| dailymed-instance:dosage | rdf:type | rdf:Property | lld:dailymed |
| dailymed-drugs:1 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:2 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:3 | dailymed-instance:dosage | 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: | lld:dailymed |
| dailymed-drugs:4 | dailymed-instance:dosage | 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 . | lld:dailymed |
| dailymed-drugs:5 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:6 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:7 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:8 | dailymed-instance:dosage | 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 . | lld:dailymed |
| dailymed-drugs:1230 | dailymed-instance:dosage | 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 . | lld:dailymed |
| dailymed-drugs:9 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:10 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:11 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:12 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:13 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:14 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:2267 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:15 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:16 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:17 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:18 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:19 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:20 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:21 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:22 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:23 | dailymed-instance:dosage | 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: | lld:dailymed |
| dailymed-drugs:24 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:25 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:26 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:27 | dailymed-instance:dosage | 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: | lld:dailymed |
| dailymed-drugs:28 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:29 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:30 | dailymed-instance:dosage | 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.) | lld:dailymed |
| dailymed-drugs:31 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:32 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:33 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:34 | dailymed-instance:dosage | Adults:<br/>For Edema:<br/>For Control of Hypertension:<br/>Infants and Children:<br/>For Diuresis and For Control of Hypertension: | lld:dailymed |
| dailymed-drugs:35 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:36 | dailymed-instance:dosage | Geocillin is available as a coated tablet to be administered orally. | lld:dailymed |
| dailymed-drugs:37 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:38 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:39 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:40 | dailymed-instance:dosage | 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). | lld:dailymed |
| dailymed-drugs:41 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:42 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:43 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:45 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:46 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:47 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:48 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:49 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:51 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:52 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:53 | dailymed-instance:dosage | 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 . | lld:dailymed |
| dailymed-drugs:54 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:55 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:56 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:1497 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:58 | dailymed-instance:dosage | 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.) | lld:dailymed |
| dailymed-drugs:59 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:60 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:61 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:62 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:63 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:64 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:65 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:66 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:67 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:68 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:70 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:71 | dailymed-instance:dosage | 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 . | lld:dailymed |
| dailymed-drugs:72 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:73 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:74 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:75 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:76 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:77 | dailymed-instance:dosage | Apply a thin film of Desoximetasone Gel USP, 0.05% to the affected skin areas twice daily. Rub in gently. | lld:dailymed |
| dailymed-drugs:78 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:79 | dailymed-instance:dosage | 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 . | lld:dailymed |
| dailymed-drugs:80 | dailymed-instance:dosage | 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). | lld:dailymed |
| dailymed-drugs:81 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:83 | dailymed-instance:dosage | 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%. | lld:dailymed |
| dailymed-drugs:85 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:87 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:88 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:89 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:90 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:91 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:92 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:93 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:94 | dailymed-instance:dosage | 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.) | lld:dailymed |
| dailymed-drugs:95 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:96 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:97 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:98 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:99 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:100 | dailymed-instance:dosage | 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.) | lld:dailymed |
| dailymed-drugs:101 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:102 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:3389 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:104 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:105 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:106 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:107 | dailymed-instance:dosage | 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 . | lld:dailymed |
| dailymed-drugs:108 | dailymed-instance:dosage | 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). | lld:dailymed |
| dailymed-drugs:109 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:110 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:111 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:112 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:113 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:114 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:115 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:116 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:117 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:118 | dailymed-instance:dosage | 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: | lld:dailymed |
| dailymed-drugs:119 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:120 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:122 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:123 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:124 | dailymed-instance:dosage | 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 | lld:dailymed |
| dailymed-drugs:125 | dailymed-instance:dosage | 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). | lld:dailymed |
| dailymed-drugs:126 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:128 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:129 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:131 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:132 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:134 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:135 | dailymed-instance:dosage | 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: | lld:dailymed |
| dailymed-drugs:136 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:137 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:139 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:3771 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:140 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:141 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:142 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:144 | dailymed-instance:dosage | 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 . | lld:dailymed |
| dailymed-drugs:145 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:146 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:147 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:148 | dailymed-instance:dosage | 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). | lld:dailymed |
| dailymed-drugs:150 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:151 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:152 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:153 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:154 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:155 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:156 | dailymed-instance:dosage | 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). | lld:dailymed |
| dailymed-drugs:158 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:159 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:161 | dailymed-instance:dosage | 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 . | lld:dailymed |
| dailymed-drugs:162 | dailymed-instance:dosage | Therapy with this product should be limited to 7 days. A
thin film is applied 2 to 4 times daily to the affected area. | lld:dailymed |
| dailymed-drugs:163 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:164 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:165 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:166 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:167 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:168 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:170 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:171 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:172 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:173 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:174 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:175 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:3815 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:176 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:177 | dailymed-instance:dosage | 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). | lld:dailymed |
| dailymed-drugs:178 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:179 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:180 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:181 | dailymed-instance:dosage | 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). | lld:dailymed |
| dailymed-drugs:182 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:184 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:186 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:187 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:188 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:189 | dailymed-instance:dosage | 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 . | lld:dailymed |
| dailymed-drugs:190 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:191 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:192 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:193 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:194 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:195 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:196 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:197 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:198 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:200 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:201 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:202 | dailymed-instance:dosage | 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). | lld:dailymed |
| dailymed-drugs:203 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:204 | dailymed-instance:dosage | 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 . | lld:dailymed |
| dailymed-drugs:205 | dailymed-instance:dosage | 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): | lld:dailymed |
| dailymed-drugs:206 | dailymed-instance:dosage | Instill one drop in the affected eye 3 times a day for 7 days. | lld:dailymed |
| dailymed-drugs:207 | dailymed-instance:dosage | 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: | lld:dailymed |
| dailymed-drugs:209 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:210 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:211 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:212 | dailymed-instance:dosage | 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): | lld:dailymed |
| dailymed-drugs:213 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:214 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:215 | dailymed-instance:dosage | 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. | lld:dailymed |
| dailymed-drugs:217 | dailymed-instance:dosage | Instill one or two drops in the conjunctival sac(s) every three to four hours as needed. | lld:dailymed |
