Generic Name: Ursodeoxycholic acid

Regulatory Class: Rx

Formulations: 500mg Tablet

Indications or Uses: Dissolution of cholesterol gallstones in the gall bladder. Symptomatic treatment of primary biliary cholangitis (PBC); biliary reflux gastritis; cholestatic liver disease. Hepatobiliary disorder associated w/ cystic fibrosis in childn 6 yr-<18 yr.

Dosage or Directions for use: Dissolution of cholesterol gallstones Approx 10 mg/kg corresponding to: >100 kg 2½ Film coated tab, 81-100 kg 2 Film coated tab, 61-80 kg 1½ Film coated tab, up to 60 kg 1 Film coated tab. Symptomatic treatment of primary biliary cholangitis (PBC) Depends on body weight & ranges from 1½-3½ Film coated tab (14±2 mg/kg). 1st 3 months of treatment: Should be divided over the day. May be taken once daily in the evening if liver values improve. Childn w/ cystic fibrosis 6 yr-<18 yr 20 mg/kg/day in 2-3 divided doses, w/ further increase to 30 mg/kg/day if necessary.

Administration: Swallow whole with some liquid. Do not chew. Take w/ or w/o food. 

Contraindications: Hypersensitivity to bile acids. Acute inflammation of the gallbladder & biliary tract; occlusion of biliary duct (occlusion of the common bile duct or a cystic duct); frequent episodes of biliary colic; radiopaque calcified gallstones; impaired contractility of the gallbladder. Unsuccessful portoenterostomy or w/o recovery of good bile flow in childn w/ biliary atresia.

Special Precautions: Monitor liver function parameters every 4 week during the 1st 3 month, thereafter every 3 month. Visualize gallbladder w/ overview (oral cholecystography) & occlusion views in standing & supine positions (ultrasound control) 6-10 mth after the beginning of treatment. Should not be used 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. 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 Reaction: Pasty stools or diarrhea.

Interactions: May inhibit absorption & efficacy w/ cholestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). May affect the absorption of ciclosporin. May reduce the absorption of ciprofloxacin. Slightly elevate plasma levels of rosuvastatin. Reduce peak plasma conc (Cmax) & AUC of nitrendipine. Reduced therapeutic effect of dapsone. Increase hepatic cholesterol secretion & biliary lithiasis w/ oestrogenic hormones & blood cholesterol lowering agents eg, clofibrate.

Presentation or Packaging: Film Coated Tablet 500mg x 50's

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