Schedule H

Oral

• Tablets: 10 mg

• Dispersible/Mouth dissolving tablets: 10 mg

• Oral suspension: 1 mg/mL (30 mL, 60 mL bottles)

• Drops (paediatric): 5 mg/mL

Note: Parenteral formulation (injection) use is restricted in India due to cardiac safety concerns. CDSCO has issued safety alerts regarding injectable domperidone. Suppositories are NOT AVAILABLE in India.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Nausea and Vomiting (Non-chemotherapy Related)

Parameter Recommendation

Starting dose 10 mg orally, three times daily, 15–30 minutes before meals

Titration Not routinely required; may increase to 20 mg TID only if inadequate response

Usual maintenance dose 10 mg three times daily

Maximum dose 30 mg/day; do not exceed 10 mg per dose

Clinical Notes:

• Limit duration to ≤7 days due to QT prolongation risk

• Administer 15–30 minutes before meals for optimal effect

• Avoid in patients with risk factors for cardiac arrhythmia

1. Gastroparesis (Diabetic or Idiopathic)

Parameter Recommendation

Starting dose 10 mg orally, three times daily before meals

Titration May increase to 20 mg TID for short-term use (≤4 weeks) if response inadequate

Usual maintenance dose 10 mg three times daily

Maximum dose 30 mg/day for routine use; up to 60 mg/day only under specialist supervision for short duration

Clinical Notes:

• Prefer short-term use (<12 weeks)

• Long-term therapy only under gastroenterologist supervision with periodic ECG monitoring

• Assess glycaemic control concurrently in diabetic gastroparesis

1. Functional Dyspepsia

Parameter Recommendation

Starting dose 10 mg orally, two to three times daily before meals

Titration Not applicable

Usual maintenance dose 10 mg two to three times daily

Maximum dose 30 mg/day

Clinical Notes:

• Course duration: ≤4 weeks; reassess benefit periodically

• Consider non-pharmacological measures concurrently

• Not for long-term maintenance without re-evaluation

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

Parkinson's disease-related nausea— OFF-LABEL 10–20 mg orally before meals, TID Short course (1–2 weeks) Neurology specialist only. Preferred over metoclopramide due to minimal CNS penetration; used for levodopa-induced nausea. Based on Indian neurology practice.

Facilitation of lactation (galactagogue)— OFF-LABEL 10 mg orally TID 7–14 days maximum Specialist only (lactation consultant/endocrinology). Weak evidence; hyperprolactinaemic effect. Risk of cardiac adverse effects. Use only when non-pharmacological measures fail. Based on limited evidence and Indian specialist practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Nausea and Vomiting — Short-term Use

Weight-based Dosing (Oral Suspension/Drops):

Weight Dose per Administration Frequency Maximum Daily Dose

<15 kg 0.25 mg/kg 2–3 times daily before meals 0.75 mg/kg/day

15–35 kg 0.25 mg/kg (typically 5 mg) 3 times daily before meals 0.75 mg/kg/day (max 30 mg/day)

35 kg 10 mg 3 times daily before meals 30 mg/day

Dosing Structure:

Parameter Recommendation

Starting dose 0.25 mg/kg/dose orally, three times daily before meals

Titration Not applicable in children

Usual maintenance dose 0.25 mg/kg/dose TID

Maximum dose 0.75 mg/kg/day or 30 mg/day, whichever is lower; maximum single dose 10 mg

Duration: ≤7 days

Secondary Indications — Paediatric (Off-label)

Indication Dose Duration Notes

Gastro-oesophageal reflux disease (GORD) — OFF-LABEL 0.25 mg/kg/dose TID before feeds Short-term only (≤2 weeks) Paediatric gastroenterologist only. NOT recommended routinely due to QT prolongation risk. Requires baseline and follow-up ECG. Based on Indian paediatric gastroenterology practice; use only when other measures fail.

Age Restrictions:

• Not recommended below 12 months of age except under specialist paediatric supervision

• Neonates: Avoid use — immature hepatic metabolism increases QT risk

• Body weight <15 kg: Use with extreme caution; prefer alternative antiemetics if available

Safety Monitoring in Children:

• Baseline ECG if duration >3 days or if cardiac risk factors present

• Monitor for lethargy, irritability, feeding difficulties

• Avoid concurrent use with macrolide antibiotics

• Watch for signs of hyperprolactinaemia in prolonged use

50 No dose adjustment required

30–50 Reduce dosing frequency to twice daily; use lowest effective dose

10–30 Once daily dosing; avoid prolonged use; monitor QTc

<10 Avoid use if possible; if essential, once daily with ECG monitoring

Haemodialysis Not significantly dialysable; avoid chronic use

Note: Domperidone and metabolites may accumulate in renal impairment, increasing risk of cardiac adverse effects.

• Known hypersensitivity to domperidone or any excipient

• Prolactin-secreting pituitary tumour (prolactinoma)

• Known QT prolongation (congenital long QT syndrome or acquired)

• Existing significant cardiac conduction disturbances or arrhythmias

• Conditions where cardiac conduction is, or could be, impaired

• Concomitant use with potent CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir)

• Concomitant use with other QT-prolonging drugs

• Severe hepatic impairment

• GI haemorrhage, mechanical obstruction, or perforation

• Children <12 months (relative; use only under specialist supervision)

• Age >60 years — significantly increased risk of ventricular arrhythmia and sudden cardiac death

• Electrolyte disturbances (hypokalaemia, hypomagnesaemia, hypocalcaemia) — correct before initiating

• Underlying cardiac disease (ischaemic heart disease, heart failure)

• Concomitant use with drugs causing electrolyte imbalance (diuretics)

• Renal impairment — accumulation risk

• Use beyond recommended duration (>7 days) or dose (>30 mg/day)

• Children with intercurrent illness causing electrolyte disturbance

• Concurrent proarrhythmic conditions

Parameter Information

Overall safety Limited human data; animal studies do not indicate teratogenicity

Risk assessment Use only if potential benefit justifies potential risk; avoid in first trimester if possible

Preferred alternatives Ondansetron (for severe hyperemesis); non-pharmacological measures first

When may be used Severe nausea/vomiting unresponsive to other measures; no cardiac risk factors; short-term only

Monitoring Maternal ECG if prolonged use; electrolytes; fetal well-being as per standard antenatal care

Parameter Information

Compatibility Compatible with breastfeeding; low milk transfer

Milk levels Low (RID <2%)

Preferred alternatives Metoclopramide has more data but higher CNS effects; domperidone may be preferred for minimal CNS penetration

When to use Short-term antiemetic use is acceptable; off-label galactagogue use requires specialist supervision

Infant monitoring Observe for irritability, feeding difficulties, sedation, weight gain

Parameter Recommendation

Starting dose 10 mg once or twice daily (not TID)

Titration Very slow; avoid dose escalation if possible

Maximum dose 20 mg/day in patients >60 years

Duration ≤7 days; avoid chronic use

Special risks Significantly increased risk of QT prolongation, ventricular arrhythmia, sudden cardiac death; falls if dizziness occurs

Monitoring Baseline ECG mandatory; repeat ECG within 3–5 days; check electrolytes and renal function

Note: Regulatory agencies worldwide have issued warnings about domperidone use in elderly. CDSCO safety alerts apply.

Drug/Class Interaction Mechanism Management

Ketoconazole, Itraconazole Markedly increased domperidone levels; high risk of QT prolongation and arrhythmia Potent CYP3A4 inhibition CONTRAINDICATED — do not co-administer

Erythromycin, Clarithromycin Increased domperidone levels and additive QT prolongation CYP3A4 inhibition + independent QT effect CONTRAINDICATED — use azithromycin with caution if macrolide required

Fluconazole Increased domperidone exposure Moderate CYP3A4 inhibition Avoid combination; if essential, reduce domperidone dose and monitor ECG

Ritonavir, Other HIV protease inhibitors Significantly increased domperidone levels Strong CYP3A4 inhibition CONTRAINDICATED

Verapamil, Diltiazem Increased domperidone levels and additive cardiac effects CYP3A4 inhibition; cardiac conduction effects Avoid combination or monitor ECG closely

Amiodarone, Sotalol, Dronedarone Additive QT prolongation; high arrhythmia risk Independent QT-prolonging effects CONTRAINDICATED

Haloperidol, Droperidol Additive QT prolongation Independent QT-prolonging effects Avoid combination

Citalopram, Escitalopram (high dose) Additive QT prolongation Independent QT effect Avoid combination; if unavoidable, ECG monitoring essential

Drug/Class Interaction Management

Azithromycin Lower QT risk than erythromycin/clarithromycin but caution still warranted Short courses acceptable; avoid in elderly or cardiac risk patients; monitor

Levodopa Domperidone may enhance GI absorption of levodopa; paradoxically used therapeutically Can be used together — actually therapeutic in Parkinson's disease

Anticholinergics May reduce prokinetic effect of domperidone Avoid unnecessary concurrent use; may reduce domperidone efficacy

Opioid analgesics May reduce prokinetic effect; domperidone may help opioid-induced nausea Can be used together; monitor for efficacy

Diuretics (loop, thiazide) May cause electrolyte disturbances increasing arrhythmia risk Check electrolytes before and during domperidone use

SSRIs (other than citalopram) Potential additive QT effect with some SSRIs Monitor; consider ECG in higher risk patients

Antacids, H2 blockers May reduce oral absorption of domperidone Separate administration by 2 hours

Grapefruit juice May increase domperidone levels Avoid large quantities during treatment

• Dry mouth

• Headache

• Abdominal cramps, bloating

• Diarrhoea

• Drowsiness (less frequent than metoclopramide)

• Breast tenderness

• Reduced libido

Effect Notes

QT prolongation Risk increases with dose >30 mg/day, age >60 years, concurrent CYP3A4 inhibitors, electrolyte imbalance; monitor ECG

Torsades de pointes Rare but life-threatening; discontinue immediately if detected; requires hospitalisation

Sudden cardiac death Epidemiological association, especially in elderly and those on >30 mg/day; use lowest effective dose for shortest duration

Hyperprolactinaemia Galactorrhoea, gynaecomastia, amenorrhoea, sexual dysfunction; reversible on discontinuation

Extrapyramidal symptoms Rare (due to poor CNS penetration); more common in children; discontinue if occurs

Seizures Very rare; reported in neonates and infants

Anaphylaxis/Angioedema Rare; discontinue immediately

After initiation/dose change ECG within 3–5 days if risk factors present; symptom assessment for palpitations, syncope

Long-term use (if specialist-approved) ECG every 4–8 weeks; electrolytes periodically; prolactin levels if symptoms of hyperprolactinaemia; clinical surveillance for extrapyramidal effects

In children ECG if use exceeds 3 days or if concurrent macrolide therapy; monitor feeding and growth

Single Ingredient:

• Domstal (Torrent)

• Vomistop (Cipla)

• Motilium (Johnson & Johnson)

• Domperi (Micro Labs)

• Domcolic (Alkem)

• Peridone (Ipca)

• Omidom (Mankind)

Fixed Dose Combinations (FDCs):

Note on FDCs: Routine use of domperidone-PPI FDCs is not recommended unless clear indication for both components exists. Irrational prescribing of FDCs exposes patients to unnecessary domperidone-related cardiac risks.

Note: Not included in NLEM 2022. Prices not NPPA-controlled; vary across brands in private sector.

1. Duration matters: Limit use to ≤7 days whenever possible. Risk of serious cardiac events increases with prolonged therapy. Beyond 7 days only under specialist supervision with ECG monitoring.

1. Dose ceiling: Keep total daily dose ≤30 mg (10 mg TID) in adults. Higher doses substantially increase QT prolongation risk without proportionate benefit increase.

1. Elderly caution: In patients >60 years, use lower doses (max 20 mg/day) for shortest duration possible. Baseline ECG is mandatory. Consider alternative antiemetics where feasible.

1. Preferred in Parkinsonism: When antiemetic needed in Parkinson's disease patients, domperidone is preferred over metoclopramide due to minimal CNS penetration and no worsening of parkinsonian symptoms.

1. Avoid irrational FDCs: Domperidone-PPI combinations are frequently overprescribed. Use FDCs only when both components are genuinely indicated — not for all dyspepsia or GORD cases.

1. Macrolide interaction: If macrolide antibiotic is essential, use azithromycin (lower CYP3A4 inhibition and QT effect) rather than erythromycin or clarithromycin. Still exercise caution.

domperidone; prokinetic; dopamine antagonist; QT prolongation; antiemetic; gastroparesis; dyspepsia; cardiac-risk; elderly-caution; Schedule H

RxIndia v1.0 — 05 Jan 2025

• CDSCO Drug Information and Safety Alerts

• Indian Pharmacopoeia 2022 / National Formulary of India

• NLEM 2022 (not included)

• API Textbook of Medicine

• IAP Drug Formulary / IAP Handbook of Paediatrics

• AIIMS Pharmacology Formulary

• DGHS/ICMR guidance on rational drug use

• Product inserts from Indian manufacturers (Torrent, Cipla, Sun Pharma)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Indian Journal of Pharmacology — Domperidone safety review