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

strides pharma science pty ltd - montelukast sodium, quantity: 10.38 mg (equivalent: montelukast, qty 10 mg) - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; hyprolose; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; carnauba wax - prophylaxis and treatment of chronic asthma in adults 15 years of age and older. ,symptomatic treatment of seasonal allergic rhinitis.

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

organon pharma pty ltd - montelukast sodium, quantity: 10.4 mg (equivalent: montelukast, qty 10 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; magnesium stearate; hyprolose; hypromellose; titanium dioxide; iron oxide red; iron oxide yellow; carnauba wax - prophylaxis and treatment of chronic asthma in adults and children two years of age and older. symptomatic treatment of seasonal allergic rhinitis

New Zealand - English - 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

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

camber pharmaceuticals, inc. - montelukast (unii: mhm278sd3e) (montelukast - unii:mhm278sd3e) - montelukast 4 mg - montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. sodium chewable tablets 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 2 of age and older. because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis , use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium chewable tablets 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 2 years of age and older. because the ben

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

organon pharma pty ltd - montelukast sodium, quantity: 10.4 mg (equivalent: montelukast, qty 10 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; iron oxide yellow; titanium dioxide; carnauba wax; hypromellose; iron oxide red; lactose monohydrate; hyprolose; magnesium stearate - prophylaxis and treatment of chronic asthma in adults and children over two years. symptomatic treatment of seasonal allergic rhinitis

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع أدوية النور - noor drug store - montelukast as sodium 10 mg - as sodium 10 mg

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.

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

sandoz 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 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

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

amneal pharmaceuticals llc - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and adolescents 15 years of age and older. montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 15 years of age and older. montelukast sodium tablets are 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. because the benefits of montelukast sodium tablets 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 are not indicated for the treatment of an acute asthma attack. montelukast sodium tablets are contraindicated in patients with hypersensitivity to any of its components. 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 (mrhdod) based on aucs [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly or moderately controlled asthma in pregnancy increases the maternal risk of perinatal adverse outcomes such as preeclampsia and infant prematurity, low birth weight, and small for gestational age. human data published data from prospective and retrospective cohort studies have not identified an association with montelukast sodium use during pregnancy and major birth defects. available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups. animal data in embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the auc in humans at the mrhdod, respectively). risk summary a published clinical lactation study reports the presence of montelukast in human milk. data available on the effects of the drug on infants, either directly [see use in specific populations (8.4)]  or through breast milk, do not suggest a significant risk of adverse reactions from exposure to montelukast sodium. the effects of the drug on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for montelukast sodium and any potential adverse reactions on the breastfed infant from montelukast sodium or from the underlying maternal condition. the safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established. of the total number of subjects in clinical studies of montelukast, 3.5% were 65 years of age and over, and 0.4% were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetic profile and the oral bioavailability of a single 10 mg oral dose of montelukast are similar in elderly and younger adults. the plasma half-life of montelukast is slightly longer in the elderly. no dosage adjustment in the elderly is required. no dosage adjustment is recommended in patients with mild-to-moderate hepatic insufficiency [see clinical pharmacology (12.3)] . no dosage adjustment is recommended in patients with renal insufficiency [see clinical pharmacology (12.3) ] .

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

fair-med healthcare australia pty ltd - montelukast sodium -