Effects of Sorbitol on the Pharmacokinetics of Lamivudine Solution and the FDA's Decision to Increase the Dose of Lamivudine Solution for Pediatric Patients

Clin Pharmacol Ther. 2018 Nov;104(5):785-787. doi: 10.1002/cpt.1147. Epub 2018 Aug 6.

Abstract

The article by Adkison et al. described sorbitol effects on lamivudine exposures. The results indicate a plausible mechanism for lower lamivudine exposures in pediatric patients receiving the solution formulation with concomitant medications containing sorbitol. In this commentary, we discuss lower lamivudine exposures in pediatric patients receiving the solution formulation, the impact of sorbitol on lamivudine exposures, and the US Food and Drug Administration's (FDA's) decision to increase the dose of the lamivudine solution for all pediatric patients.

MeSH terms

  • Administration, Oral
  • Age Factors
  • Anti-HIV Agents / administration & dosage*
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / pharmacokinetics*
  • Biological Availability
  • Child
  • Child, Preschool
  • Drug Dosage Calculations
  • Humans
  • Lamivudine / administration & dosage*
  • Lamivudine / adverse effects
  • Lamivudine / pharmacokinetics*
  • Pharmaceutical Solutions
  • Risk Assessment
  • Sorbitol / administration & dosage*
  • Sorbitol / adverse effects
  • Sweetening Agents / administration & dosage*
  • Sweetening Agents / adverse effects
  • United States
  • United States Food and Drug Administration

Substances

  • Anti-HIV Agents
  • Pharmaceutical Solutions
  • Sweetening Agents
  • Lamivudine
  • Sorbitol