Maximum Recommended Dose of Domperidone
The maximum daily dose of domperidone is 30 mg per day, with treatment duration limited to 7 days for nausea and vomiting, as mandated by regulatory authorities due to cardiac safety concerns. 1
Regulatory Restrictions and Safety Basis
Following a 2014 safety review, the European Medicines Agency restricted domperidone to a maximum daily dose of 30 mg and limited treatment duration to 7 days specifically for nausea and vomiting. 1, 2
The National Patient Safety Agency (NPSA) issued alerts highlighting QTc prolongation risks with domperidone, requiring QTc monitoring for long-term use. 3
These restrictions were implemented despite controversial evidence, as the definitive link between domperidone and sudden cardiac death remains debated in the literature. 2
Dosing in Gastrointestinal Motility Disorders
For gastroparesis and chronic gastrointestinal motility disorders, domperidone is generally not recommended for long-term use under current regulatory guidance. 3
The European Medicines Agency's Committee specifically recommends against long-term use of domperidone due to lack of consistent benefit in gastroparesis and cardiac safety concerns. 3
When domperidone must be used beyond acute indications, doses above 30 mg daily should only be considered with extreme caution, particularly in patients over 60 years of age. 4
Clinical Context and Monitoring
In specialized settings with FDA investigational protocols, doses up to 120 mg/day have been studied for refractory gastroparesis, but this requires intensive cardiac monitoring with frequent ECGs and is not standard practice. 5
A retrospective study of high-dose domperidone (40-120 mg/day) found that 9.5% of patients experienced asymptomatic QTc prolongation >450 ms (males) or >470 ms (females), though no patients reached the critical threshold of >500 ms. 5
Standard monitoring at conventional doses (30-80 mg/day) showed only 6% of patients developed clinically important QTc prolongation, with none exceeding 500 ms. 6
Common Pitfalls to Avoid
Do not prescribe domperidone as repeat prescriptions beyond 7 days without specific justification and cardiac monitoring, as this violates regulatory guidance and increases risk. 1
Avoid domperidone in patients with pre-existing cardiac conditions, electrolyte disturbances, or those taking other QTc-prolonging medications, as these significantly increase arrhythmia risk. 5
Do not use domperidone doses exceeding 30 mg/day in routine clinical practice outside of specialized investigational protocols with appropriate monitoring. 1, 4