Security and tolerability of montelukast in a single-dose pharmacokinetic research in 26 youngsters 6 to 23 months old were similar to that of clients 2 years and over [see Adverse Reactions (6.1)] The 4-mg oral granule formulation need to be used for pediatric patients 12 to 23 months old for the therapy of asthma, or for pediatric individuals 6 to 23 months of age for the therapy of perennial sensitive rhinitis.
In studies with restorative dosages, plasma focus of metabolites of montelukast are undetected at constant state in adults as well as pediatric patients.
and also Multinational) in a similar way created, randomized, 12-week, double-blind, placebo-controlled trials in 1576 patients (795 treated with Singulair, 530 treated with placebo, as well as 251 treated with active control).
Singulair ® is shown for the prophylaxis as well as persistent therapy of asthma in adults and pediatric patients 12 months old and older.
The safety in patients 6 to 23 months old is assisted by data from pharmacokinetic and safety and security and efficacy studies in asthma in this pediatric populace and also from adult pharmacokinetic research studies.