Youshi’an Ursodeoxycholic Acid Capsules

1. Indications and Usage
Gallstones: Treatment of X-ray transparent gallbladder cholesterol stones with normal gallbladder contraction.
Liver Disorders: Management of cholestatic liver diseases, such as primary biliary cirrhosis.
Gastric Disorders: Treatment of bile reflux gastritis.
2. Dosage and Administration
Gallstones and Liver Diseases: The dosage is calculated by body weight at 10 mg/kg daily, taken with water. The stone dissolution therapy generally requires 6 to 24 months.
Bile Reflux Gastritis: One capsule (250 mg) taken once daily at bedtime. The usual course is 10 to 14 days.
Children: Dosage should be determined by body weight and medical condition.
3. Mechanism of Action
Cholesterol Solubilization: It inhibits cholesterol reabsorption in the intestine and reduces cholesterol secretion into bile, thereby decreasing bile saturation and gradually dissolving cholesterol stones.
Hepatoprotection: It replaces toxic hydrophobic bile acids with hydrophilic ursodeoxycholic acid, protecting hepatocytes from bile acid-induced damage and promoting bile secretion.
4. Safety and Warnings
Contraindications: Contraindicated in acute cholecystitis, cholangitis, biliary obstruction, calcified gallstones, gallbladder non-visualization on X-ray, and frequent biliary colic.
Monitoring: Liver function tests (AST, ALT, γ-GT) must be checked every 4 weeks for the first 3 months, then every 3 months.
Pregnancy and Lactation: Contraindicated in the first trimester due to embryotoxicity in animal studies. Use with caution in pregnant women and not recommended during breastfeeding.
5. Adverse Reactions and Clinical Research
Common Effects: Diarrhea or loose stools are common.
Rare Effects: Severe right upper quadrant pain, urticaria, gallstone calcification, and decompensation of liver cirrhosis have been reported rarely.
6. Drug Interactions
Antacids: Concurrent use with cholestyramine, colestipol, or aluminum/magnesium-containing antacids may hinder absorption. A 2-hour interval is required.
Cyclosporine: May increase the intestinal absorption of cyclosporine; serum concentration monitoring is necessary.
Metabolic Enzymes: May induce CYP3A4, potentially altering the plasma concentrations of drugs like nifedipine.
7. Pharmaceutical Information
Active Ingredient: Ursodeoxycholic Acid.
Strength: Typically 250 mg per capsule.
Appearance: Hard capsules containing white granules or powder.
Storage: Store in a light-resistant, tightly closed container in a cool, dry place.