Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/indication
| Subject | Object |
|---|---|
| dailymed-drugs:3117 |
Hypertension.
|
| dailymed-drugs:3218 |
Hypertension.
|
| dailymed-drugs:1 |
Cefizox (ceftizoxime for injection, USP) is indicated in the treatment of infections due to susceptible strains of the microorganisms listed below. Lower Respiratory Tract Infections caused by Klebsiella spp.; Proteus mirabilis; Escherichia coli; Haemophilus influenzae including ampicillin���resistant strains; Staphylococcus aureus (penicillinase��and nonpenicillinase���producing); Serratia spp.; Enterobacter spp.; Bacteroides spp.; and Streptococcus spp. including S. pneumoniae, but excluding enterococci. Urinary Tract Infections caused by Staphylococcus aureus (penicillinase���and nonpenicillinase���producing); Escherichia coli; Pseudomonas spp. including P.aeruginosa; Proteus mirabilis; P. vulgaris; Providencia rettgeri (formerly Proteus rettgeri) and Morganella morganii (formerly Proteus morganii); Klebsiella spp.; Serratia spp. including S. marcescens; and Enterobacter spp. Gonorrhea including uncomplicated cervical and urethral gonorrhea caused by Neisseria gonorrhoeae. Pelvic Inflammatory Disease caused by Neisseria gonorrhoeae, Escherichia coli or Streptococcus agalactiae. NOTE: Ceftizoxime, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti��chlamydial coverage should be added. Intra���Abdominal Infections caused by Escherichia coli; Staphylococcusepidermidis; Streptococcus spp. (excluding enterococci); Enterobacter spp.; Klebsiella spp.; Bacteroides spp. including B. fragilis; and anaerobic cocci, including Peptococcus spp. and Peptostreptococcus spp. Septicemia caused by Streptococcus spp. including S. pneumoniae (but excluding enterococci); Staphylococcus aureus (penicillinase���and nonpenicillinase���producing); Escherichia coli; Bacteroides spp. including B. fragilis; Klebsiella spp.; and Serratia spp. Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase���and nonpenicillinase���producing); Staphylococcus epidermidis; Escherichia coli; Klebsiella spp.; Streptococcus spp. including Streptococcus pyogenes (but excluding enterococci); Proteus mirabilis; Serratia spp.; Enterobacter spp.; Bacteroides spp. including B. fragilis; and anaerobic cocci, including Peptococcus spp. and Peptostreptococcus spp. Bone and Joint Infections caused by Staphylococcus aureus (penicillinase���and nonpenicillinase���producing); Streptococcus spp. (excluding enterococci); Proteusmirabilis; Bacteroides spp.; and anaerobic cocci, including Peptococcus spp. and Peptostreptococcus spp. Meningitis caused by Haemophilus influenzae. Cefizox has also been used successfully in the treatment of a limited number of pediatric and adult cases of meningitis caused by Streptococcus pneumoniae. Cefizox has been effective in the treatment of seriously ill, compromised patients, including those who were debilitated, immunosuppressed, or neutropenic. Infections caused by aerobic gram���negative and by mixtures of organisms resistant to other cephalosporins, aminoglycosides, or penicillins have responded to treatment with Cefizox. Because of the serious nature of some 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. Susceptibility studies on specimens obtained prior to therapy should be used to determine the response of causative organisms to Cefizox. Therapy with Cefizox may be initiated pending results of the studies; however, treatment should be adjusted according to study findings. In serious infections, Cefizox has been used concomitantly with aminoglycosides . Before using Cefizox concomitantly with other antibiotics, the prescribing information for those agents should be reviewed for contraindications, warnings, precautions, and adverse reactions. Renal function shouldbe carefully monitored. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefizox and other antibacterial drugs, Cefizox should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:2 |
FLOVENT DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. FLOVENT DISKUS is NOT indicated for the relief of acute bronchospasm.
|
| dailymed-drugs:3 |
Angina Pectoris: Nadolol tablets are indicated for the long-term management of patients with angina pectoris.<br/>Hypertension: Nadolol tablets are indicated in the management of hypertension; they may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
|
| dailymed-drugs:4 |
Kepivance is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies .
|
| dailymed-drugs:5 |
POLOCAINE (Mepivacaine HCl Injection, USP), is indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks. The routes of administration and indicated concentrations for mepivacaine are: See DOSAGE AND ADMINISTRATION for additional information. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of mepivacaine.
|
| dailymed-drugs:6 |
Before using MUSTARGEN see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION, and HOW SUPPLIED,Special Handling. MUSTARGEN, administered intravenously, is indicated for the palliative treatment of Hodgkin's disease (Stages III and IV), lymphosarcoma, chronic myelocytic or chronic lymphocytic leukemia, polycythemia vera, mycosis fungoides, and bronchogenic carcinoma.MUSTARGEN, administered intrapleurally, intraperitoneally, or intrapericardially, is indicated for the palliative treatment of metastatic carcinoma resulting in effusion.
|
| dailymed-drugs:7 |
Fluconazole is indicated for the treatment of: Prophylaxis. Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
|
| dailymed-drugs:8 |
PRED FORTE is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
|
| dailymed-drugs:9 |
Endometriosis: LUPRON DEPOT 3.75
mg is indicated for management of endometriosis, including pain relief
and reduction of endometriotic lesions. LUPRON DEPOT monthly with
norethindrone acetate 5 mg daily is also indicated for initial management
of endometriosis and for management of recurrence of symptoms. . Duration of initial treatment
or retreatment should be limited to 6 months.<br/>Uterine Leiomyomata (Fibroids): LUPRON DEPOT 3.75
mg concomitantly with iron therapy is indicated for the preoperative
hematologic improvement of patients with anemia caused by uterine
leiomyomata. The clinician may wish to consider a one-month trial
period on iron alone inasmuch as some of the patients will respond
to iron alone. (See Table 1.)
LUPRON may be added if the response to iron alone is considered inadequate.
Recommended duration of therapy with LUPRON DEPOT 3.75 mg is up to three months. Experience with LUPRON DEPOT in females has been limited to women
18 years of age and older.
|
| dailymed-drugs:10 |
Betimol is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
|
| dailymed-drugs:11 |
CHEMET is indicated for the treatment of lead poisoning in pediatric patients with blood lead levels above 45��g/dL. CHEMET is not indicated for prophylaxis of lead poisoning in a lead-containing environment; the use of CHEMET should always be accompanied by identification and removal of the source of the lead exposure.
|
| dailymed-drugs:12 |
REMERON' (mirtazapine) Tablets
are indicated for the treatment of major depressive disorder. The efficacy of REMERON' in the
treatment of major depressive disorder was established in six-week controlled trials
of outpatients whose diagnoses corresponded most closely to the Diagnostic and
Statistical Manual of Mental Disorders���3rd edition (DSM-III) category of major
depressive disorder . A major depressive episode
(DSM-IV) implies a prominent and relatively persistent (nearly every day for at least
2 weeks) depressed or dysphoric mood that usually interferes with daily functioning,
and includes at least five of the following nine symptoms: depressed mood, loss of
interest in usual activities, significant change in weight and/or appetite, insomnia
or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of
guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt
or suicidal ideation. The effectiveness of REMERON'
in hospitalized depressed patients has not been adequately studied. The efficacy of REMERON' in
maintaining a response in patients with major depressive disorder for up to 40 weeks
following 8���12 weeks of initial open-label treatment was demonstrated in a
placebo-controlled trial. Nevertheless, the physician who elects to use REMERON' for
extended periods should periodically re-evaluate the long-term usefulness of the drug
for the individual patient (see CLINICAL
PHARMACOLOGY).
|
| dailymed-drugs:13 |
HYCOMINE (hydrocodone bitartrate and phenylpropanolamine hydrochloride) is indicated for the symptomatic relief of cough and nasal congestion.
|
| dailymed-drugs:14 |
BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris.
|
| dailymed-drugs:2267 |
BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris.
|
| dailymed-drugs:15 |
Intramuscular penicillin G benzathine is indicated
in the treatment of infections due to penicillin-G-sensitive microorganisms
that are susceptible to the low and very prolonged serum levels common
to this particular dosage form. Therapy should be guided by bacteriological
studies (including sensitivity tests) and by clinical response. The following infections will usually respond to adequate
dosage of intramuscular penicillin G benzathine: Mild-to-moderate infections of the upper-respiratory tract due to
susceptible streptococci. Venereal infections���Syphilis,
yaws, bejel, and pinta. Medical Conditions
in which Penicillin G Benzathine Therapy is Indicated as Prophylaxis: Rheumatic fever and/or chorea���Prophylaxis with penicillin G benzathine has proven effective
in preventing recurrence of these conditions. It has also been used
as follow-up prophylactic therapy for rheumatic heart disease and
acute glomerulonephritis.
|
| dailymed-drugs:16 |
Potassium Chloride
in 5% Dextrose and Sodium Chloride Injection, USP is indicated as a
source of water, electrolytes and calories.
|
| dailymed-drugs:3389 |
Potassium Chloride
in 5% Dextrose and Sodium Chloride Injection, USP is indicated as a
source of water, electrolytes and calories.
|
| dailymed-drugs:17 |
Amantadine Hydrochloride Oral Solution USP is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.<br/>Influenza A Prophylaxis: Amantadine Hydrochloride is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection when early vaccination is not feasible or when the vaccine is contraindicated or not available. In the prophylaxis of influenza, early vaccination on an annual basis as recommended by the Centers for Disease Control's Immunization Practices Advisory Committee is the method of choice. Because Amantadine Hydrochloride does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, Amantadine Hydrochloride prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response.<br/>Influenza A Treatment: Amantadine Hydrochloride is also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with Amantadine Hydrochloride will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that Amantadine Hydrochloride is effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains.<br/>Parkinson's Disease/Syndrome: Amantadine Hydrochloride is indicated in the treatment of idiopathic Parkinson's disease (Paralysis Agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication. It is indicated in those elderly patients believed to develop parkinsonismin association with cerebral arteriosclerosis. In the treatment of Parkinson's disease, Amantadine Hydrochloride is less effective than levodopa, (-)-3-(3,4-dihydroxyphenyl)-L-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established.<br/>Drug-Induced ExtrapyramidaI Reactions: Amantadine Hydrochloride is indicated in the treatment of drug-induced extrapyramidal reactions. Although anticholinergic-type side effects have been noted with Amantadine Hydrochloride when used in patients with drug-induced extrapyramidal reactions, there is a lower incidence of these side effectsthan that observed with the anticholinergic antiparkinson drugs.
|
| dailymed-drugs:18 |
Dipyridamole USP tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
|
| dailymed-drugs:19 |
Penicillin G procaine is indicated in the treatment of moderately
severe infections in both adults and pediatric patients due to penicillin-G-susceptible
microorganisms that are susceptible to the low and persistent serum levels
common to this particular dosage form in the indications listed below. Therapy
should be guided by bacteriological studies (including susceptibility tests)
and by clinical response. NOTE: When high, sustained
serum levels are required, aqueous penicillin G, either IM or IV, should be
used. The following infections will usually respond
to adequate dosages of intramuscular penicillin G procaine: Moderately severe
to severe infections of the upper respiratory tract, skin and soft-tissue
infections, scarlet fever, and erysipelas due to susceptible streptococci
(Group A-without bacteremia). NOTE: Streptococci
in Groups A, C, G, H, L, and M are very sensitive to penicillin G. Other groups,
including Group D (enterococcus), are resistant. Aqueous penicillin is recommended
for streptococcal infections with bacteremia. Moderately
severe infections of the respiratory tract due to susceptible pneumococci. NOTE: Severe pneumonia, empyema, bacteremia,
pericarditis, meningitis, peritonitis, and arthritis of pneumococcal etiology
are better treated with aqueous penicillin G during the acute stage. Moderately
severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible). NOTE:
Reports indicate an increasing number of strains of staphylococci resistant
to penicillin G, emphasizing the need for culture and sensitivity studies
in treating suspected staphylococcal infections. Indicated surgical procedures
should be performed. Fusospirochetosis (Vincent's
gingivitis and pharyngitis). Moderately severe infections of the oropharynx
due to susceptible fusiform bacilli and spirochetes. NOTE:
Necessary dental care should be accomplished in infections involving the gum
tissue. Syphilis (all stages) due to susceptible Treponema pallidum. NOTE:
This drug should not be used in the treatment of beta-lactamase producing
organisms which include most strains of Neisseria
gonorrhea. Yaws, Bejel, Pinta due to susceptible
organisms. Penicillin G procaine is an adjunct to antitoxin
for prevention of the carrier stage of diphtheria due to susceptible C. diphtheriae. Anthrax
due to Bacillus anthracis, including
inhalational anthrax (post-exposure): to reduce the incidence or progression
of the disease following exposure to aerosolized Bacillus
anthracis. Rat-bite fever due to susceptible Streptobacillus moniliformis and Spirillum
minus organisms. Erysipeloid due to susceptible Erysipelothrix rhusiopathiae. Subacute
bacterial endocarditis, only in extremely sensitive infections, due to susceptible
Group A streptococci.
|
| dailymed-drugs:20 |
Hypertension: Quinapril tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using quinapril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets do not have a similar risk (see WARNINGS).<br/>Angioedema in black patients:: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.
|
| dailymed-drugs:21 |
Dipivefrin hydrochloride ophthalmic solution is indicated as initial therapy for the control of intraocular pressure in chronic open-angle glaucoma. Patients responding inadequately to other antiglaucoma therapy may respond to addition of dipivefrin. In controlled and open-label studies of glaucoma, dipivefrin demonstrated a statistically significant intraocular pressure lowering effect. Patients using dipivefrin twice daily in studies with mean durations of 76-146 days experienced mean pressure reductions ranging from 20-24%. Therapeutic response to 0.1% dipivefrin twice daily is somewhat less than 2% epinephrine twice daily. Controlled studies showed statistically significant differences in lowering of intraocular pressure between 0.1% dipivefrin and 2% epinephrine. In controlled studies in patients with a history of epinephrine intolerance, only 3% of patients treated with dipivefrin exhibited intolerance, while 55% of those treated with epinephrine again developed intolerance. Therapeutic response to 0.1% dipivefrin twice daily is comparable to 2% pilocarpine 4 times daily. In controlled clinical studies comparing 0.1% dipivefrin and 2% pilocarpine, there were no statistically significant differences in the maintenance of IOP levels for the two medications. Dipivefrin does not produce miosis or accommodative spasm which cholinergic agents are known to produce. The blurred vision and night blindness often associated with miotic agents are not present with dipivefrin therapy. Patients with cataracts avoid the inability to see around lenticular opacities caused by constricted pupil.
|
| dailymed-drugs:22 |
This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.
|
| dailymed-drugs:3617 |
This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.
|
| dailymed-drugs:23 |
NuvaRing' is
indicated for the prevention of pregnancy in women who elect to use this
product as a method of contraception. Like oral contraceptives,
NuvaRing' is highly effective if used as recommended in this label. In three large
clinical trials of 13 cycles of NuvaRing' use, pregnancy rates were
between one and two per 100 women-years of use. Table III lists the
pregnancy rates for users of various contraceptive methods.
|
| dailymed-drugs:24 |
Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.
|
| dailymed-drugs:25 |
Surmontil is indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. In studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients. In hospitalized depressed patients, trimipramine and imipramine wereequally effective in relieving depression.
|
| dailymed-drugs:26 |
LACRISERT is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. LACRISERT is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions. LACRISERT is also indicated for patients with:Exposure keratitisDecreased corneal sensitivityRecurrent corneal erosions
|
| dailymed-drugs:27 |
Major Depressive Disorder:
|
| dailymed-drugs:864 |
Major Depressive Disorder:
|
| dailymed-drugs:28 |
14.6% Sodium Chloride Injection, USP Additive Solution is
indicated for parenteral restoration of sodium ion in patients with restricted
oral intake. Sodium replacement is specifically indicated in patients with
hyponatremia or low salt syndrome. 14.6% Sodium Chloride Additive Solution
may also be added to compatible carbohydrate solutions such as dextrose in
water to provide electrolytes.
|
| dailymed-drugs:30 |
PLAVIX (clopidogrel bisulfate)
is indicated for the reduction of atherothrombotic events as follows:
|
| dailymed-drugs:31 |
Nyamyc���(Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.
|
| dailymed-drugs:32 |
Amiodarone Hydrochloride Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after
treatment with amiodarone, patients may be transferred to oral amiodarone therapy . Amiodarone HCl Injection should be used for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.
|
| dailymed-drugs:33 |
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
|
| dailymed-drugs:2049 |
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
|
| dailymed-drugs:2889 |
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
|
| dailymed-drugs:3033 |
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
|
| dailymed-drugs:3629 |
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
|
| dailymed-drugs:3690 |
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
|
| dailymed-drugs:34 |
Use in Pregnancy:
|
| dailymed-drugs:35 |
Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac capsules and tablets are indicated: ���For acute and long-term use in the management of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis ���For the management of acute pain
|
| dailymed-drugs:36 |
Geocillin (carbenicillin indanyl sodium) is indicated in the treatment of acute and chronic infections of the upper and lower urinary tract and in asymptomatic bacteriuria due to susceptible strains of the following organisms: Escherichia coliProteus mirabilisMorganella morganii
(formerly Proteus morganii)Providencia rettgeri
(formerly Proteus rettgeri)Proteus vulgarisPseudomonasEnterobacterEnterococci Geocillin is also indicated in the treatment of prostatitis due to susceptible strains of the following organisms: Escherichia coliEnterococcus (S. faecalis)Proteus mirabilisEnterobacter
sp. WHEN HIGH AND RAPID BLOOD AND URINE LEVELS OF ANTIBIOTIC ARE INDICATED, THERAPY WITH GEOPEN (CARBENICILLIN DISODIUM) SHOULD BE INITIATED BY PARENTERAL ADMINISTRATION FOLLOWED, AT THE PHYSICIAN'S DISCRETION, BY ORAL THERAPY. NOTE: Susceptibility testing should be performed prior to and during the course of therapy to detect the possible emergence of resistant organisms which may develop. To reduce the development of drug-resistant bacteria and maintain effectiveness of Geocillin and other antibacterial drugs, Geocillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:37 |
Mirtazapine tablets are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders - 3rd edition (DSM-III) category of major depressive disorder . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities,significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied. The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8-12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patients .
|
| dailymed-drugs:38 |
Irinotecan Hydrochloride Injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
|
| dailymed-drugs:39 |
PROMETRIUM Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
|
| dailymed-drugs:40 |
Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence): TIKOSYN is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because TIKOSYN can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients.<br/>Conversion of Atrial Fibrillation/Flutter: TIKOSYN is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. TIKOSYN has not been shown to be effective in patients with paroxysmal atrial fibrillation.
|
| dailymed-drugs:41 |
Aminosyn, Sulfite-Free, (a crystalline amino acid
solution) infused with dextrose by peripheral vein infusion is indicated
as a source of nitrogen in the nutritional support of patients with
adequate stores of body fat, in whom, for short periods of time, oral
nutrition cannot be tolerated, is undesirable, or inadequate. SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION
OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN SOLUTIONS WITHOUT
ELECTROLYTES. Aminosyn can be administered peripherally
with dilute (5 to 10%) dextrose solution and I.V. fat emulsion as
a source of nutritional support. This form of nutritional support
can help to preserve protein and reduce catabolism in stress conditions
where oral intake is inadequate. When administered
with concentrated dextrose solutions with or without fat emulsions,
Aminosyn is also indicated for central vein infusion to prevent or
reverse negative nitrogen balance in patients where: (a) the alimentary
tract, by the oral, gastrostomy or jejunostomy route cannot or should
not be used; (b) gastrointestinal absorption of protein is impaired;
(c) metabolic requirements for protein are substantially increased
as with extensive burns and (d) morbidity and mortality may be reduced
by replacing amino acids lost from tissue breakdown, thereby preserving
tissue reserves, as in acute renal failure.
|
| dailymed-drugs:42 |
A. By Intravenous
or Intramuscular Injection When Oral Therapy is not Feasible::<br/>1.
Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice;
synthetic analogs may be used in conjunction with
mineralocorticoids where applicable; in infancy,
mineralocorticoid supplementation is of particular
importance) Acute adrenocortical insufficiency (hydrocortisone or
cortisone is the drug of choice; mineralocorticoid
supplementation may be necessary, particularly when
synthetic analogs are used) Preoperatively, and in the event of serious trauma or
illness, in patients with known adrenal insufficiency or
when adrenocortical reserve is doubtful Shock unresponsive to conventional therapy if
adrenocortical insufficiency exists or is suspected Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer<br/>2.
Rheumatic Disorders: As
adjunctive therapy for short-term administration (to
tide the patient over an acute episode or exacerbation)
in: Post-traumatic osteoarthritis Synovitis of osteoarthritis Rheumatoid arthritis, including juvenile rheumatoid
arthritis (selected cases may require low-dose
maintenance therapy) Acute and subacute bursitis Epicondylitis Acute nonspecific tenosynovitis Acute gouty arthritis Psoriatic arthritis Ankylosing spondylitis<br/>3. Collagen
Diseases: During an exacerbation or as maintenance therapy in
selected cases of: Systemic lupus erythematosus Acute rheumatic carditis<br/>4.
Dermatologic Diseases: Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Bullous dermatitis herpetiformis Severe seborrheic dermatitis Severe psoriasis Mycosis fungoides<br/>5. Allergic
States: Control of severe or incapacitating allergic conditions
intractable to adequate trials of conventional treatment
in: Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Urticarial transfusion reactions Acute noninfectious laryngeal edema (epinephrine is the drug of first choice)<br/>6.
Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory
processes involving the eye, such as: Herpes zoster ophthalmicus Iritis, iridocyclitis Chorioretinitis Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia Anterior segment inflammation Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers<br/>7.
Gastrointestinal Diseases: To
tide the patient over a critical period of the disease
in: Ulcerative colitis (Systemic therapy) Regional enteritis (Systemic therapy)<br/>8.
Respiratory Diseases: Symptomatic sarcoidosis Berylliosis Fulminating or disseminated pulmonary tuberculosis when
used concurrently with appropriate antituberculous
chemotherapy Loeffler's syndrome not manageable by other means Aspiration pneumonitis<br/>9.
Hematologic Disorders: Acquired (autoimmune) hemolytic anemia Idiopathic thrombocytopenic purpura in adults (IV only;
IM administration is contraindicated) Secondary thrombocytopenia in adults Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia<br/>10.
Neoplastic Diseases: For
palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood<br/>11.
Edematous States: To
induce diuresis or remission of proteinuria in the
nephrotic syndrome, without uremia, of the idiopathic
type, or that due to lupus erythematosus<br/>12.
Miscellaneous: Tuberculous meningitis with subarachnoid block or
impending block when used concurrently with appropriate
antituberculous chemotherapy Trichinosis with neurologic or myocardial
involvement<br/>13.
Diagnostic Testing Of Adrenocortical Hyperfunction:<br/>14.
Cerebral Edema associated with primary or metastatic brain
tumor, craniotomy or head injury. Use in cerebral edema is
not a substitute for careful neurosurgical evaluation and
definitive management such as neurosurgery or other specific
therapy.:<br/>B. By
Intra-Articular or Soft Tissue Injection: As
adjunctive therapy for short-term administration (to tide the
patient over an acute episode or exacerbation) in: Synovitis
of osteoarthritis Rheumatoid
arthritis Acute and
subacute bursitis Acute gouty
arthritis Epicondylitis Acute
nonspecific tenosynovitis Post-traumatic osteoarthritis<br/>C. By Intralesional
Injection: Keloids Localized
hypertrophic, infiltrated, inflammatory lesions of: lichen
planus, psoriatic plaques, granuloma annulare, and lichen
simplex chronicus (neurodermatitis) Discoid
lupus erythematosus Necrobiosis
lipoidica diabeticorum Alopecia
areata May also be
useful in cystic tumors of an aponeurosis or tendon
(ganglia).
|
| dailymed-drugs:43 |
Bupivacaine Hydrochloride is indicated for the production
of local or regional anesthesia or analgesia for surgery, dental and
oral surgery procedures, diagnostic and therapeutic procedures, and
for obstetrical procedures. Only the 0.25% and 0.5% concentrations
are indicated for obstetrical anesthesia. (See WARNINGS.) Experience with nonobstetrical surgical procedures in
pregnant patients is not sufficient to recommend use of 0.75% concentration
of Bupivacaine Hydrochloride in these patients. Bupivacaine Hydrochloride is not recommended for intravenous regional
anesthesia (Bier Block). (See WARNINGS.) The
routes of administration and indicated Bupivacaine Hydrochloride concentrations
are: (See DOSAGE AND ADMINISTRATION for additional information.) Standard textbooks should be consulted to determine the
accepted procedures and techniques for the administration of Bupivacaine
Hydrochloride.
|
| dailymed-drugs:45 |
Major Depressive Disorder: Fluoxetine is indicated for the treatment of major depressive disorder.<br/>Adult: The efficacy of fluoxetine was established in 5 and 6 week trials with depressed adult and geriatric outpatients (���18 years of age) whose diagnoses corresponded most closely to the DSM-III (currently DSM-IV) category of major depressive disorder . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood; loss of interest in usual activities; significant change in weight and/or appetite; insomnia or hypersomnia; psychomotor agitation or retardation; increased fatigue; feelings of guilt or worthlessness; slowed thinking or impaired concentration; a suicide attempt or suicidal ideation. The effects of fluoxetine in hospitalized depressed patients have not been adequately studied. The efficacy of fluoxetine 20 mg once daily in maintaining a response in major depressive disorder for up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) was demonstrated in a placebo-controlled trial.<br/>Pediatric (Children and Adolescents): The efficacy of fluoxetine in children and adolescents was established in two 8 to 9 week placebo-controlled clinical trials in depressed outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder . The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should be reevaluated periodically.<br/>Obsessive-Compulsive Disorder:<br/>Adult: Fluoxetine is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of fluoxetine was established in 13 week trials with obsessive-compulsive outpatients whose diagnoses corresponded most closely to the DSM-III-R category of OCD . OCD is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The effectiveness of fluoxetine in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient .<br/>Pediatric (Children and Adolescents): The efficacy of fluoxetine in children and adolescents was established in a 13 week, dose titration, clinical trial in patients with OCD, as defined in DSM-IV .<br/>Bulimia Nervosa: Fluoxetine is indicated for the treatment of binge eating and vomiting behaviors in patients with moderate to severe bulimia nervosa. The efficacy of fluoxetine was established in 8 to 16 week trials for adult outpatients with moderate to severe bulimia nervosa, i.e., at least three bulimic episodes per week for 6 months . The efficacy of fluoxetine 60 mg/day in maintaining a response, in patients with bulimia who responded during an 8 week acute treatment phase while taking fluoxetine 60 mg/day and were then observed for relapse during a period of up to 52 weeks, was demonstrated in a placebo-controlled trial . Nevertheless, the physician who elects to use fluoxetine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient .<br/>Panic Disorder: Fluoxetine is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks, and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of fluoxetine was established in two 12 week clinical trials in patients whose diagnoses corresponded to the DSM-IV category of panic disorder . Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four or more of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) fear of losing control; 10) fear of dying; 11) paresthesias (numbness or tingling sensations); 12) chills or hot flashes. The effectiveness of fluoxetine in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient .
|
| dailymed-drugs:46 |
Granisetron hydrochloride tablets are indicated for the prevention of:
|
| dailymed-drugs:47 |
HYPAQUE sodium 50 percent is indicated for excretory urography, cerebral and peripheral angiography, aortography, intraosseous venography, direct cholangiography, hysterosalpingography, splenoportography, and contrast enhancement of computed tomographic head imaging.<br/>UROGRAPHY: Diatrizoate salts are used in small, medium, and large dose urography . Visualization of the urinary tract can be achieved by either direct intravenous bolus injection, intravenous drip infusion, or incidentally following intra-arterial procedures.Visualization of the urinary tract is delayed in infants less than 1 month old, and in patients with urinary tract obstruction .<br/>CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING: Injectable radiopaque contrast media may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized.<br/>Tumors: Radiopaque diagnostic agents may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, craniopharyngiomas, germinomas, and metastatic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated. In calcified lesions, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement. The opacification of the inferior vermis following contrast media administration has resulted in false-positive diagnosis in a number of normal studies.<br/>Nonneoplastic Conditions: The use of injectable radiopaque diagnostic agents may be beneficial in the image enhancement of nonneoplastic lesions. Cerebral infarctions of recent onset may be better visualized with contrast enhancement, while some infarctions are obscured if contrast media are used. The use of iodinated contrast media results in contrast enhancement in about 60 percent of cerebral infarctions studied from one to four weeks from the onset of symptoms. Sites of active infection may also be enhanced following contrast media administration. Arteriovenous malformations and aneurysms will show contrast enhancement. For these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool. Hematomas and intraparenchymal bleeders seldom demonstrate any contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast media administration may be helpful in ruling out the possibility of associated arteriovenous malformation.<br/>ANGIOGRAPHY: Diatrizoate salts are used for radiographic studies throughout the cardiovascular system. Intravascular radiopaque diagnostic agents of high concentration are not recommended for cerebral or spinal angiography , and contrast agents with the lowest compatible viscosity and higher concentration of iodine (310 mg/mL to 480 mg/mL of bound iodine) must be used for angiocardiography. Contrast media approaching serum ionic content and osmolality have less potential for deleterious effects on the myocardium . Addition of chelating agents may contribute to toxicity in coronary angiography, and the sodium content of angiographic agents used in coronary arteriography is of crucial importance. In addition to the following general CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS, there are additional listings in these categories under the particular procedures.
|
| dailymed-drugs:48 |
Axid is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Axid is indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with Axid for longer than 1 year are not known. Axid is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD. Axid is indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.
|
| dailymed-drugs:49 |
Dextrose
Injections, USP are indicated as a caloric component in a parenteral
nutrition regimen. They are used with an appropriate protein (nitrogen)
source in the prevention of nitrogen loss or in the treatment of
negative nitrogen balance in patients where: (1) the alimentary tract
cannot or should not be used, (2) gastrointestinal absorption of protein
is impaired, or (3) metabolic requirements for protein are substantially
increased, as with extensive burns
|
| dailymed-drugs:51 |
Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relationship in such patients has not been defined. Minoxidil reduced supine diastolic blood pressure by 20 mm Hg or to 90 mm Hg or less in approximately 75% of patients, most of who had hypertension that could not be controlled by other drugs.
|
| dailymed-drugs:52 |
Phenytoin Sodium Injection is indicated for the control of status epilepticus of the grand mal type and prevention and treatment of
seizures occurring during neurosurgery.
|
| dailymed-drugs:53 |
CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analogue for the treatment of Stage Dmetastatic carcinoma of the prostate. CASODEX 150 mg daily is not approved for use alone or with other treatments. See CLINICAL PHARMACOLOGY-Clinical Studies- Safety Data from Clinical Studies using CASODEX 150 mg section for additional important safety information regarding CASODEX 150 mg.
|
| dailymed-drugs:54 |
In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.<br/>Tuberculosis: 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 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 (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. RIFADIN IV is indicated for the initial treatment and retreatment of tuberculosis when the drug cannot be taken by mouth.<br/>Meningococcal Carriers: Rifampin is indicated for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. Rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. Rifampin should not be used indiscriminately, and therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. So that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:55 |
Cephalexin Capsules, USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Note���Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated . To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin and other antibacterial drugs, Cephalexin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence ofsuch data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:56 |
Vasospastic Angina: Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.<br/>Chronic Stable Angina (Classical Effort-Associated Angina): Nifedipine extended-release tablets are indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents. In chronic stable angina (effort-associated angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients is incomplete. Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs.<br/>Hypertension: Nifedipine extended-release tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
|
| dailymed-drugs:58 |
Glipizide and metformin hydrochloride tablets are indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. Glipizide and metformin hydrochloride tablets are indicated as second-line therapy when diet, exercise, and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes.
|
| dailymed-drugs:2151 |
Glipizide and metformin hydrochloride tablets are indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. Glipizide and metformin hydrochloride tablets are indicated as second-line therapy when diet, exercise, and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes.
|
| dailymed-drugs:59 |
BUSULFEX (busulfan) Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
|
| dailymed-drugs:60 |
Magnesium Sulfate in 5% Dextrose Injection, USP is indicated
for use as an intravenous anticonvulsant for the prevention and control of
seizures (convulsions) in severe toxemia of pregnancy. When used judiciously
it effectively prevents and controls the convulsions of eclampsia without
producing deleterious depression of the central nervous system of the mother
or infant. However, other effective drugs are available for this purpose.
|
| dailymed-drugs:61 |
Major Depressive Disorder: Paroxetine tablets are indicated for the treatment of major depressive disorder. The efficacy of paroxetine hydrochloride in the treatment of a major depressive episode was established in 6 week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL PHARMACOLOGY, Clinical Trials). A major depressive episode implies a prominent and relatively persistent depressed ordysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The effects of paroxetine hydrochloride in hospitalized depressed patients have not been adequately studied. The efficacy of paroxetine hydrochloride in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use paroxetine hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.<br/>Obsessive Compulsive Disorder: Paroxetine tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) as defined in the DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of paroxetine hydrochloride was established in two 12 week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM-IIIR category of obsessive compulsive disorder (see CLINICAL PHARMACOLOGY, Clinical Trials). Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. Long-term maintenance of efficacy was demonstrated in a 6 month relapse prevention trial. In this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).<br/>Panic Disorder: Paroxetine tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of paroxetine hydrochloride was established in three 10 to 12 week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY, Clinical Trials). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. 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). Nevertheless, the physician who prescribes paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.<br/>Social Anxiety Disorder: Paroxetine tablets are indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM-IV (300.23). Social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of paroxetine hydrochloride was established in three 12 week trials in adult patients with social anxiety disorder (DSM-IV). Paroxetine hydrochloride has not been studied in children or adolescents with social phobia (see CLINICAL PHARMACOLOGY, Clinical Trials). The effectiveness of paroxetine hydrochloride in long-term treatment of social anxiety disorder, i.e., for more than 12 weeks, has not been systematically evaluated in adequate and well-controlled trials. Therefore, the physician who elects to prescribe paroxetine hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).<br/>Generalized Anxiety Disorder: Paroxetine tablets are indicated for the treatment of Generalized Anxiety Disorder (GAD), as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of paroxetine hydrochloride in the treatment of GAD was established in two 8 week placebo-controlled trials in adults with GAD. Paroxetine hydrochloride has not been studied in children or adolescents with Generalized Anxiety Disorder (see CLINICAL PHARMACOLOGY, Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: Restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. The efficacy of paroxetine hydrochloride in maintaining a response in patients with Generalized Anxiety Disorder, who responded during an 8 week acute treatment phase while taking paroxetine tablets and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
|
| dailymed-drugs:62 |
Diphenoxylate Hydrochloride and Atropine Sulfate tablets are effective as adjunctive therapy in the management of diarrhea.
|
| dailymed-drugs:63 |
Major Depressive Disorder: Paroxetine is indicated for the treatment of major depressive disorder. The efficacy of paroxetine in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL PHARMACOLOGY - Clinical Trials). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The effects of paroxetine in hospitalized depressed patients have not been adequately studied. The efficacy of paroxetine in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY - Clinical Trials). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.<br/>Obsessive Compulsive Disorder: Paroxetine is indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) as defined in the DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of paroxetine was established in two 12-week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM-IIIR category of obsessive compulsive disorder (see CLINICAL PHARMACOLOGY - Clinical Trials). Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY - Clinical Trials). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).<br/>Panic Disorder: Paroxetine is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of paroxetine was established in three 10- to 12-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see
CLINICAL PHARMACOLOGY - Clinical Trials). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. 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). Nevertheless, the physician who prescribes paroxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.<br/>Social Anxiety Disorder: Paroxetine is indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM-IV (300.23). Social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people orto possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of paroxetine was established in three 12-week trials in adult patients with social anxiety disorder (DSM-IV). Paroxetine has not been studied in children or adolescents with social phobia (see CLINICAL PHARMACOLOGY - Clinical Trials). The effectiveness of paroxetine in long-term treatment of social anxiety disorder, i.e., for more than 12 weeks, has not been systematically evaluated in adequate and well-controlled trials. Therefore, the physician who elects to prescribe paroxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).<br/>Generalized Anxiety Disorder: Paroxetine is indicated for the treatment of Generalized Anxiety Disorder (GAD), as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of paroxetine in the treatment of GAD was established in two 8-week placebo-controlled trials in adults with GAD. Paroxetine has not been studied in children or adolescents with Generalized Anxiety Disorder (see CLINICAL PHARMACOLOGY - Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: Restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. The efficacy of paroxetine in maintaining a response in patients with Generalized Anxiety Disorder, who responded during an 8-week acute treatment phase while taking paroxetine and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY - Clinical Trials). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).<br/>Posttraumatic Stress Disorder: Paroxetine is indicated for the treatment of Posttraumatic Stress Disorder (PTSD). The efficacy of paroxetine in the treatment of PTSD was established in two 12-week placebo-controlled trials in adults with PTSD (DSM-IV) (see CLINICAL PHARMACOLOGY - Clinical Trials). PTSD, as defined by DSM-IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response that involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include re-experiencing of the event in the form of intrusive thoughts, flashbacks, or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of paroxetine in longer-term treatment of PTSD, i.e., for more than 12 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to prescribe paroxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
|
| dailymed-drugs:64 |
Heparin sodium is indicated for: Atrial
fibrillation with embolization; Diagnosis and treatment
of acute and chronic consumption coagulopathies (disseminated intravascular
coagulation); Prevention of clotting in arterial and
heart surgery; Prophylaxis and treatment of peripheral
arterial embolism; As an anticoagulant in extracorporeal
circulation, and dialysis procedures
|
| dailymed-drugs:65 |
For the acute and chronic treatment of patients with an inborn error of metabolism that results in secondary carnitine deficiency.
|
| dailymed-drugs:66 |
Aminosyn-HF 8% (amino acid injection 8%) is indicated for
the treatment of hepatic encephalopathy in patients with cirrhosis or hepatitis.
Aminosyn-HF 8% provides nutritional support for patients with these diseases
of the liver who require parenteral nutrition and are intolerant of general
purpose amino acid injections, which are contraindicated in patients with
hepatic coma.
|
| dailymed-drugs:67 |
SPORANOX (itraconazole) Injection/Oral Solution is indicated for empiric therapy of febrile neutropenic patients with suspected fungal infections. (NOTE: In a comparative trial, the overall response rate for itraconazole-treated subjects was higher than for amphotericin B-treated subjects. However, compared to amphotericin B-treated subjects, a larger number of itraconazole-treated subjects discontinued treatment due to persistent fever and a change in antifungal medication due to fever. Whereas, a larger number of amphotericin B-treated subjects discontinued due to drug intolerance. (See CLINICAL STUDIES section.) SPORANOX (itraconazole) Injection is also indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. .
|
| dailymed-drugs:68 |
TEMODAR (temozolomide) Capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. TEMODAR Capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
|
| dailymed-drugs:70 |
Coly-Mycin M Parenteral is indicated for the treatment of
acute or chronic infections due to sensitive strains of certain gram-negative
bacilli. It is particularly indicated when the infection is caused by sensitive
strains of Pseudomonas aeruginosa.
This antibiotic is not indicated for infections due to Proteusor Neisseria. Coly-Mycin
M Parenteral has proven clinically effective in treatment of infections due
to the following gram-negative organisms: Enterobacter
aerogenes, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas
aeruginosa. Coly-Mycin M Parenteral may be
used to initiate therapy in serious infections that are suspected to be due
to gram-negative organisms and in the treatment of infections due to susceptible
gram-negative pathogenic bacilli. To reduce the development
of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M
and other antibacterial drugs, Coly-Mycin M should be used only to treat or
prevent infections that are proven or strongly suspected to be caused by susceptible
bacteria. When culture and susceptibility information are available, they
should be considered in selecting or modifying antibacterial therapy. In the
absence of such data, local epidemiology and susceptibility patterns may contribute
to the empiric selection of therapy.
|
| dailymed-drugs:71 |
Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials . Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
|
| dailymed-drugs:72 |
Promethazine HCl suppositories, are useful for: Perennial and seasonal allergic rhinitis.Vasomotor rhinitis.Allergic conjunctivitis due to inhalant allergens and foods.Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.Amelioration of allergic reactions to blood or plasma.Dermographism.Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.Preoperative, postoperative, or obstetric sedation.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.Active and prophylactic treatment of motion sickness.Antiemetic therapy in postoperative patients.
|
| dailymed-drugs:73 |
Intraocular use for obtaining miosis during surgery. In addition, Carbastat (Carbachol Intraocular Solution USP) reduces the intensity of intraocular pressure elevation in the first 24 hours after cataract surgery.
|
| dailymed-drugs:74 |
Verapamil hydrochloride extended-release capsules are indicated for the management of essential hypertension.
|
| dailymed-drugs:75 |
Trecator is primarily indicated for the treatment
of active tuberculosis in patients with M. tuberculosis resistant to isoniazid or rifampin,
or when there is intolerance on the part of the patient to other drugs.
Its use alone in the treatment of tuberculosis results in the rapid
development of resistance. It is essential, therefore, to give a suitable
companion drug or drugs, the choice being based on the results of
susceptibility tests. If the susceptibility tests indicate that the
patient's organism is resistant to one of the first-line antituberculosis
drugs (i.e., isoniazid or rifampin) yet susceptible to ethionamide,
ethionamide should be accompanied by at least one drug to which the M. tuberculosis isolate is known to
be susceptible.3 If the tuberculosis
is resistant to both isoniazid and rifampin, yet susceptible to ethionamide,
ethionamide should be accompanied by at least two other drugs to which
the M. tuberculosis isolate
is known to be susceptible.3 Patient nonadherence to prescribed treatment
can result in treatment failure and in the development of drug-resistant
tuberculosis, which can be life-threatening and lead to other serious
health risks. It is, therefore, essential that patients adhere to
the drug regimen for the full duration of treatment. Directly observed
therapy is recommended for all patients receiving treatment for tuberculosis.
Patients in whom drug-resistant M. tuberculosis organisms are isolated should be managed in consultation with an
expert in the treatment of drug-resistant tuberculosis.
|
| dailymed-drugs:76 |
ZOVIRAX Cream is indicated
for the treatment of recurrent herpes labialis (cold sores) in adults and
adolescents (12 years of age and older).
|
| dailymed-drugs:77 |
Desoximetasone Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
|
| dailymed-drugs:78 |
Fluticasone propionate ointment is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
|
| dailymed-drugs:79 |
Adult Use: REBETOL' (ribavirin, USP) Capsules and Oral Solution are indicated in combination with INTRON' A (interferon alfa-2b, recombinant) for Injection for the treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon and in patients 18 years of age and older who have relapsed following alpha interferon therapy. REBETOL Capsules are indicated in combination with PegIntron���(peginterferon alfa-2b) Powder for Injection for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age. The safety and efficacy of REBETOL Capsules or Oral Solution with interferons other than INTRON A or PegIntron products have not been established.<br/>Pediatric Use: REBETOL (ribavirin, USP) Capsules are indicated in combination with INTRON A for Injection for the treatment of chronic hepatitis C in patients 5 years of age and older with compensated liver disease previously untreated with alpha interferon and in patients who have relapsed following alpha interferon therapy. REBETOL (ribavirin, USP) Oral Solution is indicated in combination with INTRON A for Injection for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with alpha interferon and in patients who have relapsed following alpha interferon therapy. Evidence of disease progression, such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load, should be considered when deciding to treat a pediatric patient. The benefits of treatment should be weighed against the safety findings observed for pediatric subjects in the clinical trials.<br/>Description of Clinical Studies:<br/>REBETOL/INTRON A Combination Therapy:<br/>REBETOL/PegIntron Combination Therapy: A randomized study compared treatment with two PegIntron/REBETOL regimens [PegIntron 1.5��g/kg SC once weekly (QW)/REBETOL 800 mg PO daily (in divided doses); PegIntron 1.5��g/kg SC QW for 4 weeks then 0.5��g/kg SC QW for 44 weeks/REBETOL 1000/1200 mg PO daily (in divided doses)] with INTRON A [3 MIU SC thrice weekly (TIW)/REBETOL 1000/1200 mg PO daily (in divided doses)] in 1530 adults with chronic hepatitis C. Interferon-na��ve patients were treated for 48 weeks and followed for 24 weeks post-treatment. Eligible patients had compensated liver disease, detectable HCV RNA, elevated ALT, and liver histopathology consistent with chronic hepatitis. Response to treatment was defined as undetectable HCV RNA at 24 weeks posttreatment (see TABLE 6). The response rate to PegIntron 1.5���0.5��g/kg/REBETOL was essentially the same as the response to INTRON A/REBETOL (data not shown). Patients with viral genotype 1, regardless of viral load, had a lower response rate to PegIntron (1.5��g/kg)/REBETOL combination therapy compared to patients with other viral genotypes. Patients with both poor prognostic factors (genotype 1 and high viral load) had a response rate of 30% (78/256) compared to a response rate of 29% (71/247) with INTRON A/REBETOL combination therapy. Patients with lower body weight tended to have higher adverse event rates and higher response rates than patients with higher body weights. Differences in response rates between treatment arms did not substantially vary with body weight. Treatment response rates with PegIntron/REBETOL combination therapy were 49% in men and 56% in women. Response rates were lower in African American and Hispanic patients and higher in Asians compared to Caucasians. Although African Americans had a higher proportion of poor prognostic factors compared to Caucasians the number of non-Caucasians studied (11% of the total) was insufficient to allow meaningful conclusions about differences in response rates after adjusting for prognostic factors. Liver biopsies were obtained before and after treatment in 68% of patients. Compared to baseline approximately 2/3 of patients in all treatment groups were observed to have a modest reduction in inflammation.
|
| dailymed-drugs:80 |
Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 4 years and above with epilepsy. Additional pediatric use information in 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 pediatric age group.
|
| dailymed-drugs:81 |
Significant tumor response to HYDREA (hydroxyurea capsules, USP)
has been demonstrated in melanoma, resistant chronic myelocytic leukemia,
and recurrent, metastatic, or inoperable carcinoma of the ovary. Hydroxyurea used concomitantly with irradiation therapy is intended
for use in the local control of primary squamous cell (epidermoid) carcinomas
of the head and neck, excluding the lip.
|
| dailymed-drugs:82 |
Dilantin (phenytoin) is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Phenytoin serum level determinations may be necessary for optimal dosage adjustments .
|
| dailymed-drugs:83 |
Cromolyn sodium ophthalmic solution, USP 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
|
| dailymed-drugs:85 |
Intramuscular penicillin G benzathine is indicated in the treatment of infections in both children and adults due to penicillin G-susceptible microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form in the indications listed below. Therapy should be guided by clinical response. Note: When high sustained serum levels are required, injectable penicillin G either IM or IV should be used. The following infections will usually respond to adequate dosages of intramuscular penicillin G benzathine: Upper Respiratory Tract (pharyngitis): streptococci (group A���without bacteremia). Venereal Infections: Syphilis Yaws, bejel, and pinta.
|
| dailymed-drugs:87 |
ClomiPRAMINE hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of ClomiPRAMINE for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies including two 10 week studies in adults and one 8 week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking ClomiPRAMINE experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. ClomiPRAMINE-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of ClomiPRAMINE for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use ClomiPRAMINE for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
|
| dailymed-drugs:88 |
INDOCIN I.V. is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray.
|
| dailymed-drugs:89 |
Tigan is indicated for the treatment of postoperative nausea
and vomiting and for nausea associated with gastroenteritis.
|
| dailymed-drugs:90 |
Bipolar Disorder: SEROQUEL is indicated for the treatment of both:�� Depression The efficacy of SEROQUEL was established in two identical 8-week randomized, placebo-controlled double-blind clinical studies that included either bipolar I or II patients . Effectiveness has not been systematically evaluated in clinical trials for more than 8 weeks. Mania The efficacy of SEROQUEL in acute bipolar mania was established in two 12-week monotherapy trials and one 3-week adjunct therapy trial of bipolar I patients initially hospitalized for up to 7 days for acute mania . Effectiveness has not been systematically evaluated in clinical trials for more than 12 weeks in monotherapy 3 weeks in adjunct therapy. The physician who elects to use SEROQUEL for extended periods in bipolar disorder should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient .<br/>Schizophrenia: SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in short-term (6-week) controlled trials of schizophrenic inpatients . The effectiveness of SEROQUEL in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use SEROQUEL for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient .
|
| dailymed-drugs:91 |
Cystadane (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are deficiencies or defects in: Patient response to Cystadane can be monitored by homocysteine plasma levels . Response usually occurs within a week and steady state within a month. Cystadane has been administered concomitantly with vitamin B(pyridoxine), vitamin B(cobalamin), and folate.
|
| dailymed-drugs:92 |
CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. CLEOCIN PHOSPHATE products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. CLEOCIN PHOSPHATE is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below: Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes. Gynecological infections including endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes. Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:93 |
Treatment of Acute Malaria Infections: Mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae.<br/>Prevention of Malaria: Mefloquine hydrochloride tablets are indicated for the prophylaxis of P. falciparum and P. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of P. falciparum.
|
| dailymed-drugs:94 |
ARIXTRA Injection is indicated for the prophylaxis
of deep vein thrombosis, which may lead to pulmonary embolism: ARIXTRA Injection is indicated for: (See DOSAGE AND ADMINISTRATION section for appropriate
dosage regimen.)
|
| dailymed-drugs:95 |
Ridaura (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. Ridaura should be added to a comprehensive baseline program, including non-drug therapies. Unlike anti-inflammatory drugs, Ridaura does not produce an immediate response. Therapeutic effects may be seen after three to four months of treatment, although improvement has not been seen in some patients before six months. When cartilage and bone damage has already occurred, gold cannot reverse structural damage to joints caused by previous disease. The greatest potential benefit occurs in patients with active synovitis, particularly in its early stage. In controlled clinical trials comparing Ridaura with injectable gold, Ridaura was associated with fewer dropouts due to adverse reactions, while injectable gold was associated with fewer dropouts for inadequate or poor therapeutic effect. Physicians should consider these findings when deciding on the use of Ridaura in patients who are candidates for chrysotherapy.
|
| dailymed-drugs:96 |
Ipratropium Bromide Nasal Spray 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Ipratropium Bromide Nasal Spray 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.
|
| dailymed-drugs:97 |
Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.
|
| dailymed-drugs:542 |
Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.
|
| dailymed-drugs:98 |
Essential hypertension, alone or as an adjunct.
|
| dailymed-drugs:1383 |
Essential hypertension, alone or as an adjunct.
|
| dailymed-drugs:2529 |
Essential hypertension, alone or as an adjunct.
|
| dailymed-drugs:3703 |
Essential hypertension, alone or as an adjunct.
|
| dailymed-drugs:3776 |
Essential hypertension, alone or as an adjunct.
|
| dailymed-drugs:99 |
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
|
| dailymed-drugs:669 |
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
|
| dailymed-drugs:1155 |
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
|
| dailymed-drugs:2235 |
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
|
| dailymed-drugs:100 |
Riomet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
|
| dailymed-drugs:101 |
Central Cranial Diabetes Insipidus: DDAVP Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. It is ineffective for the treatment of nephrogenic diabetes insipidus. The use of DDAVP Nasal Spray in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality. This will allow the resumption of a more normal life-style with a decrease in urinary frequency and nocturia. There are reports of an occasional change in response with time, usually greater than 6 months. Some patients may show a decreased responsiveness, others a shortened duration of effect. There is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the peptide. Patients are selected for therapy by establishing the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or the response to antidiuretic hormone. Continued response to intranasal DDAVP can be monitored by urine volume and osmolality. DDAVP is also available as a solution for injection when the intranasal route may be compromised. These situations include nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may also be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, suchas transsphenoidal hypophysectomy create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.
|
| dailymed-drugs:102 |
Potassium Chloride
in Lactated Ringer's and 5% Dextrose Injection, USP are indicated as a
source of water, electrolytes, and calories or as alkalinizing
agents.
|
| dailymed-drugs:104 |
Cefezolin for Injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms: RESPIRATORY TRACT INFECTIONS due to Streptococcus pneumoniae, Klebsiella species, Haemophilus influenzae, Staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available at present. URINARY TRACT INFECTIONS due to Escherichia coli, Proteus mirabilis, Klebsiella species and some strains of enterobacter and enterococci. SKIN AND SKIM STRUCTURE INFECTIONS due to Staphylococcus aureus (penicillin-sensitive and penicillin-resistant) group A beta-hemolytic streptococci and other strains of streptococci. BILIARY TRACT INFECTIONS due to Escherichia coli, various strains of streptococci, Proteus mirabilis, Klebsiella species and Staphylococcus aureus. BONE AND JOINT INFECTIONS due to Staphylococcus aureus. GENITAL INFECTIONS (i.e., prostatitis, epididymitis) due to Escherichia coli, Proteus mirabilis, Klebsiella species and some strains of enterococci. SEPTICEMIA due to Streptococcus pneumoniae, Staphylococcus aureus (penicillin-sensitive and penicillin-resistant), Proteus mirabilis, Escherichia coli and Klebsiella species. ENDOCARDITIS due to Staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci. PERIOPERATIVE PROPHYLAXIS: The prophylactic administration of cefazolin preoperatively, intraoperatively and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginalhysterectomy, and cholecystectomy in high-rish patients such as those over 70 years of age, with acute cholecystitis, obstructive jaundice or common duct bile stones). The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for injection, USP and other antibacterial drugs. Cefazolin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:105 |
Diclofenac sodium ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.
|
| dailymed-drugs:106 |
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established. For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.
|
| dailymed-drugs:4161 |
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established. For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.
|
| dailymed-drugs:107 |
Metastatic Breast Cancer:: NOLVADEX is effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, NOLVADEX is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from NOLVADEX therapy.<br/>Adjuvant Treatment of Breast Cancer:: NOLVADEX is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some NOLVADEX adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. NOLVADEX is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant NOLVADEX therapy is likely to be beneficial. NOLVADEX reduces the occurrence of contralateral breast cancer in patients receiving adjuvant NOLVADEX therapy for breast cancer.<br/>Ductal Carcinoma in Situ (DCIS):: In women with DCIS, following breast surgery and radiation, NOLVADEX is indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with NOLVADEX for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of NOLVADEX therapy. Current data from clinical trials support five years of adjuvant NOLVADEX therapy for patients with breast cancer.<br/>Reduction in Breast Cancer Incidence in High Risk Women:: NOLVADEX is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known.In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label). NOLVADEX is indicated only for high-risk women.���High risk���is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer���1.67%, as calculated by the Gail Model. Examples of combinations of factors predicting a 5-year risk���1.67% are:<br/>Age 35 or older and any of the following combination of factors:: ���One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or ���At least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or ���LCIS<br/>Age 40 or older and any of the following combination of factors:: ���One first degree relative with a history of breast cancer, 2 or more benign biopsies, age at first live birth 25 or older, and age at menarche 11 or younger; or ���At least 2 first degree relatives with a history of breast cancer, and age at first live birth 19 or younger; or ���One first degree relative with a history of breast cancer, and a personal history of a breast biopsy showing atypical hyperplasia.<br/>Age 45 or older and any of the following combination of factors:: ���At least 2 first degree relatives with a history of breast cancer and age at first live birth 24 or younger; or ���One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, age at menarche 11 or less and age at first live birth 20 or more.<br/>Age 50 or older and any of the following combination of factors:: ���At least 2 first degree relatives with a history of breast cancer; or ���History of one breast biopsy showing atypical hyperplasia, and age at first live birth 30 or older and age at menarche 11 or less; or ���History of at least two breast biopsies with a history of atypical hyperplasia, and age at first live birth 30 or more.<br/>Age 55 or older and any of the following combination of factors:: ���One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, and age at menarche 11 or less; or ���History of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 20 or older.<br/>Age 60 or older and:: ���5-year predicted risk of breast cancer���1.67%, as calculated by the Gail Model. For women whose risk factors are not described in the above examples, the Gail Model is necessary to estimate absolute breast cancer risk. Health Care Professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-544-2007. There are insufficient data available regarding the effect of NOLVADEX on breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of NOLVADEX in these patients. After an assessment of the risk of developing breast cancer, the decision regarding therapy with NOLVADEX for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of NOLVADEX therapy. In the NSABP P-1 trial, NOLVADEX treatment lowered the risk of developing breast cancer during the follow-up period of the trial, but did not eliminate breast cancer risk .
|
| dailymed-drugs:108 |
Heart Failure: COREG CR is indicated for the treatment of
mild-to-severe heart failure of ischemic or cardiomyopathic origin,
usually in addition to diuretics, ACE inhibitor, and digitalis, to
increase survival and, also, to reduce the risk of hospitalization
(see CLINICAL TRIALS and PRECAUTIONS, Drug Interactions).<br/>Left Ventricular Dysfunction Following
Myocardial Infarction: COREG CR is indicated to reduce cardiovascular
mortality in clinically stable patients who have survived the acute
phase of a myocardial infarction and have a left ventricular ejection
fraction of���40% (with or without symptomatic heart failure)
(see CLINICAL TRIALS).<br/>Hypertension: COREG CR is indicated for the treatment of
essential hypertension. It can be used alone or in combination with
other antihypertensive agents, especially thiazide-type diuretics
(see PRECAUTIONS, Drug Interactions).
|
| dailymed-drugs:109 |
YAZ is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. Oral contraceptives are highly effective. Table II lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and contraceptive implants and IUDs, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. YAZ is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of YAZ for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders. YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS).<br/>Oral Contraceptive Clinical Trial: In the primary contraceptive efficacy study of YAZ (3 mg DRSP/0.02 mg EE) of up to 1 year duration, 1,027 subjects were enrolled and completed 11,480 28-day cycles of use. The age range was 17 to 36 years. The racial demographic was: 87.8% Caucasian, 4.6% Hispanic, 4.3% Black, 1.2% Asian, and 2.1% other. Women with a BMI greater than 35 were excluded from the trial. The pregnancy rate (Pearl Index) was 1.41 per 100 woman-years of use based on 12 pregnancies that occurred after the onset of treatment and within 14 days after the last dose of YAZ in women 35 years of age or younger during cycles in which no other form of contraception was used.<br/>Premenstrual Dysphoric Disorder Clinical Trials: Two multicenter, double-blind, randomized, placebo-controlled studies were conducted to evaluate the effectiveness of YAZ in treating the symptoms of PMDD. Women aged 18���42 who met DSM-IV criteria for PMDD, confirmed by prospective daily ratings of their symptoms, were enrolled. Both studies measured the treatment effect of YAZ using the Daily Record of Severity of Problems scale, a patient-rated instrument that assesses the symptoms that constitute the DSM-IV diagnostic criteria. The primary study was a parallel group design that included 384 evaluable reproductive-aged women with PMDD who were randomly assigned to receive YAZ or placebo treatment for 3 menstrual cycles. The supportive study, a crossover design, was terminated prematurely prior to achieving recruitment goals due to enrollment difficulties. A total of 64 women of reproductive age with PMDD were treated initially with YAZ or placebo for up to 3 cycles followed by a washout cycle and then crossed over to the alternate medication for 3 cycles. Efficacy was assessed in both studies by the change from baseline during treatment using a scoring system based on the first 21 items of the Daily Record of Severity of Problems. Each of the 21 items was rated on a scale from 1 (not at all) to 6 (extreme); thus a maximum score of 126 was possible. In both trials, women who received YAZ had statistically significantly greater improvement in their Daily Record of Severity of Problems scores. In the primary study, the average decrease (improvement) from baseline was 37.5 points in women taking YAZ, compared to 30.0 points in women taking placebo.
|
| dailymed-drugs:110 |
TYZEKA(telbivudine) is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This indication is based on virologic, serologic, biochemical and histologic responses after one year of treatment in nucleoside-treatment-na��ve adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease (See Description of Clinical Studies).
|
| dailymed-drugs:111 |
Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sj��gren's Syndrome.
|
| dailymed-drugs:112 |
IQUIX solution is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria:
|
| dailymed-drugs:113 |
Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis.
|
| dailymed-drugs:115 |
Dihydroergotamine mesylate injection is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.
|
| dailymed-drugs:116 |
Cimetidine tablets are indicated in: (1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks . 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 oral cimetidine. (2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg h.s. for periods of up to five years. (3) Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. (4) Erosive gastroesophageal reflux (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine beyond 12 weeks has not been established . (5) The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).
|
| dailymed-drugs:117 |
Famotidine is indicated in: 1. Short-term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year. 3. Short-term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks. 4. Short-term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short-term treatment of patients with symptoms of GERD . Famotidine is also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy . 5. Treatment of pathological hypersecretory conditions (e. g., Zollinger-Ellison Syndrome, multiple endocrine adenomas ) .
|
| dailymed-drugs:118 |
Carefully consider the potential benefits and risks
of INDOCIN and other treatment options before deciding to use INDOCIN.
Use the lowest effective dose for the shortest duration consistent
with individual patient treatment goals . Indomethacin
has been found effective in active stages of the following:
|
| dailymed-drugs:119 |
Treatment: CLAFORAN is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes(Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Providencia rettgeri, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum).CLAFORAN, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, Escherichia coli, Citrobacter species (including C. freundii), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcusspecies and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcusspecies and Peptococcusspecies) Proteus mirabilis, and Clostridium species. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes), Pseudomonas species (including P. aeruginosa), and Proteus mirabilis. (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniaeand Escherichia coli. Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, CLAFORAN has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to CLAFORAN. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, CLAFORAN may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if CLAFORAN is used concomitantly with an aminoglycoside.<br/>Prevention: The administration of CLAFORAN preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of CLAFORAN may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, CLAFORAN should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLAFORAN and other antibacterial drugs, CLAFORAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contributeto the empiric selection of therapy.
|
| dailymed-drugs:120 |
Vinorelbine is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced nonsmall cell lung cancer (NSCLC). In patients with Stage IV NSCLC, Vinorelbine is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, Vinorelbine is indicated in combination with cisplatin.
|
| dailymed-drugs:122 |
Naltrexone hydrochloride tablets are indicated: In the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
|
| dailymed-drugs:123 |
Totect���is indicated for the treatment of extravasation resulting from IV anthracycline chemotherapy.
|
| dailymed-drugs:124 |
Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Clinical microbiological studies in skin and skin-structure infections frequently reveal the growth of susceptible strains of both aerobic and anaerobic organisms. Cefuroxime has been used successfully in these mixed infections in which several organisms have been isolated. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefuroxime may be used concomitantly with an aminoglycoside . The recommended doses of both antibiotics may be given depending on the severity of the infection and the patient's condition. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefuroxime for Injection USP and Dextrose Injection USP and other antibacterial drugs, Cefuroxime for Injection USP and Dextrose Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available,they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.<br/>Prevention: The preoperative prophylactic administration of Cefuroxime for Injection USP and Dextrose Injection USP may prevent the growth of susceptible disease-causing bacteria and thereby may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures (e.g., vaginal hysterectomy) that are classified as clean-contaminated or potentially contaminated procedures. Effective prophylactic use of antibiotics in surgery depends on the time of administration. Cefuroxime for Injection USP and Dextrose Injection USP should usually be given one-half to 1 hour before the operation to allow sufficient time to achieve effective antibiotic concentrations in the wound tissues during the procedure. The dose should be repeated intraoperatively if the surgical procedure is lengthy. Prophylactic administration is usually not required after the surgical procedure ends and should be stopped within 24 hours. In the majority of surgical procedures, continuing prophylactic administration of any antibiotic does not reduce the incidence of subsequent infections but will increase the possibility of adverse reactions and the development of bacterial resistance. The perioperative use of Cefuroxime for Injection USP and Dextrose Injection USP has also been effective during open heart surgery for surgical patients in whom infections at the operative site would present a serious risk. For these patients it is recommended that cefuroxime therapy be continued for at least 48 hours after the surgical procedure ends. If an infection is present, specimens for culture should be obtained for the identification of the causative organism, and appropriate antimicrobial therapy should be instituted.
|
| dailymed-drugs:125 |
DUO-MEDIHALER is indicated for the treatment of bronchospasm associated with acute and chronic asthma and reversible broncho��spasm which may be associated with chronic bronchitis or emphysema.
|
| dailymed-drugs:128 |
Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
|
| dailymed-drugs:129 |
ERTACZO (sertaconazole nitrate) Cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum .
|
| dailymed-drugs:131 |
Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp.
|
| dailymed-drugs:132 |
Visken (pindolol) is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.
|
| dailymed-drugs:134 |
ZANTAC is indicated in: Concomitant antacids should be given as needed
for pain relief to patients with active duodenal ulcer; active, benign
gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
|
| dailymed-drugs:135 |
PROTONIX Delayed-Release Tablets
and PROTONIX For Delayed-Release Oral Suspension
are indicated for:<br/>Short-Term Treatment of Erosive Esophagitis Associated With
Gastroesophageal Reflux Disease (GERD): PROTONIX is indicated for the short-term treatment (up to 8 weeks) in the
healing and symptomatic relief of erosive esophagitis. 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: PROTONIX is indicated
for maintenance of healing of erosive esophagitis and reduction in
relapse rates of daytime and nighttime heartburn symptoms in patients
with gastroesophageal reflux disease (GERD). Controlled studies did
not extend beyond 12 months.<br/>Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome: PROTONIX is indicated
for the long-term treatment of pathological hypersecretory conditions,
including Zollinger-Ellison syndrome.
|
| dailymed-drugs:136 |
Alprazolam extended-release tablets are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with alprazolam extended-release tablets conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder . Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The longer-term efficacy of alprazolam extended-release tablets has not been systematically evaluated. Thus, the physician who elects to use this drug for periods longer than 8 weeks should periodically reassess the usefulness of the drug for the individual patient.
|
| dailymed-drugs:137 |
Major Depressive Disorder: Paroxetine is indicated for the treatment of major depressive disorder. The efficacy of paroxetine in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL PHARMACOLOGY���Clinical Trials). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The effects of paroxetine in hospitalized depressed patients have not been adequately studied. The efficacy of paroxetine in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY���Clinical Trials). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.<br/>Obsessive Compulsive Disorder: Paroxetine is indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) as defined in the DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of paroxetine was established in two 12-week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM-IIIR category of obsessive compulsive disorder (see CLINICAL PHARMACOLOGY���Clinical Trials). Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY���Clinical Trials). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).<br/>Panic Disorder: Paroxetine is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of paroxetine was established in three 10- to 12-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY���Clinical Trials). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. 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). Nevertheless, the physician who prescribes paroxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.<br/>Social Anxiety Disorder: Paroxetine is indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM-IV (300.23). Social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s)interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of paroxetine was established in three 12-week trials in adult patients with social anxiety disorder (DSM-IV). Paroxetine has not been studied in children or adolescents with social phobia (see CLINICAL PHARMACOLOGY���Clinical Trials). The effectiveness of paroxetine in long-term treatment of social anxiety disorder, i.e., for more than 12 weeks, has not been systematically evaluated in adequate and well-controlled trials. Therefore, the physician who elects to prescribe paroxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).<br/>Generalized Anxiety Disorder: Paroxetine is indicated for the treatment of Generalized Anxiety Disorder (GAD), as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of paroxetine in the treatment of GAD was established in two 8-week placebo-controlled trials in adults with GAD. Paroxetine has not been studied in children or adolescents with Generalized Anxiety Disorder (see CLINICAL PHARMACOLOGY���Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: Restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. The efficacy of paroxetine in maintaining a response in patients with Generalized Anxiety Disorder, who responded during an 8-week acute treatment phase while taking paroxetine and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY���Clinical Trials). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
|
| dailymed-drugs:139 |
Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa. Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa. It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: H influenzae, specifically meningeal infections. Escherichia coli, specifically urinary tract infections. Aerobacter aerogenes, specifically bacteremia. Klebsiella pneumoniae, specifically bacteremia. NOTE: IN MENINGEAL INFECTIONS, POLYMYXIN B SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE. To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:3771 |
Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa. Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa. It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: H influenzae, specifically meningeal infections. Escherichia coli, specifically urinary tract infections. Aerobacter aerogenes, specifically bacteremia. Klebsiella pneumoniae, specifically bacteremia. NOTE: IN MENINGEAL INFECTIONS, POLYMYXIN B SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE. To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:140 |
These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.
|
| dailymed-drugs:141 |
Fluphenazine hydrochloride is indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.
|
| dailymed-drugs:777 |
Fluphenazine hydrochloride is indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.
|
| dailymed-drugs:142 |
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Extended-Release Tablets USP and other antibacterial drugs, Cefaclor Extended-Release Tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The safety and effectiveness of cefaclor extended-release tablets in treating some of the indications and pathogens for which other formulations of cefaclor are approved have NOT been established. When administered at the recommended dosages and durations of therapy, cefaclor extended-release tablets are indicated for the treatment ofpatients with the following mild to moderate infections when caused by susceptible strains of the designated organisms. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections.) Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (non-��-lactamase-producing strains only), Moraxella catarrhalis (including��-lactamase-producing strains) or Streptococcus pneumoniae. NOTE: In view of the insufficient numbers of isolates of��-lactamase-producing strains of Haemophilus influenzae that were obtained from clinical trials with cefaclor extended-release tablets for patients with acute bacterial exacerbations of chronic bronchitis or secondary bacterial infections of acute bronchitis, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for bronchitis known, suspected, or considered potentially to be caused by��-lactamase-producing H. influenzae. Secondary bacterial infections of acute bronchitis due to Haemophilus influenzae (non-��-lactamase-producing strains only), Moraxella catarrhalis (including��-lactamase-producing strains), or Streptococcus pneumoniae. (See above NOTE.) Pharyngitis and tonsillitis due to Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefaclor extended-release tablets are generally effective in the eradication of S. pyogenes from the oropharynx; however, data establishing the efficacy of cefaclor extended-release tablets for the prophylaxis of subsequent rheumatic fever are not available. Uncomplicated skin and skin and structure infections due to Staphylococcus aureus (methicillin-susceptible). NOTE: In view of the insufficient numbers of isolates of Streptococcus pyogenes that were obtained from clinical trials with cefaclor extended-release tablets for patients with uncomplicated skin and skin structure infections, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for skin infections known, suspected, or considered potentially to be caused by S. pyogenes.
|
| dailymed-drugs:144 |
Ribavirin tablets in combination with peginterferon alfa-2a are indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh classA) and patients with HIV disease that is clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy).
|
| dailymed-drugs:145 |
Intravenous solutions containing sodium chloride
are indicated for parenteral replenishment of fluid and sodium chloride
as required by the clinical condition of the patient.
|
| dailymed-drugs:1036 |
Intravenous solutions containing sodium chloride
are indicated for parenteral replenishment of fluid and sodium chloride
as required by the clinical condition of the patient.
|
| dailymed-drugs:146 |
Mania: DEPAKOTE (divalproex sodium) is indicated for the
treatment of the manic episodes associated with bipolar disorder. A manic
episode is a distinct period of abnormally and persistently elevated, expansive,
or irritable mood. Typical symptoms of mania include pressure of speech,
motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity,
poor judgement, aggressiveness, and possible hostility. The efficacy of DEPAKOTE was established in 3-week trials with
patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized
for acute mania (See Clinical Trials under CLINICAL PHARMACOLOGY). The
safety and effectiveness of DEPAKOTE for long-term use in mania, i.e., more
than 3 weeks, has not been systematically evaluated in controlled clinical
trials. Therefore, physicians who elect to use DEPAKOTE for extended periods
should continually reevaluate the long-term usefulness of the drug for the
individual patient.<br/>Epilepsy: DEPAKOTE (divalproex sodium) is indicated as monotherapy
and adjunctive therapy in the treatment of patients with complex partial seizures
that occur either in isolation or in association with other types of seizures.
DEPAKOTE (divalproex sodium) is also indicated for use as sole and adjunctive
therapy in the treatment of simple and complex absence seizures, and adjunctively
in patients with multiple seizure types thatinclude absence seizures. Simple absence is defined as very brief clouding of the
sensorium or loss of consciousness accompanied by certain generalized epileptic
discharges without other detectable clinical signs. Complex absence is the
term used when other signs are also present.<br/>Migraine: DEPAKOTE is indicated for prophylaxis of migraine
headaches. There is no evidence that DEPAKOTE is useful in the acute treatment
of migraine headaches. Because valproic acid may be a hazard to the fetus,
DEPAKOTE should be considered for women of childbearing potential only after
this risk has been thoroughly discussed with the patient and weighed against
the potential benefits of treatment (see WARNINGS
- Usage In Pregnancy, PRECAUTIONS - Information for Patients). SEE WARNINGS FOR STATEMENT
REGARDING FATAL HEPATIC DYSFUNCTION.
|
| dailymed-drugs:147 |
HYCODAN (hydrocodone bitartrate and homatropine methylbromide) is
indicated for the symptomatic relief of cough.
|
| dailymed-drugs:148 |
Citalopram is indicated for the treatment of depression. The efficacy of citalopram in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
|
| dailymed-drugs:2042 |
Citalopram is indicated for the treatment of depression. The efficacy of citalopram in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
|
| dailymed-drugs:149 |
Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.<br/>Adult Patients: Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis. Acute Uncomplicated Cystitis in females caused by Escherichia coli or Staphylococcus saprophyticus. Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis. Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or penicillin-susceptible Streptococcus pneumoniae. Also, Moraxella catarrhalis for the treatment of acute exacerbations of chronic bronchitis. NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae. Acute Sinusitis caused by Haemophilus influenzae, penicillin-susceptible Streptococcus pneumoniae, or Moraxella catarrhalis. Skin and Skin Structure Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible, Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes. Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Complicated Intra-Abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis. Infectious Diarrhea caused by Escherichia coli (enterotoxigenic strains), Campylobacter jejuni, Shigella boydii, Shigella dysenteriae, Shigella flexneri or Shigella sonneiwhen antibacterial therapy is indicated. Typhoid Fever (Enteric Fever) caused by Salmonella typhi. NOTE: The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated. Uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae.<br/>Pediatric Patients (1 to 17 years of age): Complicated Urinary Tract Infections and Pyelonephritis due to Escherichia coli. Ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues. Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals.<br/>Adult and Pediatric Patients: Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001. . If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with ciprofloxacin hydrochloride may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:150 |
Dopamine Hydrochloride in 5% Dextrose Injection,
USP is indicated for the correction of hemodynamic imbalances present
in shock due to myocardial infarction, trauma, endotoxic septicemia,
open heart surgery, renal failure and chronic cardiac decompensation
as in refractory congestive failure. When indicated,
restoration of circulatory volume should be instituted or completed
with a suitable plasma expander or whole blood, prior to administration
of dopamine hydrochloride. Patients most likely
to respond to dopamine are those whose physiological parameters (such
as urine flow, myocardial function and blood pressure) have not undergone
extreme deterioration. Reports indicate that the shorter the time
between onset of signs and symptoms and initiation of therapy with
volume restoration and dopamine, the better the prognosis. Poor Perfusion of Vital
Organs: Although urine flow is apparently one of the better
diagnostic signs for monitoring vital organ perfusion, the physician
also should observe the patient for signs of reversal of mental confusion
or coma. Loss of pallor, increase in toe temperature or adequacy of
nail bed capillary filling also may be observed as indices of adequate
dosage. Reportedstudies indicate that when dopamine is administered
before urine flow has decreased to approximately 0.3 mL/minute prognosis
is more favorable. However, it has been observed
that in some oliguric or anuric patients, administration of the drug
has produced an increase in urine flow which may reach normal levels.
The drug also may increase urine flow in patients whose output is
within normal limits and thus may help in reducing the degree of pre-existing
fluid accumulation. Conversely, at higher than optimal doses for a
given patient, urinary flow may decrease, requiring a reduction of
dosage. Concomitant administration of dopamine and diuretic agents
may produce an additive or potentiating effect. Low Cardiac Output: Dopamine's
direct inotropic effect on the myocardium which increases cardiac
output at low or moderate doses is related to a favorable prognosis.
Increased output has been associated with unchanged or decreased systemic
vascular resistance (SVR). The association of static or decreased
SVR with low or moderate increases in cardiac output is regarded as
a reflection of differential effects on specific vascular beds, withincreased resistance in peripheral beds (e.g., femoral), and concurrent
decreases in mesenteric and renal vascular beds. Redistribution of
blood flow parallels these changes so that an increase in cardiac
output is accompanied by an increase in mesenteric and renal blood
flow. In many instances the renal fraction of the total cardiac output
has been found to increase. Increase in cardiac output produced by
dopamine is not associated with substantial decreases in systemic
vascular resistance as may occur with isoproterenol. Hypotension: Low to moderate
doses of dopamine, which have little effect on SVR, can be used to
manage hypotension due to inadequate cardiac output. At high therapeutic
doses, dopamine's��-adrenergic action becomes more prominent
and thus may correct hypotension due to diminished SVR. As in other
circulatory decompensation states, prognosis is better in patients
whose blood pressure and urine flow have not undergone extreme deterioration.
Therefore, it is suggested the physician administer dopamine as soon
as a definite trend toward decreased systolic and diastolic pressure
becomes apparent.
|
| dailymed-drugs:151 |
NIZORAL (ketoconazole) Tablets are
indicated for the treatment of the following systemic fungal infections: candidiasis,
chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis,
coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis.
NIZORAL Tablets should not be used for fungal meningitis
because it penetrates poorly into the cerebral-spinal fluid. NIZORAL Tablets are also indicated for the
treatment of patients with severe recalcitrant cutaneous dermatophyte infections
who have not responded to topical therapy or oral griseofulvin, or who are
unable to take griseofulvin.
|
| dailymed-drugs:152 |
Hydrochlorothiazide tablets is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.<br/>Use in Pregnancy: Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy . Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and useof support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
|
| dailymed-drugs:153 |
Potassium Chloride
Injection is indicated in the treatment of potassium deficiency states
when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE
POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF
SERUM K+ LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID
RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF
FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER
CONCENTRATION. When using these
products, these patients should be on continuous cardiac monitoring and
frequent testing for serum potassium concentration and acid-base
balance.
|
| dailymed-drugs:154 |
Aminosyn II (an amino acid injection) infused with
dextrose by peripheral vein infusion is indicated as a source of nitrogen
in the nutritional support of patients with adequate stores of body
fat, in whom, for short periods of time, oral nutrition cannot be
tolerated, is undesirable, or inadequate. SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION
OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN II SOLUTIONS
WITHOUT ELECTROLYTES. Aminosyn II can
be administered peripherally with dilute (5 to 10%) dextrose solution
and I.V. fat emulsion as a source of nutritional support. This form
of nutritional support can help to preserve protein and reduce catabolism
in stress conditions where oral intake is inadequate. Aminosyn II is also indicated for central vein infusion to
prevent or reverse negative nitrogen balance in patients where the
alimentary tract, by the oral, gastrostomy or jejunostomy route cannot
or should not be used and gastrointestinal absorption of protein is
impaired.
|
| dailymed-drugs:155 |
Postherpetic Neuralgia: Gabapentin is indicated for the management of postherpetic neuralgia in adults.<br/>Epilepsy: Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.
|
| dailymed-drugs:156 |
Phenytoin is indicated for the control of tonic-clonic (grand-mal) and psychomotor (temporal lobe) seizures. Phenytoin serum level determinations may be necessary for optimal dosage adjustments .
|
| dailymed-drugs:158 |
Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.
|
| dailymed-drugs:159 |
A. Benign Prostatic Hyperplasia (BPH): Doxazosin mesylate is indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin mesylate may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin mesylate monotherapy. Doxazosin mesylate provides rapid improvement in symptoms and urinary flow rate in 66 to 71% of patients. Sustained improvements with doxazosin mesylate were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies.<br/>B. Hypertension: Doxazosin mesylate is also indicated for the treatment of hypertension. Doxazosin mesylate may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers, or angiotensin-converting enzyme inhibitors.
|
| dailymed-drugs:161 |
Citalopram hydrobromide tablets are indicated for the treatment of depression. The efficacy of citalopram hydrobromide tablets in the treatment of depression was established in 4 to 6 week controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram hydrobromide tablets in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram hydrobromide tablets in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials . Nevertheless, the physician who elects to use citalopram hydrobromide tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
|
| dailymed-drugs:162 |
For the treatment of corticosteroidresponsive dermatoses
with secondary infection. It has not been demonstrated that this steroid-antibiotic
combination provides greater benefit than the steroid component alone after
7 days of treatment.
|
| dailymed-drugs:163 |
MYCOLOG-II (Nystatin and Triamcinolone Acetonide Cream) is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
|
| dailymed-drugs:164 |
QUIXIN solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:<br/>AEROBIC GRAM-POSITIVE MICROORGANISMS: Corynebacterium speciesStaphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniaeStreptococcus (Groups C/F)Streptococcus (Group G)Viridans group streptococci<br/>AEROBIC GRAM-NEGATIVE MICROORGANISMS: Acinetobacter IwoffiiHaemophilus influenzaeSerratia marcescens Efficacy for this organism was studied in fewer than 10 infections.
|
| dailymed-drugs:165 |
In the male���HALOTESTIN Tablets are indicated for In the female���HALOTESTIN Tablets are indicated for palliation of androgen-responsive recurrent mammary cancer in women who are more than one year but less than five years postmenopausal, or who have been proven to have a hormone- dependent tumor as shown by previous beneficial response to castration.
|
| dailymed-drugs:166 |
Diazepam is indicated for the management of anxiety
disorders or for the short-term relief of the symptoms of anxiety.
Anxiety or tension associated with the stress of everyday life usually
does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic
relief of acute agitation, tremor, impending or acute delirium tremens
and hallucinosis. As an adjunct prior to endoscopic
procedures if apprehension, anxiety or acute stress reactions are
present, and to diminish the patient's recall of the procedures.
(See WARNINGS.) Diazepam is a useful adjunct for the relief of skeletal
muscle spasm due to reflex spasm to local pathology (such as inflammation
of the muscles or joints, or secondary to trauma); spasticity caused
by upper motor neuron disorders (such as cerebral palsy and paraplegia);
athetosis; stiff-man syndrome; and tetanus. Diazepam injection is a useful adjunct in status epilepticus and
severe recurrent convulsive seizures. Diazepam
is a useful premedication (the IM route is preferred) for relief of
anxiety and tension in patients who are to undergo surgical procedures.
Intravenously, prior to cardioversion for the relief of anxiety and
tension and to diminish the patient's recall of the procedure.
|
| dailymed-drugs:167 |
Benazepril hydrochloride tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using benazepril, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril does not have a similar risk . Black patients receiving ACE-inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.
|
| dailymed-drugs:168 |
Attention Deficit Disorders, Narcolepsy: Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylin is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.<br/>Special Diagnostic Considerations: Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solelyon the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.
|
| dailymed-drugs:170 |
MICRONASE Tablets are indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (Type II) whose hyperglycemia cannot be satisfactorily controlled by diet alone. Glyburide may be used concomitantly with metformin when diet and glyburide or diet and metformin alone do not result in adequate glycemic control (see metformin insert). In initiating treatment for non-insulin-dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of MICRONASE must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitution or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient, thus requiring only short-term administration of MICRONASE. During maintenance programs, MICRONASE should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgment should be based on regular clinical and laboratory evaluations. In considering the use of MICRONASE in asymptomatic patients, it should be recognized that controlling blood glucose in non-insulin-dependent diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes.
|
| dailymed-drugs:171 |
IDAMYCIN PFS Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.
|
| dailymed-drugs:172 |
LYBREL is indicated for the prevention of pregnancy
in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy
prevention. Table 2 lists the typical
unintended pregnancy rates for users of combination oral contraceptives
and other methods of contraception. The efficacy of these contraceptive
methods, except sterilization, the IUD, and implants, depend upon
the reliability with whichthey are used. Correct and consistent use
of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded
that certain combined oral contraceptives containing ethinyl estradiol
and norgestrel or levonorgestrel are safe and effective for use as
postcoital emergency contraception. Treatment initiated within 72
hours after unprotected intercourse reduces the risk of pregnancy
by at least 75%. Lactation Amenorrhea
Method: LAM is a highly effective, temporary method of contraception. Source: Trussell
J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F,
Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth
Revised Edition. New York NY: Irvington Publishers; 1998.<br/>Clinical Studies: The efficacy and
safety of LYBREL were studied in 2 one-year clinical trials of subjects
age 18-49. There were no exclusions for body mass index (BMI), weight,
or bleeding history. The primary efficacy and safety study (313-NA) was a one-year open-label
clinical trial that treated 2,134 subjects in North America. Of these
subjects 1,213 (56.8%) discontinued prematurely, including 102 (4.8%)
discontinued by the Sponsor for early study closure. The mean weight
of subjects in this study was 70.38 kg. The efficacy of LYBREL was
assessed by the number of pregnancies that occurred after the onset
of treatment and within 14 days of the last dose. Among subjects 35
years or less, there were 23 pregnancies (4 of these occurred
during the interval 1 to 14 days after the last day of pill use) during
12,572 28-day pill packs of use. The resulting total Pearl Index was2.38 (95% CI: 1.51, 3.57) and the one-year life table pregnancy rate
was 2.39 (95% CI: 1.57, 3.62). Pill pack cycles during which subjects
used back-up contraception or were not sexually active were not included
in these calculations. Among women 35 years or less who took the pills
completely as directed, there were 15 pregnancies (method failures)
resulting in a Pearl Index of 1.55 (95% CI: 0.87, 2.56) and the one-yearlife table pregnancy rate was 1.59 (95% CI: 0.95-2.67). In a second supportive
study conducted in Europe (315-EU), 641 subjects were randomized to
LYBREL (n=323) or the cyclic comparator of 100 mcg levonorgestrel
and 20 mcg ethinyl estradiol (n=318). The mean weight of subjects
in this study was 63.86 kg. The efficacy analysis among women 35 years
or less included 2,756 LYBREL pill packs and 2,886 cyclic comparator
pill packs. There was one pregnancy in the LYBREL group that occurred
within 14 days following the last dose. There were three pregnancies
in the cyclic comparator group.<br/>Inhibition of Menses (Bleeding Profile): The bleeding profile
for subjects in Study 313-NA also was assessed. Women with a history
of unscheduled bleeding and/or spotting were not excluded from the
study. In
those subjects who provided complete bleeding data, the percentage
of patients who were amenorrheic in a given cycle and remained amenorrheic
through cycle 13 (cumulative amenorrhea rate) was determined (Figure 2). When prescribing LYBREL, the convenience of having no
scheduled menstrual bleeding should be weighed against the inconvenience
of unscheduled bleeding and spotting .
|
| dailymed-drugs:173 |
HYPAQUE-76 is indicated for excretory urography, aortography, angiocardiography (ventriculography, pulmonary angiography, selective coronary arteriography), peripheral angiography (peripheral arteriography and peripheral venography), intravenous digital arteriography, contrast enhancement of computed tomographic head imaging, contrast enhancement of computed tomographic body imaging, selective renal arteriography, selective visceral arteriography, central venography, and renal venography. In addition to the following generalCONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS, there are additional listings in these categories under the particular procedures.
|
| dailymed-drugs:174 |
ELITEK is indicated for
the initial management of plasma uric acid levels in pediatric patients
with leukemia, lymphoma, and solid tumor malignancies who are receiving
anti-cancer therapy expected to result in tumor lysis and subsequent
elevation of plasma uric acid.
|
| dailymed-drugs:175 |
Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.<br/>Use in Pregnancy: Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy . Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
|
| dailymed-drugs:176 |
Bacterial Vaginosis (BV): Flagyl ER 750 mg tablets are indicated in the treatment of women with BV. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Flagyl ER and other antibacterial drugs, Flagyl ER should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility informationare available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:178 |
Triostat (liothyronine sodium injection) (T) is indicated in the treatment of myxedema coma/precoma. Triostat can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef.
|
| dailymed-drugs:179 |
LODOSYN is indicated for use with SINEMET (Carbidopa-Levodopa) or with levodopa in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. LODOSYN is for use with SINEMET (Carbidopa-Levodopa) in patients for whom the dosage of SINEMET (Carbidopa-Levodopa) provides less than adequate daily dosage (usually 70 mg daily) of carbidopa. LODOSYN is for use with levodopa in the occasional patient whose dosage requirement of carbidopa and levodopa necessitates separate titration of each entity. LODOSYN is used with SINEMET (Carbidopa-Levodopa) or with levodopa to permit the administration of lower doses of levodopa with reduced nausea and vomiting, more rapid dosage titration, and with a somewhat smoother response. However, patients with markedly irregular (���on-off���) responses to levodopa have not been shown to benefit from the addition of carbidopa. Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, supplemental pyridoxine (vitamin B), can be given to patients when they are receiving carbidopa and levodopa concomitantly or as SINEMET (Carbidopa-Levodopa). Although the administration of LODOSYN permits control of parkinsonism and Parkinson's disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa. Certain patients who responded poorly to levodopa alone have improved when carbidopa and levodopa were given concurrently. This was most likely due to decreased peripheral decarboxylation of levodopa rather than to a primary effect of carbidopa on the peripheral nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. In considering whether to give LODOSYN with SINEMET (Carbidopa-Levodopa) or with levodopa to patients who have nausea and/or vomiting, the physician should be aware that, while many patients may be expected to improve, some may not. Since one cannot predict which patients are likely to improve, this can only be determined by atrial of therapy. It should be further noted that in controlled trials comparing carbidopa and levodopa with levodopa alone, about half the patients with nausea and/or vomiting on levodopa alone improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial.
|
| dailymed-drugs:180 |
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses.
|
| dailymed-drugs:181 |
Captopril and Hydrochlorothiazide tablets are indicated for the
treatment of hypertension. The blood pressure lowering effects of
captopril and thiazides are approximately additive. This fixed combination drug may be used as initial therapy or
substituted for previously titrated doses of the individual components. When captopril and hydrochlorothiazide are given together it may
not be necessary to administer captopril in divided doses to attain
blood pressure control at trough (before the next dose). Also, with such
a combination, a daily dose of 15 mg of hydrochlorothiazide may be
adequate. Treatment may, therefore, be initiated with Captopril and
Hydrochlorothiazide tablets 25 mg/15 mg once daily. Subsequent titration
should be with additional doses of the components (captopril,
hydrochlorothiazide) as single agents or as Captopril and
Hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg, or 50 mg/25 mg
(see DOSAGE AND
ADMINISTRATION). In using Captopril and Hydrochlorothiazide tablets, consideration
should be given to the risk of neutropenia/agranulocytosis . Captopril and Hydrochlorothiazide tablets may be used for
patients with normal renal function, in whom the risk is relatively low.
In patients with impaired renal function, particularly those with
collagen vascular disease, Captopril and Hydrochlorothiazide tablets should be reserved for hypertensives who have either developed
unacceptable side effects on other drugs, or have failed to respond
satisfactorily to other drug combinations. ACE inhibitors (for which adequate data are available) cause a
higher rate of angioedema in black than in non-black patients (seeWARNINGS:
Angioedema).
|
| dailymed-drugs:182 |
GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
|
| dailymed-drugs:184 |
Hypertension: Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.<br/>Angina Pectoris: Metoprolol tartrate is indicated in the long-term treatment of angina pectoris.<br/>Myocardial Infarction: Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient's clinical condition allows . Alternatively, treatment can begin within 3 to 10 days of the acute event .
|
| dailymed-drugs:186 |
Amiodarone HCI Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Amiodarone I.V. also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone I.V., patients may be transferred to oral amiodarone therapy . Amiodarone I.V. should be used for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone I.V. may be safely administered for longer periods if necessary.
|
| dailymed-drugs:187 |
In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.<br/>Tuberculosis: 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 the 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. Rifampin for injection is indicated for the initial treatment and retreatment of tuberculosis when the drug cannot be taken by mouth.<br/>Meningococcal Carriers: Rifampin is indicated for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. Rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. See WARNINGS. Rifampin should not be used indiscriminately, and therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. So that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:188 |
Isosorbide Mononitrate Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
|
| dailymed-drugs:190 |
SARAFEM is indicated for the treatment of premenstrual dysphoric disorder (PMDD). The efficacy of fluoxetine in the treatment of PMDD was established in 3 placebo���controlled trials . The essential features of PMDD, according to the DSM���IV, include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, jointand muscle pain, bloating, and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of SARAFEM in long-term use, that is, for more than 6 months, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use SARAFEM for extended periods should periodically reevaluate the long���term usefulness of the drug for the individual patient.
|
| dailymed-drugs:191 |
8%
Hepatasol (Amino Acid) Injection is indicated for the
treatment of hepatic encephalopathy in patients with cirrhosis or
hepatitis. 8% Hepatasol (Amino Acid) Injection provides
nutritional support for patients with these diseases of the liver who
require parenteral nutrition and are intolerant of general purpose amino
acid injections,which are contraindicated in patients with hepatic
coma.
|
| dailymed-drugs:192 |
Myocardial Infarction: Metoprolol tartrate injection USP is indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate injection USP can be initiated as soon as the patient's clinical condition allows . Alternatively, treatment can begin within 3 to 10 days of the acute event .
|
| dailymed-drugs:193 |
DRISDOL is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
|
| dailymed-drugs:194 |
Aminocaproic Acid Oral Solution is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as aplastic anemia, abruptio placentae, hepatic cirrhosis, neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may frequently be associated with life-threatening complications following severe trauma, anoxia, and shock. Symptomatic of such complications is surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). See WARNINGS.
|
| dailymed-drugs:195 |
0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
|
| dailymed-drugs:196 |
The BEXXAR therapeutic regimen (Tositumomab and
Iodine I 131 Tositumomab) is indicated for the treatment of patients
with CD20 antigen-expressing relapsed or refractory, low grade, follicular,
or transformed non-Hodgkin's lymphoma, including patients with Rituximab-refractory
non-Hodgkin's lymphoma. Determination of the effectiveness
of the BEXXAR therapeutic regimen is based on overall response rates
in patients whose disease is refractory to chemotherapy alone or to
chemotherapy and Rituximab. The effects of the BEXXAR therapeutic
regimen on survival are not known. The BEXXAR
therapeutic regimen is not indicated for the initial treatment of
patients with CD20 positive non-Hodgkin's lymphoma. (See ADVERSE REACTIONS, Immunogenicity.) The BEXXAR therapeutic regimen is intended as a single
course of treatment. The safety of multiple courses of the BEXXAR
therapeutic regimen, or combination of this regimen with other forms
of irradiation or chemotherapy, has not been evaluated.
|
| dailymed-drugs:197 |
OSMITROL Injection (Mannitol Injection, USP) is indicated for: The promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible
renal failure becomes established; The reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass; The reduction of elevated intraocular pressure when the pressure cannot be lowered by other means, and Promoting the urinary excretion of toxic substances.
|
| dailymed-drugs:198 |
Fluticasone Propionate Nasal Spray is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. Safety and effectiveness of Fluticasone Propionate Nasal Spray in children below 4 years of age have not been adequately established.<br/>CONTRAINDICATIONS: Fluticasone Propionate Nasal Spray is contraindicated in patients with a hypersensitivity to any of its ingredients.
|
| dailymed-drugs:200 |
Diovan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
|
| dailymed-drugs:201 |
Zarontin is indicated for the control of absence (petit mal) epilepsy.
|
| dailymed-drugs:1916 |
Zarontin is indicated for the control of absence (petit mal) epilepsy.
|
| dailymed-drugs:202 |
Therapy with lovastatin tablets should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.<br/>Primary Prevention of Coronary Heart Disease: In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin tablets are indicated to reduce the risk of: - Myocardial infarction - Unstable angina - Coronary revascularization procedures (See CLINICAL PHARMACOLOGY, Clinical Studies in Adults.)<br/>Coronary Heart Disease: Lovastatin tablets are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels.<br/>Hypercholesterolemia: Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for artherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb***), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate.<br/>Adolescent Patients with Heterozygous Familial Hypercholesterolemia: Lovastatin tablets are indicated as an adjunct to diet to reduce total-C, LDL-C, and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present:<br/>General Recommendations: Prior to initiating therapy with lovastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-C, HDL-C, and TG. For patients with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation: LDL-C = total-C - [0.2 x (TG) + HDL-C] For TG levels>400 mg/dL (>4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated total-C. In such cases, lovastatin tablets are not indicated. The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below: After the LDL-C goal has been achieved, if the TG is still���200 mg/dL, non-HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category. At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C is>130 mg/dL (see NCEP Guidelines above). Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the total-C be used to monitor therapy. Although lovastatin may be useful to reduce elevated LDL-C levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (Type llb hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL or IDL (i.e., hyperlipoproteinemia types I, III, IV, or V).*** The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below: Children treated with lovastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C.
|
| dailymed-drugs:203 |
Fluticasone Propionate Cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone Propionate Cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficiency of drug use for longer than 4 weeks in this population 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.
|
| dailymed-drugs:204 |
A steroid/anti-infective combination is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, Serratia marcescens. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
|
| dailymed-drugs:205 |
Hypertension:<br/>Heart Failure:<br/>Acute Myocardial Infarction:
|
| dailymed-drugs:206 |
VIGAMOX' solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic Gram-positive microorganisms: Corynebacteriumspecies* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcusviridans group Aerobic Gram-negative microorganisms: Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Other microorganisms: Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.
|
| dailymed-drugs:207 |
Because of its life-threatening side effects and the substantial management difficulties associated with its use (see WARNINGS), amiodarone hydrochloride tablets are indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not respondedto documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone hydrochloride tablets favorably affects survival. Amiodarone should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life-threatening nature of the arrhythmias treated, potential interactions with prior therapy, and potential exacerbation of the arrhythmia, initiation of therapy with amiodarone should be carried out in the hospital.
|
| dailymed-drugs:209 |
AEROSPAN Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older. AEROSPAN Inhalation Aerosol is also indicated for asthma patients requiring oral corticosteroid therapy, where adding AEROSPAN Inhalation Aerosol may reduce or eliminate the need for oral corticosteroids. AEROSPAN Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.
|
| dailymed-drugs:210 |
Pentoxifylline extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.
|
| dailymed-drugs:211 |
TENORETIC is indicated in the treatment of hypertension. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.
|
| dailymed-drugs:212 |
Carbinoxamine maleate is effective for the symptomatic treatment of: Seasonal and perennial allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. Amelioration of the severity of allergic reactions to blood or plasma.
|
| dailymed-drugs:213 |
CIPRODEX' Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Acute Otitis Media in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa. Acute Otitis Externa in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.
|
| dailymed-drugs:214 |
SYPRINE is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with SYPRINE is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. SYPRINE and penicillamine cannot be considered interchangeable. SYPRINE should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, SYPRINE is not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, SYPRINE was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. SYPRINE is not indicated for treatment of biliary cirrhosis.
|
| dailymed-drugs:215 |
FOSRENOL' is indicated to reduce serum phosphate in
patients with end stage renal disease.
|
| dailymed-drugs:216 |
For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
|
| dailymed-drugs:1672 |
For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
|
| dailymed-drugs:2835 |
For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
|
| dailymed-drugs:3256 |
For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
|
| dailymed-drugs:217 |
VASOCON REGULAR is indicated for use as a topical ocular vasoconstrictor.
|
| dailymed-drugs:219 |
RIBASPHERE (ribavirin, USP) in combination with peginterferon alfa-2a is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).
|
| dailymed-drugs:220 |
Carefully consider the potential benefits and risks of oxaprozin and other treatment options before deciding to use oxaprozin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Oxaprozin is indicated: * For relief of the signs and symptoms of osteoarthritis * For relief of the signs and symptoms of rheumatoid arthritis * For relief of the signs and symptoms of juvenile rheumatoid arthritis
|
| dailymed-drugs:221 |
Activella 1.0 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in women who have a uterus for the: 1. Treatment of moderate to severe vasomotor symptoms associated with menopause. 2. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women. Activella 1.0 mg/0.5 mg is also indicated in women who have a uterus for the: 3. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
|
| dailymed-drugs:222 |
OPHTHETIC ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g., tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.
|
| dailymed-drugs:223 |
CARAFATE (sucralfate) Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
|
| dailymed-drugs:225 |
Reduction in Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes: Altace is indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. Altace can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).<br/>Hypertension: ALTACE is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using ALTACE, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that ALTACE does not have a similar risk. In considering use of ALTACE, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients. (See WARNINGS , Angioedema.)<br/>Heart Failure Post Myocardial Infarction: Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of ramipril to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure. (See CLINICAL PHARMACOLOGY , Heart Failure Post Myocardial Infarction for details and limitations of the survival trial.)
|
| dailymed-drugs:226 |
Aldactone (spironolactone) is indicated in the management of: Primary hyperaldosteronism for: Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with:<br/>Congestive heart failure: For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. Aldactone is also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate.<br/>Cirrhosis of the liver accompanied by edema and/or ascites: Aldosterone levels may be exceptionally high in this condition. Aldactone is indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium.<br/>The nephrotic syndrome: For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.<br/>Essential hypertension: Usually in combination with other drugs, Aldactone is indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate.<br/>Hypokalemia: For the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate. Aldactone is also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.<br/>Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developing toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Aldactone is indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy (however, see Precautions: Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is unsupported and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diureticsmay provide relief and may be appropriate.
|
| dailymed-drugs:227 |
To reduce the
development of drug-resistant bacteria and maintain the effectiveness of
Ampicillin and Sulbactam for Injection and other antibacterial drugs,
Ampicillin and Sulbactam for Injection should be used only to treat or
prevent infections that are proven or strongly suspected to be caused by
susceptible bacteria. When culture and susceptibility information are
available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local epidemiology
and susceptibility patterns may contribute to the empiric selection of
therapy. Ampicillin and
Sulbactam for Injection is indicated for the treatment of infections due
to susceptible strains of the designated microorganisms in the
conditions listed below. Skin and Skin Structure Infections caused
by beta-lactamase producing strains of Staphylococcus aureus, Escherichiacoli,Klebsiella spp.(including K.pneumoniae), Proteus mirabilis,Bacteroides fragilis ,Enterobacter
spp.,andAcinetobacter calcoaceticus. NOTE: For
information on use in pediatric patients see PRECAUTIONS���Pediatric Use and CLINICAL
STUDIES sections. Intra-Abdominal Infections caused by
beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae), Bacteroides spp.
(including B. fragilis), andEnterobacter spp. Gynecological Infections caused by
beta-lactamase producing strains of Escherichia coli ,and Bacteroides
spp.(including B. fragilis). While Ampicillin
and Sulbactam for Injection is indicated only for the conditions listed
above, infections caused by ampicillin-susceptible organisms are also
amenable to treatment with Ampicillin and Sulbactam for Injection due to
its ampicillin content. Therefore, mixed infections caused by
ampicillin-susceptible organisms and beta-lactamase producing organisms
susceptible to Ampicillin and Sulbactam for Injection should not require
the addition of another antibiotic. Appropriate culture
and susceptibility tests should be performed before treatment in order
to isolate and identify the organisms causing infection and to determine
their susceptibility to Ampicillin and Sulbactam for Injection. Therapy may be
instituted prior to obtaining the results from bacteriological and
susceptibility studies, when there is reason to believe the infection
may involve any of the beta-lactamase producing organisms listed above
in the indicated organ systems. Once the results are known, therapy
should be adjusted if appropriate.
|
| dailymed-drugs:228 |
Oxycodone and Acetaminophen Tablets are indicated for the relief of moderate to moderately severe pain.
|
| dailymed-drugs:229 |
This solution is indicated for use as a source of electrolytes, calories, and water for hydration in adult and pediatric patients.
|
| dailymed-drugs:230 |
Sulfadiazine tablets are indicated in the following conditions: Chancroid Trachoma Inclusion conjunctivitis Nocardiosis Urinary tract infections (primarily pyelonephritis, pyelitis, and cystitis) in the absence of obstructive uropathy or foreign bodies, when these infections are caused by susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Staphylococcus aureus, Proteus mirabilis, and P. vulgaris. Sulfadiazine should be used for urinary tract infections only after use of more soluble sulfonamides has been unsuccessful. Toxoplasmosis encephalitis in patients with and without acquired immunodeficiency syndrome, as adjunctive therapy with pyrimethamine. Malaria due to chloroquine-resistant strains of Plasmodium falciparum, when used as adjunctive therapy. Prophylaxis of meningococcal meningitis when sul fonamide-sensitive group A strains are known to prevail in family groups or larger closed populations (the prophylactic usefulness of sulfonamides when group B or C infections are prevalent is not proved and may be harmful in closed population groups). Meningococcal meningitis, when the organism has been demonstrated to be susceptible. Acute otitis media due to Haemophilus influenzae, when used concomitantly with adequate doses of penicillin. Prophylaxis against recurrences of rheumatic fever, as an alternative to penicillin. H. influenzae meningitis, as adjunctive therapy with parental streptomycin. IMPORTANT NOTES In vitro sulfonamide susceptibility tests are not always reliable. The test must be carefully coordinated with bacteriologic and clinical response. When the patient is already taking sulfonamides, follow-up cultures should have aminobenzoic acid added to the culture media. Currently, the increasing frequency of resistant organisms limits the usefulness of antibacterial agents, including the sulfonamides, especially in the treatment of recurrent and complicated urinary tract infections. Wide variation in blood levels may result with identical doses. Blood levels should be measured in patients receiving sulfonamides for serious infections. Free sulfonamide blood levels of 5 to 15 mg per 100 mL may be considered therapeutically effective for most infections, and blood levels of 12 to 15 mg per 100 mL may be considered optimal for serious infections. Twenty mg per 100 mL should be the maximum total sulfonamide level, since adverse reactions occur more frequently above this level.
|
| dailymed-drugs:232 |
Sterile Water for Injection, USP is indicated for
use only as a solvent or diluent vehicle for parenterally administered
drugs or solutions and as a source of water for parenteral fluid replenishment
after suitable additives are introduced. For
intravenous administration, an osmolar concentration not less than
two-fifths (0.4) of the normal osmolarity of the extracellular fluid
(280 mOsmol/liter) is essential to avoid intravascular hemolysis.
|
| dailymed-drugs:1940 |
Sterile Water for Injection, USP is indicated for
use only as a solvent or diluent vehicle for parenterally administered
drugs or solutions and as a source of water for parenteral fluid replenishment
after suitable additives are introduced. For
intravenous administration, an osmolar concentration not less than
two-fifths (0.4) of the normal osmolarity of the extracellular fluid
(280 mOsmol/liter) is essential to avoid intravascular hemolysis.
|
| dailymed-drugs:233 |
Mebendazole tablets are indicated for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections. Efficacy varies as a function of such factors as pre-existing diarrhea and gastrointestinal transit time, degree of infection, and helminth strains. Efficacy rates derived from various studies are shown in the table below:
|
| dailymed-drugs:234 |
Because of its life-threatening side effects and the substantial management difficulties associated with its use , amiodarone hydrochloride is indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of Amiodarone Hydrochloride Tablets favorably affects survival. Amiodarone should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life-threatening nature of the arrhythmias treated, potential interactions with prior therapy, and potential exacerbation of the arrhythmia, initiation of therapy with amiodarone should be carried out in the hospital.
|
| dailymed-drugs:235 |
RESTASIS ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
|
| dailymed-drugs:236 |
OPANA is indicated for the relief of moderate to severe acute pain where the use of an opioid is appropriate.
|
| dailymed-drugs:237 |
Innofem���(Estradiol Tablets, USP) is indicated in the: Since estrogen administration is associated with risk, selection of patients should ideally be based on prospective identification of risk factors for developing osteoporosis. Unfortunately, there is no certain way to identify those women who will develop osteoporotic fractures. Most prospective studies of efficacy for this indication have been carried out in white menopausal women, without stratification by other risk factors, and tend to show a universally salutary effect on bone. Thus, patient selection must be individualized based on the balance of risks and benefits. A more favorable risk/benefit ratio exists in a hysterectomized woman because she has no risk of endometrial cancer . Estrogen replacement therapy reduces bone resorption and retards or halts post menopausal bone loss. Case-control studies have shown an approximately 60 percent reduction in hip and wrist fractures in women whose estrogen replacement was begun within a few years of menopause. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen prevents further loss of bone mass for as long as the treatment is continued. The results of a two-year, randomized, placebo-controlled, double-blind, dose-ranging study have shown that treatment with 0.5 mg estradiol daily for 23 days (of a 28 day cycle) prevents vertebral bone mass loss in postmenopausal women. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period. There is no evidence that estrogen replacement therapy restores bone mass to premenopausal levels. At skeletal maturity there are sex and race differences in both the total amount of bone present and its density, in favor of men and blacks. Thus, women are at higher risk than men because they start with less bone mass and, for several years following natural or induced menopause, the rate of bone mass decline is accelerated. White and Asian women are at higher risk than black women. Early menopause is one of the strongest predictors for the development of osteoporosis. In addition, other factors affecting the skeleton which are associated with osteoporosis include genetic factors (small build, family history), and endocrine factors (nulliparity, thyrotoxicosis, hyperparathyroidism, Cushing's syndrome, hyperprolactinemia, Type 1 diabetes), lifestyle (cigarette smoking, alcohol abuse, sedentary exercise habits) and nutrition (below average body weight, dietary calcium intake). The mainstays of prevention and management of osteoporosis are estrogen, an adequate lifetime calcium intake, and exercise. Postmenopausal women absorb dietary calcium less efficiently than premenopausal women and require an average of 1500 mg/day of elemental calcium to remain in neutral calcium balance. By comparison, premenopausal women require about 1000 mg/day and the average of calcium intake in the USA is 400-600 mg/day, therefore, when not contraindicated, calcium supplementation may be helpful. Weight-bearing exercise and nutrition may be important adjuncts to the prevention and management of osteoporosis. Immobilization and prolonged bed rest produce rapid bone loss, while weight-bearing exercise has been shown both to reduce bone loss and to increase bone mass. The optimal type and amount of physical activity that would prevent osteoporosis have not been established, however in two studies an hour of walking and running exercise twice or three times weekly significantly increased lumbar spine bone mass.
|
| dailymed-drugs:238 |
Intravenous solutions containing dextrose are indicated
for parenteral replenishment of fluid and minimal carbohydrate calories
as required by the clinical condition of the patient. In this dosage form, 5% Dextrose Injection, USP is intended to
be used as a diluent for the contents of an ADD-Vantage vial.
|
| dailymed-drugs:239 |
PredniSONE Tablets are indicated in the following conditions:
|
| dailymed-drugs:240 |
Labetalol HCl Tablets are indicated in the management of hypertension. Labetalol HCl Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
|
| dailymed-drugs:241 |
Dihydroergotamine Mesylate Injection, USP is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.
|
| dailymed-drugs:243 |
ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. ARIMIDEX is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. ARIMIDEX is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.
|
| dailymed-drugs:244 |
Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.
|
| dailymed-drugs:585 |
Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.
|
| dailymed-drugs:2382 |
Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.
|
| dailymed-drugs:2402 |
Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.
|
| dailymed-drugs:245 |
Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection���renal formula) is indicated only as an adjunct to management of patients
with potentially reversible acute renal failure who are unable to eat. When
infused with hypertonic dextrose as a source of calories and with added appropriate
electrolytes and vitamins, Aminosyn-RF 5.2% is suitable as an intravenous
source of protein in a parenteral nutritional regimen for such patients.
|
| dailymed-drugs:246 |
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
|
| dailymed-drugs:2438 |
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
|
| dailymed-drugs:248 |
Adult Patients: Flumazenil injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.<br/>Pediatric Patients (aged 1 to 17): Flumazenil injection is indicated for the reversal of conscious sedation induced with benzodiazepines .
|
| dailymed-drugs:249 |
Prednisolone sodium phosphate oral solution is indicated in the following conditions:
|
| dailymed-drugs:2419 |
Prednisolone sodium phosphate oral solution is indicated in the following conditions:
|
| dailymed-drugs:250 |
Disopyramide Phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Disopyramide Phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Disopyramide Phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
|
| dailymed-drugs:251 |
Diclofenac Sodium Ophthalmic Solution, 0.1% is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
|
| dailymed-drugs:252 |
Treatment of malaria: Quinidine gluconate injection is indicated for the treatment of life���threatening Plasmodium falciparum malaria.<br/>Conversion of atrial fibrillation/flutter: Quinidine gluconate injection is also indicated (when rapid therapeutic effect is
required, or when oral therapy is not feasible) as a means of restoring normal
sinus rhythm in patients with symptomatic atrial fibrillation/flutter whose
symptoms are not adequately controlled by measures that reduce the rate of
ventricular response. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time, then its use should
be discontinued.<br/>Treatment of ventricular arrhythmias: Quinidine gluconate injection is also indicated for the treatment of documented ventricular
arrhythmias, such as sustained ventricular tachycardia, that in the judgement
of the physician are life���threatening. Because of the proarrhythmic
effects of quinidine,
its use with ventricular arrhythmias of lesser severity is generally not recommended,
and treatment of patients with asymptomatic ventricular premature contractions
should be avoided. Where possible, therapy should be guided by the results
of programmed electrical stimulation and/or Holter monitoring with exercise. Antiarrhythmic drugs (including quinidine)
have not been shown to enhance survival in patients with ventricular arrhythmias.
|
| dailymed-drugs:253 |
Phentolamine Mesylate for Injection is indicated for the prevention or control of hypertensive episodes that may occur in a patient with pheochromocytoma as a result of stress or manipulation during preoperative preparation and surgical excision. Phentolamine Mesylate for Injection is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. Phentolamine Mesylate for Injection is also indicated for the diagnosis of pheochromocytoma by the phentolamine blocking test.
|
| dailymed-drugs:254 |
Flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.
|
| dailymed-drugs:255 |
LIDEX Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
|
| dailymed-drugs:256 |
Probenecid tablets are indicated for the treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.
|
| dailymed-drugs:2850 |
Probenecid tablets are indicated for the treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.
|
| dailymed-drugs:257 |
Isosorbide Dinitrate Extended-release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
|
| dailymed-drugs:258 |
Major Depressive Disorder-: Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder . A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride tablets in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride tablet in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride tablets for extended periods should be reevaluated periodically .
|
| dailymed-drugs:259 |
CONRAY is indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography. CONRAY may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space. Continuous or multiple scans separated by intervals of 1-3 seconds during the first 30-90 seconds post-injection of the contrast medium (dynamic CT scanning) may provide enhancement of diagnostic significance, and may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone, or may help to define suspicious lesions seen with unenhanced CT. . Subsets of patients in whom delayedbody CT scans might be helpful have not been identified. Inconsistent results have been reported and abnormal and normal tissues may be isodense during the time frame used for delayed CT scanning. The risks of such indiscriminate use of contrast media are well known and such use is not recommended. At present, consistent results have been documented using dynamic CT techniques only.
|
| dailymed-drugs:260 |
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORYX and other antibacterial drugs, DORYX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.<br/>Treatment: Doxycycline is indicated for the treatment of the following infections: Doxycycline also is indicated for the treatment of infections caused by the following gram-negative microorganisms: Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug: Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriological testing indicates appropriate susceptibility to the drug: Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.<br/>Prophylaxis:: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. See DOSAGE AND ADMINISTRATION section and Information for Patients subsections of the PRECAUTIONS section.
|
| dailymed-drugs:262 |
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs. Sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.<br/>Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.<br/>Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.<br/>Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent.<br/>Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.<br/>Pneumocystis Carinii Pneumonia: For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.<br/>Travelers' Diarrhea In Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.
|
| dailymed-drugs:263 |
Asthma: SEREVENT DISKUS is indicated for long-term, twice-daily
(morning and evening) administration in the maintenance treatment
of asthma and in the prevention of bronchospasm in patients 4 years
of age and older with reversible obstructive airway disease, including
patients with symptoms of nocturnal asthma. Long-acting beta-adrenergic agonists, such as salmeterol,
the active ingredient in SEREVENT DISKUS, may increase
the risk of asthma-related death (see WARNINGS).
Therefore, when treating patients with asthma, SEREVENT DISKUS should
only be used as additional therapy for patients not adequately controlled
on other asthma-controller medications (e.g., low- to medium-dose
inhaled corticosteroids) or whose disease severity clearly warrants
initiation of treatment with 2 maintenance therapies, including SEREVENT
DISKUS. It is not indicated for patients whose asthma can be managed
by occasional use of inhaled, short-acting beta-agonists
or for patients whose asthma can be successfully managed by inhaled
corticosteroids or other controller medications along with occasional
use of inhaled, short-acting beta-agonists. SEREVENT DISKUS is also indicated for prevention of exercise-induced
bronchospasm in patients 4 years of age and older.<br/>Chronic Obstructive Pulmonary Disease: SEREVENT DISKUS is indicated for the long-term,
twice-daily (morning and evening) administration in the maintenance
treatment of bronchospasm associated with COPD (including emphysema
and chronic bronchitis).
|
| dailymed-drugs:264 |
NASONEX Nasal Spray, 50 mcg is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older. NASONEX Nasal Spray, 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older. In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, initiation of prophylaxis with NASONEX Nasal Spray, 50 mcg is recommended 2 to 4 weeks prior to the anticipated start of the pollen season. Safety and effectiveness ofNASONEX Nasal Spray, 50 mcg in pediatric patients less than 2 years of age have not been established. NASONEX Nasal Spray, 50 mcg, is indicated for the treatment of nasal polyps in patients 18 years of age and older. Safety and effectiveness of NASONEX Nasal Spray, 50 mcg, for the treatment of nasal polyps in pediatric patients less than 18 years of age have not been established.
|
| dailymed-drugs:265 |
Herpes Zoster Infections Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox Acyclovir is indicated for the treatment of chickenpox (varicella).
|
| dailymed-drugs:266 |
Alprazolam XR tablets are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with Alprazolam XR conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder . Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint;(9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The longer-term efficacy of Alprazolam XR has not been systematically evaluated. Thus, the physician who elects to use this drug for periods longer than 8 weeks should periodically reassess the usefulness of the drug for the individual patient.
|
| dailymed-drugs:267 |
Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
|
| dailymed-drugs:268 |
Milrinone Lactate Injection is indicated
for the short-term intravenous treatment of
patients with acute decompensated heart
failure. Patients receiving milrinone should
be observed closely with appropriate
electrocardiographic equipment. The facility
for immediate treatment of potential cardiac
events, which may include life-threatening
ventricular arrhythmias, must be available.
The majority of experience with intravenous
milrinone has been in patients receiving
digoxin and diuretics. There is no
experience in controlled trials with
infusions of milrinone for periods exceeding
48 hours.
|
| dailymed-drugs:269 |
ULTRAM ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
|
| dailymed-drugs:270 |
Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
|
| dailymed-drugs:1309 |
Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
|
| dailymed-drugs:1984 |
Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
|
| dailymed-drugs:3472 |
Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
|
| dailymed-drugs:271 |
Dovonex (calcipotriene ointment), 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
|
| dailymed-drugs:272 |
Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Alprazolam is also indicated for the treatment of panic disorder, with or without agoraphobia. Studies support ing this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R criteria for panic disorder . Panic disorder is an illness characterized by recurrent panic attacks. The panic attacks, at least initially, are unexpected. Later in the course of this disturbance certain situations, eg, driving a car or being in a crowded place, may become associated with having a panic attack. These panic attacks are not triggered by situations in which the person is the focus of others' attention (as in social phobia). The diagnosis requires four such
attacks within a four week period, or one or more attacks followed by at least a month of persistent fear of having
another attack. The panic attacks must be characterized by at least four of the following symptoms: dyspnea or
smothering sensations; dizziness, unsteady feelings, or faintness; palpitations or tachycardia; trembling or shaking;
sweating; choking; nausea or abdominal distress; depersonalization or derealization; paresthesias; hot
flashes or chills; chest pain or discomfort; fear of dying; fear of going crazy or of doing something uncontrolled.
At least some of the panic attack symptoms must develop suddenly, and the panic attack symptoms must not be attributable to some known organic factors. Panic disorder is frequently associated with some symptoms of
agoraphobia. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to four months duration for anxiety disorder and four to ten weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to eight months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
|
| dailymed-drugs:273 |
Pediatric Patients: Nutropin AQ [somatropin (rDNA origin) injection] is indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion. Nutropin AQ [somatropin (rDNA origin) injection] is also indicated for the treatment of growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Nutropin AQ therapy should be used in conjunction with optimal management of chronic renal insufficiency. Nutropin AQ [somatropin (rDNA origin) injection] is also indicated for the long���term treatment of short stature associated with Turner syndrome. Nutropin AQ [somatropin (rDNA origin) injection] is also indicated for the long���term treatment of idiopathic short stature, also called non-growth hormone-deficient short stature, defined by height SDS������2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means<br/>Adult Patients: Nutropin AQ [somatropin (rDNA origin) injection] is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria: Adult Onset: Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. In general, confirmation of the diagnosis of adult growth hormone deficiency in both groups usually requires an appropriate growth hormone stimulation test. However, confirmatory growth hormone stimulation testing may not be required in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease.
|
| dailymed-drugs:274 |
Cefazolin Injection, USP is indicated in the treatment of the following infections due to susceptible organisms:<br/>Respiratory Tract Infections:: Due to S. pneumoniae, S. aureus (including��-lactamase-producing strains), and S. pyogenes. Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal
infections, including the prophylaxis of rheumatic fever. Cefazolin is effective in eradication of streptococci from the nasopharynx; however, data establishing the efficacy of
cefazolin in the subsequent prevention of rheumatic fever are not available.<br/>Urinary Tract Infections:: Due to E. coli, P. mirabilis.<br/>Skin and Skin Structure Infections:: Due to S. aureus (including��-lactamase-producing strains), S. pyogenes, and other strains of streptococci.<br/>Biliary Tract Infections:: Due to E. coli, various strains of streptococci, P.
mirabilis, and S. aureus.<br/>Bone and Joint Infections:: Due to S. aureus.<br/>Genital Infections:: (i.e., prostatitis, epididymitis) due to E. coli, P.
mirabilis.<br/>Septicemia:: Due to S. pneumoniae, S. aureus (including��-lactamase-producing strains) P. mirabilis, E. coli.<br/>Endocarditis:: Due to S. aureus (including��-lactamase-producing strains), and S. pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to
cefazolin.<br/>Perioperative Prophylaxis:: The prophylactic administration of cefazolin preoperatively, intraoperatively, and postoperatively may reduce the incidence of
certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and
cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would
present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical
procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of
cefazolin may be continued for 3 to 5 days following the completion of surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so
that appropriate therapy may be instituted. (See DOSAGE AND
ADMINISTRATION.) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin and other antibacterial drugs,
cefazolin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information
are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute
to the empiric selection of therapy.
|
| dailymed-drugs:275 |
NORVIR is indicated in combination
with other antiretroviral agents for the treatment of HIV-infection.
This indication is based on the results from a study in patients
with advanced HIV disease that showed a reduction in both mortality
and AIDS-defining clinical events for patients who received NORVIR
either alone or in combination with nucleoside analogues. Median
duration of follow-up in this study was 13.5 months.<br/>Description of Clinical Studies: The activity of
NORVIR as monotherapy or in combination with nucleoside reverse transcriptase
inhibitors has been evaluated in 1446 patients enrolled in two double-blind,
randomized trials.<br/>Advanced Patients with Prior Antiretroviral Therapy: Study 247
was a randomized, double-blind trial (with open-label follow-up) conducted
in HIV-infected patients with at least nine months of prior antiretroviral
therapy and baseline CDcell counts���100 cells/��L.
NORVIR 600 mg twice-daily or placebo was added to each patient's
baseline antiretroviral therapy regimen, which could have consisted
of up to two approved antiretroviral agents. The study accrued 1090
patients, with mean baseline CDcell count at study entry
of 32 cells/��L. After the clinical benefit of NORVIR therapy
was demonstrated, all patients were eligible to switch to open-label
NORVIR for the duration of the follow-up period. Median duration
of double-blind therapy with NORVIR and placebo was 6 months. The
median duration of follow-up through the end of the open-label phase
was 13.5 months for patients randomized to NORVIR and 14 months
for patients randomized to placebo. The cumulative incidence of clinical disease
progression or death during the double-blind phase of Study 247 was
26% for patients initially randomized to NORVIR compared to 42% for
patients initially randomized to placebo. This difference in rates
was statistically significant (see Figure 1). The cumulative
mortality through the end of the open-label follow-up phase for patients
enrolled in Study 247 was 18% for patients initially randomized to
NORVIR compared to 26% for patients initially randomized to placebo.
This difference in rates was statistically significant (see Figure
2). Since the analysis at the end of the open-label phase includes
patients in the placebo arm who were switched from placebo to NORVIR
therapy, the survival benefit of NORVIR cannot be precisely estimated. Figure 3 and
Figure 4 summarize the mean change from baseline for CDcell count and plasma HIV RNA (copies/mL), respectively, during
the first 24 weeks for the double-blind phase of Study 247.<br/>Patients Without Prior Antiretroviral Therapy: In Study
245, 356 antiretroviral-naive HIV-infected patients (mean baseline
CD= 364 cells/��L) were randomized
to receive either NORVIR 600 mg twice-daily, zidovudine 200 mg three-times-daily,
or a combination of these drugs. Figure 5 and Figure 6 summarize
the mean change from baseline for CDcell count and plasma
HIV RNA (copies/mL), respectively, during the first 24 weeks for the
double-blind phase of Study 245.
|
| dailymed-drugs:276 |
Ciprofloxacin injection is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below when the intravenous administration offers a route of administration advantageous to the patient. Please see DOSAGE AND ADMINISTRATION for specific recommendations.<br/>ADULT PATIENTS: Urinary Tract Infections caused by Escherichia coli (including cases with secondary bacteremia), Klebsiella pneumoniae subspecies pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis. Lower Respiratory Infections caused by Escherichia coli, Klebsiella pneumoniae subspecies pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Penicillin-susceptible streptococcus pneumoniae. Also, Moraxella catarrhalis for the treatment of acute exacerbations of chronic bronchitis. NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae. Nosocomial Pneumonia caused by Haemophilus influenzae or Klebsiella pneumoniae. Skin and Skin Structure Infections caused by Escherichia coli, Klebsiella pneumoniae subspecies pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, Staphylococcus epidermidis, or Streptococcus pyogenes. Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Complicated Intra-Abdominal Infections (used in conjunction with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis. Acute Sinusitis caused by Haemophilus influenzae, penicillin-susceptible Streptococcus pneumoniae, or Moraxella catarrhalis. Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis. Empirical Therapy for Febrile Neutropenic Patients in combination with piperacillin sodium.<br/>Pediatric patients (1 to 17 years of age): Complicated Urinary Tract Infections and Pyelonephritis due to Escherichia coli. NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues. Ciprofloxacin, like other fluoroquinolones, is associated with arthopathy and histopathological changes in weight-bearing joints of juvenile animals.<br/>Adult and Pediatric Patients:<br/>Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001. If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with ciprofloxacin injection may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. As with other drugs, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin injection and other antibacterial drugs, ciprofloxacin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:277 |
Major Depressive Disorder: Lexapro (escitalopram) is indicated for the treatment of major depressive disorder. The efficacy of Lexapro in the treatment of major depressive disorder was established in three, 8-week, placebo-controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-IV category of major depressive disorder . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Lexapro in hospitalized patients with major depressive disorders has not been adequately studied. The efficacy of Lexapro in maintaining a response, in patients with major depressive disorder who responded during an 8-week, acute-treatment phase while taking Lexapro and were then observed for relapse during a period of up to 36 weeks, was demonstrated in a placebo-controlled trial . Nevertheless, the physician who elects to use Lexapro for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient .<br/>Generalized Anxiety Disorder: Lexapro is indicated for the treatment of Generalized Anxiety Disorder (GAD). The efficacy of Lexapro was established in three, 8-week, placebo-controlled trials in patients with GAD . Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance. The efficacy of Lexapro in the long-term treatment of GAD, that is, for more than 8 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use Lexapro for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
|
| dailymed-drugs:278 |
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY��-lactamase-negative) strains of the designated microorganisms in the conditions listed below: Infections of the ear, nose, and throat - due to Streptococcus spp. (��- and��-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (��- and��-hemolytic strains only), Staphylococcus spp., or E. coli Infections of the lower respiratory tract - due to Streptococcus spp. (��- and��-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence<br/>Triple Therapy:<br/>Amoxicillin/clarithromycin/lansoprazole: Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.<br/>Dual Therapy:<br/>Amoxicillin/lansoprazole: Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.
|
| dailymed-drugs:279 |
Seromycin is
indicated in the treatment of active pulmonary and extrapulmonary tuberculosis
(including renal disease) when the causative organisms are susceptible to
this drug and when treatment with the primary medications (streptomycin, isoniazid,
rifampin, and ethambutol) has proved inadequate. Like all antituberculosis
drugs, Seromycin should
be administered in conjunction with other effective chemotherapy and not as
the sole therapeutic agent. Seromycin may
be effective in the treatment of acute urinary tract infections caused by
susceptible strains of gram���positive and gram���negative bacteria,
especially Enterobacter spp.
and Escherichia
coli. It is generally no more and is usually less effective than
other antimicrobial agents in the treatment of urinary tract infections caused
by bacteria other than mycobacteria. Use of Seromycin in
these infections should be considered only when more conventional therapy
has failed and when the organism has been demonstrated to be susceptible to
the drug.
|
| dailymed-drugs:280 |
Ticlopidine hydrochloride tablets are indicated:
|
| dailymed-drugs:281 |
For the treatment of postoperative nausea and vomiting
and nausea associated with gastroenteritis.
|
| dailymed-drugs:282 |
Hypertension: Quinapril tablets USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using quinapril tablets USP, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets USP do not have a similar risk (see WARNINGS).<br/>Angiodema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.
|
| dailymed-drugs:283 |
Lindane Shampoo is indicated for the treatment of head lice (infestations of Pediculosis humanis capitis), crab lice (infestations of Pthirus pubis), and their ova only in patients who Lindane Shampoo should be used in the context of an overall lice management program that includes: Caregivers applying this product to patients should wear gloves less permeable to Lindane such as nitrile, latex with neoprene or sheer vinyl, and thoroughly clean hands after application. Natural latex gloves should be avoided because they are more permeable to Lindane. Lindane Shampoo does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.
|
| dailymed-drugs:284 |
AMERGE Tablets
are indicated for the acute treatment of migraine attacks with or
without aura in adults. AMERGE Tablets are
not intended for the prophylactic therapy of migraine or for use in
the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS).
Safety and effectiveness of AMERGE Tablets have not been established
for cluster headache, which is present in an older, predominantly
male population.
|
| dailymed-drugs:286 |
Kinevac (Sincalide for Injection) may be used: (1) to stimulate gallbladder contraction, as
may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration
a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and
crystals; (2) to stimulate pancreatic secretion (especially in conjunction with secretin) prior
to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology;
(3) to acceleratethe transit of a barium meal through the small bowel, thereby decreasing
the time and extent of radiation associated with fluoroscopy and x-ray examination of the
intestinal tract.
|
| dailymed-drugs:288 |
DESYREL is indicated for the treatment of depression. The efficacy of DESYREL has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association's Diagnostic and Statistical Manual, III. Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least two weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexualdrive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.
|
| dailymed-drugs:289 |
Major Depressive Disorder: Fluoxetine Oral Solution, USP is indicated for the treatment of major depressive disorder.<br/>Adult: The efficacy of fluoxetine was established in 5- and 6-week trials with depressed adult and geriatric outpatients (���18 years of age) whose diagnoses corresponded most closely to the DSM-III (currently DSM-IV) category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effects of fluoxetine in hospitalized depressed patients have not been adequately studied. The efficacy of fluoxetine 20 mg once daily in maintaining a response in major depressive disorder for up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) was demonstrated in a placebo-controlled trial.<br/>Pediatric (children and adolescents): The efficacy of fluoxetine in children and adolescents was established in two 8- to 9-week placebo-controlled clinical trials in depressed outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder . The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should be reevaluated periodically.<br/>Obsessive Compulsive Disorder:<br/>Adult: Fluoxetine is indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of fluoxetine was established in 13-week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM-III-R category of OCD . OCD is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The effectiveness of fluoxetine in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient .<br/>Pediatric (children and adolescents): The efficacy of fluoxetine in children and adolescents was established in a 13-week, dose titration, clinical trial in patients with OCD, as defined in DSM-IV .<br/>Bulimia Nervosa: Fluoxetine is indicated for the treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa. The efficacy of fluoxetine was established in 8- to 16-week trials for adult outpatients with moderate to severe bulimia nervosa, i.e., at least 3 bulimic episodes per week for 6 months . The efficacy of fluoxetine 60 mg/day in maintaining a response, in patients with bulimia who responded during an 8-week acute treatment phase while taking fluoxetine 60 mg/day and were then observed for relapse during a period of up to 52 weeks, was demonstrated in a placebo-controlled trial . Nevertheless, the physician who elects to use fluoxetine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient .<br/>Panic Disorder: Fluoxetine is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks, and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of fluoxetine was established in two 12-week clinical trials in patients whose diagnoses corresponded to the DSM-IV category of panic disorder . Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 or more of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5)feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) fear of losing control; 10) fear of dying; 11) paresthesias (numbness or tingling sensations); 12) chills or hot flashes. The effectiveness of fluoxetine in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient .
|
| dailymed-drugs:290 |
Clindamycin Injection, USP is indicated in the treatment
of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection, USP is also indicated in the treatment
of serious infections due to susceptible strains of streptococci,
pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic
patients or other patients for whom, in the judgment of the physician,
a penicillin is inappropriate. Because of the risk of antibiotic-associated
pseudomembranous colitis, as described in the WARNING box, before selecting clindamycin the physician
should consider the nature of the infection and the suitability of
less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative
organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction
with antibiotic therapy. Clindamycin Injection,
USP is indicated in the treatment of serious infections caused by
susceptible strains of the designated organisms in the conditions
listed below: Lower respiratory tract infections
including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci
(except E. faecalis), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes. Gynecological infections including endometritis, nongonococcal
tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal
cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal
abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus
aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes. Bone and joint infections including acute hematogenous
osteomyelitis caused by Staphylococcus
aureus and as adjunctive therapy in the surgical treatment
of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria
and maintain the effectiveness of clindamycin and other antibacterial
drugs, clindamycin should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible
bacteria. When culture and susceptibility information are available,
they should be considered in selecting or modifying antibacterial
therapy. In the absence of such data, local epidemiology and susceptibility
patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:291 |
Carefully consider the potential benefits and risks of naproxen sodium extended-release tablets and other treatment options before deciding to use naproxen sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . Naproxen sodium extended-release tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, and acute gout. They are also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea.
|
| dailymed-drugs:292 |
Estradiol Tablets, USP are indicated in the: Since estrogen administration is associated with risk, selection of patients should ideally be based on prospective identification of risk factors for developing osteoporosis. Unfortunately, there is no certain way to identify those women who will develop osteoporotic fractures. Most prospective studies of efficacy for this indication have been carried out in white menopausal women, without stratification by other risk factors, and tend to show a universally salutary effect on bone. Thus, patient selection must be individualized based on the balance of risks and benefits. A more favorable risk/benefit ratio exists in a hysterectomized woman because she has no risk of endometrial cancer . Estrogen replacement therapy reduces bone resorption and retards or halts postmenopausal bone loss. Case-control studies have shown an approximately 60 percent reduction in hip and wrist fractures in women whose estrogen replacement was begun within a few years of menopause. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen prevents further loss of bone mass for as long as the treatment is continued. The results of a two-year, randomized, placebo-controlled, double-blind, dose-rangingstudy have shown that treatment with 0.5 mg estradiol daily for 23 days (of a 28 day cycle)
prevents vertebral bone mass loss in postmenopausal women. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period. There is no evidence that estrogen replacement therapy restores bone mass to premenopausal levels. At skeletal maturity there are sex and race differences in both the total amount of bone present and its density, in favor of men and blacks. Thus, women are at higher risk
than men because they start with less bone mass and, for several years following natural or induced menopause, the rate of bone mass decline is accelerated. White and Asian women are at higher risk than black women. Early menopause is one of the strongest predictors for the development of osteoporosis. In addition, other factors affecting the skeleton which are associated with osteoporosis
include genetic factors (small build, family history), and endocrine factors (nulliparity, thyrotoxicosis, hyperparathyroidism, Cushing's syndrome, hyperprolactinemia, Type I diabetes), lifestyle (cigarette smoking, alcohol abuse, sedentary exercise habits) and nutrition (below average body weight, dietary calcium intake). The mainstays of prevention and management of osteoporosis are estrogen, an adequate lifetime calcium intake, and exercise. Postmenopausal women absorb dietary calcium less efficiently than premenopausal women and require an average of 1500 mg/day of elemental calcium to remain in neutral calcium balance. By comparison, premenopausal women require about 1000 mg/day and the average calcium intake in the USA is 400 to 600 mg/day. Therefore, when not contraindicated, calcium supplementation may be helpful. Weight-bearing exercise and nutrition may be important adjuncts to the prevention and management of osteoporosis. Immobilization and prolonged bed rest produce rapid
bone loss, while weight-bearing exercise has been shown both to reduce bone loss and to increase bone mass. The optimal type and amount of physical activity that would prevent osteoporosis have not been established, however in two studies an hour of walking and running exercise twice or three times weekly significantly increased lumbar spine bone mass.
|
| dailymed-drugs:293 |
Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:<br/>Upper Respiratory Tract::<br/>Pharyngitis/Tonsillitis:: Caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention ofrheumatic fever are not available at present.<br/>Otitis Media:: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including��-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including��-lactamase-producing strains). NOTE: In the treatment of otitis media due to��-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific��-lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing��-lactamase inhibitors.<br/>Acute Sinusitis:: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including��-lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including��-lactamase-producing strains).<br/>Lower Respiratory Tract::<br/>Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis:: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including��-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including��-lactamase-producing strains).<br/>Skin and Skin Structure::<br/>Uncomplicated Skin and Skin-Structure Infections:: Caused by Staphylococcus aureus (including penicillinase producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil tablets and other antibacterial drugs, cefprozil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|
| dailymed-drugs:294 |
Zazole Vaginal Cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As Zazole Vaginal Cream 0.4% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
|