Tab: Suppression of synthesis & secretion of cholesterol by the liver & inhibits intestinal absorption of cholesterol; dissolution of cholesterol-rich gallstones in patients w/ functioning gallbladders. FC tab: Management of cholestatic liver disease, eg, primary biliary cirrhosis (PBC).
Tab 6-12 mg/kg daily as single bedtime dose or in 2 or 3 divided doses; obese patient Up to 15 mg/kg daily. Treatment should be continued for 3-4 mth after radiological disappearance of the stones. Prevention of gallstones in patient undergoing rapid wt loss 300 mg bid. PBC 10-15 mg/kg daily in 2-4 divided doses. FC tabPBC Adult 13-15 mg/kg daily in 2-4 divided doses.
View Lupibile overdosage for action to be taken in the event of an overdose.
Administration
Should be taken with food.
Contraindications
Tab: Hypersensitivity to ursodeoxycholic acid. FC tab: Hypersensitivity to ursodiol or to ursodeoxycholic acid. Patients w/ complete biliary obstruction of extrahepatic origin, widespread intrahepatic obstruction.
FC tab: Patients w/ variceal bleeding, hepatic encephalopathy, ascites, or in need of urgent liver transplant. Caution in patients w/ partial biliary obstruction of extra-hepatic origin. Monitor γ-GT, alkaline phosphatase, AST, ALT & bilirubin levels every mth for 3 mth after start of therapy & every 6 mth thereafter. Not to be use during pregnancy. Women of childbearing potential should use an effective non-hormonal method of contraception. Safety & effectiveness in childn have not been established.
Tab: Not be used w/ drugs that increase bile cholesterol eg, oestrogenic hormones & cholesterol-lowering drugs eg, clofibrate. Avoid concomitant use w/ bile-acid binding drugs including antacids, charcoal & colestyramine since this may reduce effectiveness. FC tab: Should not be concomitantly administered w/ colestyramine, colestipol or antacids containing Al hydroxide &/or smectite due to inhibition of absorption & efficacy. May affect absorption of ciclosporin. Reduced absorption of ciprofloxacin. Reduced plasma peak conc Cmax & AUC of nifedipine. Reduced therapeutic effect of dapsone. Increase hepatic cholesterol secretion & may encourage biliary lithiasis w/ clofibrate; increased plasma levels w/ rosuvastatin.
Sign Out
