Ursofalk

Ursodeoxycholic acid

Dissolution of cholesterol gallstones in the gallbladder. Symptomatic treatment of primary biliary cirrhosis (PBC) in patients w/o decompensated hepatic cirrhosis. Cap: Bile reflux gastritis.

Cap Dissolution of cholesterol gallstones Approx 10 mg/kg body wt equiv to: >100 kg 5 cap, 81-100 kg 4 cap, 61-80 kg 3 cap, up to 60 kg 2 cap. To be taken daily in the evening at bedtime for 6-24 mth. Bile reflux gastritis 1 cap once daily in the evening before bedtime for 10-14 days. Symptomatic treatment of PBC Daily dose depends on body wt & ranges from 3-7 cap (14±2 mg/kg body wt). Take in divided doses throughout the day for the 1st 3 mth of treatment. May be taken once daily in the evening when liver function parameters improve. FC tab Dissolution of cholesterol gallstones Approx 10 mg/kg body wt equiv to: >100 kg 2½ FC tab, 81-100 kg 2 FC tab, 61-80 kg 1½ FC tab, up to 60 kg 1 FC tab. To be taken daily in the evening at bedtime for 6-24 mth. Symptomatic treatment of PBC Daily dose depends on body wt & ranges from 1½-3½ FC tab (14±2 mg/kg body wt). Take in divided doses over the day for the 1st 3 mth of treatment. May be taken once daily in the evening when liver function parameters improve.

Should be taken with food.

Hypersensitivity to bile acids or any excipient of the formulation. Acute inflammation of the gallbladder or biliary tract. Biliary tract occlusion. Frequent episodes of biliary colic. Radio-opaque calcified gallstones. Impaired gallbladder contractility.

Monitor liver function parameters during the 1st 3 mth of treatment (every 4 wk, thereafter every 3 mth). Visualize gallbladder w/ overview & occlusion views in standing & supine positions 6-10 mth after beginning of treatment for dissolution of cholesterol gallstones. Do not use if gallbladder cannot be visualized on X-ray images; in calcified gallstones; impaired gallbladder contractility or frequent episodes of biliary colic. Possible decompensation of hepatic cirrhosis when used for advanced stage of PBC. May worsen clinical symptoms at the beginning of treatment (eg, itching) in patients w/ PBC; reduce dose to 1 cap or ½ FC tab daily then gradually increase again. Reduce dose if diarrhoea occurs; discontinue therapy in cases of persistent diarrhoea. Use effective non-hormonal contraception in female patients taking Ursofalk for dissolution of gallstones. Women of childbearing potential should be treated only if they are using reliable contraception. Exclude possibility of pregnancy before treatment initiation. Pregnancy & lactation.

Pasty/soft stools or diarrhoea.

Inhibition of absorption & efficacy when administered concomitantly w/ colestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). May affect absorption of ciclosporin. May reduce absorption of ciprofloxacin. Slight elevation of rosuvastatin plasma levels. Reduced C_max & AUC of nitrendipine. Reduced therapeutic effects of dapsone. Oestrogenic hormones & blood cholesterol lowering agents (eg, clofibrate) may increase hepatic cholesterol secretion; may encourage biliary lithiasis, which is a 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.

POM