Population pharmacokinetics of intravenous ondansetron in oncology and surgical patients aged 1-48 months

Eur J Clin Pharmacol. 2010 Jan;66(1):77-86. doi: 10.1007/s00228-009-0730-8. Epub 2009 Oct 2.


Purpose: Until recently, ondansetron was approved for the prevention of nausea and vomiting only in patients older than 2 years. However, as the use of ondansetron in patients younger than 2 years had been documented, characterization of ondansetron pharmacokinetics in this younger pediatric age group was warranted.

Methods: The pharmacokinetics of intravenously administered ondansetron were evaluated in oncology and surgical patients aged 1-48 months. Pooled data from 124 patients, including 745 pharmacokinetic samples, were analyzed using nonlinear mixed-effects modeling.

Results: Ondansetron pharmacokinetics were described by a two-compartment model. Body-size effects on ondansetron disposition were accounted for via standard allometric relationships, normalized to 10.4 kg. A maturation process with a half-life of approximately 4 months was incorporated to describe a decrease in clearance (CL) in infants. Clearance [95% confidence interval (CI)] for a typical patient was 1.53 (1.34-1.78) L/h/kg(0.75) with an interindividual variability of 56.8%. Ondansetron CL was reduced by 31%, 53%, and 76% for the typical 6-month-, 3-month-, and 1-month-old patient, respectively. Simulations showed that an ondansetron dose of 0.1 mg/kg in children younger than 6 months produced exposure similar to a 0.15-mg/kg dose in older children.

Conclusions: The population pharmacokinetic analysis of ondansetron allows for characterization of individual patients based on body weight and age. It is recommended that patients younger than 4 months receiving ondansetron be closely monitored.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anesthesia, General / adverse effects*
  • Antiemetics / administration & dosage
  • Antiemetics / pharmacokinetics*
  • Antiemetics / therapeutic use
  • Antineoplastic Agents / adverse effects*
  • Child, Preschool
  • Computer Simulation
  • Female
  • Humans
  • Infant
  • Injections, Intravenous
  • Male
  • Metabolic Clearance Rate
  • Nausea / chemically induced*
  • Nausea / prevention & control
  • Ondansetron / administration & dosage
  • Ondansetron / pharmacokinetics*
  • Ondansetron / therapeutic use
  • Serotonin Antagonists / administration & dosage
  • Serotonin Antagonists / pharmacokinetics*
  • Serotonin Antagonists / therapeutic use


  • Antiemetics
  • Antineoplastic Agents
  • Serotonin Antagonists
  • Ondansetron