Domperidone


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Acute treatment of nausea and vomiting 10 mg tid. Max: 30 mg/day. Max treatment duration: 7 days. Use the lowest effective dose for the shortest possible duration. Rectal Nausea and vomiting 30 mg bid. Max treatment duration: 7 days.
Dosage Details
Oral
Acute treatment of nausea and vomiting
Adult: 10 mg up to 3 times daily. Max: 30 mg daily. Max treatment duration: 7 days. Use the lowest effective dose for the shortest possible duration.
Child: <12 years <35 kg: 0.25 mg/kg given up to 3 times daily. Max: 0.75 mg/kg daily. ≥12 years ≥35 kg: Same as adult dose.

Rectal
Nausea and vomiting
Adult: 30 mg bid. Max treatment duration: 7 days.
Child: <12 years <35 kg: 0.75 mg/kg bid. ≥12 years ≥35 kg: Same as adult dose.
Renal Impairment
Oral:
Severe: Reduce dose and dosing frequency to 1 or 2 times daily depending on the severity of the impairment for repeated administration.
Hepatic Impairment
Moderate to severe: Contraindicated.
Administration
Should be taken on an empty stomach. Take 15-30 min before meals.
Contraindications
Prolactin-releasing pituitary tumour (prolactinoma), existing QTc interval prolongation, significant electrolyte disturbances (e.g. hypokalaemia, hypomagnesaemia, hyperkalaemia), underlying cardiac disease (e.g. CHF), gastrointestinal haemorrhage, mechanical obstruction or perforation. Moderate to severe hepatic impairment. Concomitant use with QT-prolonging drugs, and potent CYP3A4 inhibitors e.g. ketoconazole, macrolide (e.g. erythromycin), protease inhibitors, or nefazodone.
Special Precautions
Patients with personal or family history of breast cancer, risk factors for sudden cardiac death (e.g. family history of coronary artery disease, high blood pressure, high blood cholesterol, diabetes mellitus, obesity, smoking, excessive alcohol consumption). Renal and mild hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Elevated prolactin levels, hypersensitivity reactions (e.g. anaphylaxis, angioedema). Rarely, neurological or extrapyramidal side effects (in children).
Eye disorders: Oculogyric crisis.
Gastrointestinal disorders: Dry mouth, diarrhoea, transient intestinal cramps.
General disorders and admin site conditions: Asthenia.
Immune system disorders: Urticaria.
Investigations: Abnormal LFT.
Nervous system disorders: Headache, migraine, dizziness, convulsions.
Psychiatric disorders: Anxiety, agitation, nervousness, loss of libido, somnolence.
Renal and urinary disorders: Urinary retention.
Reproductive system and breast disorders: Galactorrhoea, breast pain or tenderness, gynaecomastia, amenorrhoea.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Potentially Fatal: Serious ventricular arrhythmias, sudden cardiac death, QT interval prolongation, torsades de pointes.
Patient Counseling Information
This drug may cause dizziness and somnolence, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor ECG, renal function at baseline and periodically during treatment.
Overdosage
Symptoms: Agitation, altered consciousness, somnolence, disorientation, convulsions, and extrapyramidal reactions. Management: Symptomatic and supportive treatment. May perform gastric lavage and administer activated charcoal. Consider anticholinergic or anti-Parkinsonian drugs to control extrapyramidal reactions. Monitor ECG for possible QT interval prolongation.
Drug Interactions
May increase risk of QT interval prolongation with azithromycin, roxithromycin, and with bradycardia- and hypokalaemia-inducing drugs. May decrease bioavailability with antacids or antisecretory agents. May antagonise the prokinetic effects of anticholinergics (e.g. bromocriptine). Increased plasma concentrations of levodopa.
Potentially Fatal: Increased risk of QT interval prolongation with potent CYP3A4 inhibitors (e.g. protease inhibitors, systemic azole antifungals, clarithromycin, telithromycin, nefazodone), moderate CYP3A4 inhibitors (e.g. diltiazem, verapamil), and QT-prolonging drugs (e.g. quinidine, disopyramide, dofetilide, amiodarone, haloperidol, pimozide, citalopram, erythromycin, levofloxacin, pentamidine, halofantrine, lumefantrine, cisapride, dolasetron, mizolastine, mequitazine, toremifene, vandetanib, vincamine, bepridil, methadone; apomorphine [unless the benefit outweighs the risk and recommended precaution is strictly fulfilled]).
Food Interaction
May increase serum concentration with grapefruit or grapefruit juice. Slightly delayed absorption with food.
Action
Description: Domperidone is a peripheral dopamine-receptor blocker. It increases oesophageal peristalsis, lower oesophageal sphincter pressure, gastric motility and peristalsis, and enhances gastroduodenal coordination, thereby facilitating gastric emptying and decreasing small bowel transit time.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Slightly delayed absorption with food. Bioavailability: Approx 15%. Time to peak plasma concentration: Approx 30 minutes.
Distribution: Does not readily cross the blood-brain barrier. Enters breast milk (small amounts). Plasma protein binding: Approx 93%.
Metabolism: Rapidly and extensively metabolised in the liver via N-dealkylation by CYP3A4 isoenzyme and via hydroxylation by CYP3A4, CYP1A2 and CYP2E1 isoenzymes.
Excretion: Mainly via faeces (66%, 10% as unchanged drug); urine (31%; mainly as metabolites, approx 1% as unchanged drug). Elimination half-life: Approx 7.5 hours.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store between 15-30°C. Protect from light and moisture.
ATC Classification
A03FA03 - domperidone ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Disclaimer: This information is independently developed by MIMS based on Domperidone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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