthy adults. There is insufficient data in pediatric
patients below the age of 16 years to make dosage recommendations (see PRECAUTIONS). NOTE:
Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration whenever the solution and container
permit. Solutions that are discolored and/or contain particulate matter should
not be used. Unused portions of solutions should be
discarded following initial use. 5% Lidocaine Hydrochloride
and 7.5% Dextrose Injection, USP may be autoclaved once at 15 pounds pressure,
121��C (250��F) for 15 minutes. Since this preparation contains dextrose,
carmelization may occur under prolonged heating and, in some instances, prolonged
storage. Therefore this preparation should not be autoclaved more than once,
according to the above instructions, and should not be permitted to remain
in the autoclave any longer than necessary. Do not administer any solution
which is discolored or contains particulate matter.
|
| dailymed-drugs:483 |
As directed by a
physician. Dosage is dependent upon the age, weight and clinical
condition of the patient as well as laboratory determinations. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. All injections in
VIAFLEX plastic containers are intended for intravenous administration
using sterile equipment. Additives may be
incompatible. Complete information is not available. Those additives
known to be incompatible should not be used. Consult with pharmacist, if
available. If, in the informed judgment of the physician, it is deemed
advisable to introduce additives, use aseptic technique. Mix thoroughly
when additives have been introduced. Do not store solutions containing
additives.
|
| dailymed-drugs:2262 |
As directed by a
physician. Dosage is dependent upon the age, weight and clinical
condition of the patient as well as laboratory determinations. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. All injections in
VIAFLEX plastic containers are intended for intravenous administration
using sterile equipment. Additives may be
incompatible. Complete information is not available. Those additives
known to be incompatible should not be used. Consult with pharmacist, if
available. If, in the informed judgment of the physician, it is deemed
advisable to introduce additives, use aseptic technique. Mix thoroughly
when additives have been introduced. Do not store solutions containing
additives.
|
| dailymed-drugs:484 |
One tablet of 200 mg of hydroxychloroquine sulfate is equivalent to 155 mg base. Malaria: Suppression���In adults, 400 mg (=310 mg base) on exactly the same day of each week. In infants and children, the weekly suppressive dosage is 5 mg, calculated as base, per kg of body weight, but should not exceed the adult dose regardless of weight. If circumstances permit, suppressive therapy should begin two weeks prior to exposure. However, failing this, in adults an initial double (loading) dose of 800 mg (=620 mg base), or in children 10 mg base/kg may be taken in two divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after leaving the endemic area. Treatment of the acute attack���In adults, an initial dose of 800 mg (= 620 mg base) followed by 400 mg (=310 mg base) in six to eight hours and 400 mg (=310 mg base) on each of two consecutive days (total 2 g hydroxychloroquine sulfate or 1.55 g base). An alternative method, employing a single dose of 800 mg(=620 mg base), has also proved effective. The dosage for adults may also be calculated on the basis of body weight; this method is preferred for infants and children. A total dose representing 25 mg of base per kg of body weight is administered in three days, as follows: First dose: 10 mg base per kg (but not exceeding a single dose of 620 mg base). Second dose: 5 mg base per kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose. Third dose: 5 mg base per kg 18 hours after second dose. Fourth dose: 5 mg base per kg 24 hours after third dose. For radical cure of vivax and malariae malaria concomitant therapy with an 8-aminoquinoline compound is necessary.
|
| dailymed-drugs:485 |
For treatment of uncomplicated P. falciparum malaria in adults, the Qualaquin dosage is 648 mg (two capsules) every 8 hours for 7 days . Qualaquin should be taken with food to minimize gastric upset .<br/>For patients with hepatic impairment: In otherwise healthy subjects with Child-Pugh B hepatic impairment, the AUC of quinine increased by 55% compared to subjects with normal liver function. In patients with mild to moderate hepatic impairment (Child-Pugh A and Child-Pugh B, respectively), dosage reduction is not warranted but patients should be monitored closely for adverse reactions associated with quinine . The effects of severe hepatic impairment (Child-Pugh C) on the safety and pharmacokinetics of quinine sulfate are not known.<br/>For patients with renal impairment: In otherwise healthy subjects with severe chronic renal failure not receiving any form of dialysis (mean serum creatinine = 9.6 mg/dL), the median plasma quinine exposure (AUC) increased by 195% compared to subjects with normal renal function. In patients with acute uncomplicated malaria and severe chronic renal failure, the following modified dosageregimen is recommended: one loading dose of 648 mg Qualaquin followed 12 hours later by maintenance doses of 324 mg every 12 hours . The effects of mild and moderate renal impairment on the pharmacokinetics and safety of quinine sulfate are not known.
|
| dailymed-drugs:486 |
Apply a thin film of clindamycin phosphate topical solution twice daily to affected area. Keep container tightly closed.
|
| dailymed-drugs:487 |
Dosage of oxytocin is determined by uterine response. The following dosage information is based upon the various regimens and indications in general use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, wherever solution and container permit.<br/>A. Induction of Stimulation of Labor: Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor. Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocin stimulation of the uterine musculature will soon wane.<br/>B. Control of Postpartum Uterine Bleeding:<br/>C. Treatment of Incomplete or Inevitable Abortion: Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of Syntocinon (oxytocin) have been added should be infused at a rate of 20-40 drops/minute.
|
| dailymed-drugs:489 |
In Scabies: Thoroughly massage into the skin
of the whole body from the chin down, paying particular attention to all folds
and creases. A second application is advisable 24 hours later. Clothing and
bed linen should be changed the next morning. A cleansing bath should be taken
48 hours after the last application. In Pruritus: Massage gently into affected areas
until medication is completely absorbed. Repeat as needed. LOTION: Shake well before using. DIRECTIONS FOR PATIENTS WITH SCABIES:
|
| dailymed-drugs:490 |
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage for adults should not exceed 8 tablets.
|
| dailymed-drugs:491 |
The following
information is suggested as a guide and is subject to variation
according to the preference and experience of the surgeon. It is
required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP
(10 mEq each of sodium and bicarbonate) be added aseptically and
thoroughly mixed with each 1000 mL of cardioplegic solution to adjust
pH. Use 10 mL of AbbottList 4900, 8.4% Sodium Bicarbonate
Injection, USP, to achieve the approximate pH of 7.8 when measured
at room temperature. Use of any other Sodium Bicarbonate Injection
may not achieve this pH due to the varying pH's of Sodium
Bicarbonate Injections. Due to its inherent instability
with other components, sodium bicarbonate must be added just prior to
administration. After this addition, the solution must be stored under
refrigeration and used within 24 hours. The solution should be cooled to
4��C prior to use. Following institution of cardiopulmonary
bypass at perfusate temperatures of 28��to 30��C, and
after cross-clamping of the ascending aorta, the buffered solution is
administered by rapid infusion into the aortic root. The initial rate of
infusion may be 300 mL/m2/minute (about 540 mL/min in a 5'
8���, 70 kg adult with 1.8 square meters of surface area) given
for a period of two to four minutes. Concurrent external cooling
(regional hypothermia of the pericardium) may be accomplished by
instilling a refrigerated (4��C) physiologic solution such as
balanced electrolyte replacement solution or Ringer's
Injection into the chest cavity. Should myocardial
electromechanical activity persist or recur, the solution may be
reinfused at a rate of 300 mL/m2/min for a period of two minutes.
Reinfusion of the solution may be repeated every 20 to 30 minutes or
sooner if myocardial temperature rises above 15��to
20��C or returning cardiac activity is observed. The regional
hypothermia solution around the heart also may be replenished
continuously or periodically in order to maintain adequate hypothermia.
Suction may be used to remove warmed infusates. An implanted thermistor
probe may be used to monitor myocardial temperature. The volumes of
solution instilled into the aortic root may vary depending on the
duration or type of open heart surgical procedure. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container
permit. See PRECAUTIONS
|
| dailymed-drugs:492 |
The dose is dependent upon the capacity or surface area of
the structure to be irrigated and the nature of the procedure. When used as
a diluent or vehicle for drugs, the manufacturer's recommendations
should be followed. Drug Interactions Additives may be incompatible. Consult with
pharmacist, if available. When introducing additives, use aseptic technique,
mix thoroughly and do not store. Parenteral drug products
should be inspected visually for particulate matter and discoloration prior
to administration, whenever solution container permits. See PRECAUTIONS.
|
| dailymed-drugs:493 |
Prevention of Chemotherapy-Induced
Nausea and Vomiting: Adult Dosing: The recommended I.V. dosage of ondansetron for adults
is a single 32 mg dose or three 0.15 mg/kg doses. A single 32 mg dose
is infused over 15 minutes beginning 30 minutes before the start of
emetogenic chemotherapy. The recommended infusion rate should not
be exceeded (see OVERDOSAGE). With the three-dose (0.15 mg/kg) regimen,
the first dose is infused over 15 minutes beginning 30 minutes before
the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg)
are administered 4 and 8 hours after the first dose of ondansetron. Ondansetron injection should not be mixed with solutions
for which physical and chemical compatibility have not been established.
In particular, this applies to alkaline solutions as a precipitate
may form. Flexible Plastic Container: Ondansetron in 5% Dextrose
Injection, 32 mg/50 mL (0.64 mg/mL), REQUIRES
NO DILUTION. Pediatric Dosing: On the basis
of the available information (see CLINICAL TRIALS: Pediatric Studies
and CLINICAL PHARMACOLOGY: Pharmacokinetics), the dosage in pediatric
cancer patients 4 to 18 years of age should be three 0.15 mg/kg doses.
The first dose is to be administered 30 minutes before the start of
moderately to highly emetogenic chemotherapy, subsequent doses (0.15
mg/kg) are administered 4 and 8 hours after the first dose of ondansetron.
The drug should be infused intravenously over 15 minutes. Little information
is available about dosage in pediatric cancer patients younger than
6 months of age. Dosing information for
pediatric cancer patients 6 months to 48 months of age is approved
for GlaxoSmithKline Corporation's ondansetron injection. However,
due to GlaxoSmithKline's marketing exclusivity rights, this
drug product is not labeled for use in this subpopulation of pediatric
patients. Flexible Plastic Container: Ondansetron in 5% Dextrose
Injection, 32 mg/50 mL (0.64 mg/mL), REQUIRES
NO DILUTION. Geriatric Dosing: The dosage recommendation
is the same as for the general population. Dosage Adjustment for Patients With Impaired Renal
Function: The dosage recommendation is the same as for the
general population. There is no experience beyond first-day administration
of ondansetron. Dosage
Adjustment for Patients With Impaired Hepatic Function: In
patients with severe hepatic impairment (Child-Pughscore
of 10 or greater), a single maximal daily dose of 8 mg to be infused
over 15 minutes beginning 30 minutes before the start of the emetogenic
chemotherapy is recommended. There is no experience beyond first-day
administration of ondansetron. Ondansetron in 5% Dextrose Injection in Flexible
Plastic Containers: Instructions
for Use: ToOpen: Tear outer wrap at notch
and remove solution container. Check for minute leaks by squeezing
container firmly. If leaks are found, discard unit as sterility may
be impaired. Preparation for Administration: Use aseptic technique. Caution: Ondansetron in 5% dextrose injection in flexible plastic containers
is to be administered by I.V. drip infusion only. Ondansetron in 5%
dextrose injection should not be mixed with solutions for which physical
and chemical compatibility have not been established. In particular,
this applies to alkaline solutions as a precipitate may form. If used
with a primary I.V. fluid system, the primary solution should be discontinued
during ondansetron in 5% dextrose injection infusion. Do not administer unless solution is clear and container
is undamaged. Warning: Do not use flexible plastic container in series
connections. Note: Parenteral drug products should be inspected visually for particulate
matter and discoloration before administration whenever solution and
container permit.
|
| dailymed-drugs:494 |
Carefully consider the potential benefits and risks of naproxen tablets and naproxen delayed-release tablets and other treatment options before deciding to use naproxen tablets and naproxen delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . After observing the response to initial therapy with naproxen tablets or naproxen delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Different dose strengths and formulations (i.e., tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation. Although naproxen tablets and naproxen delayed-release tablets both circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 1 hour in patients taking naproxen. Because naproxen delayed-release tablets dissolve in the small intestine rather than in the stomach, the absorption of the drug is delayed compared to the other naproxen formulations . The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients .<br/>Geriatric Patients: Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.<br/>Patients With Moderate to Severe Renal Impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance<30 mL/min) .<br/>Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis: To maintain the integrity of the enteric coating, the naproxen delayed-release tablet should not be broken, crushed or chewed during ingestion. During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary. In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response .<br/>Juvenile Arthritis: The use of naproxen oral suspension is recommended for juvenile arthritis in children 2 years or older because it allows for more flexible dose titration based on the child's weight. In pediatric patients, doses of 5 mg/kg/day produced plasma levels of naproxen similar to those seen in adults taking 500 mg of naproxen . The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (i.e., 5 mg/kg given twice a day).<br/>Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis: Because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium is recommended for the management of acute painful conditions when prompt onset of pain relief is desired. Naproxen tablets may also be used but naproxen delayed-release tablets are not recommended for initial treatment of acute pain because absorption of naproxen is delayed compared to other naproxen-containing products .<br/>Acute Gout: The recommended starting dose is 750 mg of naproxen tablets followed by 250 mg every 8 hours until the attack has subsided. Naproxen delayed-release tablets are not recommended because of the delay in absorption .
|
| dailymed-drugs:495 |
Initial Treatment: Citalopram hydrobromide tablets should be administered at an initial dose of 20 mg once daily, generally with an increase to a dose of 40 mg/day. Dose increases should usually occur in increments of 20 mg at intervals of no less than one week. Although certain patients may require a dose of 60 mg/day, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose; doses above 40 mg are therefore not ordinarily recommended. Citalopram hydrobromide tablets should be administered once daily, in the morning or evening, with or without food.<br/>Special Populations: 20 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment, with titration to 40 mg/day only for nonresponding patients. No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram hydrobromide tablets should be used with caution in patients with severe renal impairment.<br/>Treatment of Pregnant Women During the Third Trimester: Neonates exposed to citalopram and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding . When treating pregnant women with citalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering citalopram in the third trimester.<br/>Maintenance Treatment: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of citalopram hydrobromide tablets in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of citalopram hydrobromide tablets (20 to 60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients wereassigned randomly to continuation of citalopram hydrobromide tablets 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups . Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.<br/>Discontinuation of Treatment with Citalopram: Symptoms associated with discontinuation of citalopram and other SSRIs and SNRIs have been reported . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.<br/>Switching Patients To or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of citalopram hydrobromide tablet therapy. Similarly, at least 14 days should be allowed after stopping citalopram hydrobromide tablets before starting an MAOI .
|
| dailymed-drugs:496 |
The patient dose should be measured by a suitable radioactivity
calibration system immediately prior to administration. Mix the contents of the vial by gentle inversion just prior to
withdrawing a patient dose. Mix the contents of the syringe just before
injection. If blood is drawn into the syringe, any unnecessary delay
prior to injection may lead to clot formation. Slow injection is
recommended. Imaging may begin immediately after intravenous injection
of Technetium Tc 99m Albumin Aggregated; follow-up imaging should be
performed as needed.<br/>Lung Imaging: The recommended intravenous dose range for the average
ADULT patient (70 kg) is 37 MBq to 148 MBq (1 to 4 mCi)
Technetium Tc 99m Albumin Aggregated after reconstitution with
oxidant-free Sodium Pertechnetate Tc 99m Injection. The
recommended number of particles per single injection is
200,000-700,000 with suggested number being approximately
350,000. The number of particles available per megabecquerel
(millicurie) dose of Technetium Tc 99m Albumin Aggregated Injection will vary depending on the physical decay of the
technetium Tc 99m that has occurred. The number of particles
available in any specific dose may be estimated by calculating
the number of particles per milliliter. In PEDIATRIC patients, the suggested intravenous doses
employed for perfusion lung imaging are in the range of 0.925
MBq to 1.85 MBq per kilogram (25 to 50��Ci/kg) of body weight
with a usual dose of 1.11 MBq per kilogram (30��Ci/kg), except
in newborns, in whom the administered dose should be 7.4 MBq to
18.5 MBq (200-500��Ci). A minimum dose of 7.4 MBq (200��Ci)
should be employed for this procedure. The number of particles
administered will vary with age and weight of the child as
indicated in Table 4.<br/>Isotopic Venography: The usual dose for unilateral or bilateral isotopic venography of the lower extremities is 74 to 148 MBq (2-4 mCi)
Technetium Tc 99m Albumin Aggregated Injection per limb,
injected intravenously peripheral to the suspected areas of
venous clot formation. For isotopic venography of the lower extremities, the
patient should be supine and properly positioned under the
scintillation camera. For unilateral or bilateral imaging of the
lower extremities, a tourniquet should be applied just above the
malleolus of each leg to be imaged in order to promote deep vein
filling. For simultaneous bilateral imaging, doses should be
administered from separate syringes. Rapid sequential
scintiphotographs should then be taken along the course of
venous flow from the calf to the abdomen. If retention of
radioactivity ("hot spots") occurs in the calf region, the
patient should be instructed to exercise the lower extremities
by flexion and extension of the knees and ankles; reimaging
should be performed after about 15 minutes. Following vein imaging, lung imaging may be performed
without need of additional Technetium Tc 99m Albumin
Aggregated.<br/>LeVeen Shunt Patency: The suggested intraperitoneal dosage range used in the
average patient (70 kg) for peritoneo-venous (LeVeen) shunt
patency evaluation is 37 to 111 megabecquerels (1 to 3
millicuries). Adequate measures should be taken to assure
uniform mixing with peritoneal fluid. Serial images of both the shunt and target organ should be obtained and correlated with
other clinical findings. Alternatively, the drug may be
administered by percutaneous transtubal injection. The suggested
percutaneous transtubal (efferent limb) dosage range for the
average patient (70 kg) is 12 to 37 megabecquerels (0.3 to 1.0
millicurie) in a volume not to exceed 0.5 mL.<br/>Radiation Dosimetry: The estimated absorbed radiation dosesto an
average ADULT patient (70 kg) from an intravenous injection of
148 MBq (4 mCi) of Technetium Tc 99m Albumin Aggregated
Injection are shown in Table 5. Method of calculation: "S", Absorbed-Dose per
Unit Cumulated Activity for Selected Radionuclides and
Organs, MIRD Pamphlet No. 11 (1975) In PEDIATRIC patients, the radiation absorbed doses using
the maximum recommended dose for lung imaging are based on 1.85
MBq (50��Ci) per kilogram of body weight (except in the newborn
where the maximum recommended dose of 18.5 MBq (500��Ci) is
used) and are shown in Table 6, which lists the maximum dosage
for children up to the age of 15 years. Note the recommendations
regarding number of particles to be administered. NOTE: DOSES TO TESTES, OVARIES AND BLADDER INCREASE WITH
VOIDING INTERVAL. Method of Calculation: The following table represents the absorbed radiation
dose resulting from the intraperitoneal administration of 111 megabecquerels (3 millicuries) of Technetium Tc 99m Albumin
Aggregated.<br/>Assumptions:: Calculations for the absorbed radiation dose are based
upon an effective half-time of 3 hours for the open shunt and
6.02 hours for the closed shunt and an even distribution of the
radiopharmaceutical in the peritoneal cavity with no biological
clearance.
|
| dailymed-drugs:497 |
Lorazepam must never be used without individualization of
dosage particularly when used with other medications capable of producing
central-nervous-system depression. EQUIPMENT NECESSARY
TO MAINTAIN A PATENT AIRWAY SHOULD BE IMMEDIATELY AVAILABLE PRIOR TO INTRAVENOUS
ADMINISTRATION OF LORAZEPAM (see���WARNINGS���). Status
Epilepticus General
Advice Status epilepticus is a potentially
life-threatening condition associated with a high risk of permanent neurological
impairment, if inadequately treated. The treatment of status, however, requires
far more than the administration of an anticonvulsant agent. It involves observation
and management of all parameters critical to maintaining vital function and
the capacity to provide support of those functions as required. Ventilatory
support must be readily available. The use of benzodiazepines, like Lorazepam
Injection, is ordinarily only an initial step of a complex and sustained intervention
which may require additional interventions, (e.g., concomitant intravenous
administration of phenytoin). Because status epilepticus may result from a
correctable acute cause such as hypoglycemia, hyponatremia, or other metabolic
or toxic derangement, such an abnormality must be immediately sought and corrected.
Furthermore, patients who are susceptible to further seizure episodes should
receive adequate maintenance antiepileptic therapy. Any
health care professional who intends to treat a patient with status epilepticus
should be familiar with this package insert and the pertinent medical literature
concerning current concepts for the treatment of status epilepticus. A comprehensive
review of the considerations critical to the informed and prudent management
of status epilepticuscannot be provided in drug product labeling. The archival
medical literature contains many informative references on the management
of status epilepticus, among them the report of the working group on status
epilepticus of the Epilepsy Foundation of America���Treatment of Convulsive
Status Epilepticus���(JAMA 1993; 270: 854-859). As noted in the report
just cited, it may be useful to consult with a neurologist if a patient fails
to respond (e.g., fails to regain consciousness). Intravenous Injection For
the treatment of status epilepticus, the usual recommended dose of Lorazepam
Injection is 4 mg given slowly (2 mg/min) for patients 18 years and older.
If seizures cease, no additional Lorazepam Injection is required. If seizures
continue or recur after a 10- to 15-minute observation period, an additional
4 mg intravenous dose may be slowly administered. Experience
with further doses of lorazepam is very limited. The usual precautions
in treating status epilepticus should be employed. An intravenous infusion
should be started, vital signs should be monitored, an unobstructed airway
should be maintained, and artificial ventilation equipment should be available. Intramuscular Injection IM
lorazepam is not preferred in the treatment of status epilepticus because
therapeutic lorazepam levels may not be reached as quickly as with IV administration.
However, when an intravenous port is not available, the IM route may prove
useful (see���CLINICAL PHARMACOLOGY���, Pharmacokinetics and Metabolism). Pediatric The safety of
lorazepam in pediatric patients has not been established. Preanesthetic Intramuscular
Injection For the designated indications as
a premedicant, the usual recommended dose of lorazepam for intramuscular injection
is 0.05 mg/kg up to a maximum of 4 mg. As with all premedicant drugs, the
dose should be individualized. (See also���CLINICAL
PHARMACOLOGY,������WARNINGS,������PRECAUTIONS,���and���ADVERSE REACTIONS.���)
Doses of other central-nervous-system depressant drugs should be ordinarily
reduced (see���PRECAUTIONS���). For optimum effect, measured as lack of recall, intramuscular
lorazepam should be administered at least 2 hours before the anticipated operative
procedure. Narcotic analgesics should be administered at their
usual preoperative time. There are insufficient data to support efficacy to
make dosage recommendations for intramuscular lorazepam in patients less than
18 years of age; therefore, such use is not recommended. Intravenous Injection For
the primary purpose of sedation and relief of anxiety, the usual recommended
initial dose of lorazepam for intravenous injection is 2 mg total, or 0.02
mg/lb (0.044 mg/kg), whichever is smaller. This dose will suffice for sedating
most adult patients and should not ordinarily be exceeded in patients over
50 years of age. In those patients in whom a greater likelihood of lack of
recall for perioperative events would be beneficial, larger doses as high
as 0.05 mg/kg up to a total of 4 mg may be administered. (See���CLINICAL PHARMACOLOGY,������WARNINGS,������PRECAUTIONS,���and���ADVERSE REACTIONS.���) Doses of other injectable central-nervous-system depressant
drugs should ordinarily be reduced (see���PRECAUTIONS���). For optimum effect, measured
as lack of recall, intravenous lorazepam should be administered 15 to 20 minutes
before the anticipated operative procedure. There
are insufficient data to support efficacy or make dosage recommendations for
intravenous lorazepam in patients less than 18 years of age; therefore, such
use is not recommended. Dose
Administration in Special Populations Elderly Patients and Patients with Hepatic Disease No
dosage adjustments are needed in elderly patients and in patients with hepatic
disease. Patients with
Renal Disease For acute dose administration,
adjustment is not needed for patients with renal disease. However, in patients
with renal disease, caution should be exercised if frequent doses are given
over relatively short periods of time (see also���CLINICAL
PHARMACOLOGY���). Dose
Adjustment Due to Drug Interactions The dose
of lorazepam should be reduced by 50% when coadministered with probenecid
or valproate (see PRECAUTIONS, Drug Interactions). It may be necessary to increase the dose
of lorazepam in female patients who are concomitantly taking oral contraceptives. Administration When
given intramuscularly, Lorazepam Injection, undiluted, should be injected
deep in the muscle mass. Lorazepam in the Blunt Cannula or InterLink packaging
is not intended for intramuscular (IM) use. Injectable
lorazepam can be used with atropine sulfate, narcotic analgesics, other parenterally
used analgesics, commonly used anesthetics, and muscle relaxants. Immediately
prior to intravenous use, Lorazepam Injection must be diluted with an equal
volume of compatible solution. When properly diluted the drug may be injected
directly into a vein or into the tubing of an existing intravenous infusion.
The rate of injection should not exceed 2 mg per minute. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. Do not use
if solution is discolored or contains a precipitate. Lorazepam
Injection is compatible for dilution purposes with the following solutions:
Sterile Water for Injection, USP; Sodium Chloride Injection, USP; 5% Dextrose
Injection, USP.
|
| dailymed-drugs:498 |
Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.<br/>Clinical Studies: Two controlled clinical trials evaluated the pediculicidal activity of OVIDE Lotion. Patients applied the lotion to the hair and scalp in quantities, up to a maximum of 2 fl. oz., sufficient to thoroughly wet the hair and scalp. The lotion was allowed to air dry and was shampooed with Prell shampoo 8 to 12 hours after application. Patients in both the OVIDE Lotion group and in the vehicle group were examined immediately after shampooing, 24 hours after, and 7
days after for the presence of live lice. Results are shown in the following table: The presence or absence of ova at day 7 was not evaluated in these studies. The presence or absence of live lice or ova at 14 days following treatment was not evaluated in these studies. The residual amount of malathion on hair and scalp is unknown.
|
| dailymed-drugs:499 |
The dosage of sufentanil should be individualized in each
case according to body weight, physical status, underlying pathological condition,
use of other drugs, and type of surgical procedure and anesthesia. In obese
patients (more than 20% above ideal total body weight), the dosage of sufentanil
citrate should be determined on the basis of lean body weight. Dosage should
be reduced in elderly and debilitated patients (see PRECAUTIONS). Vital
signs should be monitored routinely. Intravenous
Use Sufentanil Citrate may be administered
intravenously by slow injection or infusion 1) in doses of up to 8 mcg/kg
as an analgesic adjunct to general anesthesia, and 2) in doses���8
mcg/kg as a primary anesthetic agent for induction and maintenance of anesthesia
(see Dosage Range Chart). If benzodiazepines, barbiturates,
inhalation agents, other opioids or other central nervous system depressants
are used concomitantly, the dose of sufentanil and/or these agents should
be reduced (see PRECAUTIONS). In all cases dosage should be titrated to individual
patient response. Usage
In Children: For induction and maintenance of anesthesia in children
less than 12 years of age undergoing cardiovascular surgery, an anesthetic
dose of 10-25 mcg/kg administered with 100% oxygen is generally recommended.
Supplemental dosages of up to 25-50 mcg are recommended for maintenance, based
on response to initial dose and as determined by changes in vital signs indicating
surgical stress or lightening of anesthesia. Premedication: The selection of preanesthetic
medications should be based upon the needs of the individual patient. Neuromuscular Blocking Agents: The neuromuscular
blocking agent selected should be compatible with the patient's condition,
taking into account the hemodynamic effects of a particular muscle relaxant
and the degree of skeletal muscle relaxation required (see CLINICAL PHARMACOLOGY,
WARNINGS and PRECAUTIONS). In patients administered high doses of sufentanil citrate,
it is essential that qualified personnel and adequate facilities are available
for the management of postoperative respiratory depression. Also
see WARNINGS and PRECAUTIONS sections. For purposes
of administering small volumes of sufentanil citrate injection accurately,
the use of a tuberculin syringe or equivalent is recommended. Epidural Use in Labor and Delivery Proper
placement of the needle or catheter in the epidural space should be verified
before sufentanil is injected to assure that unintentional intravascular or
intrathecal administration does not occur. Unintentional intravascular injection
of sufentanil could result in a potentially serious overdose, including acute
truncal muscular rigidity and apnea. Unintentional intrathecal injection of
the full sufentanil, bupivacaine epidural doses and volume could produce effects
of high spinal anesthesia including prolonged paralysis and delayed recovery.
If analgesia is inadequate, the placement and integrity of the catheter should
be verified prior to the administration of any additional epidural medications.
Sufentanil should be administered by slow injection. Respiration should be
closely monitored following each administration of an epidural injection of
sufentanil. Dosage for Labor and Delivery: The recommended
dosage is sufentanil 10-15 mcg administered with 10 mL bupivacaine 0.125%
with or without epinephrine. Sufentanil and bupivacaine should be mixed together
before administration. Doses can be repeated twice (for a total of three doses)
at not less than one-hour intervals until delivery. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit.
|
| dailymed-drugs:500 |
OptiMARK Injection should be administered as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection.<br/>Imaging: The imaging procedure should be completed within 1 hour of the injection of OptiMARK Injection. The safety of repeat doses has not been studied. OptiMARK MRI images should be interpreted in comparison to unenhanced MRI.<br/>Drug Handling: Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Concurrent medications or Parenteral Nutrition should not be physically mixed with contrast agents and should not be administered in the same intravenous line because of the potential for chemical incompatibility. When OptiMARK Injection is to be injected using plastic disposable syringes, the contrast should be drawn into the syringe and used immediately. This product has not been evaluated for use in magnetic resonance angiography. OptiMARK Injection should be drawn into the syringe and administered using sterile technique. If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents. To ensure complete injection of the contrast medium the injection should be followed by a 5mL normal saline flush. Unused portions of the drug must be discarded.
|
| dailymed-drugs:501 |
The dose is dependent upon the age, weight and clinical condition
of the patient. In infants, Ionosol MB and 5% Dextrose
Injection is given only after administration of an initial priming solution:
15 mL of half isotonic saline in 5% dextrose and 0.45% Sodium Chloride Injection/kg
of body weight, administered to small infants at a maximum rate of 0.8 mL/minute.
Infants typically tolerate not more than 150 to 200 mL of Ionosol MB and 5%
Dextrose Injection per kg body weight/day. As reported
in the literature, the dosage and constant infusion rate of intravenous dextrose
must be selected with caution in pediatric patients, particularly neonates
and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. In
adults, intravenous infusions of Ionosol MB and 5% Dextrose Injection are
given postoperatively, at a rate not greater than 4 mL/minute. Drug Interactions Additives
may be incompatible. Consult with pharmacist, if available. When introducing
additives, use aseptic technique, mix thoroughly and do not store. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration. See PRECAUTIONS. INSTRUCTIONS
FOR USE To Open: Tear outer wrap at notch and remove solution
container. Some opacity of the plastic due to moisture absorption during sterilization
process may be observed. This is normal and does not affect the solution quality
or safety. The opacity will diminish gradually. If supplemental
medication is desired, follow directions below before preparing for administration. To Add Medication To Administer WARNING: Do not use flexible container
in series connections.
|
| dailymed-drugs:502 |
Terconazole vaginal suppositories, 80 mgOne terconazole vaginal suppositories 80 mg should be administered intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of terconazole vaginal suppositories is not affected by menstruation.
|
| dailymed-drugs:504 |
Ammonium Chloride Injection, USP is administered intravenously
and must be diluted before use. Solutions for intravenous infusion should
not exceed a concentration of 1% to 2% of ammonium chloride. Dosage
is dependent upon the condition and tolerance of the patient. It is recommended
that the contents of one to two vials (100 to 200 mEq) be added to 500 or
1000 mL of isotonic (0.9%) sodium chloride injection. The rate of intravenous
infusion should not exceed 5 mL per minute in adults (approximately 3 hours
for infusion of 1000 mL). Dosage should be monitored by repeated serum bicarbonate
determinations. Parenteral drug products should be inspected
visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. See PRECAUTIONS.
|
| dailymed-drugs:505 |
Accurate diagnosis of infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium. Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium-depending on rate of growth-fingernails, at least 4 months; toenails, at least 6 months. General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis. In some forms of athlete's foot, yeasts and bacteria may be involved as well as fungi. Griseofulvin will not eradicate the bacterial or monilial infection. Gris-PEG tablets may be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing.<br/>Adults: Daily administration of 375 mg (as a single dose or in divided doses) will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis. For those fungal infections more difficult to eradicate, such as tinea pedis and tinea unguium, a divided dose of 750 mg is recommended.<br/>Pediatric Use: Approximately 3.3 mg per pound of body weight per day of ultramicrosize griseofulvin is an effective dose for most pediatric patients. On this basis, the following dosage schedule is suggested: Children weighing 35-60 pounds - 125 mg to 187.5 mg daily. Pediatric patients weighing over 60 pounds - 187.5 mg to 375 mg daily. Children and infants 2 years of age and younger - dosage has not been established. Clinical experience with griseofulvin in children with tinea capitis indicates that a single daily dose is effective. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.
|
| dailymed-drugs:506 |
Gently massage sufficient clotrimazole and betamethasone dipropionate lotion into the affected skin areas twice a day, in the morning and evening. Clotrimazole and betamethasone dipropionate lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 mL per week of clotrimazole and betamethasone dipropionate lotion should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after one week of treatment with clotrimazole and betamethasone dipropionate lotion, the diagnosis should be reviewed. Clotrimazole and betamethasone dipropionate lotion should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 mL per week of clotrimazole and betamethasone dipropionate lotion should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate lotion, the diagnosis should be reviewed. Clotrimazole and betamethasone dipropionate lotion should not be used with occlusive dressings.
|
| dailymed-drugs:507 |
Apply a thin layer of clobetasol propionate cream or ointment to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE). Clobetasol cream and ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g per week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol cream and ointment should not be used with occlusive dressings.
|
| dailymed-drugs:508 |
Milrinone Injection should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines: LOADING DOSE 50 mcg/kg: Administer slowly over 10 minutes The table below shows the loading dose in milliliters (mL) of Milrinone (1mg/mL) by patient body weight (kg). The loading dose may be given undiluted, but diluting to a rounded total volume of 10 or 20 mL (see Maintenance Dose for diluents) may simplify the visualization of the injection rate. MAINTENANCE DOSE Milrinone Injection drawn from vials should be diluted prior to maintenance dose administration. The diluents that may be used are 0.45% Sodium Chloride Injection USP, 0.9% Sodium Chloride Injection USP, or 5% Dextrose Injection USP. The table below shows the volume of diluent in milliliters (mL) that must be used to achieve 200 mcg/mL concentration for infusion, and the resultant total volumes. The infusion rate should be adjusted according to hemodynamic and clinical response. Patients should be closely monitored. In controlled clinical studies, most patients showed an improvement in hemodynamic status as evidenced by increases in cardiac output and reductions in pulmonary capillary wedge pressure. Note: See "Dosage Adjustment in Renally Impaired Patients." Dosage may be titrated to the maximum hemodynamic effect and should not exceed 1.13 mg/kg/day. Duration of therapy should depend upon patient responsiveness. The maintenance dose in mL/hr by patient body weight (kg) may be determined by reference to the following table. When administering milrinone by continuous infusion, it is advisable to use a calibrated electronic infusion device. Intravenous drug products should be inspected visually and should not be used if particulate matter or discoloration is present.<br/>Dosage Adjustment in Renally Impaired Patients: Data obtained from patients with severe renal impairment (creatinine clearance = 0 to 30 mL/min) but without congestive heart failure have demonstrated that the presence of renal impairment significantly increases the terminal elimination half-life of milrinone. Reductions in infusion rate may be necessary in patients with renal impairment. For patients with clinical evidence of renal impairment, the recommended infusion rate can be obtained from the following table:
|
| dailymed-drugs:509 |
There is considerable variation from patient to patient in the amount of medication required for treatment. As with all drugs, used to treat schizophrenia, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control. To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels. Parenteral medication, administered intramuscularly in doses of 2 to 5 mg, is utilized for prompt control of the acutely agitated schizophrenic patient with moderately severe to very severe symptoms. Depending on the response of the patient, subsequent doses may be given, administered as often as every hour, although 4 to 8 hour intervals maybe satisfactory. Controlled trials to establish the safety and effectiveness of intramuscular administration in children have not been conducted. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.<br/>Switchover Procedure: An oral form should supplant the injectable as soon as practicable. In the absence of bioavailability studies establishing bioequivalence between these two dosage forms the following guidelines for dosage are suggested. For an initial approximation of the total daily dose required, the parenteral dose administered in the preceding 24hours may be used. Since this dose is only an initial estimate, it is recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy, sedation, and adverse effects, be carried out periodically for the first several days following the initiation of switchover. In this way, dosage adjustments, either upward or downward, can be quickly accomplished. Depending on the patient's clinical status, the first oral dose should be given within 12 to 24 hours following the last parenteral dose.
|
| dailymed-drugs:510 |
Amoxicillin tablets may be given without regard to meals. The 875 mg tablet has been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 500 mg formulation.<br/>Neonates and Infants Aged���12 Weeks (���3 Months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.<br/>Adults and Pediatric Patients>3 Months: All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS, Laboratory Tests.) Larger doses may be required for stubborn or severe infections.<br/>General: It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.<br/>H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:<br/>Triple Therapy:<br/>Dual Therapy:<br/>Dosing Recommendations for Adults with Impaired Renal Function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of<30 mL/min should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. There are currently no dosing recommendations for pediatric patients with impaired renal function.
|
| dailymed-drugs:511 |
Contraindicated in pediatric patients less than 2 months of age.<br/>Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients and Acute Otitis Media in Pediatric Patients:<br/>Adults: The usual adult dosage in the treatment of urinary tract infections is four teaspoonfuls (20 mL) sulfamethoxazole and trimethoprim oral suspension every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.<br/>Pediatric Patients: The recommended dose for pediatric patients with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage: Pediatric patients Two months of age or older<br/>For Patients With Impaired Renal Function: When renal function is impaired, a reduced dosage should be employed using the following table:<br/>Acute Exacerbations of Chronic Bronchitis in Adults: The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is four teaspoonfuls (20 mL) sulfamethoxazole and trimethoprim oral suspension every 12 hours for 14 days.<br/>Travelers' Diarrhea in Adults: For the treatment of travelers' diarrhea, the usual adult dosage is four teaspoonfuls (20 mL) of sulfamethoxazole and trimethoprim oral suspension every 12 hours for 5 days.<br/>Pneumocystis carinii Pneumonia:<br/>Treatment:<br/>Prophylaxis:<br/>Adults: The recommended dosage for prophylaxis in adults is four teaspoonfuls (20 mL) of the suspension daily.<br/>Pediatric Patients: For pediatric patients, the recommended dose is 750 mg/m/day sulfamethoxazole with 150 mg/m/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1,600 mg sulfamethoxazole and 320 mg trimethoprim. The following table is a guideline for the attainment of this dosage in pediatric patients:
|
| dailymed-drugs:512 |
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.<br/>Anxiety Disorders and Transient Symptoms of Anxiety: Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment. In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.<br/>Panic Disorder: The successful treatment of many panic disorder patients has required the use of alprazolam at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received alprazolam in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mga day to achieve a successful response.<br/>Dose Titration: Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.<br/>Dose Maintenance: For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of alprazolam greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. The necessary duration of treatment for panic disorder patients responding to alprazolam is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.<br/>Dose Reduction: Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided . In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction. In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.<br/>Dosing in Special Populations: In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.
|
| dailymed-drugs:513 |
Following suitable
admixture of prescribed drugs, the dosage is usually dependent upon the
age, weight and clinical condition of the patient as well as laboratory
determinations. See directions accompanying drugs. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. Use of a final filter is recommended during administration of
all parenteral solutions where possible. Sterile Water for
Injection, USP in the Pharmacy Bulk Package is intended for use in the
preparation of sterile, intravenous admixtures. Additives may be
incompatible with the fluid withdrawn from this container. Complete
information is not available. Those additives known to be incompatible
should not be used. Consult with pharmacist, if available. When
compounding admixtures, use aseptic technique. Mix thoroughly. Do not
store any unused portion of Sterile Water for Injection,
USP.<br/>Directions for use
of Viaflex Plastic Pharmacy Bulk Package Container:<br/>To Open: Tear overwrap down side at slit and remove solution
container. Some opacity of the plastic due to moisture absorption during the sterilization process may be
observed. This is normal and does not affect the
solution quality or safety. The opacity will diminish
gradually. Check for minute leaks by squeezing inner bag
firmly, if leaks are found, discard solution as
sterility may be impaired. For
compounding only, not for direct infusion.<br/>Preparation
for Admixing: 1.
The Pharmacy Bulk Package is to be used only in a
suitable work area such as a laminar flow hood (or an
equivalent clean air compounding area). 2.
Suspend container from eyelet support. 3.
Remove plastic protector from outlet port at bottom of
container. 4.
Attach solution transfer set. Refer to complete
directions accompanying set. Note: The closure shall be penetrated only one time
with a suitable sterile transfer device or dispensing
set which allows measured dispensing of the contents. 5.
Viaflex containers should not be written
on directly since ink migration has not been
investigated. Affix accompanying label for date and time
of entry. 6.
Once container closure has been penetrated, withdrawal
of contents should be completed without delay. After
initial entry, maintain contents at room temperature
(25��C/77��F) and dispense within 4 hours.
|
| dailymed-drugs:515 |
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract),100 mg every 12 hours is recommended. For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For children over 100 lbs the usual adult dose should be used. The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. When used in streptococcal infections, therapy should be continued for 10 days. Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment. Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg by mouth twice a day for 7 days. Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg by mouth twice a day for 7 days. Syphilis���early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice a day for 2 weeks. Syphilis of more than one year's duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice a day for 4 weeks. Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days. Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days. For the prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1���2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area. Inhalational anthrax (post-exposure):
|
| dailymed-drugs:516 |
Hypertension: Initial Therapy: In patients with uncomplicated essential hypertension not on diuretic therapy, the recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours. If it is not, an increase in dose should be considered. Doses up to 80 mg have been used but do not appear to give a greater effect. If blood pressure is not controlled with lisinopril alone, a low dose of a diuretic may be added. Hydrochlorothiazide 12.5 mg has been shown to provide an additive effect. After the addition of a diuretic, it may be possible to reduce the dose of lisinopril. Diuretic Treated Patients: In hypertensive patients who are currently being treated with a diuretic, symptomatic hypotension may occur occasionally following the initial dose of lisinopril. The diuretic should be discontinued, if possible, for two to three days before beginning therapy with lisinopril to reduce the likelihood of hypotension. (See WARNINGS.) The dosage of lisinopril should be adjusted according to blood pressure response. If the patient's blood pressure is not controlled with lisinopril alone, diuretic therapy may be resumed as described above. If the diuretic cannot be discontinued, an initial dose of 5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS, Drug Interactions.) Concomitant administration of lisinopril with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see PRECAUTIONS). Dosage Adjustment in Renal Impairment: The usual dose of lisinopril (10 mg) is recommended for patients with a creatinine clearance>30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance���10 mL/min���30 mL/min (serum creatinine���3 mg/dL), the first dose is 5 mg once daily. For patients with creatinine clearance<10 mL/min (usually on hemodialysis) the recommended initial dose is 2.5 mg. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily. See WARNINGS, Anaphylactoid reactions during membrane exposure Dosage or dosing interval should be adjusted depending on the blood pressure response.<br/>Heart Failure: Lisinopril is indicated as adjunctive therapy with diuretics and (usually) digitalis. The recommended starting dose is 5 mg once a day. When initiating treatment with lisinopril in patients with heart failure, the initial dose should be administered under medical observation, especially in those patients with low blood pressure (systolic blood pressure below 100 mmHg). The mean peak blood pressure lowering occurs six to eight hours after dosing. Observation should continue until blood pressure is stable. The concomitant diuretic dose should be reduced, if possible, to help minimize hypovolemia which may contribute to hypotension. (See WARNINGS and PRECAUTIONS, DrugInteractions.) The appearance of hypotension after the initial dose of lisinopril does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension. The usual effective dosage range is 5 to 40 mg per day administered as a single daily dose. The dose of lisinopril can be increased by increments of no greater than 10 mg, at intervals of no less than 2 weeks to the highest tolerated dose, up to a maximum of 40 mg daily. Dose adjustment should be based on the clinical response of individual patients. Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia: In patients with heart failure who have hyponatremia (serum sodium<130 mEq/L) or moderate to severe renal impairment (creatinine clearance���30 mL/min or serum creatinine>3 mg/dL), therapy with lisinopril should be initiated at a dose of 2.5 mg once a day under close medical supervision. (See WARNINGS and PRECAUTIONS, Drug Interactions.)<br/>Acute Myocardial Infarction: In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, the first dose of lisinopril is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg of lisinopril once daily. Dosing should continue for six weeks. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers. Patients with a low systolic blood pressure (���120 mmHg) when treatment is started or during the first 3 days after the infarct should be given a lower 2.5 mg oral dose of lisinopril (see WARNINGS). If hypotension occurs (systolic blood pressure���100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure<90 mmHg for more than 1 hour) lisinopril should be withdrawn. For patients who develop symptoms of heart failure, see DOSAGE AND ADMINISTRATION, Heart Failure. Dosage Adjustment in Patients with Myocardial Infarction with Renal Impairment: In acute myocardial infarction, treatment with lisinopril should be initiated with caution in patients with evidence of renal dysfunction, defined as serum creatinine concentration exceeding 2 mg/dL. No evaluation of dosage adjustment in myocardial infarction patients with severe renal impairment has been performed.<br/>Use in Elderly: In general, the clinical response was similar in younger and older patients given similar doses of lisinopril. Pharmacokinetic studies, however, indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients, so that dosage adjustments should be made with particular caution.<br/>Pediatric Hypertensive Patients���6 years of age: The usual recommended starting dose is 0.07 mg/kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients. (See CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism and Pharmacodynamics and Clinical Effects.) Lisinopril is not recommend in pediatric patients<6 years or in pediatric patients with glomerular filtration rate<30 mL/min/1.73 min(see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism and Pharmacodynamics and Clinical Effects and PRECAUTIONS). Preparation of Suspension (for 200 mL of a 1 mg/mL suspension): Add 10 mL of Purified Water USP to a polyethylene terephthalate (PET) bottle containing ten 20 mg tablets of lisinopril and shake for at least one minute. Add 30 mL of Bicitradiluent and 160 mL of Ora-Sweet SFto the concentrate in the PET bottle and gently shake for several seconds to disperse the ingredients. The suspension should be stored at or below 25��C (77��F) and can be stored for up to four weeks. Shake the suspension before each use. Registered trademark of Alza Corporation Trademark of Paddock Laboratories, Inc.
|
| dailymed-drugs:517 |
Adult and Pediatric Asthma: For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage of XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol for adults and children 4 years of age and older is 2 inhalations (90 mcg) repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a larger number of inhalations is not routinely recommended. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 3 days by releasing 4 test sprays into the air, away from the face. If a previously effective dosage regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. Cleaning: To maintain proper use of this product, it is critical that the actuator be washed and dried thoroughly at least once a week. The inhaler may cease to deliver medication if not properly cleaned and dried thoroughly. See Information for Patients. Keeping the plastic actuator clean is very important to prevent medication build-up and blockage. If the actuator becomes blocked with drug, washing the actuator will remove the blockage.
|
| dailymed-drugs:518 |
Dosing and Administration in Adults:<br/>Initiation of BETAPACE AF Therapy: Step 1. Electrocardiographic assessment: Prior to administration of the first dose, the QT interval must be determined using an average of 5 beats. If the baseline QT is greater than 450 msec (JT���330 msec if QRS over 100 msec), BETAPACE AF is contraindicated. Step 2. Calculation of creatinine clearance: Prior to the administration of the first dose, the patient's creatinine clearance should be calculated using the following formula: When serum creatinine is given in��mol/L, divide the value by 88.4 (1 mg/dL = 88.4��mol/L). Step 3. Starting Dose: The starting dose of BETAPACE AF is 80 mg twice daily (BID) if the creatinine clearance is>60 mL/min, and 80 mg once daily (QD) if the creatinine clearance is 40-60 mL/min. If the creatinine clearance is<40 mL/min BETAPACE AF is contraindicated. Step 4. Administer the appropriate daily dose of BETAPACE AF and begin continuous ECG monitoring with QT interval measurements 2-4 hours after each dose. Step 5. If the 80 mg dose level is tolerated and the QT interval remains<500 msec after at least 3 days (after 5 or 6 doses if patient receiving QD dosing), the patient can be discharged. Alternatively, during hospitalization, the dose can be increased to 120 mg bid and the patient followed for 3 days on this dose (followed for 5 or 6 doses if patient receiving QD doses). The steps described above are summarized in the following diagram: Place Patient on Telemetry Check Baseline QT If QT>450 msec BETAPACE AF is CONTRAINDICATED If QT���450 msec, proceed Calculate Creatine Clearance (Clcr) If Clcr is<40 mL/min BETAPACE AF is CONTRAINDICATED If Clcr is 40-60 mL/min start BETAPACE AF 80 mg QD If Clcr is>60 mL/min start BETAPACE AF 80 mg BID Monitor QT 2-4 hours after each dose. If QT���500 msec discontinue BETAPACE AF If QT<500 msec after 3 days (after 5th or 6th dose if patient receiving QD dosing) discharge patient on current treatment. Alternatively, during hospitalization, the dose can be increased to 120 mg BID and the patient followed for 3 days on this dose (followed for 5 or 6 doses if patient receiving QD doses).<br/>Upward Titration of Dose: If the 80 mg dose level (given BID or QD depending upon the creatinine clearance) does not reduce the frequency of relapses of AFIB/AFL and is tolerated without excessive QT interval prolongation (i.e.,���520 msec), the dose level may be increased to 120 mg (BID or QD depending upon the creatinine clearance). As proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment, Steps 2 through 5 used during initiation of BETAPACE AF therapy should be followed when increasing the dose level. In the U.S. multicenter dose-response study, the 120 mg dose (BID or QD) was found to be the most effective in prolonging the time to ECG documented symptomatic recurrence of AFIB/AFL. If the 120 mg dose does not reduce the frequency of early relapse of AFIB/AFL and is tolerated without excessive QT interval prolongation (���520 msec), an increase to 160 mg (BID or QD depending upon the creatinine clearance), can be considered. Steps 2 through 5 used during the initiation of therapy should be used again to introduce such an increase.<br/>Maintenance of BETAPACE AF Therapy: Renal function and QT should be re-evaluated regularly if medically warranted. If QT is 520 msec or greater (JT 430 msec or greater if QRS is>100 msec), the dose of BETAPACE AF therapy should be reduced and patients should be carefully monitored until QT returns to less than 520 msec. If the QT interval is���520 msec while on the lowest maintenance dose level (80 mg) the drug should be discontinued. If renal function deteriorates, reduce the daily dose in half by administering the drug once daily as described in Initiation of BETAPACE AF Therapy, Step 3.<br/>Special Considerations: The maximum recommended dose in patients with a calculated creatinine clearance greater than 60 mL/min is 160 mg BID, doses greater than 160 mg BID have been associated with an increased incidence of Torsade de Pointes and are not recommended. A patient who misses a dose should NOT double the next dose. The next dose should be taken at the usual time.<br/>Dosing and Administration in Children: As in adults the following precautionary measures should be considered when initiating sotalol treatment in children: initiation of treatment in the hospital after appropriate clinical assessment; individualized regimen as appropriate; gradual increase of doses if required; careful assessment of therapeutic response and tolerability; and frequent monitoring of the QTinterval and heart rate. For children aged about 2 years and greater, with normal renal function, doses normalized for body surface area are appropriate for both initial and incremental dosing. Since the Class III potency in children is not very different from that in adults, reaching plasma concentrations that occur within the adult dose range is an appropriate guide. From pediatric pharmacokinetic data the following is recommended. For initiation of treatment, 30 mg/mthree times a day (90 mg/mtotal daily dose) is approximately equivalent to the initial 160 mg total daily dose for adults. Subsequent titration to a maximum of 60 mg/m(approximately equivalent to the 360 mg total daily dose for adults) can then occur. Titration should be guided by clinical response, heart rate and QT, with increased dosing being preferably carried out in-hospital. At least 36 hours should be allowed between dose increments to attain steady-state plasma concentrations of sotalol in patients with age-adjusted normal renal function. For children aged about 2 years or younger, the above pediatric dosage should be reduced by a factor that depends heavily upon age, as shown in the following graph, age plotted on a logarithmic scale in months. For a child aged 20 months, the dosing suggested for children with normal renal function aged 2 years or greater should be multiplied by about 0.97; the initial starting dose would be (30 X 0.97)=29.1 mg/m, administered three times daily. For a child aged 1 month, the starting dose should be multiplied by 0.68; the initial starting dose would be (30 X 0.68)=20 mg/m, administered three times daily. For a child aged about 1 week, the initial starting dose should be multiplied by 0.3; the starting dose would be (30 X 0.3)=9 mg/m. Similar calculations should be made for increased doses as titration proceeds. Since the half-life of sotalol decreases with decreasing age (below about 2 years), time to steady-state will also increase. Thus, in neonates the time to steady-state may be as long as a week or longer. In all children, individualization of dosage is required. As in adults BETAPACE (sotalol hydrochloride) should be used with particular caution in children if the QTis greater than 500 msec on therapy and serious consideration should be given to reducing the dose or discontinuing therapy when QTexceeds 550 msec. The use of BETAPACE AF (sotalol hydrochloride) in children with renal impairment has not been investigated. Sotalol elimination is predominantly via the kidney in the unchanged form. Use of sotalol in any age group with decreased renal function should be at lower doses or at increased intervals between doses. Monitoring of heart rate and QTis more important and it will take much longer to reach steady-state with any dose and/or frequency of administration.<br/>Transfer to BETAPACE AF from BETAPACE: Patients with a history of symptomatic AFIB/AFL who are currently receiving BETAPACE for the maintenance of normal sinus should be transferred to BETAPACE AF because of the significant differences in labeling (i.e., patient package insert, dosing administration, and safety information).<br/>Transfer to BETAPACE AF from Other Antiarrhythmic Agents: Before starting BETAPACE AF, previous antiarrhythmic therapy should generally be withdrawn under careful monitoring for a minimum of 2-3 plasma half-lives if the patient's clinical condition permits . Treatment has been initiated in some patients receiving I.V. lidocaine without ill effect. After discontinuation of amiodarone, BETAPACE AF should not be initiated until the QT interval is normalized .
|
| dailymed-drugs:519 |
One dose (1 packet or 1 level teaspoon) of COLESTID Granules contains 5 grams of colestipol hydrochloride. One dose (1 packet or 1 level scoopful) of FLAVORED COLESTID Granules is approximately 7.5 grams which contains 5 grams of colestipol hydrochloride. The recommended daily adult dose is one to six packets or level scoopfuls given once or in divided doses. Treatment should be started with one dose once or twice daily with an increment of one dose/day at one- or two-month intervals. Appropriate use of lipid profiles as per NCEP guidelines including LDL-cholesterol and triglycerides is advised so that optimal, but not excessive doses are used to obtain the desired therapeutic effect on LDL-cholesterol level. If the desired therapeutic effect is not obtained at one to six doses/day with good compliance and acceptable side effects, combined therapy or alternate treatment should be considered. To avoid accidental inhalation or esophageal distress, COLESTID and FLAVORED COLESTID should not be taken in its dry form. COLESTID and FLAVORED COLESTID should always be mixed with water or other fluids before ingesting. Patients should take other drugs at least one hour before or four hours after COLESTID or FLAVORED COLESTID to minimize possible interference with their absorption.<br/>Before COLESTID or FLAVORED COLESTID Administration:<br/>During COLESTID or FLAVORED COLESTID Administration:<br/>Mixing and Administration Guide: COLESTID and FLAVORED COLESTID should always be mixed in a liquid such as water or the beverage of your choice. It may also be taken in soups or with cereals or pulpy fruits. COLESTID or FLAVORED COLESTID should never be taken in its dry form. FLAVORED COLESTID is an orange-flavored product. Although it may be mixed with a variety of liquids or foods, the selection should be based on patient preference.<br/>With Beverages: Rinse the glass with a small amount of additional beverage to make sure all the medication is taken.<br/>With cereals, soups, and fruits: COLESTID and FLAVORED COLESTID may be taken mixed with milk in hot or regular breakfast cereals, or even mixed in soups that have a high fluid content. It may also be added to fruits that are pulpy such as crushed pineapple, pears, peaches, or fruit cocktail.
|
| dailymed-drugs:520 |
SHAKE VIGOROUSLY BEFORE USING. One drop instilled into the affected eye(s) four times daily.
|
| dailymed-drugs:521 |
Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one or two capsules every four to six hours as needed for pain. The total daily dosage should not exceed 8 capsules.
|
| dailymed-drugs:522 |
To achieve maximum contraceptive effectiveness, ORTHO-NOVUM
Tablets and MODICON Tablets must be taken exactly as directed and at intervals
not exceeding 24 hours. ORTHO-NOVUM Tablets and MODICON Tablets are available
in the DIALPAK Tablet Dispenser which is preset for a Sunday
Start. Day 1 Start is also available.<br/>Sunday Start: When taking ORTHO-NOVUM 7/7/7, ORTHO-NOVUM 1/35, and MODICON,
the first "active" tablet should be taken on the first Sunday after menstruation
begins. If period begins on Sunday, the first "active" tablet should be taken
that day. Take one active tablet daily for 21 days followed by one green "reminder"
tablet daily for 7 days. After28 tablets have been taken, a new course is
started the next day (Sunday). For the first cycle of a Sunday Start regimen,
another method of contraception should be used until after the first 7 consecutive
days of administration. If the patient misses one (1)
"active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as
she remembers. If the patient misses two (2) "active" tablets in Week 1 or
Week 2, the patient should take two (2) tablets the day she remembers and
two (2) tablets the next day; and then continue taking one (1) tablet a day
until she finishes the pack. The patient should be instructed to use a back-up
method of birth control such as condoms or spermicide if she has sex in the
seven (7) days after missing pills. If the patient misses two (2) "active"
tablets in the third week or misses three (3) or more "active" tablets in
a row, the patient should continue taking one tablet every day until Sunday.
On Sunday the patient should throw out the rest of the pack and start a new
pack that same day. The patient should be instructed to use a back-up method
of birth control if she has sex in the seven (7) days after missing pills. Complete
instructions to facilitate patient counseling on proper pill usage may be
found in the Detailed Patient
Labeling ("How to Take the Pill" section).<br/>Day 1 Start: The dosage of ORTHO-NOVUM 7/7/7, ORTHO-NOVUM 1/35, and MODICON,
for the initial cycle of therapy is one "active" tablet administered daily
from the 1st through the 21st day of the menstrual cycle, counting the first
day of menstrual flow as "Day 1" followed by one green "reminder" tablet daily
for 7 days. Tablets are taken without interruption for 28 days. After 28
tablets have been taken, a new course is started the next day. If
the patient misses one (1) "active" tablet in Weeks 1, 2, or 3, the tablet
should be taken as soon as she remembers. If the patient misses two (2) "active"
tablets in Week 1 or Week 2, the patient should take two (2) tablets the day
she remembers and two (2) tablets the next day; and then continue taking one
(1) tablet a day until she finishes the pack. The patient should be instructed
to use a back-upmethod of birth control such as condoms or spermicide if
she has sex in the seven (7) days after missing pills. If the patient misses
two (2) "active" tablets in the third week or misses three (3) or more "active"
tablets in a row, the patient should throw out the rest of the pack and start
a new pack that same day. The patient should be instructed to use a back-up
method of birth control if she has sex in the seven (7) days after missing
pills. Complete instructions to facilitate patient
counseling on proper pill usage may be found in the Detailed Patient Labeling
("How to Take the Pill" section). The use of ORTHO-NOVUM
7/7/7, ORTHO-NOVUM 1/35, and MODICON for contraception may be initiated 4
weeks postpartum in women who elect not to breast feed. When the tablets are
administered during the postpartum period, the increased risk of thromboembolic
disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning
thromboembolic disease. See also PRECAUTIONS for "Nursing
Mothers.") The possibility of ovulation and conception prior to
initiation of medication should be considered. (See
Discussion of Dose-Related Risk of Vascular
Disease from Oral Contraceptives.)
|
| dailymed-drugs:523 |
Cytarabine is not active orally. The schedule and method of administration varies with the program of therapy to be used. Cytarabine Injection may be given by intravenous infusion or injection or subcutaneously. Thrombophlebitis has occurred at the site of drug injection or infusion in some patients, and rarely patients have noted pain and inflammation at subcutaneous injection sites. In most instances, however, the drug has been well tolerated. Patients can tolerate higher total doses when they receive the drug by rapid intravenous injection as compared with slow infusion. This phenomenon is related to the drug's rapid inactivation and brief exposure of susceptible normal and neoplastic cells to significant levels after rapid injection. Normal and neoplastic cells seem to respond in somewhat parallel fashion to these different modes of administration and no clear-cut clinical advantage has been demonstrated for either. In the induction therapy of acute non-lymphocytic leukemia, the usual cytarabine dose in combination with other anticancer drugs is 100 mg/m/day by continuous IV infusion (Days 1-7) or 100 mg/mIV every 12 hours (Days 1-7). The literature should be consulted for the current recommendations for use in acute lymphocytic leukemia. Intrathecal Use in Meningeal Leukemia: DO NOT USE CYTARABINE INJECTION (which contains benzyl alcohol) INTRATHECALLY. The following dosage information regarding intrathecal use is included for informational purposes only. Cytarabine has been used intrathecally in acute leukemia in doses ranging from 5 mg/mto 75 mg/mof body surface area. The frequency of administration varied from once a day for 4 days to once every 4 days. The most frequently used dose was 30 mg/mevery 4 days until cerebrospinal fluid findings were normal, followed by one additional treatment. The dosage schedule is usually governed by the type and severity of central nervous system manifestations and the response to previous therapy. Cytarabine given intrathecally may cause systemic toxicity and careful monitoring of the hemopoietic system is indicated. Modifications of other anti-leukemia therapy may be necessary. Major toxicity is rare. The most frequently reported reactions after intrathecal administration were nausea, vomiting and fever; these reactions are mild and self-limiting. Paraplegia has been reported. Necrotizing leukoencephalopathy occurred in 5 children; these patients had also been treated with intrathecal methotrexate and hydrocortisone, as well as by central nervous system radiation. Isolated neurotoxicity has been reported. Blindness occurred in two patients in remission whose treatment had consisted of combination systemic chemotherapy, prophylactic central nervous system radiation and intrathecal cytarabine. When cytarabine is administered both intrathecally and intravenously within a few days, there is an increased risk of spinal cord toxicity, however, in serious lifethreatening disease, concurrent use of intravenous and intrathecal cytarabine is left to the discretion of the treating physician. Focal leukemic involvement of the central nervous system may not respond to intrathecal cytarabine and may be better treated with radiotherapy.<br/>Chemical Stability in Infusion Solutions: Chemical stability studies were performed by a stability indicating HPLC assay on Cytarabine Injection in infusion solutions. These studies showed that when Cytarabine Injection was diluted with Water for Injection, 5% Dextrose Injection or Sodium Chloride Injection, 97-100% of the cytarabine was still present after 8 days storage at room temperature. This chemical stability information in no way indicates that it would be acceptable practice to infuse a cytarabine admixture well after the preparation time. Good professional practice suggests that administration of an admixture should be as soon after preparation as feasible. Parenteral drugs should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution and container permit.<br/>Handling and Disposal: Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published.There is no general agreement that all of the procedures in the guidelines are necessary or appropriate.
|
| dailymed-drugs:524 |
Carefully consider the potential benefits and risks of naproxen sodium and other treatment options before deciding to use naproxen sodium. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . After observing the response to initial therapy with naproxen sodium, the dose and frequency should be adjusted to suit an individual patient's needs. Although naproxen sodium circulates in the plasma as naproxen, it has pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 30 minutes in patients taking naproxen sodium and within 1 hour in patients taking naproxen. The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hapatic impairment or in elderly patients . Geriatric Patients: Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose. Patients With Moderate to Severe Renal Impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance<30 mL/min) . Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis: The recommended dose of naproxen sodium is 275 mg (equivalent to 250 mg naproxen with 25 mg sodium) or 550 mg (equivalent to 500 mg of naproxen with 50 mg sodium) twice daily. During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary. In patients who tolerate lower doses well, the dose may be increased to naproxen sodium 1650 mg per day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. When treating such patients with naproxen sodium 1650 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response . Juvenile Arthritis: The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (i.e., 5 mg/kg given twice a day). Naproxen sodium tablets are not well suited to this dosage so use of naproxen oral suspension is recommended for this indication. Management of Pain, Primary Dysmenorrhea and Acute Tendinitis and Bursitis: The recommended starting dose is 550 mg of naproxen sodium, followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required. The initial total daily dose should not exceed 1375 mg of naproxen sodium. Thereafter, the total daily dose should not exceed1100 mg of naproxen sodium. Because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium is recommended for the management of acute painful conditions when prompt onset of pain relief is desired . Acute Gout: The recommended starting dose is 825 mg of naproxen sodium, followed by 275 mg every 8 hours until the attack has subsided.
|
| dailymed-drugs:525 |
Adults and Pediatric Patients (Neonates and Older):Apply liberally to affected areas twice daily or as indicated until healing is complete.
|
| dailymed-drugs:526 |
Treatment with Potassium Citrate Tablets should be added to a regimen that limits salt intake (avoidance of foods with high salt content and of added salt at the table) and encourages high fluid intake (urine volume should be at least two liters per day). The objective of treatment with Potassium Citrate Tablets is to provide potassium citrate in sufficient dosage to restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 to 7.0. In patients with severe hypocitraturia (urinary citrate of less than 150 mg/day), therapy should be initiated at a dosage of 60 mEq/day (20 mEq three times/day or 15 mEq four times/day with meals or within 30 minutes after meals or bedtime snack). In patients with mild-moderate hypocitraturia (>150 mg/day), Potassium Citrate Tablets should be initiated at a dosage of 30 mEq/day (10 mEq three times/day with meals). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. In addition, urinary citrate and/or pH should be measured every four months. Doses of Potassium Citrate Tablets greater than 100 mEq/day have not been studied and should be avoided. Serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine, and complete blood count should be monitored every four months. Treatment should be discontinued if there is hyperkalemia, a significant rise in serum creatinine, or a significant fall in blood hematocrit or hemoglobin.
|
| dailymed-drugs:527 |
A loading dose of 40 mg of SOMAVERT should be administered subcutaneously under physician supervision. The patient should then be instructed to begin daily subcutaneous injections of 10 mg of SOMAVERT. Serum IGF-I concentrations should be measured every four to six weeks, at which time the dosage of SOMAVERT should be adjusted in 5-mg increments if IGF-I levels are still elevated (or 5-mg decrements if IGF-I levels have decreased below the normal range).While the goals of therapy are to achieve (and then maintain) serum IGF-I concentrations within the age-adjusted normal range and to alleviate the signs and symptoms of acromegaly, titration of dosing should be based on IGF-I levels. It is unknown whether patients who remain symptomatic while achieving normalized IGF-I levels would benefit from increased dosing with SOMAVERT. The maximum daily maintenance dose should not exceed 30 mg. SOMAVERT is supplied as a lyophilized powder. Each vial of SOMAVERT should be reconstituted with 1 mL of the diluent provided in the package (Sterile Water for Injection, USP). Instructions regarding reconstitution and administration are included in the package of SOMAVERT and should be closely followed. To prepare the solution, withdraw 1 mL of Sterile Water for Injection, USP and inject it into the vial of SOMAVERT, aiming the stream of liquid against the glass wall. Hold the vial between the palms of both hands and gently roll it to dissolve the powder. DO NOT SHAKE THE VIAL, as this may cause denaturation of pegvisomant. Discard the diluent vial containing the remaining water for injection. After reconstitution, each vial of SOMAVERT contains 10, 15, or 20 mg of pegvisomant protein in one mL of solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The solution should be clear after reconstitution. If the solution is cloudy, do not inject it. Only one dose should be administered from each vial. SOMAVERT should be administered within six hours after reconstitution. Pegvisomant may be given in the thigh, buttocks, upper arm, or abdomen; the site of SC injections should be rotated daily to help prevent lipohypertrophy.
|
| dailymed-drugs:528 |
There is no fixed dosage regimen for the management of diabetes mellitus with AMARYL or any other hypoglycemic agent. The patient's fasting blood glucose and HbAmust be measured periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levelsshould be performed to monitor the patients response to therapy. Short-term administration of AMARYL may be sufficient during periods of transient loss of control in patients usually controlled well on diet and exercise.<br/>Usual Starting Dose: The usual starting dose of AMARYL as initial therapy is 1���2 mg once daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1 mg once daily, and should be titrated carefully. No exact dosage relationship exists between AMARYL and the other oral hypoglycemic agents. The maximum starting dose of AMARYL should be no more than 2 mg. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.<br/>Usual Maintenance Dose: The usual maintenance dose is 1 to 4 mg once daily. The maximum recommended dose is 8 mg once daily. After reaching a dose of 2 mg, dosage increases should be made in increments of no more than 2 mg at 1���2 week intervals based upon the patient's blood glucose response. Long-term efficacy should be monitored by measurement of HbAlevels, for example, every 3 to 6 months.<br/>AMARYL-Metformin Combination Therapy: If patients do not respond adequately to the maximal dose of AMARYL monotherapy, addition of metformin may be considered. Published clinical information exists for the use of other sulfonylureas including glyburide, glipizide, chlorpropamide, and tolbutamide in combination with metformin. With concomitant AMARYL and metformin therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant AMARYL and metformin therapy, the risk of hypoglycemia associated with AMARYL therapy continues and may be increased. Appropriate precautions should be taken.<br/>AMARYL-Insulin Combination Therapy: Combination therapy with AMARYL and insulin may also be used in secondary failure patients. The fasting glucose level for instituting combination therapy is in the range of>150 mg/dL in plasma or serum depending on the patient. The recommended AMARYL dose is 8 mg once daily administered with the first main meal. After starting with low-dose insulin, upward adjustments of insulin can be done approximately weekly as guided by frequent measurements of fasting blood glucose. Once stable, combination-therapy patients should monitor their capillary blood glucose on an ongoing basis, preferably daily. Periodic adjustments of insulin may also be necessary during maintenance as guided by glucose and HbAlevels.<br/>Specific Patient Populations: AMARYL (glimepiride tablets) is not recommended for use in pregnancy or nursing mothers. Data are insufficient to recommend pediatric use of AMARYL. In elderly, debilitated, or malnourished patients, or in patients with renal or hepatic insufficiency, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions.<br/>Patients Receiving Other Oral Hypoglycemic Agents: As with other sulfonylurea hypoglycemic agents, no transition period is necessary when transferring patients to AMARYL. Patients should be observed carefully (1���2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to AMARYL due to potential overlapping of drug effect.
|
| dailymed-drugs:529 |
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.<br/>Anxiety Disorders and Transient Symptoms of Anxiety: Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment. In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered. In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.<br/>Panic Disorder: The successful treatment of many panic disorder patients has required the use of Alprazolam Tablets USP at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of Alprazolam Tablets USP in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received Alprazolam Tablets USP in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Thereafter, the dose can be increased at intervals equal to at least 5 times the elimination half-life (about 11 hours in young patients, about 16 hours in elderly patients). Longer titration intervals should probably be used because the maximum therapeutic response may not occur until after the plasma levels achieve steady state. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained. For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of Alprazolam Tablets USP greater than 4 mg/day for three months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).<br/>The following regimen is one that follows the principles outlined above: Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of Alprazolam Tablets USP. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule. The necessary duration of treatment for panic disorder patients responding to Alprazolam Tablets USP is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena. In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every three days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.
|
| dailymed-drugs:530 |
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended. For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For children over 100 pounds the usualadult dose should be used. The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. When used in streptococcal infections, therapy should be continued for 10 days. Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration (see ADVERSE REACTIONS). If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment. Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth, twice a day for 7 days. Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum: 100 mg, by mouth, twice a day for 7 days. Syphilis - early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks. Syphilis of more than one year's duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks. Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days. Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days. For the prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area. Inhalational anthrax (post-exposure): ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days. CHILDREN: weighing less than 100 pounds (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 pounds or more should receive the adult dose.
|
| dailymed-drugs:531 |
Intestinal amebiasis: Adults and Children: Usual dose���25 to 35 mg/kg body weight daily, administered in three doses with meals, for five to ten days. Management of hepatic coma: Adults: Usual dose���4 g daily in divided doses, given at regular intervals for five to six days.
|
| dailymed-drugs:532 |
One tablet of 200 mg of hydroxychloroquine sulfate is equivalent to 155 mg base.<br/>Malaria:<br/>Suppression: In adults, 400 mg (=310 mg base) on exactly the same day of each week. In infants and children, the weekly suppressive dosage is 5 mg, calculated as base, per kg of body weight, but should not exceed the adult dose regardless of weight. If circumstances permit, suppressive therapy should begin two weeks prior to exposure. However, failing this, in adults an initial double (loading) dose of 800 mg (=620 mg base), or in children 10 mg base/kg may be taken in two divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after leaving the endemic area.<br/>Treatment of the acute attack: In adults, an initial dose of 800 mg (=620 mg base) followed by 400 mg (=310 mg base) in six to eight hours and 400 mg (=310 mg base) on each of two consecutive days (total 2 g hydroxychloroquine sulfate or 1.55 g base). An alternative method, employing a single dose of 800 mg (=620 mg base), has also proved effective. The dosage for adults may also be calculated on the basis of body weight; this method is preferred for infants and children. A total dose representing 25 mg of base per kg of body weight is administered in three days, as follows: First dose: 10 mg base per kg (but not exceeding a single dose of 620 mg base). Second dose: 5 mg base per kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose. Third dose: 5 mg base per kg 18 hours after second dose. Fourth dose: 5 mg base per kg 24 hours after third dose. For radical cure of vivax and malariae malaria concomitant therapy with an 8-aminoquinoline compound is necessary.
|
| dailymed-drugs:533 |
This product is given orally. The usual dosage is 65 mg propoxyphene hydrochloride every 4 hours as needed for pain. The maximum recommended dose of propoxyphene hydrochloride is 390 mg per day. Consideration should be given to a reduced total daily dosage in patients with hepatic or renal impairment.<br/>Symptoms of Propoxyphene Overdosage: The manifestations of acute overdosage with propoxyphene are those of narcotic overdosage. The patient is usually somnolent but may be stuporous or comatose and convulsing. Respiratory depression is characteristic. The ventilatory rate and or tidal volume is decreased, which results in cyanosis and hypoxia. Pupils, initially pinpoint, may become dilated ashypoxia increases. Cheyne-Stokes respira-tion and apnea may occur. Blood pressure and heart rate are usually normal initially, but blood pressure falls and cardiac performance deteriorates, which ultimately results in pul-monary edema and circulatory collapse, unless the respiratory depression is corrected and adequate ventilation is restored promptly. Cardiac arrhythmias and conduction delay may be present. A combined respiratory-metabolic acidosis occurs owing to retained CO2 (hypercapnia) and to lacticacid formed during anaerobic glycolysis. Acidosis may be severe if large amounts of salicylates have also been ingested. Death may occur. Subacute painful myopathy has occurred following chronic propoxyphene overdosage.<br/>Treatment of Propoxyphene Overdosage: Attention should be directed first to establishing a patent airway and to restoring ventilation. Mechanically assisted ventilation, with or with-out oxygen, may be required, and positive pressure respiration may be desirable if pul-monary edema is present. The narcotic antagonist naloxone will markedly reduce the degree of respiratory depression, and 0.4 to 2 mg should be administered promptly,prefer-ably intravenously. If the desired degree of counteraction with improvement in respiratory functions is not obtained, naloxone should be repeated at 2 to 3-minute intervals. The dura-tion of action of the antagonist may be brief. If no response is observed after 10 mg of naloxone have been administered, the diagnosis of propoxyphene toxicity should be ques-tioned. Naloxone may also be administered by continuous intravenous infusion.<br/>Treatment of Propoxyphene Overdosage in Pediatric Patients: The usual initial dose of naloxone in pediatric patients is 0.01 mg/kg body weight given intravenously. If this dose does not result in the desired degree of clinical improvement, a subsequent increased dose of 0.1 mg/kg body weight may be administered. If an IV route of administration is not avail-able, naloxone may be administered IM or subcutaneously in divided doses. If necessary, naloxone can be diluted with Sterile Water for Injection. Blood gases, pH, and electrolytes should be monitored in order that acidosis and any elec-trolyte disturbance present may be corrected promptly. Acidosis, hypoxia, and generalized CNS depression predispose to the development of cardiac arrhythmias. Ventricular fibrilla-tion or cardiac arrest may occur and necessitate the full complement of cardiopulmonary resuscitation (CPR) measures. Respiratory acidosis rapidly subsides as ventilation is restored and hypercapnia eliminated, but lactic acidosis may require intravenous bicarbon-ate for prompt correction. Electrocardiographic monitoring is essential. Prompt correction of hypoxia, acidosis and electrolyte disturbance (when present) will help prevent these cardiac complications and will increase the effectiveness of agents administered to restore normal cardiac function. In addition to the use of a narcotic antagonist, the patient may require careful titration with an anticonvulsant to control convulsions. Analeptic drugs (for example, caffeine or amphet-amine) should not be used because of their tendency to precipitate convulsions. General supportive measures, in addition to oxygen, include, when necessary, intravenous fluids, vasopressor-inotropic compounds, and when infection is likely, anti-infective agents. Gastric lavage may be useful, and activated charcoal can adsorb a significant amount of ingested propoxyphene. Dialysis is of little value in poisoning due to propoxyphene. Efforts should be made to determine whether other agents, such as alcohol, barbiturates, tran-quilizers or other CNS depressants, were also ingested, since these increase CNS depres-sion as well as cause specific toxic effects.
|
| dailymed-drugs:534 |
Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration, whenever solution
and container permit. Slight discoloration does not alter potency (see PRECAUTIONS). Heparin
Lock Flush Solution, USP 100 USP Units/mL, is injected as a single dose into
an intravenous injection device using a volume of solution equivalent to that
of the indwelling venipuncture device (see catheter manufacturer's
labeling for specific catheter lumen volumes). A single
dose should be injected following venipuncture when the indwelling device
is not to be used immediately. After each use of the indwelling venipuncture
device for injection or infusion of medication, or withdrawal of blood samples,
another dose (using a volume of solution equivalent to that of the indwelling
venipuncture device) should be injected to restore the effectiveness of the
heparin lock. The amount of heparin solution in each single dose is sufficient
to prevent clotting within the lumen of indwelling venipuncture devices for
up to twenty-four hours. When the indwelling device
is used to administer a drug which is incompatible with heparin, the entire
heparin lock set should be flushed with 0.9% Sodium Chloride Injection, USP
before and after the medication is administered. Following the second flush,
another dose of heparin solution should be injected to restore the effectiveness
of the heparin lock. When the indwelling device is used
for repeated withdrawal of blood samples for laboratory analyses and the presence
of heparin or saline is likely to interfere with or alter results of the desired
blood tests, the in situ heparin flush
solution should be cleared from the device by aspirating and discarding a
volume of solution equivalent to that of the indwelling venipuncture device
before the desired blood sample is drawn. (See PRECAUTIONS.)
|