Ursodeoxycholic acid


Generic Medicine Info
Administration
Should be taken with food.
Contraindications
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.
Disclaimer: This information is independently developed by CIMS based on ursodeoxycholic acid from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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