Domperidone

 

1. Generic & Brand Names

• Generic: Domperidone

• Brands: Motilium® (Global), Domstal® (India), Nauzelin® (JP)

• Formulations:

  • Tablets (10mg)

  • Oral suspension (1mg/mL)

  • Suppositories (30mg) rare

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2. Drug Class & Mechanism

• Class: Dopamine D₂-receptor antagonist

• Mechanism:

  • Blocks dopamine receptors in the chemoreceptor trigger zone (CTZ) → antiemetic

  • Enhances gastric motility → prokinetic for bloating

• NO CNS penetration (unlike metoclopramide) → fewer neurological side effects

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3. Approved Uses (Varies by Country)

Condition	Approved Regions
Nausea/Vomiting	EU, Canada, Asia
Gastroparesis	Limited approval (UK, AU)
Lactation Stimulation	Off-label globally
Functional Bloating	Off-label

⚠️ Banned in the USA by FDA (cardiac risks)

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4. Dosing Guidelines

Indication	Adult Dose	Max Duration
Nausea	10-20 mg TID-QID	≤1 week
Bloating	10 mg TID before meals	≤4 weeks
Lactation	10-20 mg TID	Short-term
Critical Rules:

• Max 30mg/day (cardiac risk ↑ with higher doses)

• Take 15-30 min BEFORE meals

• Avoid in patients >60 years (↑ arrhythmia risk)

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5. Black Box Warnings (EMA/FDA)

1. QT Prolongation → Torsades de Pointes

   • Risk ↑ with:

     • Dose >30mg/day

     • Pre-existing heart disease

     • Concomitant QT-prolonging drugs

2. Sudden Cardiac Death

   • Cases reported even with normal doses

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6. Side Effects

Common (≥5%)	Serious (Discontinue Immediately)
Dry mouth	Cardiac arrhythmias
Headache	Seizures (rare)
Abdominal cramps	Hyperprolactinemia → galactorrhea, gynecomastia
Diarrhea	Neuroleptic malignant syndrome (rare)

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7. Absolute Contraindications

• Cardiac conditions:

  • Prolonged QTc (>450ms), heart failure, significant electrolyte imbalances

• Concomitant use with:

  • QT-prolonging drugs (amiodarone, fluoroquinolones)

  • Strong CYP3A4 inhibitors (ketoconazole, clarithromycin)

• GI hemorrhage/obstruction

• Prolactinoma

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8. Drug Interactions

Medication	Risk	Action
CYP3A4 Inhibitors	↑ Domperidone 3-5x → arrhythmias	Absolute contraindication
Antipsychotics	↑ QT prolongation	Avoid combo
Anticholinergics	↓ Prokinetic effect	Separate doses

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9. Special Populations

Group	Recommendation
Children	Avoid <12 years (no safety data)
Elderly	Avoid >60 years (↑ cardiac risk)
Pregnancy	Category C (avoid unless critical)
Lactation	Short-term use only; monitor infant

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10. Current Regulatory Status

Region	Status	Restrictions
USA	❌ Not approved (banned)	Import for IND use only
EU/UK	⚠️ Restricted (max 10mg TID ≤1 week)	ECG required before prescribing
Canada	⚠️ Warning: Cardiac risks	Max 30mg/day
India	✅ Available (OTC in some states)	No ECG mandate

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Safer Alternatives

Symptom	First-Line Alternatives
Nausea	Ondansetron, Ginger (250-1000mg)
Bloating	Simethicone, Probiotics, Peppermint oil
Gastroparesis	Metoclopramide (short-term), Prucalopride

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Clinical Recommendations

⚠️ Use ONLY If:

• Other antiemetics failed AND

• Normal baseline ECG/QTc AND

• No CYP3A4 inhibitor use AND

• Dose ≤30mg/day

✅ Monitoring Required:

• ECG at baseline, after 3 days, and weekly if chronic use

• Serum potassium/magnesium

• Signs of arrhythmia (palpitations, syncope)

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Patient Counseling

1. "Stop immediately for:

   • Fainting/fast heartbeat

   • Breast swelling/milk leakage (males/females)"

2. "Avoid grapefruit juice (inhibits CYP3A4)."

3. "Do NOT exceed 3 doses/day."

4. "Seek alternatives for long-term bloating (diet/lifestyle changes)."

⚠️ Red Flag: Combining domperidone with erythromycin, fluconazole, or amiodarone may cause fatal arrhythmias.

Prescribing Note: In available regions, limit prescriptions to 1-week supply. Report cardiac adverse events to local pharmacovigilance authorities.

Sources: EMA (2014), Health Canada (2015), FDA Import Alert 66-83.