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

Br J Clin Pharmacol. 2007 May;63(5):534-40. doi: 10.1111/j.1365-2125.2006.02810.x.

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 t(1/2) (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.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aging / blood
  • Body Weight
  • Child
  • Child, Preschool
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Histamine H1 Antagonists, Non-Sedating / administration & dosage
  • Histamine H1 Antagonists, Non-Sedating / adverse effects
  • Histamine H1 Antagonists, Non-Sedating / blood*
  • Humans
  • Loratadine / administration & dosage
  • Loratadine / adverse effects
  • Loratadine / analogs & derivatives*
  • Loratadine / blood
  • Male

Substances

  • Histamine H1 Antagonists, Non-Sedating
  • Loratadine
  • desloratadine