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Pharmacokinetics of Montelukast in Asthmatic Patients 6 to 24 Months Old

From Merck Research Laboratories, Rahway, New Jersey (Dr. Migoya, Dr. Hartford, Dr. Zhao, Dr. van Adelsberg, Dr. Tozzi, Dr. Knorr, Dr. Deutsch); Division of Pediatric Pharmacology and Medical Toxicology, Children's Mercy Hospitals and Clinics, Kansas City, Missouri (Dr. Kearns); and Departments of Pediatric and Pharmacology, University of Missouri-Kansas City, Kansas City, Missouri (Dr. Kearns).

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.

Key Words: Montelukast • asthma • pediatrics • pharmacokinetics

Address for reprints: Elizabeth Migoya, PharmD, Merck Research Laboratories, 126 East Lincoln Avenue, Rahway, NJ 07065.

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