Domperidone Dosing for Infants (1-12 Months)
The recommended dose of domperidone for infants aged 1 month to 12 months is 0.2-0.3 mg/kg per dose given three times daily, NOT 2 mg/kg. The 2 mg/kg figure represents a total daily dose divided into multiple administrations for older children, not a per-dose amount for infants.
Correct Dosing by Age
Infants (1-12 months)
- 0.2-0.3 mg/kg per dose, administered three times daily before meals 1, 2
- This translates to approximately 0.6-0.9 mg/kg/day total daily dose 2
- A 1979 double-blind trial demonstrated that 0.3 mg/kg three times daily was significantly more effective than placebo and metoclopramide for chronic vomiting in infants 2
Older Children (>1 year to 12.7 years)
- 2 mg/kg/day divided into four times daily (0.5 mg/kg per dose) 1
- This higher total daily dose applies only to children beyond infancy
Evidence Quality and Efficacy
The evidence supporting domperidone use in infants is limited and dated:
- A 2006 uncontrolled study showed 64.5% improvement in cough symptoms at 0.2 mg/kg three times daily in infants 1
- A 1985 study of 15 infants (mean age 7.9 months) demonstrated significant improvement in GER symptoms and motility parameters over 6 weeks of treatment 3
- No recent high-quality randomized controlled trials exist to support domperidone efficacy in pediatric patients 1, 4
Critical Safety Concerns
Cardiac Risks
- Domperidone has been repeatedly shown to cause sudden cardiac death at doses ≥30 mg/day in adults 5
- QTc interval prolongation has been documented in infants receiving domperidone 6:
Recommended Monitoring
- Obtain baseline and follow-up ECGs in all infants treated with domperidone 6
- Report any adverse cardiac events to pharmacovigilance systems 6
Common Pitfalls to Avoid
- Do not confuse per-dose and total daily dosing: The 2 mg/kg figure is a total daily dose for older children divided into 4 doses, not a single dose for infants
- Do not exceed recommended infant dosing: Doses above 0.3 mg/kg per dose (0.9 mg/kg/day total) increase cardiac risk without established additional benefit 2, 6
- Do not use without cardiac monitoring: Given documented proarrhythmic effects, ECG surveillance is essential 6
- Consider alternative therapies first: Given weak evidence and cardiac risks, PPIs or H₂ antagonists may be safer first-line options for confirmed GERD 4
Clinical Context
The 2014 Cochrane review concluded that RCT evidence is insufficient to assess domperidone efficacy, and methodological differences precluded meta-analysis 4. The review found that in younger children, the largest RCT (80 children aged 1-18 months) showed no evidence of symptom improvement with domperidone alone 4.