Each capsule contains Ursodeoxycholic acid 250 mg.
Indications/Uses
For dissolution of cholesterol gallstones in selected patient with uncomplicated radiolucent gallstone disease.
Prevention of gallstone formation in obese patients experiencing rapid weight loss.
Dosage/Direction for Use
For dissolution of cholesterol gallstones: 8 to 10 mg/kg of body weight a day, divided into two or three doses, usually taken with meals.
Prevention of gallstone formation: 300 mg two times a day.
Gallstone dissolution may require 6 months to 2 years of continuous dosing depending on the size and composition of the stone(s). Response should be monitored by ultrasonograms performed at 6-month intervals during the first year of therapy. After complete dissolution, it is recommended that URSODE be continued for at least 3 months to promote dissolution of particles that are too small to image.
Contraindications
URSODE must not be used in the presence of calcified cholesterol stones, radiopaque stones, acute cholecystitis and biliary obstruction.
Warnings
Safety of use of ursodiol beyond 24 months is not established.
Non-visualizing gallbladder developing during ursodiol treatment predicts failure of complete stone dissolution and therapy should be discontinued.
Bile acids might be involved in the pathogenesis of human colon cancer in patients who have undergone a cholecystectomy.
Use In Pregnancy & Lactation
Do not use the drug during pregnancy. Exercise caution when ursodiol is administered to a nursing mother.
URSODE should not be taken at the same time as cholestyramine, colestipol or aluminium hydroxide - containing antacids as these preparations bind ursodeoxycholic acid in the intestine, thus impairing absorption and efficacy.
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