1. Clinical & Scientific Overview
Domperidone (TIP-MED-000074, Reference Code [5.6]) is classified under
Gastrointestinal & Hepatobiliary Medicines (Ch 05) as a Peripheral Dopamine D2-Receptor Antagonist; Gastroprokinetic & Antiemetic.
Within the Indian regulatory and compendial framework, it is governed under Schedule H Prescription Drug (To be sold by retail on the prescription of a Registered Medical Practitioner only — Drugs Rules 1945).
Representative Indian Market Examples (Edition 2.7 Ch 05 [5.6], p. 62): Domstal (Torrent), Vomistop (Cipla), Motinorm; Widely dispensed in FDCs with PPIs: Pan-D, Pantocid-DSR, Razo-D, Omez-D — Strengths & Dosage Forms: Oral Uncoated / Dispersible Tablets: 10 mg; Sustained-Release (SR) Capsules (in PPI FDCs): 30 mg SR; Oral Suspension: 1 mg/mL
Oral Uncoated / Dispersible Tablets: 10 mg; Sustained-Release (SR) Capsules (in PPI FDCs): 30 mg SR; Oral Suspension: 1 mg/mL
3. Mechanism of Action & Pharmacodynamics
Peripheral Dopamine D2-Receptor Antagonist; Gastroprokinetic & Antiemetic acting on target receptor/enzyme pathways in Gastrointestinal & Hepatobiliary Medicines (Ch 05): clinical efficacy is mediated via Peripheral Dopamine D2-Receptor Antagonist; Gastroprokinetic & Antiemetic for Short-term relief of nausea and vomiting (including levodopa/dopamine-agonist-induced nausea in Parkinson's disease, as domperidone barely crosses the blood-brain barrier); gastroparesis and functional dyspepsia with early satiety/bloating..
4. Therapeutic Indications & Evidence-Supported Uses
- Short-term relief of nausea and vomiting (including levodopa/dopamine-agonist-induced nausea in Parkinson's disease, as domperidone barely crosses the blood-brain barrier)
- gastroparesis and functional dyspepsia with early satiety/bloating
🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: General Adult Reference: 10 mg up to three times daily before meals (Maximum recommended daily dose: 30 mg/day) for the shortest possible duration (usually ≤7 days for acute nausea). Follow physician prescription.
Administration & Meal Timing: Strictly 15 to 30 minutes BEFORE meals (taking after meals delays absorption and misses the mealtime gastric emptying window). | Before breakfast, lunch, and dinner (or once daily 30 min before breakfast if 30 mg SR capsule inside a PPI-DSR combination).
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: In severe renal impairment (CrCl <30 mL/min), reduce dosing frequency to once or twice daily (max 10–20 mg/day) and avoid repeated prolonged administration. Hepatic: Contraindicated in moderate-to-severe hepatic impairment.
Renal: In severe renal impairment (CrCl <30 mL/min), reduce dosing frequency to once or twice daily (max 10–20 mg/day) and avoid repeated prolonged administration. Hepatic: Contraindicated in moderate-to-severe hepatic impairment.
Renal: In severe renal impairment (CrCl <30 mL/min), reduce dosing frequency to once or twice daily (max 10–20 mg/day) and avoid repeated prolonged administration. Hepatic: Contraindicated in moderate-to-severe hepatic impairment.
7. Contraindications, Precautions & High-Risk Warnings
- Strictly CONTRAINDICATED in patients with known QTc interval prolongation, significant electrolyte disturbances (hypokalaemia, hypomagnesaemia), congestive heart failure, moderate-to-severe hepatic impairment, prolactinoma (pituitary tumour), mechanical GI obstruction/perforation, and concurrent potent CYP3A4 inhibitors.
Key Clinical Precautions: Renal: In severe renal impairment (CrCl <30 mL/min), reduce dosing frequency to once or twice daily (max 10–20 mg/day) and avoid repeated prolonged administration. Hepatic: Contraindicated in moderate-to-severe hepatic impairment.
8. Adverse Effects Profile
- Dry mouth, headache, transient abdominal cramping, hyperprolactinaemia (galactorrhoea, breast tenderness/gynaecomastia, menstrual amenorrhoea with prolonged use).
- QTc interval prolongation, torsades de pointes, serious ventricular arrhythmias, and sudden cardiac death (especially in patients >60 years or taking >30 mg/day!), rare acute dystonic/extrapyramidal reactions (mostly in young children or very frail elderly).
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Strictly contraindicated with potent CYP3A4 inhibitors and QT-prolonging drugs: Clarithromycin, Erythromycin, Azithromycin, Fluconazole, Itraconazole, Ketoconazole, Voriconazole, Amiodarone, Sotalol, Diltiazem, Verapamil, Fluoroquinolones (levofloxacin/ciprofloxacin), Ondansetron, Escitalopram, Haloperidol, and Teneligliptin
- Anticholinergics (dicyclomine, hyoscine, amitriptyline) directly antagonise domperidone's prokinetic action
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.
Pharmacist Patient Counselling Points:
- Patient Counselling Checklist: Educate patients that capsules ending in '-D' or '-DSR' (like Pan-D, Pantocid-DSR, Razo-D) contain 30 mg of domperidone in addition to the acidity medicine. Once nausea/bloating settles, elderly patients should ask their doctor to switch from the '-D' combination to the plain PPI (e.g., plain Pantoprazole 40 mg) to protect the heart rhythm.
- Meal & Clock Timing Instruction: Strictly 15 to 30 minutes BEFORE meals (taking after meals delays absorption and misses the mealtime gastric emptying window). (Before breakfast, lunch, and dinner (or once daily 30 min before breakfast if 30 mg SR capsule inside a PPI-DSR combination).)
- Missed Dose Protocol: If remembered before eating, take it; if the meal is already finished, skip the missed dose.
- Geriatric Dispensing Pearl: International and national pharmacovigilance agencies warn that patients >60 years taking domperidone (especially >30 mg/day or alongside cardiac/antibiotic medicines) have a significantly elevated risk of sudden ventricular arrhythmia. Always audit elderly CGHS prescriptions to stop unnecessary chronic '-DSR' combinations and ensure no macrolide, azole, or fluoroquinolone is co-administered.
Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Oral Uncoated / Dispersible Tablets: 10 mg; Sustained-Release (SR) Capsules (in PPI FDCs): 30 mg SR; Oral Suspension: 1 mg/mL
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 05 [5.6] (p. 62)
Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: HANDBOOK_SOURCE_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.
13. Related Reference Monographs, Educational Guides & Visual Concept
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