Product Overview
[Drug Name]
Generic Name: Ursodeoxycholic Acid Capsules (C-terminal only)
Trade Name: Xuannuoxin Ursodeoxycholic Acid Capsules (C-terminal only) 250mg x 25 capsules
Pinyin Code: XuanNuoXin XiongQuYangDanSuanJiaoNang (JinXianCDuan) 250mg x 25Li
[Main Ingredient]
Chemical Name: 3α,7β-dihydroxy-5β-cholestane-24-oic acid. Molecular Formula: C24H4004. Molecular Weight: 392.58
[Properties]
This product is a white, opaque, hard capsule containing white powder or granules.
[Indications/Main Functions]
1. Cholesterol gallstones (must be X-ray-translucent and have normal gallbladder contraction); 2. Cholestatic liver disease (e.g., primary biliary cirrhosis); 3. Bile reflux gastritis.
[Specifications]
250mg*25 tablets
[Dosage and Administration]
1. For cholesterol gallstones and cholestatic liver disease: Take regularly with a small amount of water. The daily dose is 10mg/kg of body weight, i.e. (See instructions for details). Litholytic treatment: Generally requires 6-24 months. If the stones do not decrease in size after 12 months, discontinue use. Treatment results are assessed by ultrasound or X-ray examination every 6 months. 2. For bile reflux gastritis: Take one 250mg tablet (250mg) with water at night before bed. It must be taken regularly, once daily. Generally, take for 10-14 days. Continue taking the medication according to your doctor's advice.
Adverse Reactions:
Adverse reactions are assessed based on the following frequency data: Very Common: ≥10%
Common: ≥1%-<10%
Uncommon: >0.1%-<1%
Rare: ≥0.01%-<0.1%
Very Rare: <0.01% or data not available
Gastrointestinal Disorders: In clinical trials, reports of loose stools or diarrhea were common with ursodeoxycholic acid treatment. Severe right upper quadrant pain has rarely occurred with treatment of primary biliary cirrhosis. Hepatobiliary Disorders: Calcified gallstones have rarely occurred with ursodeoxycholic acid treatment. Decompensated cirrhosis has rarely occurred with treatment discontinuation in advanced primary biliary cirrhosis, with partial recovery after discontinuation of treatment. Allergic Reactions: Urticaria has rarely occurred.
[Contraindications]
Ursodeoxycholic acid capsules are contraindicated in the following conditions: - Acute cholecystitis and cholangitis; - Biliary obstruction (common bile duct and cystic duct); - Recurrent biliary colic; - Radiopaque calcified gallstones; - Impaired gallbladder function; - Gallbladder no longer visible on X-ray; - Hypersensitivity to bile acids or any of the ingredients in this product.
[Precautions]
Ursodeoxycholic acid capsules must be used under medical supervision. The attending physician should monitor liver function tests, such as AST (SGOT), ALT (SGPT), and Y-GT, every four weeks for the first three months of treatment and every three months thereafter. In addition to distinguishing responders from non-responders in patients with primary biliary cirrhosis, this monitoring can also detect potential liver function deterioration early, particularly in patients with advanced primary biliary cirrhosis. When used to dissolve cholesterol gallstones, to evaluate treatment effectiveness and detect gallstone calcification early, a gallbladder X-ray (oral cholecystography) should be performed 6 to 10 months after the start of treatment, depending on the size of the gallstones. X-rays should be taken in the standing and lying positions (using ultrasound monitoring).
