What is the recommended dose of domperidone (antiemetic and prokinetic agent) for infants and children?

Domperidone Dosing for Infants and Children

The recommended dose of domperidone for infants is 0.2 mg/kg three times daily, and for children aged 1 month to 12.7 years is 2 mg/kg/day divided into four times daily (0.5 mg/kg per dose). 1

Standard Dosing Regimens

Infants

• 0.2 mg/kg administered three times daily (before meals) 1
• This regimen showed 64.5% improvement in cough symptoms in uncontrolled studies, though evidence quality is limited 1

Children (1 month to 12.7 years)

• 2 mg/kg/day divided into four doses (0.5 mg/kg per dose) 1
• This regimen demonstrated 100% improvement in symptoms in older uncontrolled studies 1

Alternative Historical Dosing

• An older 1979 study used 0.3 mg/kg three times daily in infants and children with chronic vomiting, which showed superiority over metoclopramide and placebo 2

Critical Safety Considerations

Cardiac Risk Profile

• Domperidone carries significant cardiac risk, including QTc prolongation and sudden cardiac death, particularly at doses ≥30 mg/day in adults 3
• In pediatric studies, QTc prolongation has been documented even at therapeutic doses:
  • One case report showed QTc = 463 ms in a 3-month-old receiving 1.8 mg/kg/day 4
  • In 31 neonates receiving 1.3 mg/kg/day, nine developed QTc prolongation >30 ms 4
  • Two of 40 premature infants on 1 mg/kg/day developed QTc >450 ms 4, 5

Monitoring Requirements

• Obtain baseline ECG before initiating domperidone 4
• Monitor ECG at regular intervals during treatment (suggested at 3,7, and 14 days based on available studies) 5
• Report any adverse cardiac events to pharmacovigilance systems 4

Current Authorization Status

• Domperidone is currently restricted to children older than 12 years for short-term relief of nausea and vomiting only 6
• Use in infants and younger children is off-label 6
• Pediatric gastroenterologists commonly use it off-label for gastroesophageal reflux disease, dyspepsia, and gastroparesis, but solid evidence from adequately sized randomized trials is missing 6, 3

Evidence Quality Limitations

• No recent high-quality evidence supports domperidone efficacy in pediatric patients 1
• Available data comes primarily from older, uncontrolled studies with small sample sizes 1
• The risk-benefit ratio remains uncertain, particularly given documented cardiac risks 3, 4

Clinical Pitfalls to Avoid

• Do not use domperidone without baseline and follow-up ECG monitoring 4
• Avoid doses exceeding the recommended weight-based calculations 4
• Do not prescribe for prolonged periods without reassessing necessity 6
• Consider alternative therapies first, given the off-label status and cardiac safety concerns 6, 3