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Pharmacokinetics and antipruritic effects of hydroxyzine in children with atopic dermatitis
Insights
Hydroxyzine hydrochloride effectively reduces itching in children with severe atopic dermatitis. Lower doses provide comparable relief to higher doses with less sedation.
Area of Science:
- Pharmacology
- Dermatology
- Pediatrics
Background:
- Severe atopic dermatitis significantly impacts children's quality of life.
- Effective management of pruritus in pediatric atopic dermatitis is crucial.
- Hydroxyzine hydrochloride is a potential therapeutic agent for pruritus.
Purpose of the Study:
- To evaluate the pharmacokinetics of hydroxyzine hydrochloride in children with severe atopic dermatitis.
- To assess the antipruritic efficacy and safety of hydroxyzine hydrochloride.
- To compare different dosing regimens of hydroxyzine hydrochloride.
Main Methods:
- Single-dose pharmacokinetic study in 12 children (mean age 6.1 years).
- Administration of 0.7 mg/kg oral hydroxyzine hydrochloride.
- Double-blind, crossover, multiple-dose study comparing 0.7 mg/kg and 1.4 mg/kg three times daily.
Main Results:
- Mean peak serum concentration: 47.4 ng/ml at 2.0 hours.
- Mean elimination half-life: 7.1 hours, increasing with age.
- Significant pruritus suppression (85% from 2-12 hours); sedation was the main adverse effect.
- Both 0.7 mg/kg and 1.4 mg/kg tid doses were effective; 0.7 mg/kg tid caused less sedation.
Conclusions:
- Hydroxyzine hydrochloride exhibits predictable pharmacokinetics in children with severe atopic dermatitis.
- A dose of 0.7 mg/kg three times daily is effective for managing pruritus and skin lesions with reduced sedation.
- Hydroxyzine hydrochloride is a viable treatment option for severe pediatric atopic dermatitis, with dose optimization for safety.
Abstract:
We studied the pharmacokinetics and antipruritic effects of hydroxyzine hydrochloride in 12 children, mean age 6.1 +/- 4.6 years, with severe atopic dermatitis. After a single 0.7 mg/kg orally administered dose of the drug, the mean peak serum hydroxyzine concentration of 47.4 +/- 17.3 ng/ml occurred at a mean time of 2.0 +/- 0.9 hours. The mean elimination half-life was 7.1 +/- 2.3 hours, the mean clearance rate was 32.08 +/- 11.05 ml/min/kg, and the mean apparent volume of distribution was 18.5 +/- 8.6 L/kg. The elimination half-life increased with increasing age (r = 0.83). Pruritus was significantly suppressed from 1 to 24 hours after the administration of the dose, with greater than 85% suppression from 2 to 12 hours. The only adverse effect reported was sedation. In a subsequent double-blind, crossover, multiple-dose study of 2 weeks' duration, hydroxyzine 0.7 mg/kg three times daily was as effective as hydroxyzine 1.4 mg/kg three times daily in relieving pruritus and promoting resolution of the skin lesions. The 0.7 mg/kg tid dose caused significantly less sedation than the 1.4 mg/kg tid dose.
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