Domperidone Dosing in Pediatric Patients
The recommended pediatric dosage of domperidone is 0.2-0.3 mg/kg three times daily (before meals), with a maximum daily dose not exceeding 30 mg/day and treatment duration limited to less than 7 days due to cardiac safety concerns. 1, 2
Standard Dosing Regimens
Age-Based Recommendations
- Infants: 0.2 mg/kg three times daily (before meals) 1
- Children 1 month to 12.7 years: 2 mg/kg/day divided into four doses daily 1
- Alternative dosing: 0.3 mg/kg three times daily has been used effectively in clinical trials 3
Maximum Dose Limitations
- Daily maximum: Do not exceed 30 mg/day total dose 2
- Duration: Limit continuous use to less than 7 days 2
- These restrictions were implemented following 2014 safety warnings regarding cardiac adverse effects in children 2
Clinical Context and Safety Considerations
Regulatory Status and Off-Label Use
- Domperidone is currently authorized only for nausea and vomiting in children older than 12 years for short-term use 4
- Pediatric gastroenterologists commonly prescribe it off-label for gastroesophageal reflux disease, dyspepsia, and gastroparesis 4
- Critical caveat: After the 2014 safety warning, prescribing patterns appropriately shifted toward lower doses, shorter durations, and fewer drug interactions 2
Evidence Quality
- The highest quality pediatric dosing evidence comes from a 2006 uncontrolled study showing 64.5% improvement in infants at 0.2 mg/kg three times daily and 100% improvement in older children at 2 mg/kg/day divided four times daily 1
- A 1979 double-blind trial demonstrated that 0.3 mg/kg three times daily was significantly more effective than both metoclopramide and placebo for chronic vomiting and regurgitation 3
- Important limitation: No recent high-quality controlled trials exist to support domperidone efficacy in pediatric patients 1
Administration Guidelines
- Timing: Administer before meals (three times daily dosing) 3
- Formulation: Available as 1% drops for easier administration in infants and young children 3
- Intravenous use: If given IV (primarily in oncology settings), use 0.7 mg/kg per dose with adequate dilution to prevent injection site pain 5
Drug Interactions and Contraindications
- Following the 2014 safety warning, co-prescription of medications that interact with domperidone significantly decreased 2
- Avoid concurrent use with drugs that prolong QT interval or inhibit CYP3A4 metabolism 2
- Monitor for cardiac arrhythmias, particularly in patients with underlying cardiac conditions 2