Motilium (domperidone) is a dopamine antagonist medication specifically designed to address impaired gastric motility and associated upper gastrointestinal symptoms. As a peripherally selective agent, it enhances coordination between the stomach and duodenum while increasing lower esophageal sphincter tone. This comprehensive product card provides healthcare professionals with detailed information regarding its pharmacological profile, clinical applications, and safety considerations to support informed prescribing decisions.

Features

• Active ingredient: Domperidone 10mg per tablet
• Mechanism: Selective dopamine D₂ and D₃ receptor antagonist
• Peripheral action: Limited blood-brain barrier penetration
• Formulation: Oral tablets with rapid disintegration properties
• Pharmacokinetics: Peak plasma concentration within 30-60 minutes
• Half-life: Approximately 7-9 hours in healthy adults
• Metabolism: Hepatic via CYP3A4 isoenzyme system
• Excretion: Primarily fecal (66%) with renal elimination (30%)

Benefits

• Accelerates gastric emptying and improves gastroduodenal coordination
• Reduces symptoms of nausea and vomiting through central chemoreceptor trigger zone action
• Decreases postprandial fullness and early satiety in functional dyspepsia
• Improves upper gastrointestinal symptoms without significant central nervous system effects
• Provides predictable pharmacokinetic profile with dose-dependent response
• Offers favorable safety profile compared to metoclopramide regarding extrapyramidal effects

Common use

Motilium is primarily indicated for the relief of symptoms associated with delayed gastric emptying, including chronic postprandial dyspeptic symptoms such as fullness, early satiety, bloating, and epigastric pain. It is commonly prescribed for diabetic gastroparesis, functional dyspepsia, and nausea/vomiting of various etiologies. The medication demonstrates particular efficacy in managing symptoms refractory to conventional antiemetic therapy and finds application in pediatric gastroenterology for persistent vomiting. Clinical studies support its use in lactation stimulation through prolactin elevation, though this represents an off-label application requiring careful benefit-risk assessment.

Dosage and direction

Adults and adolescents (12 years and older, ≥35 kg): 10-20 mg (1-2 tablets) three to four times daily, taken 15-30 minutes before meals and at bedtime. Maximum daily dose: 80 mg.

Children (≥12 kg to <35 kg): 0.25-0.5 mg/kg body weight three to four times daily. Maximum single dose: 10 mg; maximum daily dose: 2.4 mg/kg, not exceeding 80 mg.

Administration: Tablets should be taken with water before meals for optimal effect. Duration of treatment should not exceed one week for nausea and vomiting indications without reevaluation. For chronic conditions, periodic assessment of continued therapy necessity is recommended.

Dosage adjustment required in hepatic impairment: Reduce frequency to once or twice daily with careful monitoring. Not recommended in severe hepatic impairment (Child-Pugh Class C).

Precautions

Cardiac monitoring is advised in patients with underlying cardiac conditions or electrolyte disturbances due to potential QTc interval prolongation. Hepatic function should be assessed before initiation and periodically during prolonged therapy. Use with caution in patients receiving concomitant CYP3A4 inhibitors, requiring dose reduction or alternative therapy. Elderly patients may require lower doses due to potential decreased clearance. Pregnancy Category C: Use only if potential benefit justifies potential risk to fetus. Breastfeeding: Domperidone transfers into breast milk; monitor infant for potential effects. Discontinue immediately if neurological symptoms develop.

Contraindications

Known hypersensitivity to domperidone or any excipients. Prolactin-releasing pituitary tumor (prolactinoma). Moderate to severe hepatic impairment. Concomitant use with potent CYP3A4 inhibitors including ketoconazole, erythromycin, and protease inhibitors. Conditions where cardiac conduction is impaired, especially prolonged QTc interval (>450 ms in males, >470 ms in females). Significant electrolyte disturbances (hypokalemia, hypomagnesemia). Existing ventricular arrhythmias or history of serious ventricular arrhythmias. Severe renal impairment (CrCl <30 mL/min).

Possible side effect

Common (≥1/100 to <1/10): Headache, dry mouth, abdominal cramps, diarrhea, nervousness, drowsiness, fatigue, breast tenderness, galactorrhea, menstrual irregularities.

Uncommon (≥1/1,000 to <1/100): Extrapyramidal symptoms (usually dose-related), dizziness, insomnia, thirst, rash, pruritus.

Rare (<1/1,000): Anaphylactic reactions, angioedema, urinary retention, convulsions, hepatic enzyme elevation, gynecomastia, cardiac arrhythmias including ventricular tachycardia.

Post-marketing reports: QT prolongation, torsades de pointes, sudden cardiac death (primarily in patients with risk factors or exceeding recommended doses).

Drug interaction

CYP3A4 inhibitors: Ketoconazole, fluconazole, voriconazole, clarithromycin, erythromycin, ritonavir, saquinavir - significantly increase domperidone exposure. Contraindicated.

CYP3A4 inducers: Rifampicin, carbamazepine, phenytoin - may decrease domperidone efficacy.

Anticholinergic agents: May antagonize prokinetic effects.

Dopaminergic agents: Levodopa, bromocriptine - potential mutual antagonism.

QT-prolonging drugs: Class IA/III antiarrhythmics, antipsychotics, antidepressants, fluoroquinolones - additive effect on QT interval.

Gastric pH modifiers: Antacids, H2-receptor antagonists, PPIs - no clinically significant interaction.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. Do not double the dose to make up for a missed administration. Maintain regular dosing schedule and consult healthcare provider if multiple doses are missed. For patients using Motilium on an as-needed basis for nausea, take at onset of symptoms rather than on fixed schedule.

Overdose

Symptoms: Drowsiness, disorientation, extrapyramidal reactions, agitation, seizures, QT prolongation, cardiac arrhythmias.

Management: Gastric lavage and activated charcoal if presented within 1 hour. Supportive care including ECG monitoring for至少 24 hours. Treat extrapyramidal symptoms with anticholinergic agents (e.g., biperiden). Arrhythmias may require magnesium sulfate or other antiarrhythmic therapy. No specific antidote exists. Hemodialysis is not effective due to high protein binding.

Storage

Store below 30°C in original packaging to protect from moisture and light. Keep out of reach of children. Do not use after expiration date printed on packaging. Tablets should remain in blister strips until administration to maintain stability. Do not transfer to alternative containers. Discard any tablets showing signs of deterioration or discoloration.

Disclaimer

This information is intended for healthcare professionals and should not replace clinical judgment. Prescribers should consult full prescribing information and current clinical guidelines. Dosage and administration must be individualized based on patient characteristics and response. The prescriber should be familiar with the most recent safety information, including cardiac risk considerations. Patients should be advised to report any cardiac symptoms immediately. Regulatory status and approved indications may vary by country.

Reviews

Clinical evidence summary: Multiple randomized controlled trials demonstrate significant improvement in gastric emptying parameters and symptom scores compared to placebo. Systematic reviews support efficacy in functional dyspepsia with number needed to treat of 7 for global symptom improvement. Real-world evidence confirms benefit in diabetic gastroparesis with favorable tolerability profile. Cardiac safety concerns have led to restricted use in certain populations, emphasizing need for appropriate patient selection.

Expert consensus: Gastroenterologists recognize Motilium as a valuable option for motility disorders when used according to guidelines. The European Society for Neurogastroenterology and Motility recommends domperidone as second-line therapy for functional dyspepsia. International guidelines emphasize cardiac risk assessment and avoidance in high-risk populations. Ongoing pharmacovigilance continues to inform optimal risk-benefit balance.