Montelukast dose selection in 6-to 14-year-olds: Comparison of single-dosepharmacokinetics in children and adults

Montelukast, an oral leukotriene-receptor antagonist, has demonstrated effi cacy and tolerability for the treatment of chronic asthma in adults. A once -daily 10 mg dose (film-coated tablet) was selected as the optimal adult do se based on dose-ranging studies. Asthma is a similar disease and is treate d with the same medications in children and adults. These observations sugg ested that a dose of montelukast in children providing overall drug exposur e (i.e., montelukast plasma concentrations) similar to that of the 10 mg fi lm-coated tablet dose in adults would be efficacious, well tolerated, and o bviate the need for separate dose-ranging studies in children. Therefore, t he dose of montelukast for 6- to 14-year-old children was selected by ident ifying the chewable tablet dose of montelukast yielding a single-dose area under the plasma concentration-time curve (AUC) comparable to that achieved with the adult 10 mg film-coated tablet dose. Based on this approach, whic h included dose normalization of data from several pediatric pharmacokineti c studies, a 5 mg chewable tablet dose of montelukast was selected for use in clinical efficacy studies in 6- to 14-year-old children with asthma. Jou rnal of Clinical pharmacology, 1999;39:786-793 (C) 1999 the American Colleg e of Clinical Pharmacology.