Domperidone Pediatric Dosing
The recommended pediatric dose of domperidone is 0.3 mg/kg given three times daily before meals, though this medication carries significant cardiac safety concerns and is not FDA-approved in the United States.
Standard Dosing Regimen
- 0.3 mg/kg administered three times daily (t.d.s.) before meals is the established pediatric dose based on clinical trial data 1
- This dosing was demonstrated to be superior to both metoclopramide and placebo for chronic vomiting and regurgitation in infants and children 1
Critical Safety Considerations and Dose Limitations
Maximum Daily Dose Restrictions
- Total daily doses should not exceed 30 mg/day in pediatric patients due to cardiac safety concerns 2
- Doses above 30 mg/day are associated with increased risk of serious arrhythmias and sudden cardiac death, particularly in patients over 60 years (though pediatric-specific data is limited) 3
- Following safety warnings, prescribing patterns have appropriately shifted toward lower maximum daily dosages 2
Duration of Treatment
- Treatment duration should be limited to 7 days or less whenever possible 2
- After regulatory safety warnings, the number of prescriptions exceeding 7 days of continuous use significantly decreased, reflecting improved safety practices 2
Cardiac Monitoring Requirements
QTc Interval Prolongation Risk
- Baseline and follow-up ECGs are essential when prescribing domperidone to pediatric patients 4
- QTc prolongation >30 ms has been documented in approximately 29% of neonates receiving an average dose of 1.3 mg/kg/day 4
- At 1 mg/kg/day in premature infants, 5% developed QTc intervals exceeding 450 ms 4
- One case report documented QTc = 463 ms in a 3-month-old infant receiving 1.8 mg/kg/day for one month 4
Specific Monitoring Protocol
- Obtain baseline ECG before initiating therapy 4
- Monitor for QTc prolongation during treatment (>450 ms in males, >470 ms in females is considered meaningful) 5
- Report any adverse cardiac events to pharmacovigilance systems 4
Age-Specific Considerations
- Neonates and premature infants are at highest risk for QTc prolongation even at doses of 1-1.3 mg/kg/day 4
- Infants (mean age 5.6 months) receiving 0.8 mg/kg/day showed no QTc prolongation in one small study, but this does not eliminate risk 4
Drug Interactions
- Avoid co-prescribing medications that prolong QTc interval or interact with domperidone 2
- Following safety warnings, the prescription of interacting medications with domperidone significantly decreased, reflecting improved prescribing practices 2
Clinical Context and Alternatives
Regulatory Status
- Domperidone is not FDA-approved in the United States and is only available through investigational protocols with mandatory ECG monitoring 5
- Multiple international regulatory agencies have issued safety warnings regarding cardiac risks 2
Alternative Antiemetic Consideration
- Metoclopramide (0.1 mg/kg PO/IM/IV) is an alternative, though it carries a black box warning for tardive dyskinesia and should be limited to 5 days or less 6
- Metoclopramide has central dopamine antagonist effects that may cause extrapyramidal symptoms 6
- For acute dystonic reactions from metoclopramide, administer diphenhydramine 1-2 mg/kg parenterally 6
Common Pitfalls to Avoid
- Do not exceed 30 mg total daily dose in pediatric patients 2
- Do not prescribe for longer than 7 days without compelling justification and enhanced monitoring 2
- Do not prescribe without baseline ECG in any pediatric patient 4
- Do not use in patients with pre-existing QTc prolongation or electrolyte disturbances 5
- Do not assume safety based on peripheral dopamine antagonism alone—cardiac effects are well-documented 4, 3