Tridelta

Primary biliary cirrhosis (PBC) & dissolution of small to medium-sized radiolucent, cholesterol-rich gallstones in patients w/ a functioning gallbladder.

PBC Adult & elderly 10-15 mg/kg daily in 2-4 divided doses. Childn Dose should be related to body wt. Dissolution of gallstone Adult & elderly 6-12 mg/kg daily either as single night time dose or in divided doses, may be increased to 15 mg/kg daily in obese patients. Duration: Up to 2 yr depending on size of stone, & should be continued for 3 mth after apparent dissolution of stone. Childn Dose should be related to body wt.

Should be taken with food: Take w/ water.

Should not be used in patients w/ hypersensitivity to bile acids; radio-opaque calcified gallstones; acute inflammation of the gallbladder or biliary tract; occlusion of the biliary tract; frequent episodes of biliary colic; impaired contractility of the gallbladder; chronic liver disease, peptic ulcers or those w/ inflammatory diseases of the small intestine & colon; who are pregnant or breastfeeding, or in women who may become pregnant.

Monitor liver function parameters [eg, AST (SGOT), ALT (SGPT) & γ-GT] every 4 wk during the 1st 3 mth of treatment, then every 3 mth thereafter. Visualize the gallbladder (oral cholecystography) w/ overview & occlusion views in standing & supine positions (ultrasound control) 6-10 mth after beginning treatment. Do not use if gallbladder cannot be visualised on X-ray images, or in cases of calcified gallstones, impaired contractility of the gallbladder or frequent episodes of biliary colic. Reduce dose if diarrhea occurs & discontinue treatment in cases of persistent diarrhea. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not to be concomitantly administered w/ charcoal, cholestyramine, colestipol or antacids containing Al hydroxide &/or smectite; take at least 2 hr before or after ursodeoxycholic acid. Very rare cases of hepatic cirrhosis decompensation. Exclude possibility of pregnancy prior to treatment. Women of childbearing potential should use reliable contraception. Not recommended in women who are breastfeeding.

Pasty stools or diarrhea.

Inhibited absorption & efficacy w/ charcoal, cholestyramine, colestipol or antacids containing Al hydroxide &/or smectite. Increased intestinal absorption of cyclosporine. Reduced absorption of ciprofloxacin. Reduced C_max & AUC of Ca antagonist nitrendipine. Reduced therapeutic effect of dapsone. May increase biliary lithiasis w/ OCs, estrogenic hormones & blood cholesterol lowering agents eg, clofibrate (which is a counter effect to ursodeoxycholic acid used for gallstone dissolution).

Cholagogues, Cholelitholytics & Hepatic Protectors

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

Rx