Primary biliary cirrhosis (PBC) & for dissolution of small to medium sized radiolucent, cholesterol-rich gall-stones in patients w/ functioning gall bladder.
PBCAdult & elderly 10-15 mg/kg/day in 2-4 divided doses. Childn Dosage should be related to body wt. Dissolution of gallstonesAdult & elderly 6-12 mg/kg/day either as a single nighttime dose or in divided doses. Obese patients May be increased to 15 mg/kg/day if necessary. Childn Dosage should be related to body wt. Duration of treatment may be up to 2 yr depending on stone size & should be continued for 3 mth after apparent stone dissolution.
Hypersensitivity to ursodeoxycholic acid or bile acid. Radio-opaque calcified gall-stones; acute inflammation of gall bladder or biliary tract; biliary tract occlusion (occlusion of common bile duct or cystic duct); frequent episodes of biliary colic; impaired contractility of gall bladder; chronic liver disease, peptic ulcers or in those w/ inflammatory diseases of small intestine & colon. Women who may become pregnant. Pregnancy & lactation.
Decompensation of hepatic cirrhosis. Discontinue in cases of persistent diarrhea. Visualize (oral cholecystography) gall bladder 6-10 mth after beginning of treatment. Do not use if gallbladder cannot be visualized on x-ray images or w/ calcified gallstones, impaired contractility of gallbladder or frequent episodes of biliary colic. Monitor AST, ALT & γ-glutamyl transferase every 4 wk during the 1st 3 mth of treatment, thereafter every 3 mth. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
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