Domperidone


Generic Medicine Info
Indications and Dosage
Oral
Nausea and vomiting
Adult: As short-term treatment: ≥35 kg: 10 mg up to tid. Max: 30 mg daily. Max treatment duration: 1 week. Use the lowest effective dose for the shortest possible duration needed to control the symptoms.
Child: ≥12 years weighing ≥35 kg: Same as adult dose.
Renal Impairment
Dose and frequency reduction may be required.
Hepatic Impairment
Moderate or severe: Contraindicated.
Administration
Should be taken on an empty stomach. Take 15-30 min before meals.
Contraindications
Prolactin-releasing pituitary tumour (prolactinoma), conditions where stimulation of gastric motility may be harmful (e.g. gastrointestinal haemorrhage, mechanical obstruction or perforation), known existing prolongation of cardiac conduction intervals (particularly QTc), underlying cardiac disease (e.g. CHF), significant electrolyte disturbances (e.g. hypokalaemia, hypomagnesaemia, hyperkalaemia). Moderate or severe hepatic impairment. Concomitant use with QT-prolonging drugs or potent CYP3A4 inhibitors (e.g. azole antifungals, macrolides, protease inhibitors, nefazodone).
Special Precautions
Patient with personal or family history of breast cancer, risk factors for sudden cardiac arrest (e.g. family history of coronary artery disease, high blood pressure, obesity, hypercholesterolaemia, diabetes, alcoholism, smoking). Renal and mild hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Increased prolactin levels (dose-dependent). Very rarely, QT prolongation.
Eye disorders: Oculogyric crisis.
Gastrointestinal disorders: Dry mouth, diarrhoea.
General disorders and administration site conditions: Asthenia.
Immune system disorders: Very rarely, anaphylactic reaction (including anaphylactic shock).
Investigations: Very rarely, abnormal LFT.
Nervous system disorders: Headache, somnolence. Very rarely, convulsion, extrapyramidal disorder.
Psychiatric disorders: Anxiety, loss of libido. Very rarely, agitation, nervousness.
Renal and urinary disorders: Very rarely, urinary retention.
Reproductive system and breast disorders: Breast pain and tenderness, galactorrhoea. Rarely, amenorrhoea, gynaecomastia.
Skin and subcutaneous tissue disorders: Rash, pruritus. Very rarely, angioedema, urticaria.
Potentially Fatal: Very rarely, ventricular arrhythmias, Torsade de Pointes, sudden cardiac death.
Monitoring Parameters
Monitor renal function. Obtain ECG at baseline then periodically during treatment.
Overdosage
Symptoms: Altered consciousness, agitation, convulsions, disorientation, extrapyramidal reactions, and somnolence. Management: Supportive and symptomatic treatment. Perform gastric lavage and administer activated charcoal. Monitor ECG for the possibility of QT interval prolongation. May administer anticholinergics or anti-Parkinsonian agents to control extrapyramidal reactions.
Drug Interactions
Decreased bioavailability with antacids or antisecretory agents; avoid concurrent use. Anticholinergic agents (e.g. dextromethorphan, diphenhydramine) may antagonise the anti-dyspeptic effect of domperidone.
Potentially Fatal: Increased risk of serious ventricular arrhythmias or sudden cardiac death with QT-prolonging drugs (e.g. disopyramide, amiodarone, haloperidol, citalopram, erythromycin, pentamidine, halofantrine, cisapride, mizolastine, toremifene, aprepitant, bepridil, methadone) or potent CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, ritonavir, nefazodone).
Food Interaction
May increase serum concentrations with grapefruit juice.
Action
Description: Domperidone is a dopamine antagonist with antiemetic properties. Its effect may be attributed to a combination of peripheral (gastrokinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger zone (located in the area postrema). It increases oesophageal peristalsis, pressure in the lower oesophageal sphincter, gastric motility and peristalsis, and improves gastroduodenal coordination, thus facilitating gastric emptying and reducing small bowel transit time.
Pharmacokinetics:
Absorption: Rapidly absorbed. Bioavailability: Approx 15%. Time to peak plasma concentration: Approx 30-60 minutes.
Distribution: Enters breast milk (small amounts). Plasma protein binding: 91-93%.
Metabolism: Rapidly and extensively metabolised in the liver by CYP3A4 isoenzyme via N-dealkylation and by CYP3A4, CYP1A2, and CYP2E1 isoenzymes via hydroxylation. Undergoes extensive first-pass metabolism.
Excretion: Via urine (31%; approx 1% as unchanged drug); faeces (66%; 10% as unchanged drug). Elimination half-life: 7-9 hours.
Chemical Structure

Chemical Structure Image
Domperidone

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3151, Domperidone. https://pubchem.ncbi.nlm.nih.gov/compound/Domperidone. Accessed Mar. 29, 2022.

Storage
Store between 15-30°C. Protect from moisture and light.
MIMS Class
Antiemetics
ATC Classification
A03FA03 - domperidone ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
References
Anon. Domperidone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/02/2022.

Buckingham R (ed). Domperidone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/02/2022.

Domperidone 1 mg/mL Oral Suspension (Zentiva Pharma UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/02/2022.

Janssen-Cilag (New Zealand) Ltd. Motilium 10 mg Film-Coated Tablets data sheet 19 November 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 10/02/2022.

Joint Formulary Committee. Domperidone. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/02/2022.

Motilium 10 mg Film-Coated Tablets (Zentiva Pharma UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/02/2022.

Motilium Tablet 10 mg, Oral Suspension 1 mg/mL (Johnson & Johnson Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/02/2022.

Naupastad 10 (Stellapharm J.V. Co Ltd). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 10/02/2022.

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 © 2022 MIMS. All rights reserved. Powered by MIMS.com
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