Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - montelukast sodium, quantity: 5.2 mg - tablet, chewable - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; mannitol; magnesium stearate; iron oxide red; aspartame; flavour - -prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. ,-symptomatic treatment of seasonal allergic rhinitis.

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. pregnancy category b:  there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, montelukast sodium should be used during pregnancy only if clearly needed. teratogenic effect: no teratogenicity was observed in rats and rabbits at doses approximately 100 and 110 times, respectively, the maximum recommended daily oral dose in adults based on aucs [see nonclinical toxicology (13.2)] . during worldwide marketing experience, congenital limb defects h

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 5 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium is not indicated for the treatment of an acute asthma attack. montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. risk summary    available data from published prospective and retrospective cohort studies over

United States - English - NLM (National Library of Medicine)

carilion materials management - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. hypersensitivity to any component of this product. pregnancy category b: there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, montelukast sodium should be used during pregnancy only if clearly needed. teratogenic effect: no teratogenicity was observed in rats and rabbits at doses approximately 100 and 110 times, respectively, the maximum recommended daily oral dose in adults based on aucs [see nonclinical toxicology (13.2)]. during worldwide marketing

United States - English - NLM (National Library of Medicine)

carilion materials management - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 5 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, montelukast sodium should be used during pregnancy only if clearly needed. no teratogenicity was observed in rats and rabbits at doses approximately 100 and 110 times, respectively, the maximum recommended daily oral dose in adults based on aucs [see nonclinical toxicology (13.2) ]. during worldwide marketing experience, congenital limb defects have been rarely reported in the offspring of women being

United States - English - NLM (National Library of Medicine)

carilion materials management - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. hypersensitivity to any component of this product. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, montelukast sodium should be used during pregnancy only if clearly needed. pregnancy category b: no teratogenicity was observed in rats and rabbits at doses approximately 100 and 110 times, respectively, the maximum recommended daily oral dose in adults based on aucs teratogenic e

United States - English - NLM (National Library of Medicine)

a-s medication solutions - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium  is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium  is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium  is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium is not indicated for the treatment of an acute asthma attack.. montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. risk summary available data from published prospective and retrospective cohort studies over decades

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 4 mg - montelukast sodium tablets, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. montelukast sodium tablets and chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium tablets, chewable tablets and oral granules are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. because the benefits of montelukast sodium tablets, chewable tablets and oral granules may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium tablets, chewable tablets and oral granules are not indicated for the treatment of an acute asth

Canada - English - Health Canada

apotex inc - montelukast sodium - tablet - 10mg - montelukast sodium 10mg - leukotriene modifiers

Canada - English - Health Canada

apotex inc - montelukast sodium - tablet (chewable) - 4mg - montelukast sodium 4mg - leukotriene modifiers