Ursodeoxycholic acid

Generic Medicine Info
Should be taken with food.
Acute inflammation of gallbladder or biliary tract, biliary tract occlusion (common bile duct or cystic duct), frequent episodes of biliary colic, radio-opaque calcified gallstones, impaired contractility of gallbladder, gallstone pancreatitis or biliary-gastrointestinal fistula, non-functioning gallbladder, inflammatory bowel disease; hepatic and intestinal conditions interfering with enterohepatic recirculation of bile acids (e.g. extrahepatic and intrahepatic cholestasis, ileal resection and stoma, regional ileitis); active duodenal and gastric ulcer; unsuccessful portoenterostomy or without recovery of normal bile flow in children with biliary atresia. Acute, chronic or severe hepatic impairment.
Special Precautions
Patients with non-visualising gallbladder, variceal bleeding, hepatic encephalopathy, ascites. Obese patients. Children. Pregnancy and lactation. Monitoring Parameters Monitor liver function tests (e.g. AST, ALT, γ-GT) as clinically necessary. If used for the dissolution of gallstone, perform oral cholecystography and ultrasound periodically. Evaluate pregnancy status before initiation of therapy.
Adverse Reactions
Significant: Biliary obstruction. Gastrointestinal disorders: Diarrhoea, pasty stools, nausea, vomiting, constipation, dyspepsia; rarely, severe right upper abdominal pain (if used for primary biliary cirrhosis). Hepatobiliary disorders: Rarely, calcification of gallstones, decompensation of liver cirrhosis. Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Headache, dizziness. Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection. Skin and subcutaneous tissue disorders: Urticaria, pruritus.
Drug Interactions
May reduce absorption and efficacy with bile acid-binding resins (e.g. colestyramine, colestipol), antacids (e.g. aluminium hydroxide, aluminium oxide), charcoal. May increase absorption and serum concentration of ciclosporin. May reduce absorption of ciprofloxacin, nitrendipine. Increased hepatic cholesterol secretion and reduced efficacy with estrogen hormones, oral contraceptives, blood cholesterol-lowering agents (e.g. clofibrate). May increase serum concentration of rosuvastatin.
CIMS Class
Cholagogues, Cholelitholytics & Hepatic Protectors
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
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