Generic Name: Ursodeoxycholic acid

Regulatory Class: Rx

Formulations: 250mg Capsule

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 Adult >100 kg 5 cap (1,250 mg); 81-100 kg 4 cap (1,000 mg); 61-80 kg 3 cap (750 mg); up to 60 kg 2 cap (500 mg). Primary biliary cirrhosis stage I & II & other conditions associated w/ intrahepatic cholestasis 10-15 mg/kg daily (2-6 cap) in 2-3 divided doses. Reactive gastritis in duodenogastritis reflux Adult 1 cap (250 mg) daily for 10-14 days. Childn >2 yr 10 mg/kg daily. Children & adolescents w/ cystic fibrosis 6-18 yr 20 mg/kg daily in 2-3 divided doses, w/ further increase to 30 mg/kg daily if necessary.

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

Contraindications: Hypersensitivity. Acute inflammation of the gallbladder or bile ducts; occlusion of extrahepatic bile duct (choledochus or cystic duct); frequent episodes of biliary colics; radiopaque calcified gallstones; impaired contractility of the gallbladder.

Special Precautions: Monitor AST, ALT & γ-GT every 4 wk, thereafter every 3 months to allow timely detection of a potential hepatic damage especially in patients w/ advanced stage of primary biliary cirrhosis. Reduce treatment if diarrhea occurs. Discontinue therapy in case of persistent diarrhea. Should not be used if the gallbladder cannot be imagined using radiography & in cases of calcified gallstones. Women of childbearing potential. Pregnancy & lactation. Not suitable for childn <6 yr.

Adverse Reaction: Loose stools or diarrhea during therapy.

Interactions: Inhibition of absorption & efficacy w/ cholestyramine, colestipol or antacids containing Aluminum hydroxide &/or smectite (Aluminum oxide). Affect the absorption of ciclosporin. Reduce the absorption of ciprofloxacin. Decreased Cmax & AUC of nitrendipine. Decreased therapeutic effect of dapsone. May increase hepatic cholesterol secretion & biliary lithiasis w/ oestrogenic hormones & blood cholesterol-lowering agents eg, clofibrate.

Presentation or Packaging: Capsule 250 mg x 30's

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