title: Pharmacokinetics of montelukast in asthmatic patients 6 to 24 months old.
abstract: 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 > or = 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.
authors.affiliation: Merck Research Laboratories, 126 East Lincoln Avenue, Rahway, NJ 07065, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Migoya
authors.forename: Gregory L
authors.initials: GL
authors.lastname: Kearns
authors.forename: Alan
authors.initials: A
authors.lastname: Hartford
authors.forename: Jamie
authors.initials: J
authors.lastname: Zhao
authors.forename: Janet
authors.initials: J
authors.lastname: van Adelsberg
authors.forename: Carol A
authors.initials: CA
authors.lastname: Tozzi
authors.forename: Barbara
authors.initials: B
authors.lastname: Knorr
authors.forename: Paul
authors.initials: P
authors.lastname: Deutsch
mesh_terms: D000085:Acetates / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D000284:Administration, Oral; D019540:Area Under Curve; D001249:Asthma / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D001806:Blood Urea Nitrogen; D002626:Chemistry, Pharmaceutical; D002675:Child, Preschool; D003521:Cyclopropanes; D003967:Diarrhea / Q000139:chemically induced; D006207:Half-Life; D006801:Humans; D007223:Infant; D008297:Male; D008409:Mastication; D011804:Quinolines / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D018102:Receptors, Leukotriene B4 / Q000008:administration & dosage / Q000037:antagonists & inhibitors / Q000627:therapeutic use; D013440:Sulfides; D013607:Tablets
chemical_list: D000085:Acetates; D003521:Cyclopropanes; D011804:Quinolines; D018102:Receptors, Leukotriene B4; D013440:Sulfides; D013607:Tablets; C093875:montelukast