Motilium

Dyspeptic symptom complex often 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 mouth. Nausea & vomiting of functional, organic, infectious, or dietary origin; induced by RT or drug therapy, or dopamine agonists (eg, L-dopa & bromocriptine) used in Parkinson's disease.

Use under medical supervision Adult & adolescent ≥12 yr & weighing ≥35 kg, & childn <12 yr & weighing ≥35 kg 1 tab tid-qid. Max daily dose: 40 mg. Duration: Up to 4 wk (not to exceed 1 wk for treatment of acute nausea & vomiting). OTC use Adult & adolescent 12-60 yr & weighing ≥35 kg 10 mg up to tid. Max daily dose: 30 mg. Duration: Not to exceed 7 days for treatment of acute nausea & vomiting, & 14 days for dyspeptic symptom complex. Prescription & non-prescription use Patient w/ severe renal impairment (serum creatinine >6 mg/100 mL) Reduce dosing frequency to once daily or bid. Depending on severity of impairment, dose may need to be reduced.

Should be taken on an empty stomach: Take 15-30 min before meals.

Hypersensitivity. Prolactinoma. Whenever stimulation of gastric motility might be dangerous eg, in presence of GI hemorrhage, mechanical obstruction or perforation. Co-administration w/ potent CYP3A4 inhibitors (regardless of their QT prolonging effects) causing QT interval prolongation eg, clarithromycin, erythromycin, itraconazole, oral ketoconazole, posaconazole, ritonavir, saquinavir, telithromycin, telaprevir & voriconazole; QT-prolonging drugs (at the exception of apomorphine). Patients w/ moderate or severe hepatic impairment.

Use has been associated w/ prolongation of the QT interval on ECG. Post-marketing reports of very rare cases of QT prolongation & torsades de pointes in patients w/ confounding risk factors, electrolyte abnormalities & concomitant treatment which may have been contributing factors. May be associated w/ increased risk of serious ventricular arrhythmias or sudden cardiac death; risk may be higher in patients >60 yr or in patients taking oral doses >30 mg daily. Not recommended in patients w/ known existing prolongation of cardiac conduction intervals (particularly QTc), significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), bradycardia, or underlying cardiac diseases eg, CHF. Discontinue use if signs or symptoms that may be associated w/ cardiac arrhythmia occur. Closely monitor for signs or symptoms of adverse reactions when co-administered w/ potent CYP3A4 inhibitors which have not been shown to cause QT interval prolongation (eg, indinavir). Closely monitor for signs or symptoms of CV adverse reactions when co-administered w/ drugs causing QT interval prolongation eg, anti-arrhythmics class IA (eg, disopyramide, quinidine) & class III (eg, amiodarone, dofetilide, dronedarone, ibutilide, sotalol); certain 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), other drugs (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. Dizziness & somnolence following domperidone use; advise patient not to drive or use machinery or engage in other activities requiring mental alertness & coordination until domperidone effects are established. Patients w/ severe renal impairment should be reviewed regularly. Should only be used during pregnancy when justified by anticipated therapeutic benefit. Breastfeeding is not recommended during treatment. Unsuitable for use in adults & adolescents <35 kg. Not to be administered to childn <12 yr & weighing ≥35 kg unless prescribed for use.

Depression, anxiety, decreased/loss of libido; headache, somnolence, akathisia; diarrhea; rash, pruritus; breast enlargement/gynecomastia, breast tenderness or pain, galactorrhea, amenorrhea, irregular menstruation, lactation disorder; asthenia. OTC use: Dry mouth.

Plasma levels may be increased w/ CYP3A4 inhibitors. Clinically relevant changes in QT intervals w/ potent CYP3A4 inhibitors causing QT interval prolongation. Exercise caution when co-administered w/ potent CYP3A4 inhibitors which have not been shown to cause QT interval prolongation or drugs which have been shown to cause QT interval prolongation. Anti-dyspeptic effect may be antagonized w/ anticholinergic drugs eg, dextromethorphan, diphenhydramine. May influence absorption of oral drugs particularly 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.

Rx