Ursodeoxycholic acid


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Dissolution of cholesterol-rich gallstones 8-12 mg/kg once daily at bedtime or in 2 divided doses continued for 3-4 mth after radiological disappearance of gallstones. Duration: Up to 2 yr. Primary biliary cirrhosis 10-16 mg/kg/day in 2-4 divided doses, may be taken once daily in the evening after the 1st 3 mth. Prophylaxis of gallstones in patients undergoing rapid wt loss 300 mg bid.
Administration
Should be taken with food.
Contraindications
Acute inflammation of gallbladder or biliary tract, occlusion of biliary tract, frequent episodes of biliary colic, radio-opaque calcified gallstones, impaired contractility of gallbladder, non-functioning gallbladder, inflammatory bowel disease, hepatic and intestinal conditions interfering w/ enterohepatic recirculation of bile acids, extrahepatic and intrahepatic cholestasis, ileal resection and stoma, regional ileitis, active duodenal and gastric ulcer; acute, chronic or severe hepatic disease.
Special Precautions
Pregnancy and lactation. Monitoring Parameters Monitor LFTs mthly for the 1st 3 mth and every 6 mth thereafter.
Adverse Reactions
Nausea, vomiting, diarrhoea, other GI disturbances, pruritus, viral infection, headache, upper resp tract infection, sinusitis, pharyngitis, arthralgia, back pain, cough, bronchitis, UTI, arthritis, myalgia, cholecystitis, rhinitis, fatigue, dysmenorrhoea, musculoskeletal pain, asthenia, peripheral oedema, HTN. Rarely, gallstone calcification, liver function deterioration.
Drug Interactions
Reduced absorption w/ Al-containing antacids, bile acid sequestrants (e.g. cholestyramine, colestipol), charcoal. Possibly reduced efficacy w/ clofibrate, oestrogens and OCs. May increase the absorption of ciclosporin.
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 © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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