ursodeoxycholic acid






A. Menarini
Concise Prescribing Info
Ursodeoxycholic acid
Dissolution of cholesterol-rich gallstones in the gallbladder & for the treatment of biliary reflux gastritis & cholestatic liver disease. FC tab: Symptomatic treatment of primary biliary cirrhosis (PBC), in patients w/o decompensated hepatic cirrhosis.
Dosage/Direction for Use
Cap Dissolution of cholesterol gallstones Approx 10 mg/kg equiv to: >100 kg 5 cap, up to 100 kg 4 cap, up to 80 kg 3 cap, up to 60 kg 2 cap. Duration: 6-24 mth to dissolve. Biliary reflux gastritis 1 cap daily at bedtime. Duration: 10-14 days. Primary biliary cirrhosis 1 cap tid during the 1st 3 mth. As liver function tests improve, daily dose may be taken once in the evening. Childn 6-18 yr w/ cystic fibrosis 20 mg/kg/day in 2-3 divided doses, increase to 30 mg/kg/day if necessary. FC tab Dissolution of cholesterol gallstones Approx 10 mg/kg 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. Duration: 6-24 mth to dissolve. Symptomatic treatment of primary biliary cirrhosis Daily dose depends on body wt & ranges from 1½-3½ FC tab (14±2 mg/kg). 1st 3 mth of treatment: 500 mg FC tab divided over the day. May be taken once daily in the evening if liver function parameters improve.
Should be taken with food: Swallow whole, do not chew.
Hypersensitivity to bile acids. Acute inflammation of the gallbladder or biliary tract; occlusion of the biliary tract (occlusion of the common bile duct or cystic duct); frequent episodes of biliary colic; radio-opaque calcified gallstones; impaired contractility of the gallbladder. Cap: Unsuccessful portoenterostomy or w/o recovery of good bile flow in childn w/ biliary atresia.
Special Precautions
Monitor liver function every 4 wk during the 1st 3 mth of therapy, thereafter every 3 mth. Visualize gallbladder w/ overview (oral cholecystography) & occlusion views in standing & supine positions (ultrasound control) 6-10 mth after the beginning of treatment. Impaired contractility of gallbladder or frequent episodes of biliary colic. Decompensation of the hepatic cirrhosis (very rare); discontinue if persistent diarrhea occurs. Long-term high dose therapy in patients w/ primary sclerosing cholangitis. Female patients should use an effective non-hormonal method of contraception. Pregnancy.
Adverse Reactions
Drug Interactions
May inhibit absorption & efficacy w/ colestyramine, colestipol or antacid-containing Al hydroxide &/or smectite (Al oxide).  May affect absorption of ciclosporin. May reduce absorption of ciprofloxacin. Slightly elevate plasma levels of rosuvastatin. Reduced peak plasma conc (Cmax) & AUC of nitrendipine. Reduced therapeutic effect of dapsone. Increased biliary lithiasis w/ estrogenic hormones & blood cholesterol-lowering agents eg, clofibrate.
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
Ursofalk FC tab 500 mg
50's (P100/film-coated tab)
Ursofalk cap 250 mg
100's (P50/cap)
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