Single-Dose Pharmacokinetic Study of Diphenhydramine HCl in Children and Adolescents.

Clin Pharmacol Drug Dev

GA Thompson Consulting, LLC, West Chester, OH, USA.

Published: May 2018

AI Article Synopsis

  • A study evaluated the pharmacokinetics of diphenhydramine in children aged 2 to 17 years using a more nuanced weight- and age-based dosing schedule compared to current recommendations.
  • Participants received oral doses ranging from 6.25 to 50 mg, and blood samples were collected for up to 48 hours post-dosing to analyze how the drug behaved in their bodies.
  • Results showed that while drug concentration and area under the curve increased significantly across different age groups, the rate of drug clearance didn't change noticeably with maturation after adjusting for body size.

Article Abstract

Diphenhydramine pharmacokinetics were characterized following a single oral dose in children aged 2 to 17 years using a weight- and age-based dosing schedule with more tiers than the current age-based dosing schedule recommended by the nonprescription drug monograph. This study was conducted in 42 subjects, aged 2 to 17 years. Doses were based on a weight-age dosing schedule, ranging from 6.25 to 50 mg. An oral dose was administered with water about 2 hours after a light breakfast. Plasma samples were obtained up to 48 hours after dosing and analyzed for diphenhydramine. Pharmacokinetic parameters were estimated using noncompartmental methods, and the relationship of oral clearance with age was assessed using linear regression. Over an 8-fold range of doses, C and AUC increased ∼90 % to ∼140% across age groups, with a similar T (1.5 hours). Oral CL/F increased with age, but after allometric scaling, no maturation-related change in CL/F was apparent. Mild somnolence was the most commonly reported adverse event (95% of the subjects). A weight-age dosing schedule using an 8-fold range of doses achieved C and AUC that increased about 2-fold across age groups. No effect of maturation on CL/F was observed after allometric scaling.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5947143PMC
http://dx.doi.org/10.1002/cpdd.391DOI Listing

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