Udarin

Treatment of primary biliary cirrhosis & for dissolution of small to medium sized radiolucent, cholesterol-rich gallstones in patients w/ functioning gall bladder. Hepatobiliary disorder associated w/ cystic fibrosis in childn 6-<18 yr.

Primary biliary cirrhosis Adult & elderly 10-15 mg/kg/day in 2-4 divided doses. Childn Dosage should be related to body wt. Dissolution of gallstones Adult & elderly 6-12 mg/kg/day either as single night-time dose or in divided doses. May be increased to 15 mg/kg/day in obese patients if necessary. Duration of treatment may be up to 2 yr, depending on the size of stones, & should be continued for 3 mth after the apparent dissolution of stones. Childn Dosage should be related to body wt. Hepatobiliary disorder associated w/ cystic fibrosis Childn 6-<18 yr 20 mg/kg/day in 2-3 divided doses, w/ further increase to 30 mg/kg/day if necessary.

Should be taken with food: Take w/ water.

Hypersensitivity to ursodeoxycholic acid or bile acids. Patients w/ radio-opaque calcified gallstones; acute inflammation of gall bladder or biliary tract; occlusion of biliary tract (occlusion of the common bile duct or a cystic duct); frequent episodes of biliary colic; impaired contractability of gall bladder; chronic liver disease, peptic ulcers or inflammatory diseases of small intestine & colon. Women who may become pregnant. Pregnancy & lactation.

Monitor liver function parameters AST, ALT & γ-glutamyl transferase every 4 wk during the 1st 3 mth of treatment, thereafter every 3 mth. When used for dissolution of cholesterol gallstones, gall bladder should be visualized (oral cholecystography) w/ overview & occlusion views in standing & supine positions (ultrasound control) 6-10 mth after beginning of treatment. Do not use if gall bladder cannot be visualized on X-ray images. Very rare cases of hepatic cirrhosis decompensation when used for treatment of advanced stage of primary biliary cirrhosis, which partially regressed after treatment discontinuation. Reduce dose if diarrhea occurs; discontinue in cases of persistent diarrhea. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine. Women of childbearing potential should be treated only if they are using reliable contraception.

Pasty stools or diarrhea.

Inhibited absorption & efficacy w/ charcoal, cholestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). Can increase absorption of ciclosporin from intestine. Can reduce absorption of ciprofloxacin. Reduced C_max & AUC of nitrendipine. Reports of interaction w/ reduced therapeutic effect of dapsone. OCs, estrogenic hormones & blood cholesterol lowering agents eg, clofibrate may increase biliary lithiasis (counter-effect to ursodeoxycholic acid used for dissolution of gallstones).

Cholagogues, Cholelitholytics & Hepatic Protectors

A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.

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