What is the recommended dose of ondansetron (Zofran) per kilogram for neonates?

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Ondansetron (Zofran) Dosing in Neonates

The recommended dose of ondansetron (Zofran) for neonates is 0.04 mg/kg intravenously or 0.07 mg/kg orally. 1

Dosing Considerations for Neonates

Ondansetron dosing in neonates requires special consideration due to their unique pharmacokinetics and potential for adverse effects:

  • IV administration: 0.04 mg/kg per dose 1
  • Oral administration: 0.07 mg/kg per dose 1
  • Pharmacokinetics: Neonates have a longer elimination half-life compared to adults or older children 1

Clinical Context and Administration Guidelines

When administering ondansetron to neonates, consider the following:

  • Ondansetron is not routinely recommended as part of initial resuscitative efforts in the delivery room for newborns with respiratory depression 2
  • For neonates with food protein-induced enterocolitis syndrome (FPIES), ondansetron is generally not recommended for those under 6 months of age 2
  • For neonates ≥6 months with FPIES:
    • Mild symptoms: Consider ondansetron 0.15 mg/kg/dose IM (maximum 16 mg/dose)
    • Moderate-severe symptoms: Administer ondansetron 0.15 mg/kg/dose IV or IM (maximum 16 mg/dose) 2

Safety Considerations

Ondansetron should be used with caution in neonates due to potential risks:

  • Overdose can cause serious adverse effects including obtundation, seizures, hepatotoxicity, QTc prolongation, and serotonin syndrome 3
  • Administer IV doses slowly to minimize the risk of hypotension
  • Monitor for:
    • Cardiovascular effects (QT prolongation)
    • Neurological effects (seizures, altered mental status)
    • Hepatic function

Alternative Antiemetics for Neonates

When considering antiemetic therapy in neonates, alternative options may include:

  • For specific conditions like hypercyanotic spells in tetralogy of Fallot, morphine is considered the first-line treatment (IV: 0.1 mg/kg) 2
  • Diphenhydramine may be used in infants at 1-2 mg/kg per dose (maximum 50 mg) 4, but is not first-line for nausea and vomiting

Monitoring

When administering ondansetron to neonates:

  • Monitor vital signs, particularly heart rate and blood pressure
  • Observe for neurological symptoms (lethargy, seizures)
  • Consider ECG monitoring for QT prolongation with repeated dosing
  • Monitor for adequate hydration status

Ondansetron has been shown to be effective in preventing chemotherapy-induced nausea and vomiting in children 5, but specific neonatal data is limited, requiring careful consideration of risks and benefits in this vulnerable population.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Obtundation and seizure following ondansetron overdose in an infant.

Clinical toxicology (Philadelphia, Pa.), 2008

Guideline

Antihistamine Therapy in Children

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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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