Montezyd 4/Montezyd 5/Montezyd 10 Adverse Reactions

Montelukast has been generally well tolerated. Adverse effects, which usually were mild, generally did not require discontinuation of therapy. The overall incidence of adverse effects (including laboratory adverse effects) reported with Montelukast was comparable to placebo.
Montezyd 4/Montezyd 5: Paediatric Patients 6 to 14 Years of Age with Asthma: Montelukast has been evaluated in approximately 475 paediatric patients 6 to 14 years of age. The safety profile in paediatric patients is generally similar to the adult safety profile and to placebo.
In an 8‑week, placebo‑controlled clinical study, the only adverse experience reported as medicine‑related in >1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo was headache. The incidence of headache was not significantly different in the two treatment groups.
In studies evaluating the growth rate, the safety profile in these paediatric patients was consistent with the safety profile previously described for Montelukast. Cumulatively, 263 paediatric patients 6 to 14 years of age were treated with Montelukast for at least 3 months and 164 for 6 months or longer. With prolonged treatment, the adverse experience profile did not change.
Paediatric Patients 2 to 5 Years of Age with Asthma: Montelukast has been evaluated in 573 paediatric patients 2 to 5 years of age. In a 12‑week, placebo‑controlled clinical study, the only adverse experience reported as medicine‑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, 426 paediatric patients 2 to 5 years of age were treated with Montelukast for at least 3 months, 230 for 6 months or longer, and 63 patients for 12 months or longer. With prolonged treatment, the adverse experience profile did not change.
Paediatric Patients 2 to 14 Years of Age with Seasonal Allergic Rhinitis: Montelukast has been evaluated in 280 paediatric patients 2 to 14 years of age for the treatment of seasonal allergic rhinitis in a 2‑week, placebo‑controlled, clinical study. Montelukast administered once daily in the evening was generally well tolerated with a safety profile similar to that of placebo. In this study, no 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 observed.
Montezyd 10: Adults 15 Years of Age and Older with Asthma: Montelukast has been evaluated 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 medicine-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. Cumulatively, 544 patients were treated with Montelukast for at least 6 months, 253 for one year and 21 for 2 years in clinical studies. With prolonged treatment, the adverse experience profile did not change.
Adults 15 Years of Age and Older with Seasonal Allergic Rhinitis: Montelukast has been evaluated in 2199 adult patients 15 years of age and older for the treatment of seasonal allergic rhinitis in clinical studies. Montelukast administered once daily in the morning or in the evening was generally well tolerated with a safety profile similar to that of placebo. In placebo-controlled clinical studies, no 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 observed. In a 4-week, placebo-controlled clinical study, the safety profile was consistent with that observed in 2-week studies. The incidence of somnolence was similar to that of placebo in all studies.
Adults 15 Years of Age and Older with Perennial Allergic Rhinitis: Montelukast has been evaluated in 3235 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis (defined as a history of symptoms for at least two years and positive skin tests for at least two perennial allergens) in two, 6 week, placebo -controlled, clinical studies. Montelukast administered once daily was generally well tolerated, with a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo. In these two studies, no 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 observed. The incidence of somnolence was similar to that of placebo.