Pharmacokinetics of desloratadine in children between 2 and 11 years of age

Abstract

Aims: The aim of the studies was to characterize the pharmacokinetics of desloratadine in healthy children and to determine the appropriate dose for paediatric patients 2-11 years old. Methods: Two open-label, single-dose studies were carried out in healthy children between 2-5 (n = 18) and 6-11 years old (n = 18). On day 1, subjects received a single oral dose of desloratadine syrup (1.25 mg for 2-5 year olds or 2.5 mg for 6-11 year olds). Subjects were followed for an additional 4 days during which vital signs were measured daily and blood samples were collected periodically. Results: Plasma desloratadine C max occurred at a median of 2.0 h after dosing in both age groups. Median values for the younger (2-5 years old) and older (6-11 years old) groups were 2.28 and 2.05 ng ml-1, respectively. Arithmetic (and harmonic) mean t1/2 (h) values for each group, respectively, were 16.4 (13.9) and 19.4 (15.8). Exposure to desloratadine was similar in both the younger and older age groups, with a median AUC(last) of 38.8 and 38.2 ng ml-1 h, respectively. These data were similar to values in adults, who received 5 mg doses of desloratadine. No adverse events or clinically significant abnormal laboratory values were noted in either group. Conclusions: Single doses of desloratadine syrup (1.25 and 2.5 mg) were well tolerated in children 2-5 and 6-11 years old. Desloratadine exposure in children appears to be similar to that observed in adults, in whom efficacy has been established. © 2006 Schering-Plough.