DOMPY 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

Short-term treatment of nausea and vomiting (oral domperidone 10 mg tablets).

Off-Label Uses

Galactagogue (to increase breast milk supply); sometimes used for gastroparesis/functional dyspepsia where permitted, but these uses are off-label and risk-benefit must be carefully assessed.

Dosage & Administration

Dosing by Condition

Nausea/vomiting (adults/adolescents ≥12 years and ≥35 kg): 10 mg up to three times daily, preferably 15-30 minutes before meals; maximum 30 mg/day; generally short-term use (often ≤7 days) with reassessment if symptoms persist.

Initial Dose

10 mg up to three times daily, taken 15-30 minutes before meals.

Maintenance Dose

10 mg up to three times daily, taken 15-30 minutes before meals.

Maximum Dose

30 mg per day.

Children's Dosage

Children weighing ≥35kg: 10mg up to three times daily. Children <35kg: 0.25mg/kg per dose up to three times daily (use oral suspension). Not recommended in neonates due to incomplete metabolic function.

How to Take

Swallow tablet whole with water. Take 15-30 minutes before meals. Do not crush or chew.

Side Effects

Common Side Effects

Dry mouth; headache; diarrhea; somnolence/drowsiness; rash/pruritus; hyperprolactinaemia-related effects (e.g., breast tenderness, galactorrhoea, menstrual irregularities).

Side Effect Frequency

Common: dry mouth; Uncommon: headache, diarrhea, rash/pruritus, hyperprolactinemia-related effects (e.g., breast tenderness, galactorrhea, menstrual irregularities); Rare/very rare: somnolence/drowsiness, extrapyramidal symptoms (more in children), hypersensitivity reactions, QT prolongation/serious ventricular arrhythmias (risk increased with higher doses, older age, cardiac disease, electrolyte abnormalities, and CYP3A4 inhibitors).

Safety & Warnings

Age Restriction

Not recommended in children <12 years or <35 kg for this 10 mg tablet formulation; use only under specialist direction with weight-based dosing if used in younger children.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Avoid/contraindicated with QT-prolonging drugs and potent CYP3A4 inhibitors (e.g., ketoconazole/itraconazole, clarithromycin/erythromycin, ritonavir) due to increased arrhythmia risk; antacids/antisecretory agents can reduce absorption (separate dosing); anticholinergics and opioids may reduce prokinetic effect.

Food Interaction

Take 15-30 minutes before meals (food delays absorption and may reduce/slow onset).

Special Populations

Breastfeeding

Caution

Children

Children weighing ≥35kg: 10mg up to three times daily. Children <35kg: 0.25mg/kg per dose up to three times daily (use oral suspension). Not recommended in neonates due to incomplete metabolic function.

Elderly

Use lowest effective dose (10mg up to three times daily); increased risk of QT prolongation and cardiac events in patients over 60 years - reassess regularly

Kidney Impairment

In severe renal impairment, reduce dosing frequency to once or twice daily and use the lowest effective dose; mild impairment usually no adjustment.

Liver Impairment

Contraindicated in moderate to severe hepatic impairment; in mild impairment no routine dose adjustment but use with caution.

Storage & Patient Advice

Overdose

Symptoms: drowsiness, disorientation, agitation/altered consciousness, extrapyramidal reactions; management: urgent medical assessment, supportive care, consider activated charcoal if early, ECG monitoring for QT/arrhythmias, treat extrapyramidal symptoms with anticholinergic/antiparkinson agents as needed.

Patient Counseling

Take 10 mg 15-30 minutes before meals; do not exceed 3 tablets/day and use for the shortest time (often ≤1 week unless prescriber advises). Avoid combining with macrolide antibiotics/azole antifungals or other QT-prolonging medicines unless your prescriber confirms safety. Seek urgent care for palpitations, fainting, or irregular heartbeat. Report breast/milk secretion, breast enlargement, or menstrual changes. Store below 30°C.

Pharmacology

Mechanism of Action

Peripherally selective dopamine D2 receptor antagonist (also activity at D3) acting at the CTZ and GI tract to enhance gastric motility/emptying and provide antiemetic effect.

Half-Life

Terminal half-life ~7-9 hours; prolonged in severe renal impairment (reported up to ~20 hours).

Bioavailability

Approximately 15% oral bioavailability (extensive first-pass metabolism).

Metabolism

Extensive first-pass metabolism in the gut wall and liver, primarily via CYP3A4 (minor contributions from other CYPs may occur).

Product Information

Available Dosage Forms

Tablet (film-coated), oral use (this product).

Composition per Dose

Each film-coated tablet: 10mg domperidone

Generic Availability

Yes

Gi Condition

Nausea/Vomiting

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