USA - engelsk - NLM (National Library of Medicine)

direct rx - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - 1.1 asthma montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. 1.2 exercise-induced bronchoconstriction (eib) montelukast sodium tablet is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 15 years of age and older. pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (eib) is approved for merck sharp & dohme corp’s montelukast tablet products. however, due to merck sharp & dohme corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 allergic rhinitis montelukast sodium tablet is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. hypersensitivity to any component of this product 8.1 pregnancy pregnancy category b: there are no adequat

USA - engelsk - NLM (National Library of Medicine)

{preferred pharmaeutials inc. - 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 12 months 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 6 months of age and older. risk summary            available  data  from  published  prospective  and  retrospective  cohort  studies  over decades  with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see data] . in animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (mr

USA - engelsk - 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

USA - engelsk - 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

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

apotex nz ltd - montelukast sodium 4.16mg equivalent to 4 mg motelukast - chewable tablet - 4 mg - active: montelukast sodium 4.16mg equivalent to 4 mg motelukast excipient: aspartame cherry flavour 501027 ap0551 croscarmellose sodium iron oxide red magnesium stearate mannitol microcrystalline cellulose - apo-montelukast is indicated in adult and paediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day- and night-time symptoms and the prevention of exercise-induced bronchospasm.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

apotex nz ltd - montelukast sodium 5.2mg equivalent to 5 mg montelukast - chewable tablet - 5 mg - active: montelukast sodium 5.2mg equivalent to 5 mg montelukast excipient: aspartame cherry flavour 501027 ap0551 croscarmellose sodium iron oxide red magnesium stearate mannitol microcrystalline cellulose - apo-montelukast is indicated in adult and paediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day- and night-time symptoms and the prevention of exercise-induced bronchospasm.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

apotex nz ltd - montelukast sodium 10.4mg equivalent to montelukast 10 mg - tablet - 10 mg - active: montelukast sodium 10.4mg equivalent to montelukast 10 mg excipient: colloidal silicon dioxide croscarmellose sodium hyprolose hypromellose iron oxide red iron oxide yellow lactose magnesium stearate microcrystalline cellulose titanium dioxide - apo-montelukast is indicated in adult and paediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day-time and night-time symptoms and the prevention of exercise-induced bronchospasm

USA - engelsk - 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

USA - engelsk - 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

USA - engelsk - 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