Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

sandoz inc - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - lamotrigine is an antiepileptic drug (aed) indicated for: epilepsy—adjunctive therapy in patients ≥ 2 years of age: (1.1) - partial seizures. - generalized seizures of lennox-gastaut syndrome. epilepsy—monotherapy in patients ≥ 16 years of age: conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single aed. (1.1) bipolar disorder in patients ≥ 18 years of age: maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.(1.2) adjunctive therapy: lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥2 years of age: - partial seizures - generalized seizures of lennox-gastaut syndrome monotherapy: lamotrigine tablets are indicated for conversion to monotherapy in adults (≥16 years of age) with partial seizures who are receiving treatment with carbamaze

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

sandoz inc - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 4 mg - ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron tablets are contraindicated in patients: risk summary available data do not reliably inform the association of ondansetron and adverse fetal outcomes. published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation [see data ]. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively [see data ]. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth def

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

orchidpharma inc - cefdinir monohydrate (unii: 6e7sn358se) (cefdinir - unii:ci0fao63wc) - cefdinir 125 mg in 5 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. cefdinir for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. adults and adolescents community-acquired pneumonia caused by haemophilus influenzae (including β-lactamase producing strains), haemophilus parainfluenzae (including β-lactamase producing strains), streptococcus pneumoniae (penicillin-susceptible strains only), and moraxella catarrhalis (inclu

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

procter & gamble pharmaceuticals - nitrofurantoin, macrocrystalline (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l) - capsule - 25 mg - macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of escherichia coli, enterococci, staphylococcus aureus , and certain susceptible strains of klebsiella and enterobacter species. nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. to reduce the development of drug-resistant bacteria and maintain the effectiveness of macrodantin and other antibacterial drugs, macrodantin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. consequently, many patient

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

aurobindo pharma limited - hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - hydrochlorothiazide 12.5 mg - hydrochloro­thiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. unlike potassium sparing combina­tion diuretic products, hydrochloro­thiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ace inhibitors. usage in pregnancy: the rou­tine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unneces­sary hazard. diuretics do not prevent development of tox­emia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. diuretics are indi­cated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. dependent edema in pregnan­cy resulting from restriction of venous return

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

breckenridge pharmaceutical, inc. - rabeprazole sodium (unii: 3l36p16u4r) (rabeprazole - unii:32828355ll) - rabeprazole sodium 20 mg - rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (gerd). for those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered. rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (gerd maintenance). controlled studies do not extend beyond 12 months. rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with gerd in adults for up to 4 weeks. rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. most patients heal within four weeks. rabeprazole

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

cipla usa inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 0.1 mg in 1 ml - granisetron hydrochloride injection is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: •  the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not alw

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

cipla usa inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg in 1 ml - granisetron hydrochloride injection is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not alwa

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

apotheca inc. - misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - misoprostol 200 ug - misoprostol is indicated for reducing the risk of nsaid (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking nsaids. misoprostol should be taken for the duration of nsaid therapy. misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. it had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with nsaid use. see boxed warnings. misoprostol should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (nsaids). misoprostol should not be taken by anyone with a history of allergy to prostaglandins.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 80 mg in 1 ml - (to understand fully the indication for this product, please read the entire indications and usage section of the labeling.) ciclopirox topical solution, 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to trichophyton rubrum . the comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. the results of use of ciclopirox topical solution, 8% in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the united states. in these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% in conjun