Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/indication
| Subject | Object |
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| dailymed-drugs:3117 |
Hypertension.
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| dailymed-drugs:3218 |
Hypertension.
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| 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.
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| 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.
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| 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.
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| 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 .
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| 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.
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| 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.
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| 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.
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| 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.
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| 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.
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| dailymed-drugs:10 |
Betimol is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
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| 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.
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| 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).
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| dailymed-drugs:13 |
HYCOMINE (hydrocodone bitartrate and phenylpropanolamine hydrochloride) is indicated for the symptomatic relief of cough and nasal congestion.
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| dailymed-drugs:14 |
BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris.
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| dailymed-drugs:2267 |
BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris.
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| 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.
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| dailymed-drugs:16 |
Potassium Chloride
in 5% Dextrose and Sodium Chloride Injection, USP is indicated as a
source of water, electrolytes and calories.
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| dailymed-drugs:3389 |
Potassium Chloride
in 5% Dextrose and Sodium Chloride Injection, USP is indicated as a
source of water, electrolytes and calories.
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| 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.
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| 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.
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| 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.
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| 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.
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| 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.
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| dailymed-drugs:22 |
This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.
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| dailymed-drugs:3617 |
This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.
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| 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.
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| 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.
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| 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.
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| 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
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| dailymed-drugs:27 |
Major Depressive Disorder:
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| dailymed-drugs:864 |
Major Depressive Disorder:
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| 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.
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| dailymed-drugs:30 |
PLAVIX (clopidogrel bisulfate)
is indicated for the reduction of atherothrombotic events as follows:
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| 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.
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| 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.
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| dailymed-drugs:33 |
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
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| 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.
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| dailymed-drugs:3033 |
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
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| 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.
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| dailymed-drugs:34 |
Use in Pregnancy:
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| 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
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| 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.
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| 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 .
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| 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.
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| 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.
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| 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.
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| 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.
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| 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).
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| 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. .
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| 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.
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| 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.
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| 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.
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| 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.
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| 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.
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| 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.
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| 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.
|