Population Pharmacokinetics of Tapentadol in Children from Birth to <18 Years Old.

ABSTRACT:

Objective

The main aim of this analysis was to characterize the pharmacokinetics (PK) of tapentadol in pediatric patients from birth to <18 years old who experience acute pain, requiring treatment with an opioid analgesic.

Patients and methods

Data from four clinical trials and 148 pediatric patients who received a single dose of tapentadol oral or intravenous solution were included. Population PK analysis was performed to determine the contribution of size-related (bodyweight) and function-related (maturation) factors to the changes in oral bioavailability (F), volume of distribution (V), and clearance (CL) with age. Simulations were carried out to compare pediatric exposures to reference adult values.

Results

A one-compartment model with allometric scaling on dispos

SUBMITTER: Khalil F 

PROVIDER: S-EPMC7700087 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature