Motilium-M

Domperidone maleate

Dyspeptic symptom complex associated w/ delayed gastric emptying, gastro-esophageal reflux & esophagitis: epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain; bloating, eructation, flatulence; nausea & vomiting; heartburn w/ or w/o regurgitations of gastric contents in the mouth. Nausea & vomiting of functional, organic, infectious or dietary origin; induced by radiotherapy or drug therapy or dopamine agonists used in Parkinson's disease.

Adult, adolescent ≥12 yr & childn weighing ≥35 kg 1 tab tds-qds. Max: 40 mg daily. Duration: Up to 4 wk (not to exceed 1 wk for acute nausea & vomiting).

Should be taken on an empty stomach.

Hypersensitivity. Prolactinoma. Whenever stimulation of gastric motility might be dangerous eg, in the presence of GI hemorrhage, mechanical obstruction or perforation. Coadministration w/ potent CYP3A4 inhibitors shown to cause QT interval prolongation eg, clarithromycin, erythromycin, itraconazole, oral ketoconazole, posaconazole, ritonavir, saquinavir, telithromycin, telaprevir & voriconazole. Moderate or severe hepatic impairment.

Discontinue if signs & symptoms that may be associated w/ cardiac arrhythmia occur. Increased risk of serious ventricular arrhythmias or sudden cardiac death; proarrhythmia. Coadministration w/ potent CYP3A4 inhibitors not shown to cause QT interval prolongation (eg, indinavir); drugs shown to cause QT interval prolongation eg, anti-arrhythmics class IA (eg, disopyramide, quinidine) & III (eg, amiodarone, dofetilide, dronedarone, ibutilide, sotalol), antipsychotics (eg, haloperidol, pimozide, sertindole), antidepressants (eg, citalopram, escitalopram), antibiotics (eg, levofloxacin, moxifloxacin), antifungal agents (eg, pentamidine); antimalarial agents (eg, halofantrine), GI drugs (eg, dolasetron), drugs used in cancer (eg, toremifene, vandetanib), others (eg, bepridil, methadone). Not to be taken simultaneously w/ antacids or antisecretory agents. May be unsuitable for patients w/ lactose intolerance, galactosemia or glucose/galactose malabsorption. May affect ability to drive & use machines. Severe renal impairment. Contraindicated in moderate (Child-Pugh 7-9) or severe (Child-Pugh >9) hepatic impairment. Pregnancy. Not recommended during lactation. Elderly.

Depression, anxiety, decreased libido/loss of libido; headache, somnolence, akathisia; diarrhea; rash, pruritus; gynaecomastia, breast tenderness & pain; galactorrhoea, amenorrhea, irregular menstruation, lactation disorder; asthenia.

Plasma levels may be increased w/ potent CYP3A4 inhibitors (contraindicated). Anti-dyspeptic effect may be antagonized w/ anticholinergic drugs eg, dextromethorphan, diphenhydramine. May influence absorption of oral drugs w/ SR or EC formulations.

GIT Regulators, Antiflatulents & Anti-Inflammatories / Antiemetics

A03FA03 - domperidone ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.

POM