Pharmacokinetics of Montelukast in Asthmatic Patients 6 to 24 Months Old

Montelukast is a cysteinyl leukotriene receptor antagonist approved for the treatment of asthma for those ages 1 year old to adult. The purpose of this study was to evaluate the pharmacokinetic comparability of a 4‐mg dose of montelukast oral granules in patients >6 to < 24 months old to the 10‐mg approved dose in adults. This was an open‐label study in 32 patients. Population pharmacokinetic parameters included estimates of AUC pop , C max , and t max . Results were compared with estimates from adults (10‐mg film‐coated tablet [FCT]). Dose selection criteria were for the 95% confidence interval (CI) for the AUC pop estimate ratio (pediatric/adult 10 mg FCT) to be within comparability bounds of (0.5, 2.00). The AUC pop ratio and the 95% CI for children compared with adults were within the predefined comparability bounds. Observed plasma concentrations were also similar. Based on systemic exposure of montelukast, a 4‐mg dose of montelukast appears appropriate for children as young as 6 months of age.