Resolor Prucalopride Succinate Tablets

1. Indications and Usage
Chronic Constipation: Treatment of chronic constipation in adult women who have not been sufficiently relieved by laxatives.
2. Dosage and Administration
Recommended Dose: The typical dosage is 2 mg once daily for adults.
Special Populations: The starting dose for elderly patients (>65 years) is 1 mg once daily, which may be increased to 2 mg once daily if necessary. For patients with severe renal impairment (GFR <30 mL/min/1.73m²) or severe hepatic impairment (Child-Pugh C class), the dose should be 1 mg once daily.
Administration: Oral administration, irrespective of meals.
Duration: If the treatment is ineffective after 4 weeks, the patient should be re-evaluated.
3. Mechanism of Action
Target: Prucalopride is a high-affinity, selective agonist of serotonin 5-HT4 receptors.
Action: It enhances gastrointestinal motility by activating 5-HT4 receptors, thereby increasing peristaltic reflexes and propulsive motor patterns in the gut.
4. Safety and Warnings
Contraindications: Contraindicated in patients with intestinal perforation, obstruction, or ileus; severe inflammatory bowel disease; or recent bowel surgery.
Gastrointestinal Events: Severe diarrhea may occur. If severe diarrhea develops, treatment should be stopped immediately.
Cardiac Risks: Use with caution in patients with a history of cardiac arrhythmias or ischemic cardiovascular disease.
5. Adverse Reactions and Clinical Research
Adverse Reactions: The most common adverse reactions are headache and gastrointestinal symptoms (diarrhea, abdominal pain, or nausea), each occurring in approximately 20% of patients. These usually resolve after a few days of continued use.
Clinical Research: Clinical trials have demonstrated good efficacy and safety in patients with chronic constipation.
6. Drug Interactions
CYP3A4 Inhibitors: Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) may increase the exposure to prucalopride.
Oral Contraceptives: Severe diarrhea may reduce the efficacy of oral contraceptives; alternative contraceptive methods are recommended during episodes of severe diarrhea.
Digoxin: Prucalopride may increase the plasma concentration of digoxin; close monitoring of digoxin levels is advised.
7. Pharmaceutical Information
Composition: The active ingredient is prucalopride succinate.
Excipients: Includes lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Appearance: White or off-white film-coated tablets.
Storage: Store in a sealed container, protected from moisture.