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

nucare pharmaceuticals,inc. - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. montelukast sodium tablet is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 15 years of age and older. 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. 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

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

remedyrepack inc. - 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 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.  - hypersensitivity to any component of this product. 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 recomme

Israel - English - Ministry of Health

abic marketing ltd, israel - montelukast as sodium - film coated tablets - montelukast as sodium 10 mg - montelukast - montelukast - montelukast teva is indicated in adult and adolescents 15 years of age and older for the prophylaxis and chronic treatment of asthma including prevention of daytime and nighttime symptoms the treatment of aspirin-sensitive asthmatic patients and the prevention of exercise-induced bronchoconstriction. montelukast teva is effective alone or in combination with other agents used in the maintenance treatment of chronic asthma. montelukast teva and inhaled corticosteroids may be used concomitantly with additive effects to control asthma or to reduce the inhaled corticosteroid dose while maintaining clinical stability. montelukast teva is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and adolescents 15 years of age and older.

Israel - English - Ministry of Health

trima israel pharmaceutical products maabarot ltd - montelukast as sodium salt - chewable tablets - montelukast as sodium salt 4 mg - montelukast - montelukast - montelukast - trima is indicated in adult and pediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including prevention of daytime and nighttime symptoms, the treatment of aspirin-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction. montelukast - trima is effective alone or in combination with other agents used in the maintenance treatment of chronic asthma. montelukast - trima and inhaled corticosteroids may be used concomitantly with additive effects to control asthma or to reduce the inhaled corticosteroid dose while maintaining clinical stability. montelukast - trima is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.

Israel - English - Ministry of Health

trima israel pharmaceutical products maabarot ltd - montelukast as sodium salt - chewable tablets - montelukast as sodium salt 5 mg - montelukast - montelukast - montelukast - trima is indicated in adult and pediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including prevention of daytime and nighttime symptoms, the treatment of aspirin-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction. montelukast - trima is effective alone or in combination with other agents used in the maintenance treatment of chronic asthma. montelukast - trima and inhaled corticosteroids may be used concomitantly with additive effects to control asthma or to reduce the inhaled corticosteroid dose while maintaining clinical stability. montelukast - trima is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.

Israel - English - Ministry of Health

trima israel pharmaceutical products maabarot ltd - montelukast as sodium salt - tablets - montelukast as sodium salt 10 mg - montelukast - montelukast - montelukast - trima is indicated in adult and pediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including prevention of daytime and nighttime symptoms, the treatment of aspirin-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction. montelukast - trima is effective alone or in combination with other agents used in the maintenance treatment of chronic asthma. montelukast - trima and inhaled corticosteroids may be used concomitantly with additive effects to control asthma or to reduce the inhaled corticosteroid dose while maintaining clinical stability. montelukast - trima is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.

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

preferred pharmaceuticals, inc. - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 4 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 2 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)

aphena pharma solutions - tennessee, llc - 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 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. montelukast sodium is indicated for the relief of symptoms of seasonal 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

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)

bryant ranch prepack - 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 w