Pharmacokinetics and antipruritic effects of hydroxyzine in children with atopic dermatitis

• Published in: The Journal of pediatrics Vol. 104; no. 1; pp. 123 - 127
• Main Authors: Estelle, F., Simons, R., Simons, Keith J., Becker, Allan B., Haydey, Richard P.
• Format: Journal Article
• Language: English
• Published: United States Mosby, Inc 1984
• Subjects: Antipruritics - therapeutic use; Child; Child, Preschool; Clinical Trials as Topic; Dermatitis, Atopic - drug therapy; Dermatologic Agents - therapeutic use; Double-Blind Method; Female; Half-Life; Humans; Hydroxyzine - administration & dosage; Hydroxyzine - blood; Hydroxyzine - therapeutic use; Kinetics; Male; Metabolic Clearance Rate; Random Allocation; Time Factors
• ISSN: 0022-3476; 1097-6833
• DOI: 10.1016/S0022-3476(84)80608-3

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.