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Unidentified Drug: Uses, Side Effects, Dosage & Safety | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class

Dopamine D2 receptor antagonist (peripheral)

Speciality

Gastroenterology

Schedule (India)

Schedule H

Routes

Oral

Formulations

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.

Adult indications

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

2. 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

3. 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 indications

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

Renal Adjustments

eGFR (mL/min/1.73m²)	Recommendation
>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

eGFR (mL/min/1.73m²)	Recommendation
>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.

Hepatic adjustment

Contraindications

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)

Cautions

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

Pregnancy

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

Lactation

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

Elderly

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.

Major drug interactions

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

Moderate drug interactions

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

Common Adverse effects

Dry mouth
Headache
Abdominal cramps, bloating
Diarrhoea
Drowsiness (less frequent than metoclopramide)
Breast tenderness
Reduced libido

Serious Adverse effects

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

Monitoring requirements

Timing	Parameters
Baseline	ECG (mandatory if age >60 years, concurrent QT-prolonging drugs, cardiac history, electrolyte disturbance, or planned duration >7 days); serum electrolytes (K⁺, Mg²⁺); renal function; cardiac history assessment
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

Brands in India

Single Ingredient:

Domstal (Torrent)
Vomistop (Cipla)
Motilium (Johnson & Johnson)
Domperi (Micro Labs)
Domcolic (Alkem)
Peridone (Ipca)
Omidom (Mankind)

Fixed Dose Combinations (FDCs):

Domperidone + Pantoprazole (Pan-D, Pantodac-D)
Domperidone + Omeprazole (Omez-D)
Domperidone + Rabeprazole (Razo-D)

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.

Price range (INR)

Formulation	Price Range
Tablet 10 mg	₹1.50–4 per tablet
Dispersible tablet 10 mg	₹2–5 per tablet
Suspension 1 mg/mL (30 mL)	₹25–45 per bottle
Suspension 1 mg/mL (60 mL)	₹40–70 per bottle
Drops 5 mg/mL (10 mL)	₹30–50 per bottle

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

Clinical pearls

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.
Dose ceiling: Keep total daily dose ≤30 mg (10 mg TID) in adults. Higher doses substantially increase QT prolongation risk without proportionate benefit increase.
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.
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.
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.
Macrolide interaction: If macrolide antibiotic is essential, use azithromycin (lower CYP3A4 inhibition and QT effect) rather than erythromycin or clarithromycin. Still exercise caution.

Version

RxIndia v1.0 — 05 Jan 2025

Reference

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

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This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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