What is the pediatric dose of Ondansetron (Zofran)?

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From the Guidelines

The pediatric dose of Zofran is 0.1-0.15 mg/kg, with a maximum dose depending on the administration route and age of the child. When determining the pediatric dose of Zofran, it's essential to consider the child's weight, age, and administration route. However, the provided evidence does not directly address the pediatric dose of Zofran, as it discusses the dosage of an unspecified medication for non-tuberculous mycobacterial pulmonary disease (NTM-PD) in adults and children, with a dosage of 7.5–10 mg/kg once a day (oral) for children 1. Given the lack of direct evidence for Zofran, we must rely on general medical knowledge to guide dosing decisions. Key considerations include:

  • Weight-based dosing, especially in younger children
  • Monitoring for side effects such as headache, dizziness, or constipation
  • Caution in patients with cardiac conditions or electrolyte abnormalities
  • Effectiveness for chemotherapy-induced, radiation-induced, and post-operative nausea and vomiting in children. In clinical practice, the dose of Zofran for children is typically calculated based on weight, with 0.1-0.15 mg/kg being a standard calculation, and the route of administration (oral or IV) also plays a crucial role in determining the dose.

From the FDA Drug Label

In these trials, 58% of the 170 evaluable patients had a complete response (no emetic episodes) on Day 1 In 2 trials the response rates to ondansetron tablets 4 mg three times a day in patients younger than 12 years was similar to ondansetron tablets 8 mg three times daily in patients 12 to 18 years. The pediatric dose of Zofran (ondansetron) is 0.04 to 0.87 mg per kg (total dose of 2.16 mg to 12 mg) for the initial dose, followed by 4 to 24 mg daily for 3 days, with a dose of 4 mg three times a day for patients younger than 12 years and 8 mg three times daily for patients 12 to 18 years 2.

From the Research

Pediatric Dose of Zofran

The pediatric dose of Zofran (ondansetron) can be determined based on the following studies:

  • A study published in the Journal of Clinical Anesthesia in 1997 3 found that ondansetron is an effective medication for the treatment and prevention of postoperative nausea and vomiting in pediatric patients. The study compared the efficacy of different doses of ondansetron (0.05 mg/kg, 0.1 mg/kg, and 0.15 mg/kg) in pediatric patients undergoing tonsillectomy and adenoidectomy or strabismus surgery. The results showed that all doses of ondansetron were significantly more effective than placebo in reducing the incidence of emesis.
  • Key findings from the study include:
    • Ondansetron 0.05 mg/kg was as effective as 0.1 mg/kg and 0.15 mg/kg in reducing the incidence of emesis.
    • The addition of oral metoclopramide 0.15 mg/kg had no effect on the incidence of emesis in the ondansetron or placebo study groups.
  • Other studies, such as the one published in Seminars in Oncology in 1992 4, have also evaluated the safety and efficacy of ondansetron in pediatric patients, but do not provide specific dosing information for pediatric patients.

Dosage Information

Based on the available evidence, the recommended pediatric dose of Zofran (ondansetron) is:

  • 0.05 mg/kg to 0.15 mg/kg, with 0.05 mg/kg being as effective as higher doses 3 Note that the dosage may vary depending on the specific clinical context and the patient's individual needs.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Ondansetron dose response curve in high-risk pediatric patients.

Journal of clinical anesthesia, 1997

Research

Clinical safety of ondansetron.

Seminars in oncology, 1992

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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