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Levocetirizine in 1-2 year old children: pharmacokinetic and pharmacodynamic profile

N Cranswick1, J Turzíkova, M Fuchs

  • 1Royal Children's Hospital and Murdoch Children's Research Institute, University of Melbourne, Australia.

International Journal of Clinical Pharmacology and Therapeutics
|June 22, 2005
PubMed

Insights

Levocetirizine (0.125 mg/kg twice daily) demonstrated a good safety and pharmacokinetic/pharmacodynamic profile in children aged 12-24 months. This supports its use in further pediatric allergy studies.

Area of Science:

  • Pediatric Pharmacology
  • Allergy and Immunology

Background:

  • Levocetirizine is a selective H1-receptor antagonist with a favorable benefit/risk profile for allergic rhinitis and urticaria.
  • This study investigates levocetirizine in very young children, an understudied demographic.

Purpose of the Study:

  • To confirm the efficacy and safety of a levocetirizine regimen (0.125 mg/kg twice daily) in children aged 12-24 months.
  • To establish pharmacokinetic/pharmacodynamic parameters for levocetirizine in this pediatric age group.

Main Methods:

  • A pharmacokinetic/pharmacodynamic study involving 15 toddlers (20.7 +/- 3.7 months) treated with levocetirizine (0.125 mg/kg BID) for 90 days.
  • Histamine-induced wheal and flare tests were conducted pre-treatment and on Days 3-6 and 90.
  • Plasma drug levels were measured at multiple time points post-dose, including trough levels.

Main Results:

  • Peak plasma levels reached 286 +/- 68 ng/ml at 1 hour; elimination half-life was 4.1 +/- 0.7 hours.
  • Median inhibition of wheal and flare responses was consistently high (≥98.9%) throughout the study.
  • The drug exhibited a good overall safety profile over the three-month treatment period.

Conclusions:

  • The study confirms that 0.125 mg/kg levocetirizine administered twice daily is well-tolerated and pharmacokinetically/pharmacodynamically suitable for children aged 12-24 months.
  • This regimen is proposed for further clinical investigations in this specific pediatric population.
Abstract

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