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Cardiac effects: Epidemiological studies have shown domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see Adverse Reactions). Those studies suggest this increased risk may be higher in patients older than 60 years of age or in patients taking oral doses greater than 30 mg per day. Therefore, MOTILIUM-M should be used with caution in older patients.
Treatment with MOTILIUM-M should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patient should promptly consult their physician.
Drug interaction potential: The main metabolic pathway of domperidone is through CYP3A4. In vitro and human data show that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone.
Co-administration of domperidone with potent CYP3A4 inhibitors which have been shown to cause QT interval prolongation is contraindicated (see Contraindications).
Caution should be exercised when domperidone is co-administered with potent CYP3A4 inhibitors which have not been shown to cause QT interval prolongation such as indinavir and patients should be monitored closely for signs or symptoms of adverse reactions (see Adverse Reactions).
Caution should be exercised when domperidone is co-administered with drugs which have been shown to cause QT interval prolongation and patients should be monitored closely for signs or symptoms of cardiovascular adverse reactions (see Adverse Reactions). Examples include: anti-arrhythmics class IA (e.g., disopyramide, quinidine); anti-arrhythmics class III (e.g., amiodarone, dofetilide, dronedarone, ibutilide, sotalol); certain antipsychotics (e.g., haloperidol, pimozide, sertindole); certain antidepressants (e.g., citalopram, escitalopram); certain antibiotics (e.g., levofloxacin, moxifloxacin); certain antifungal agents (e.g., pentamidine); certain antimalarial agents (e.g., halofantrine); certain gastro-intestinal drugs (e.g., dolasetron); certain drugs used in cancer (e.g., toremifene, vandetanib); certain other drugs (e.g., bepridil, methadone).
The previously mentioned list is representative and not exhaustive. Refer to relevant lists appropriate for the country.
Antacids or antisecretory agents should not be taken simultaneously with oral formulations of MOTILIUM-M as they lower the oral bioavailability of domperidone. When used concomitantly, MOTILIUM-M should be taken before meals and antacids or antisecretory agents after meals.
Excipients of MOTILIUM-M (domperidone maleate): The film-coated tablets contain lactose and may be unsuitable for patients with lactose intolerance, galactosemia or glucose/galactose malabsorption.
Effects on Ability to Drive and Use Machines: Dizziness and somnolence have been observed following use of domperidone (see Adverse Reactions). Therefore, patients should be advised not to drive or use machinery or engage in other activities requiring mental alertness and coordination until they have established how MOTILIUM-M affects them.
