Product Overview
[Drug Name]
Generic Name: Prucalopride Succinate Tablets
Trade Name: Ruiyisheng Prucalopride Succinate Tablets 2mg*7 Tablets
Pinyin Full Code: RuiYiSheng ZuoZuoSuanPuLuKaBiLiPian 2mg*7 Tablets
[Main Ingredient]
Prucalopride succinate.
[Indications/Main Functions]
For the treatment of chronic constipation in adult female patients that is inadequately relieved by laxatives.
[Specifications]
2mg*7 tablets
[Dosage and Administration]
Usage: Oral. Can be taken at any time of day, before or after meals. Adults: Take 2 mg once daily. Elderly patients (>65 years): Start with 1 mg once daily. Increase to 2 mg once daily if needed. Children and Adolescents: This product is not recommended for children or adolescents under 18 years of age. Patients with Renal Impairment: For patients with severe renal impairment (GFR < mL/min/1.73 m²), the dose is 1 mg once daily. No dose adjustment is required for patients with mild to moderate renal impairment. Patients with Hepatic Impairment: For patients with severe hepatic impairment (Child-Pugh class C), the dose is 1 mg once daily. No dose adjustment is required for patients with mild to moderate hepatic impairment. Given the specific prokinetic mechanism of action of this drug, daily doses exceeding 2 mg may not increase efficacy. If this drug is ineffective after 4 weeks of treatment, the patient should be reassessed and the benefit of continued treatment reconsidered. This drug has demonstrated good efficacy in double-blind, placebo-controlled studies of up to 3 months. If treatment is extended, patients should be regularly assessed for benefit.
Adverse Reactions
The most commonly reported adverse reactions related to drug treatment are headache and gastrointestinal symptoms (diarrhea, abdominal pain, or nausea), each occurring in approximately 20% of patients. These adverse reactions mostly occur during the initial phase of treatment and generally resolve after several days of continued treatment. Other adverse reactions have been reported occasionally. Most adverse reactions are mild to moderate.
[Contraindications]
Patients with hypersensitivity to the active ingredient or any of the excipients. Patients with renal impairment requiring dialysis. Patients with intestinal perforation or obstruction due to structural or functional abnormalities of the intestinal wall, occlusive ileus, or severe inflammatory bowel diseases such as Crohn's disease, ulcerative colitis, and toxic megacolon/megarectum. Prucalopride succinate tablets are contraindicated in patients who have recently undergone intestinal surgery.
[Precautions]
See package insert for details.
