[Drug Name] Genetic Name: Ursodeoxycholic Acid Tablets 
　　　　　　English Name: Ursodeoxycholic Acid Tablets 
　　　　　　Chinese Pinyin: Xiongquyangdansuan pian 
[Compositions] The main component of the medicine is ursodeoxycholic acid, 
　　Chemical name: 3α, 7β-dihydroxy-5β-cholestan-24-oic acid. 
Chemical Structural Formula: 

　　　　　　Molecular Formula: C24H40O4
　　Molecular Weight: 392.58 
[Description] The medicine is a white tablet. 
[Indications] The medicine is not only used for cholesterol type gallstones, formation and bile deficiency steatorrhea, but also for the prevention of drug-induced stone formation and treatment of steatorrhea (after taken the ileal resection). 
[Specification] 50 mg 
[Dosage and Administration] Adults: orally, 8 to 10 mg/kg daily in divided doses with morning and evening meals. The shortest course of treatment lasts 6 months; after 6 months, under ultrasound examination and if there is no improvement on cholecystography, it can be suspended; if the stone has been partially dissolved, continue to take medicine until the stone is completely dissolved. 
[Adverse Reactions] With less toxicity and side effects than chenodeoxycholic acid, the medicine generally does not induce diarrhea. Other occasional adverse reactions include constipation, allergy, headache, dizziness, pancreatitis and tachycardia. 
[Contraindications] Patients with complete biliary obstruction and severe hepatic dysfunction are prohibited to take the medicine. 
[Precautions] 
　　(1) Long-term use of the medicine may increase the number of peripheral platelets. 
　　(2) In treating patients with cholesterol stones repeatedly onset biliary colic without improvement but even aggravated, or observe obvious stone calcification, the treatment should be discontinued and replaced by surgery. 
　　(3) The medicine cannot dissolve bile pigment stones, mixed stones and radiopaque stones. 
[Use in Pregnant and Lactating Women] 
　　Classified into Class B drug by FDA, the medicine should be used with caution in pregnant and lactating women. 
[Pediatric Use] No reliable references, unknown. 
[Geriatric Use] Use with caution in elderly. 
[Drug Interactions] 
　　(1) Contraceptive pills can increase bile saturation, and other birth control measures should be taken as far as possible to avoid affecting the efficacy of treatment with the medicine. 
　　(2) Cholestyramine, colestipol and aluminum-based antacids bind to CDCA and reduce the medicine absorption, which should not be taken at the same time. 
[Overdosage] 
　　In case of overdose, gastric lavage with not less than 1 liter of cholestyramine or activated charcoal (2g per 100 mL of water) immediately and then orally taken 50 mL of oral aluminum hydroxide suspension. 
[Pharmacology and Toxicology] 
　　The medicine can increase the secretion of bile acids, at the same time changing bile acid composition, thus the content of the medicine in the bile increased. Moreover, it can also meaningfully reduce the molar concentration of cholesterol and cholesterol ester, and saturation index of cholesterol in human bile, which is beneficial to the gradual dissolution of cholesterol in stones. 
[Pharmacokinetics] 
　　Ursodeoxycholic acid is a weak acid with a pKa of about 6.0 when microcapsules accumulate, which is mainly absorbed from the ileum after oral administration. It is absorbed by 5% to 60% when passing through the liver, which is significantly lower than that of chenodeoxycholic acid (CDCA), and only a small amount of drug enters the systemic circulation. Two peaks of plasma concentrations presented at the 1st and 3rd hours after orally taken respectively. The effects of UDCA do not depend on the plasma concentration but on the concentration of the drug in the bile. T1/2 is 3.5 to 5.8 days. Rapidly conjugated with glycine or taurine in the liver, excreted from the bile into the small intestine, UDCA participates in the hepatic circulation. A part of the conjugated UDCA in the small intestine reverts to its free form upon hydrolysis, and another portion is converted to lithocholic acid by bacteria, which in turn is sulfated, thereby reducing its potential liver toxicity. 
[Storage] Seal up. 
[Package] Oral solid medicinal high-density polyethylene bottles. 30 tablets/bottle × 20 bottles/box. 
[Shelf Life] 60 months. 
[Executive Standard] Chinese Pharmacopoeia (2015), Volume II. 
[Approval No.]: GYZZ H21022060 
[Manufacturer] 
　　Company Name: Panjin Hengchanglong Pharmaceutical Co., Ltd. 
　　Manufacturing Add.: Ping’an Town, Dawa County, Panjin City 
　　Post Code: 124207 
　　Phone No.: 0427-8854288 
　　Fax No.: 0427-6888502 
　　Website: www.hclyy.com.cn