Active Ingredient

Motilium contains domperidone as its active ingredient. Domperidone is a dopamine antagonist that facilitates gastrointestinal motility. The chemical structure is C22H24ClN5O2.

Mechanism of Action

Domperidone works by blocking dopamine receptors in the gut. This inhibition enhances the motility of the gastrointestinal tract, allowing for smoother passage of food. It also facilitates an increase in the amplitude of gastric contractions.

Therapeutic Indications

Motilium is indicated for relief of symptoms associated with chronic and subacute gastritis. It also alleviates nausea and vomiting of various etiologies, including those induced by chemotherapy or radiotherapy. Motilium is used for treating gastrointestinal dysmotility and gastroparesis.

Pharmacokinetics

Motilium is rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations occur at approximately 30 minutes post-administration. Domperidone has a bioavailability of about 15% due to first-pass metabolism in the liver. It is primarily metabolized by CYP3A4 enzymes.

Dosage and Administration

Adults and adolescents a dose of 10 mg, one to three times daily, is recommended. Maximum daily dose should not exceed 30 mg. It should be taken 15 to 30 minutes before meals.

Formulations Available

Motilium is available in tablet form, as well as an oral suspension. Tablets come in a 10 mg dosage. The oral suspension concentration is usually 1 mg/mL. Both forms are suitable for patients having difficulty swallowing pills.

Contraindications

Motilium is contraindicated in patients with known hypersensitivity to domperidone. It should not be used in patients with prolactinoma or other prolactin-releasing pituitary tumors. Contraindicated in patients with moderate to severe hepatic impairment.

Drug Interactions

Domperidone is metabolized by the cytochrome P450 enzyme CYP3A4. Concomitant use of strong CYP3A4 inhibitors such as ketoconazole, ritonavir, and erythromycin is not recommended. It may also interact with anticholinergic medications reducing its efficacy.

Side Effects

Common side effects include dry mouth, headache, and gastrointestinal disturbances such as abdominal cramps or diarrhea. Rare side effects may include allergic reactions, galactorrhea, gynecomastia, and amenorrhea. Long QT syndrome cases are reported, especially with high doses.

Special Population Use

In elderly patients, careful monitoring for side effects is necessary. Dose adjustment may be required. Use during pregnancy should be evaluated based on the risk-benefit ratio as domperidone is excreted in small amounts in breast milk.

Storage Conditions

Store Motilium at room temperature between 15°C to 30°C. Keep away from light and moisture. Ensure it is kept out of reach of children and pets to prevent accidental ingestion.

Patient Counseling

Advise patients to take Motilium before meals. Alert them about potential side effects such as dry mouth and gastrointestinal disturbances. Instruct them to report any symptoms of heart rhythm disturbances immediately. Emphasize the importance of not exceeding the prescribed dose.

Monitoring Parameters

Regular monitoring of liver function tests is recommended during prolonged treatment. ECG monitoring may be required for patients at risk of long QT syndrome. Assess efficacy in symptomatic control of nausea and gastrointestinal disturbances periodically.

Administration Tips

Swallow tablets whole with a glass of water. Do not crush or chew tablets. If administering the oral suspension, shake the bottle well before use to ensure the uniform dispersion of domperidone. Use a proper measuring device for accurate dosing.

Dietary Considerations

Advise patients to avoid alcoholic beverages as alcohol may exacerbate gastrointestinal side effects. Encourage a balanced diet to support gastrointestinal health. Consumption of small frequent meals can help manage symptoms efficiently.

Research and Studies

Clinical studies have demonstrated the efficacy of domperidone in treating symptoms of gastroparesis and functional dyspepsia. Research indicates a favorable safety profile with short-term use. Long-term safety remains a subject of ongoing research.

Legal and Regulatory Status

Motilium is classified as a prescription-only medication in many jurisdictions. It is approved by various regulatory agencies including the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA). Approval status may vary by country.