Domperidone dosing regimen for children
Domperidone dosing for children weighing <35 kg should be calculated by body weight as 0.25 mg/kg by mouth up to three times daily. [1]
The maximum treatment duration should not normally exceed 1 week. [1]
Domperidone has contraindications related to cardiac conduction abnormalities, hepatic impairment, and drug–drug interactions that increase QT risk or domperidone exposure. [1], [2]
Dosing interval and duration of therapy
The dosing interval is up to three times daily (every ~8 hours when given three times daily). [1]
Usually, the maximum treatment duration should not exceed one week. [1], [2]
Dose per kilogram and maximum dose
For children with suitable licensed products, the recommended dose is 0.25 mg/kg by mouth up to three times daily. [1]
In pediatric efficacy/safety evaluation using domperidone oral suspension, the dose used was 0.25 mg/kg with a maximum of 30 mg domperidone per day. [2]
Contraindications
Domperidone is contraindicated with known hypersensitivity to domperidone or any excipients. [2]
Domperidone is contraindicated with prolactin-releasing pituitary tumor (prolactinoma). [2]
Domperidone is contraindicated in confirmed or suspected pheochromocytoma due to risk of severe hypertension episodes. [2]
Domperidone is contraindicated when stimulation of gastric motility could be harmful, including gastrointestinal hemorrhage, mechanical obstruction, or perforation. [2]
Domperidone is contraindicated in moderate or severe hepatic impairment. [1], [2]
Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, with significant electrolyte disturbances, or with underlying cardiac diseases such as congestive heart failure. [1], [2]
Domperidone is contraindicated with co-administration of QT-prolonging drugs (with apomorphine being an exception only under strictly defined conditions in the apomorphine SmPC). [1], [2]
Domperidone is contraindicated with co-administration of potent CYP3A4 inhibitors (regardless of their QT-prolonging effects). [1], [2]
Key practical constraints embedded in labeling
Domperidone should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting. [2]
Domperidone dosing should be selected to avoid exceeding the licensed pediatric dosing limits for body-weight-based regimens. [1], [2]
Safety constraints driving avoidance of use
Domperidone has been associated with QT interval prolongation and rare post-marketing reports of torsades de pointes. [2]
Domperidone exposure has been associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death, with higher risk observed in patients older than 60 years and with daily doses greater than 30 mg in adults. [2]
Domperidone risk increases with concomitant use of QT-prolonging drugs and with CYP3A4 inhibitors. [1], [2]