Population Pharmacokinetics and Pharmacodynamics of Oral Propranolol in Pediatric Patients With Infantile Hemangioma.

ABSTRACT: This study aimed to characterize the population pharmacokinetics and exposure-response relationship of propranolol (Hemangiol^® Syrup for Pediatric) in infants with infantile hemangioma. Using nonlinear mixed-effects modeling with 63 pooled sets of plasma concentration-time data from 32 Japanese patients aged 35-150 days, we described the disposition of propranolol adequately by a 1-compartment model with first-order absorption. The estimated population mean apparent clearance and apparent central volume of distribution were 9.34 L/h and 146 L, respectively. Body weight and postnatal age influenced the population pharmacokinetic model. The clinical end points-success (complete or nearly complete resolution of the target hemangioma) and failure-at weeks 12 and 24 were characterize

SUBMITTER: Takechi T 

PROVIDER: S-EPMC6175224 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature