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

a-s medication solutions - montelukast (unii: mhm278sd3e) (montelukast - unii:mhm278sd3e) - 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 benefits of montelukast sodium chewable 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. • 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 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. data 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 events 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 effects on the breastfed infant from montelukast sodium or from the underlying maternal condition. safety and efficacy of montelukast sodium have been established in adequate and well-controlled studies in pediatric patients with asthma 6 to 14 years of age. safety and efficacy profiles in this age group are similar to those seen in adults [see adverse reactions ( 6.1), clinical pharmacology, special populations ( 12.3), and clinical studies ( 14.1, 14.2)] . the efficacy of montelukast sodium for the treatment of seasonal allergic rhinitis in pediatric patients 2 to 14 years of age and for the treatment of perennial allergic rhinitis in pediatric patients 2 to 14 years of age is supported by extrapolation from the demonstrated efficacy in patients 15 years of age and older with allergic rhinitis as well as the assumption that the disease course, pathophysiology and the drug’s effect are substantially similar among these populations. the safety of montelukast sodium 4-mg chewable tablets in pediatric patients 2 to 5 years of age with asthma has been demonstrated by adequate and well-controlled data [see adverse reactions ( 6.1)] . efficacy of montelukast sodium in this age group is extrapolated from the demonstrated efficacy in patients 6 years of age and older with asthma and is based on similar pharmacokinetic data, as well as the assumption that the disease course, pathophysiology and the drug’s effect are substantially similar among these populations. efficacy in this age group is supported by exploratory efficacy assessments from a large, well-controlled safety study conducted in patients 2 to 5 years of age. the safety of montelukast sodium 4-mg and 5-mg chewable tablets in pediatric patients aged 2 to 14 years with allergic rhinitis is supported by data from studies conducted in pediatric patients aged 2 to 14 years with asthma. a safety study in pediatric patients 2 to 14 years of age with seasonal allergic rhinitis demonstrated a similar safety profile [see adverse reactions ( 6.1)]. 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. growth rate in pediatric patients a 56-week, multi-center, double-blind, randomized, active- and placebo-controlled parallel group study was conducted to assess the effect of montelukast sodium on growth rate in 360 patients with mild asthma, aged 6 to 8 years. treatment groups included montelukast sodium 5 mg once daily, placebo, and beclomethasone dipropionate administered as 168 mcg twice daily with a spacer device. for each subject, a growth rate was defined as the slope of a linear regression line fit to the height measurements over 56 weeks. the primary comparison was the difference in growth rates between montelukast sodium and placebo groups. growth rates, expressed as least-squares (ls) mean (95% ci) in cm/year, for the montelukast sodium, placebo, and beclomethasone treatment groups were 5.67 (5.46, 5.88), 5.64 (5.42, 5.86), and 4.86 (4.64, 5.08), respectively. the differences in growth rates, expressed as least-squares (ls) mean (95% ci) in cm/year, for montelukast sodium minus placebo, beclomethasone minus placebo, and montelukast sodium minus beclomethasone treatment groups were 0.03 (-0.26, 0.31), -0.78 (-1.06, -0.49); and 0.81 (0.53, 1.09), respectively. growth rate (expressed as mean change in height over time) for each treatment group is shown in figure 1. figure 1: change in height (cm) from randomization visit by scheduled week (treatment group mean ± standard error* of the mean) *the standard errors of the treatment group means in change in height are too small  to be visible on the plot  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 required 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)] .

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.

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)

strides pharma science pty ltd - montelukast sodium, quantity: 5.19 mg - tablet, chewable - excipient ingredients: mannitol; microcrystalline cellulose; hyprolose; croscarmellose sodium; iron oxide red; aspartame; magnesium stearate; flavour - prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. symptomatic treatment of seasonal allergic rhinitis.

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

strides pharma science pty ltd - montelukast sodium, quantity: 4.15 mg - tablet, chewable - excipient ingredients: mannitol; microcrystalline cellulose; hyprolose; croscarmellose sodium; iron oxide red; aspartame; magnesium stearate; 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)

macleods pharmaceuticals limited - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in patients 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 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. 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 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)

camber pharmaceuticals, inc. - 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 pediatric patients 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.   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  of age and older. because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with   reserve use for patients who have an inadequate response or intolerance to alternative therapies. 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

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

pd-rx 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 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.  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  co