From the Guidelines
The recommended dose of ondansetron (Zofran) for infants to prevent nausea and vomiting is 2 mg/kg for infants less than 6 months of age, administered intravenously. This dose is based on the most recent and highest quality study available, which provides specific dosage guidelines for infants 1.
Key Considerations
- For infants, the intravenous route is often preferred due to its reliability and rapid onset of action.
- The dose of 2 mg/kg is specifically recommended for infants under 6 months, highlighting the need for careful consideration of age when determining the appropriate dose.
- Weight-based dosing is crucial in infants to ensure accuracy and safety, given the significant variability in size and development at this age.
- It is essential for parents or caregivers to consult with a pediatrician or healthcare provider before administering ondansetron to an infant, especially since the medication's use in children under 4 years old is not FDA-approved for most indications.
- Ondansetron's mechanism of action involves blocking serotonin receptors in the brain, which are responsible for triggering nausea and vomiting.
- Potential side effects include mild headache, constipation, or drowsiness, and any signs of allergic reaction or irregular heartbeat should prompt immediate medical attention.
Administration and Monitoring
- The oral dissolving tablet or liquid formulation may be considered for infants when the intravenous route is not feasible, but this should be decided under medical guidance.
- Monitoring for side effects and efficacy is crucial, especially in infants, due to their sensitive physiology and the potential for rapid changes in their condition.
- The use of ondansetron in infants should always be approached with caution, particularly in those under 6 months of age, due to the limited data on its safety and efficacy in this age group 1.
From the FDA Drug Label
- 1 Dosage The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively.
Table 2: Pediatric Recommended Dosage Regimen for Prevention of Nausea and Vomiting Indication Dosage Regimen Moderately Emetogenic Cancer Chemotherapy 12 to 17 years of age: 8 mg administered 30 minutes before the start of chemotherapy, with a subsequent 8-mg dose 4 and 8 hours after the first dose. 4 to 11 years of age: 4 mg administered 30 minutes before the start of chemotherapy, with a subsequent 4-mg dose 4 and 8 hours after the first dose.
The FDA drug label does not provide a recommended dose of ondansetron for infants to prevent nausea and vomiting. The label only provides dosage recommendations for adults and pediatric patients aged 4 to 17 years. 2
From the Research
Recommended Dose of Ondansetron for Infants
The recommended dose of ondansetron for infants to prevent nausea and vomiting is not explicitly stated in the provided studies. However, some studies provide information on the dosage of ondansetron used in children.
- In the study 3, children aged 1 to 60 months received ondansetron suspension orally at a dose of 0.15 mg/kg body weight.
- In the study 4, oral ondansetron was administered to children, but the exact dosage is not specified.
- In the study 5, a single dose of intravenous ondansetron was administered to children, but the exact dosage is not specified.
Efficacy of Ondansetron in Preventing Vomiting
Ondansetron has been shown to be effective in preventing vomiting in children with acute gastroenteritis.
- In the study 6, ondansetron was superior to bromopride and metoclopramide in preventing vomiting in children.
- In the study 3, ondansetron was more efficacious than domperidone in cessation of vomiting associated with acute gastroenteritis in children.
- In the study 4, oral ondansetron ensured cessation of emesis for 67% of patients within the first 4 hours and 58% of patients in the first 24-hour period.
Safety of Ondansetron in Infants
The safety of ondansetron in infants is not explicitly stated in the provided studies. However, some studies provide information on the safety of ondansetron in children.