Domperidone Dosing for a 2-Year-Old Child Weighing 10.4 kg
Critical Safety Warning
Domperidone is not approved by the FDA for use in the United States and should not be prescribed for this child. The medication has significant cardiac safety concerns and lacks regulatory approval for pediatric use in many jurisdictions. 1
Why Domperidone Should Not Be Used
Regulatory Status: Domperidone is currently restricted to relief of nausea and vomiting in children older than 12 years for short periods only, making use in a 2-year-old completely off-label and outside authorized indications. 1
Cardiac Risk: The medication has been associated with QT prolongation and serious cardiac arrhythmias, particularly concerning in young children. 1
Limited Pediatric Evidence: While historical studies from the 1980s-1990s used domperidone in children, contemporary guidelines have significantly restricted its use due to safety concerns that emerged over time. 2, 3
Historical Dosing Information (For Reference Only)
If this question pertains to a jurisdiction where domperidone remains available for pediatric use under specific circumstances:
Weight-based dosing: Historical literature suggests 0.2-0.3 mg/kg per dose, given 3-4 times daily, though this is not currently recommended practice. 2, 3
Calculated dose for 10.4 kg: This would theoretically be 2.1-3.1 mg per dose (3-4 times daily), but this should not be prescribed given current safety restrictions. 2
Recommended Alternatives
For nausea/vomiting in a 2-year-old:
Ondansetron: For children ≥6 months, dose at 0.15 mg/kg/dose (maximum 16 mg), which would be approximately 1.6 mg for this 10.4 kg child. 4
Supportive care: Oral rehydration, dietary modifications, and treatment of underlying cause remain first-line for most pediatric gastrointestinal symptoms. 3
Clinical Context
The evidence shows domperidone had minimal efficacy even in historical trials—a 4-week double-blind study in children with gastroesophageal reflux showed it only reduced postprandial reflux episodes without symptomatic improvement or significant objective benefits. 3 Combined with current safety restrictions, there is no justification for its use in this age group. 1