Product Overview
[Drug Name]
Generic Name: Ursodeoxycholic Acid Tablets
Trade Name: Xinyi
English Name: Ursodeoxycholic Acid Tablets
Chinese Pinyin: Xiongquyangdansuan Pian
[Ingredients]
The main ingredient of this product is ursodeoxycholic acid. Its chemical name is 3,7-dihydroxy-5,2-cholestane-2,4-oic acid.
[Properties]
Ursodeoxycholic acid is a white crystalline powder, odorless, and bitter. It is virtually insoluble in water, freely soluble in ethanol and glacial acetic acid, slightly soluble in ethanol, and very slightly soluble in ether. It appears as a white tablet.
[Indications]
This product is used for the treatment of cholesterol gallstones and cholestatic steatorrhea. It can also be used to prevent drug-induced gallstone formation and treat steatorrhea (after ileal resection).
[Dosage and Administration]
Oral administration, choleretic: 50 mg (1 tablet) once, 150 mg (3 tablets) per day; gallstone dissolving: 450-600 mg (9-12 tablets) per day, divided into 2 doses; or 8-10 mg/kg per day according to body weight, 15 mg/kg per day for obese patients, divided into 2 doses during meals. [Adverse Reactions] This product has less toxicity and side effects than chenodeoxycholic acid and generally does not cause diarrhea. Other occasional adverse reactions include constipation, allergies, headache, dizziness, pancreatitis and tachycardia. Gallstone calcification and soft stools may occur during treatment. [Contraindications] Acute biliary infection, biliary obstruction, pregnant and lactating women. [Precautions] (1) Long-term use of this product may increase the number of peripheral platelets. (2) If recurrent biliary colic occurs during the treatment of cholesterol stones, the symptoms do not improve or even worsen, or if obvious stone calcification occurs, treatment should be discontinued and surgery should be performed. (3) This product cannot dissolve bile pigment stones, mixed stones, and stones that are not radiopaque.
[Use in pregnant and lactating women]
This product is classified as a Class B drug by the FDA and should be used with caution in pregnant and lactating women.
[Use in elderly patients]
Use with caution in elderly patients.
[Use in special populations]
Precautions for children: This experiment has not been conducted and there are no reliable references.
Precautions for pregnancy and lactation: This product is contraindicated in pregnant and lactating women.
Precautions for the elderly: This product should be used with caution in elderly patients.
[Drug interactions]
Ursodeoxycholic acid capsules should not be taken simultaneously with drugs such as cholestyramine (cholestyramine), colestipol (cholestyramine), aluminum hydroxide and/or aluminum hydroxide-magnesium trisilicate, because these drugs can bind to ursodeoxycholic acid in the intestine, thereby hindering absorption and affecting efficacy. If taking the above medications is necessary, ursodeoxycholic acid capsules should be taken two hours before or two hours after taking the above medications. Ursodeoxycholic acid capsules can increase intestinal absorption of cyclosporine. Patients taking cyclosporine should monitor cyclosporine serum concentrations and adjust their cyclosporine dosage as necessary. In some cases, ursodeoxycholic acid capsules can reduce the absorption of ciprofloxacin.
[Pharmacological Action]
Ursodeoxycholic acid constitutes a small fraction of human bile. Oral administration of ursodeoxycholic acid reduces cholesterol saturation in bile by inhibiting intestinal cholesterol reabsorption and reducing cholesterol secretion into bile. This may result in the gradual dissolution of cholesterol stones due to the dispersion of cholesterol and the formation of liquid crystals. Based on current knowledge, the effectiveness of ursodeoxycholic acid capsules in treating liver and cholestatic diseases is primarily based on the relative replacement of lipophilic, detergent-like, toxic bile acids with hydrophilic, cytoprotective, and non-cytotoxic ursodeoxycholic acid, thereby promoting hepatocyte secretion and immune regulation.
Storage: Protect from light and store in a sealed container.
Specifications: 50 mg
Packaging: 50 mg x 30 seconds
Validity Period: 48 months
Approval Number: National Medicine Standard H31021875
Manufacturer: Shanghai Xinyi Pharmaceutical Co., Ltd.
