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

Abstract

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.

Ondansetron Pharmacokinetics in Pregnant Women and Neonates: Towards a New Treatment for Neonatal Abstinence Syndrome

“…Our findings are consistent with the pharmacokinetic properties of ondansetron that were measured in other nonpregnant adult populations. Our finding that ondansetron kinetics follow a biexponential disposition, and the measured clearance parameters ( Table ), are in good agreement with previously reported results . Because 95% of ondansetron's clearance is mediated by hepatic oxidation, the dose‐dependent clearance is probably due to saturation of hepatic metabolic enzymes, as previously reported .…”

“…Because an external ondansetron dose was not administered to neonates, it was not possible to uniquely identify clearance or volume of distribution. However, the assumption of equal distribution volumes in neonates and 1–48‐month‐old infants is valid, since the birthweight of our neonates is in range of the weights studied by Mondick et al …”

“…Absorption parameters were set to values equal to that in adults, as explained in the previous paragraph. The volume of distribution for the external administration in neonates was set to 3.5 L/kg (steady‐state distribution volume in 1–48‐month‐old infants).…”

“…For this goal to be achieved, ondansetron pharmacokinetics and transplacental transmission in mothers undergoing elective cesarean section and their neonates need to be characterized. Ondansetron pharmacokinetics have been previously characterized in healthy volunteers, the elderly, and pediatric patients older than 6 months . However, its pharmacokinetics have not been evaluated in pregnant women or newborns (0–28 days old), nor has its transplacental passage been characterized.…”

Fatal Cardiac Arrest in 2 Children

“…[22][23][24][25][26][27][28][29] Other studies reported efficacy of the drug in pediatric surgical or oncology patients. [30][31][32][33][34][35][36][37][38][39] One of those studies reported mild, asymptomatic QT prolongations that remained within normal limits. 31 A literature search was performed for reports of ventricular arrhythmias, fatalities, or any type of toxicity thought to be related to ondansetron in pediatric patients.…”