Domperidone Pediatric Dosing
The recommended pediatric dose of domperidone is 0.3 mg/kg given three times daily before meals, with a maximum daily dose not exceeding 30 mg and treatment duration limited to less than 7 days due to cardiac safety concerns.
Standard Dosing Regimen
- Oral dosing: 0.3 mg/kg administered three times daily (t.d.s.) before meals 1
- Alternative dosing: 0.5 mg/kg has been studied, though lower doses appear equally effective 2
- Optimal antiemetic dose: 0.7 mg/kg per dose for chemotherapy-induced nausea and vomiting 3
Critical Safety Considerations and Dosing Limits
Maximum daily dose should not exceed 30 mg in pediatric patients 4. This represents a significant safety threshold that emerged from post-marketing surveillance data.
- Duration of therapy: Limit continuous use to 7 days or less 4
- Treatment patterns shifted significantly after 2014 safety warnings, with prescriptions exceeding 7 days decreasing substantially 4
- The Korean Ministry of Food and Drug Safety issued warnings regarding adverse cardiac effects in children, leading to a 30% reduction in prescription probability 4
Age-Specific Guidance
- Studied population: Primarily infants and children aged 1-6 years 1, 2
- Current authorization: Restricted to children older than 12 years for short-term relief of nausea and vomiting 5
- Use in younger children represents off-label prescribing, though this has been common practice in pediatric gastroenterology 5
Clinical Context and Efficacy
Domperidone demonstrated superior efficacy compared to metoclopramide and placebo for chronic vomiting and regurgitation in pediatric patients 1. However, its use should be carefully weighed against alternatives:
- Comparative effectiveness: Domperidone showed significantly better symptom control than both metoclopramide and placebo in double-blind trials 1
- Current evidence limitations: Controversial data exist regarding efficacy for GI motility disorders in children, with little robust evidence supporting its use 5
- Safer alternatives: Ondansetron has stronger evidence for acute gastroenteritis-related vomiting 2
Important Prescribing Caveats
- Drug interactions: Avoid co-prescribing medications that interact with domperidone, as this practice decreased significantly after safety warnings 4
- Cardiac monitoring: Consider baseline ECG in patients with risk factors for QT prolongation, though specific guidelines are not well-established in pediatrics 4
- Off-label awareness: Most pediatric use for GERD, dyspepsia, and gastroparesis lacks authorization and robust efficacy data 5