Cidine Cisapride Tartrate Tablets

1. Indications and Usage
Gastrointestinal Motility: Treatment of dyspepsia characterized by feelings of fullness, abdominal bloating, distension, pain, nausea, and vomiting.
Symptomatic Relief: Used to alleviate symptoms associated with delayed gastric emptying and upper gastrointestinal motility disorders.
2. Dosage and Administration
Adults: The usual dosage is 1 tablet (10 mg) taken 3 times daily, approximately 15 to 30 minutes before meals.
Maximum Daily Dose: Do not exceed 30 mg per day.
Duration: For self-medication, the duration should generally not exceed 1 week unless directed by a physician.
Administration: Swallow tablets whole with water.
3. Mechanism of Action
Dopamine Antagonism: Domperidone acts as a selective antagonist at dopamine D2 receptors in the chemoreceptor trigger zone (CTZ) and the gastrointestinal tract.
Prokinetic Effects: By blocking dopamine receptors in the gut, it enhances the tone and coordination of gastrointestinal contractions, accelerating gastric emptying and intestinal transit.
Anti-emetic Effects: Inhibition of dopamine receptors in the CTZ reduces nausea and vomiting without affecting central nervous system functions to a significant degree.
4. Safety and Warnings
Contraindications: Contraindicated in patients with gastrointestinal hemorrhage, mechanical obstruction, or perforation. Also contraindicated in patients with prolactin-secreting pituitary tumors.
Cardiac Risk: There is a risk of QT interval prolongation and serious ventricular arrhythmias. It should not be used in patients with known cardiac arrhythmias, electrolyte imbalances, or those taking other QT-prolonging drugs.
Special Populations: Use with caution in patients with hepatic impairment (dose adjustment may be required). Safety in children and pregnant women should be carefully evaluated.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Dry mouth, headache, diarrhea, abdominal cramps, and rash may occur occasionally.
Endocrine Effects: Galactorrhea, gynecomastia, and menstrual irregularities may occur due to increased prolactin secretion.
Serious Risks: Cardiac adverse reactions, including QT prolongation, ventricular arrhythmias, and sudden cardiac death, have been reported, particularly in patients with pre-existing cardiac conditions.
6. Drug Interactions
QT-Prolonging Drugs: Concomitant use with drugs known to prolong the QT interval (e.g., antiarrhythmics, macrolide antibiotics, antipsychotics) is contraindicated due to increased risk of arrhythmias.
Anticholinergics: May antagonize the prokinetic effects of domperidone.
CYP3A4 Inhibitors: Drugs that inhibit CYP3A4 (e.g., ketoconazole, itraconazole) may increase plasma concentrations of domperidone.
7. Pharmaceutical Information
Active Ingredient: Domperidone Maleate.
Strength: Each tablet typically contains 10 mg of domperidone maleate.
Appearance: Tablets are usually white or off-white.
Storage: Store in a well-closed, light-resistant container, protected from moisture, at temperatures not exceeding 25°C.