MOTILIUM 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

Short-term treatment of nausea and vomiting (including nausea/vomiting associated with dopaminergic therapy in Parkinson’s disease where applicable).

Off-Label Uses

Gastroparesis (symptomatic prokinetic use); promotion of lactation (galactagogue).

Dosage & Administration

Initial Dose

10mg up to 3 times daily, taken 15-30 minutes before meals

Maintenance Dose

10mg up to three times per day.

Children's Dosage

Children ≥12 years and body weight ≥35kg: 10mg up to 3 times daily (same as adults). For children <12 years or <35kg: oral suspension 0.25mg/kg up to 3 times daily; not recommended in neonates due to immature metabolic function

Side Effects

Common Side Effects

Dry mouth; headache; diarrhea; somnolence/drowsiness; hyperprolactinaemia-related effects (e.g., galactorrhoea, breast tenderness, gynaecomastia, amenorrhoea).

Side Effect Frequency

Common: dry mouth. Uncommon: headache, diarrhea, somnolence/drowsiness, hyperprolactinaemia-related effects (e.g., galactorrhoea, breast tenderness, gynaecomastia, amenorrhoea). Rare/very rare: extrapyramidal effects; serious cardiac events including QT prolongation/ventricular arrhythmias/sudden cardiac death (risk increased with higher doses, older age, and CYP3A4 inhibitors).

Safety & Warnings

Age Restriction

Film‑coated 10 mg tablets are not recommended in children <12 years or weighing <35 kg; in older adults (especially >60 years) use only if clearly needed at the lowest effective dose for the shortest duration due to higher cardiac risk.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: (1) QT‑prolonging drugs (additive QT/TdP risk); (2) potent CYP3A4 inhibitors (increase domperidone levels and QT risk); (3) antacids/antisecretory agents can reduce absorption if taken together-separate dosing; (4) anticholinergics may reduce prokinetic effect.

Food Interaction

Take 15-30 minutes before meals (i.e., on an empty stomach).

Special Populations

Breastfeeding

Caution

Children

Children ≥12 years and body weight ≥35kg: 10mg up to 3 times daily (same as adults). For children <12 years or <35kg: oral suspension 0.25mg/kg up to 3 times daily; not recommended in neonates due to immature metabolic function

Elderly

Use with caution in patients >60 years due to increased risk of QT prolongation and cardiac arrhythmias; use lowest effective dose for shortest duration

Kidney Impairment

No adjustment is usually needed in mild renal impairment; in severe renal impairment (e.g., CrCl <30 mL/min), reduce dosing frequency to once or twice daily and consider dose reduction with prolonged therapy, with close monitoring.

Liver Impairment

Mild impairment: No adjustment needed. Moderate-to-severe impairment: Contraindicated.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is nearly time for the next dose. Do not double the dose

Overdose

Symptoms may include drowsiness/somnolence, disorientation/altered consciousness, agitation, extrapyramidal reactions, and rarely seizures/convulsions; management is supportive with consideration of activated charcoal (and/or gastric decontamination if early), ECG monitoring for QT prolongation/arrhythmias, and anticholinergic/antiparkinson agents for extrapyramidal symptoms.

Pharmacology

Mechanism of Action

Peripherally selective dopamine D2 receptor antagonist (limited CNS penetration) that enhances upper GI motility and exerts antiemetic action via blockade of D2 receptors in the chemoreceptor trigger zone (area postrema).

Half-Life

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

Bioavailability

Low oral bioavailability ~13-17% (often cited ~15%) due to 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 but are not the main pathway).

Product Information

Available Dosage Forms

For this SFDA-registered product: Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 10mg domperidone

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Gi Condition

Nausea/Vomiting

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.