From the Guidelines
Ondansetron should not be used as a first-line treatment for nausea and vomiting in an 8-month-old male, as the current evidence recommends its use in children over 4 years of age. According to the 2017 Infectious Diseases Society of America clinical practice guidelines for the diagnosis and management of infectious diarrhea 1, antinausea and antiemetic medications like ondansetron may be given to facilitate tolerance of oral rehydration in children >4 years of age and in adolescents with acute gastroenteritis associated with vomiting.
However, in the context of managing acute FPIES, ondansetron may be considered as an adjunctive management of emesis, although the evidence strength is IV and the evidence grade is D 1. It is essential to note that ondansetron is a serotonin 5-HT3 receptor antagonist used to treat nausea and vomiting, and special caution might be warranted in children with heart disease because of the potential to prolong the QT interval.
When considering the use of ondansetron in an 8-month-old male, it is crucial to weigh the potential benefits against the risks, particularly in children with heart conditions or electrolyte abnormalities. The recommended dose for infants is not well-established, but a dose of 0.1-0.15 mg/kg every 8 hours as needed may be considered, with close monitoring for side effects. The oral dissolving tablet (ODT) formulation is often preferred for infants, with the 4 mg tablet divided into appropriate portions.
Key considerations for the use of ondansetron in infants include:
- Close monitoring for side effects, including diarrhea, headache, or rarely, abnormal heart rhythms
- Caution in children with heart conditions or electrolyte abnormalities
- Consultation with a pediatrician before administering any medication to an infant
- Individual factors may affect dosing recommendations, and the evidence for ondansetron use in infants is limited.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Ondansetron Use in 8-Month-Old Male
- The use of ondansetron in infants, including an 8-month-old male, has been studied in various contexts, including its efficacy as an antiemetic and its safety profile 2, 3.
- In the context of chemotherapy and radiotherapy, ondansetron has been shown to be effective in preventing nausea and vomiting in children, including infants 2, 4.
- A study on the use of ondansetron in children with acute gastroenteritis found that oral ondansetron was effective in managing vomiting, with a dose of 0.15 mg/kg being used 3.
- Another study on ondansetron dosing in pediatric gastroenteritis found that within the dose range of 0.13-0.26 mg/kg, higher doses of ondansetron were not superior to lower doses, nor were they associated with increased side effects 5.
- However, a case report of an infant who ingested a large quantity of ondansetron highlighted the potential for severe toxicity, including obtundation, seizures, and hepatotoxicity, in the setting of an overdose 6.
Safety and Efficacy
- Ondansetron is generally well-tolerated in children, with rare reports of adverse events 2, 3.
- The most frequently reported adverse events in children receiving ondansetron include mild to moderate headache, constipation, and diarrhea 2.
- In comparison to other antiemetics, ondansetron has been shown to have a more favorable tolerability profile 2, 4.
Dosage and Administration
- The dosage of ondansetron used in children varies depending on the context, with doses ranging from 0.075 to 0.15 mg/kg being used in various studies 2, 3, 5.
- Oral ondansetron has been shown to be effective in managing vomiting in children with acute gastroenteritis, with a dose of 0.15 mg/kg being used 3.