What is the recommended dose of ondansetron (Zofran) for a 12 kg infant?

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Ondansetron Dosing for a 12 kg Infant

For a 12 kg infant, administer ondansetron 0.15 mg/kg per dose, which equals 1.8 mg (can be rounded to 2 mg for practical administration), with a maximum single dose of 16 mg. 1

Route-Specific Dosing

Intravenous (IV) Administration

  • Dose: 0.15 mg/kg/dose (1.8 mg for a 12 kg infant) 2, 1
  • Maximum single dose: 16 mg 2, 1
  • This is the preferred route for severe symptoms requiring immediate intervention 2

Intramuscular (IM) Administration

  • Dose: 0.15 mg/kg/dose (1.8 mg for a 12 kg infant) 2, 1
  • Maximum single dose: 16 mg 2, 1
  • Use when IV access is difficult or delayed 2

Oral Administration

  • Dose: 0.1 mg/kg for oral disintegrating formulation 3
  • For a 12 kg infant, this equals 1.2 mg
  • Oral route is appropriate for mild-to-moderate symptoms in outpatient settings 4

Age Restrictions and Safety

Ondansetron should only be used in infants ≥6 months of age. 2, 1 This is a critical safety threshold established by the American Academy of Allergy, Asthma, and Immunology. 2

Important Safety Considerations

  • Special caution is warranted in children with heart disease due to potential QT interval prolongation 1
  • Monitor for cardiac effects, particularly if the infant has underlying cardiac conditions 1
  • The dose range of 0.13-0.26 mg/kg has been shown to be safe without increased side effects at higher doses within this range 5

Clinical Context-Specific Dosing

For Acute Gastroenteritis

  • Mild symptoms (1-2 episodes of vomiting, no lethargy): Consider ondansetron 0.15 mg/kg IM if age ≥6 months 2
  • Moderate symptoms (>3 episodes of vomiting with mild lethargy): Administer ondansetron 0.15 mg/kg IM 2
  • Severe symptoms (>3 episodes with severe lethargy, hypotonia, or cyanosis): Administer ondansetron 0.15 mg/kg IV; if IV access is difficult, use IM route 2

For Chemotherapy-Induced Nausea/Vomiting

  • Standard dosing: 0.15 mg/kg IV for three doses (30 minutes before chemotherapy, then 4 and 8 hours afterward) 6
  • Loading doses of 16 mg/m² (maximum 24 mg) have been shown to be safe in pediatric oncology patients 7

For Postoperative Nausea/Vomiting

  • Dose: 0.075-0.15 mg/kg IV administered before or during surgery 3
  • Single dose is typically sufficient for prophylaxis 3

Practical Administration Tips

  • Rounding for ease of administration: The dose can be rounded by up to 15% for practical home administration 8
  • For a 12 kg infant receiving 1.8 mg, rounding to 2 mg is acceptable and practical 8
  • Oral disintegrating tablets dissolve rapidly and do not require water, making administration easier in vomiting children 4

Common Pitfalls to Avoid

  • Do not use in infants <6 months old – this is outside the approved age range and safety data are insufficient 2, 1
  • Do not exceed 16 mg as a single dose regardless of weight-based calculation 2, 1
  • Avoid in children with known cardiac conduction abnormalities without cardiology consultation 1
  • Do not assume higher doses are more effective – research shows no additional benefit beyond 0.15 mg/kg within the therapeutic range 5

Efficacy Data

  • A single oral dose of ondansetron decreased continued vomiting within the first 4 hours from 42.9% to 19.5% (54.5% reduction) in children with acute gastroenteritis 4
  • Number needed to treat: 4 children to prevent one case of continued vomiting 4
  • The medication is cost-effective, reducing total mean costs by 31.2% compared to care without ondansetron 4

References

Guideline

Ondansetron Dosing Guidelines for Children

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Cost-effectiveness of oral ondansetron for children with acute gastroenteritis in primary care: a randomised controlled trial.

The British journal of general practice : the journal of the Royal College of General Practitioners, 2021

Research

Ondansetron: a novel antiemetic agent.

Southern medical journal, 1993

Research

Safety of ondansetron loading doses in children with cancer.

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2008

Guideline

Guaifenesin Dosing Guidelines for Pediatric Patients

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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