What is the pediatric dose of Ondansetron (Zofran)?

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Last updated: May 19, 2025View editorial policy

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From the Guidelines

The recommended pediatric dose of ondansetron is 5 mg/m2 or 0.15 mg/kg, as established in clinical practice. This dose is based on the guidelines for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting, as outlined in the study published in the Annals of Oncology 1. The study highlights the importance of using a 5-HT3 receptor antagonist, such as ondansetron, in combination with dexamethasone for antiemetic prophylaxis in pediatric patients receiving chemotherapy of high or moderate emetogenic potential.

Key Considerations

  • The optimal dose and scheduling of 5-HT3 receptor antagonists have been evaluated in several trials, but the studies are small and it is difficult to identify the optimal oral and intravenous doses in children 1.
  • Established doses for ondansetron in clinical practice are 5 mg/m2 or 0.15 mg/kg, and for granisetron 0.01 mg/kg or 10 lg/kg once a day 1.
  • Ondansetron has been shown to be superior to other antiemetic agents, such as chlorpromazine, dimenhydrate, and metoclopramide combined with dexamethasone, with fewer side effects 1.

Administration and Precautions

  • Ondansetron can be administered orally or intravenously, with the dose adjusted according to the child's weight and age.
  • It is essential to use ondansetron cautiously in children with cardiac conditions or electrolyte abnormalities due to potential QT interval prolongation.
  • The medication typically takes effect within 30 minutes and can last 4-8 hours, making it effective for both prevention and treatment of nausea and vomiting in pediatric patients.

From the FDA Drug Label

For pediatric patients 12 years of age and older, the dosage is the same as for adults For pediatric patients 4 through 11 years of age, the dosage is 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of Ondansetron Oral Solution, USP given 3 times a day.

The recommended pediatric dose of odansetron is:

  • For patients 12 years and older: same as the adult dose
  • For patients 4-11 years: 4 mg (5 mL) three times a day 2 In pediatric patients, the dosage is the same as for the general population for postoperative use, but there is no experience with the use of Ondansetron Oral Solution, USP in the prevention of radiation-induced nausea and vomiting in pediatric patients 2.

From the Research

Odansatron Pediatric Dose

  • The pediatric dose of odansatron is not strictly defined, but several studies provide guidance on its use in children 3, 4, 5, 6, 7.
  • In children receiving chemotherapy, odansatron doses of 0.15 mg/kg intravenous and/or oral doses were effective in reducing nausea and vomiting 3.
  • For children undergoing surgery, intravenous administration of odansatron 0.1 to 0.15 mg/kg was significantly superior to droperidol 0.02 to 0.075 mg/kg or metoclopramide 0.2 to 0.25 mg/kg in preventing emesis 3.
  • In the treatment of pediatric gastroenteritis, odansatron doses ranging from 0.13 to 0.26 mg/kg were not significantly different in terms of efficacy or side effects 4.
  • A study on the use of odansatron in the pediatric emergency room for diagnoses other than acute gastroenteritis found that the most common primary diagnoses for non-gastroenteritis discharged patients were fever, abdominal pain/tenderness, head injury/concussion, pharyngitis, viral infection, migraine variants, and otitis media 6.

Dosage Considerations

  • The dose of odansatron may vary depending on the specific condition being treated and the individual patient's response to the medication 3, 4, 5, 6, 7.
  • In general, odansatron is well tolerated in children, with mild to moderate headache, constipation, and diarrhea being the most frequently reported adverse events 3.
  • Higher doses of odansatron were not superior to lower doses in reducing emesis in children with acute gastroenteritis, and were not associated with increased side effects 4.

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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