PENDO-MONTELUKAST

Adverse Drug Reaction Overview Montelukast has been generally well tolerated. Side effects, which usually were mild, generally did not require discontinuation of therapy. The overall incidence of side effects reported with montelukast was comparable to placebo.

Clinical Trial Adverse Drug Reactions Adults 15 Years of Age and Older with Asthma Montelukast has been evaluated for safety in approximately 2600 adult patients 15 years of age and older in clinical studies. In two similarly designed, 12-week placebo-controlled clinical studies, the only adverse experiences reported as drug-related in ≥1% of patients treated with montelukast and at a greater incidence than in patients treated with placebo were abdominal pain and headache.

The incidences of these events were not significantly different in the two treatment groups. 9 * Number of patients tested (montelukast and placebo, respectively): ALT and AST, 1935, 1170; pyuria, 1924, 1159. Cumulatively, 544 patients were treated with montelukast for at least 6 months, 253 for one year and 21 for two years in clinical trials.

With prolonged treatment, the adverse experience profile did not change. Pediatric Patients 6 to 14 Years of Age with Asthma Montelukast has been evaluated for safety in approximately 475 pediatric patients 6 to 14 years of age. Cumulatively, 263 pediatric patients 6 to 14 years of age were treated with montelukast for at least 3 months, 164 for 6 months or longer in clinical trials.

The safety profile in pediatric patients is generally similar to the adult safety profile and to placebo. With prolonged treatment, the adverse experience profile did not change. In a 56-week double-blind study evaluating growth rate in pediatric patients 6 to 8 years of age receiving montelukast, the following events not previously observed with the use of montelukast occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: atopic dermatitis, myopia, rhinitis (infective), skin pendo-MONTELUKAST FC & pendo-MONTELUKAST Product Monograph Page 9 of 33 infection, tooth infection, headache, varicella, gastroenteritis and acute bronchitis.

Pediatric Patients 2 to 5 Years of Age with Asthma Montelukast has been evaluated for safety in 573 pediatric patients 2 to 5 years of age. In a 12-week, placebo-controlled clinical study, the only adverse experience reported as drug-related in >1% of patients treated with montelukast and at a greater incidence than in patients treated with placebo was thirst.

The incidence of thirst was not significantly different in the two treatment groups. Cumulatively, 363 patients 2 to 5 years of age were treated with montelukast. Of these, 338 were continuously treated for at least 6 months and 256 for >1 year.

The safety profile of montelukast in pediatric patients 2 to 5 years of age is generally similar to the safety profiles in adults 15 years of age and older in pediatric patients 6 to 14 years of age, and to placebo. With prolonged treatment, the adverse experience profile did not change.

Pediatric Patients 6 Months to 2 Years of Age with Asthma Montelukast has been evaluated in 175 pediatric patients 6 months to 2 years of age. In a 6-week, placebo-controlled clinical study, the adverse experiences reported as drug related in >1% of patients treated with montelukast and at a greater incidence than in patients treated with placebo were diarrhea, hyperkinesia, asthma, eczematous dermatitis and rash.

The incidences of these adverse experiences were not significantly different in the two treatment groups. Adults 15 Years of Age and Older with Seasonal Allergic Rhinitis Montelukast has been evaluated in 1751 adult patients 15 years of age and older for the treatment of seasonal allergic rhinitis in clinical studies.

Montelukast administered once daily at bedtime was generally well tolerated with a safety profile similar to that of placebo. In similar designed, 2-week, placebo-controlled, clinical studies, no adverse experience reported as drug related in ≥1% of patients treated with montelukast and at a greater incidence than in patients treated with placebo were observed.

The incidence of somnolence was similar to that of placebo. Post-Market Adverse Drug Reactions The following adverse drug reactions have been reported very rarely (<1/10,000) in post-marketing use of montelukast. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and Infestations: upper respiratory infection Blood and lymphatic system disorders: increased bleeding tendency, thrombocytopenia. Immune system disorders: hypersensitivity reactions including anaphylaxis, and very rarely, hepatic eosinophilic infiltration.

Psychiatric disorders: agitation including aggressive behavior or hostility (including […]