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 recommended dose for pediatric patients is not explicitly stated, but the trials suggest that 4 mg three times a day for patients younger than 12 years and 8 mg three times daily for patients 12 to 18 years may be effective in preventing emesis.
- Key points:
- Age: 4 to 18 years
- Dose: 4 mg three times a day (younger than 12 years), 8 mg three times daily (12 to 18 years)
- Response rate: 58% complete response (no emetic episodes) on Day 1 1
From the Research
Zofran (ondansetron) can be used in children to treat nausea and vomiting, with dosing based on the child's weight, and the most recent evidence suggests a single dose of 0.1 mg/kg is effective in stopping vomiting in children with acute gastroenteritis 2. For children 4-11 years old, the typical dose is 4 mg every 8 hours as needed, while children 6 months to 4 years weighing less than 15 kg usually receive 2 mg every 8 hours. The medication comes in various forms including oral tablets, orally disintegrating tablets (ODT), and liquid formulation, making it easier to administer to children. Some key points to consider when using Zofran in children include:
- The ODT form dissolves on the tongue without water, which is particularly helpful for children experiencing nausea.
- Zofran works by blocking serotonin receptors in the brain and gut that trigger nausea and vomiting.
- Side effects are generally mild but may include headache, constipation, or dizziness.
- Parents should consult a healthcare provider before giving Zofran to children, especially those under 6 months of age, as safety and efficacy haven't been well established in very young infants.
- A single dose of ondansetron has been shown to be effective in reducing vomiting in children with acute gastroenteritis, with a lower risk of oral rehydration therapy failure, intravenous hydration needs, and hospitalization rates 3.
- The use of ondansetron in children undergoing chemotherapy has also been studied, with single daily dosing and divided dosing strategies showing similar effectiveness in preventing chemotherapy-induced nausea and vomiting 4.