What is the youngest age for administration of Zofran (ondansetron)?

Youngest Age for Zofran (Ondansetron) Administration

Ondansetron can be safely administered to children as young as 1 month of age for prevention of postoperative nausea and vomiting, and to children 6 months of age and older for prevention of chemotherapy-induced nausea and vomiting. 1

FDA-Approved Indications by Age

• For prevention of chemotherapy-induced nausea and vomiting:

  • Approved for children 6 months of age and older at a dosage of 0.15 mg/kg per dose for 3 doses (maximum 16 mg per dose) 1
  • First dose should be administered 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours after the first dose 1

• For prevention of postoperative nausea and vomiting:

  • Approved for children 1 month of age and older 1
  • Limited information is available for surgical patients younger than 1 month 1

Special Considerations for Young Infants

• The clearance of ondansetron in pediatric patients aged 1-4 months is slower than in older children 1
• Half-life is approximately 2.5 times longer in infants 1-4 months compared to children 4-24 months 1
• Close monitoring is recommended for patients younger than 4 months receiving ondansetron 1

Dosing Recommendations

• For children receiving chemotherapy:

  • 0.15 mg/kg per dose for 3 doses (maximum 16 mg per dose) 1, 2
  • Administered intravenously over 15 minutes 1

• For postoperative nausea and vomiting:

  • Intravenous doses of 0.1-0.15 mg/kg have been shown to be effective and safe 2
  • Oral doses of 0.1 mg/kg have demonstrated efficacy in preventing postoperative emesis 2

Safety Profile in Young Children

• Ondansetron is generally well tolerated in children 2
• Most common adverse events in children receiving chemotherapy are mild to moderate headache, constipation, and diarrhea 2
• In post-surgical settings, common adverse events include wound problems, anxiety, headache, drowsiness, and pyrexia 2
• Adverse events rarely necessitate treatment withdrawal in pediatric patients 2

Efficacy in Pediatric Populations

• Ondansetron has demonstrated good efficacy in preventing acute nausea and vomiting in children receiving moderately or highly emetogenic chemotherapy 2
• In surgical settings, ondansetron shows superior prophylactic antiemetic efficacy compared to placebo, droperidol, and metoclopramide 2
• Efficacy can be enhanced when combined with dexamethasone in chemotherapy settings 2, 3

Clinical Pearls

• For gastroenteritis in children, doses between 0.13-0.26 mg/kg have shown similar efficacy with no dose-dependent increase in side effects 4
• Ondansetron does not accumulate with repeated oral administration 5
• The elimination half-life averages approximately 3.8 hours in adults but is slightly shorter in children 5, 6
• No dosage adjustment is needed for patients with renal impairment 1