Adults and adolescents

12 years of age and older and weighing 35 kg or more

The efficacy of domperidone in adolescents 12 years of age and weighing less than 35 kg has not been established.

Domperidone is contraindicated in the following situations:

• Known hypersensitivity to domperidone or any of the excipients.
• Prolactin-releasing pituitary tumour (prolactinoma).
• When stimulation of the gastric motility could be harmful, e.g. In patients with gastro-intestinal haemorrhage, mechanical obstruction or perforation.
• In patients with moderate or severe hepatic impairment.
• Patients with known existing prolongation of cardiac conduction intervals, particularly QTc patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure.
• Co-administration with QTc-prolonging drugs given below
  • anti-arrhythmics class IA (eg., disopyramide, hydroquinidine, quinidine)
  • anti-arrhythmics class Ill (e.g., amiodarone, dofetilide, dronedarone, ibutilide, sotalol)
  • certain anti-psychotics (e.g., haloperidol, pimozide, sertindole)
  • certain anti-depressants (e.g., citalopram, escitalopram)
  • certain antibiotics (e.g., erythromycin, levofloxacin, moxifloxacin, spiramycin)
  • certain antifungal agents (e.g., pentamidine)
  • certain antimalarial agents (in particular halofantrine, lumefantrine)
  • certain gastro-intestinal medicines (e.g., cisapride, dolasetron, prucalopride)
  • certain antihistaminics (e.g., mequitazine, mizolastine)
  • certain medicines used in cancer (e.g., toremifene, vandetanib, vincamine)
  • certain other medicines (e.g., bepridil, diphemanil, methadone).
  • apomorphine; unless the benefit of the co- administration outweighs the risks, and only if the recommended precautions for co-administration are strictly fulfilled.
• Co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects) i.e.
  • protease inhibitors
  • systemic azole antifungals
• some macrolides (erythromycin, clarithromycin, telithromycin)