Ursodeoxycholic acid

Generic Medicine Info
Indications and Dosage
Dissolution of cholesterol-rich gallstones
Adult: 8-12 mg/kg once daily at bedtime or in 2 divided doses continued for 3-4 mth after radiological disappearance of gallstones. Duration of treatment: Up to 2 yr. Obese patients: Up to 15 mg/kg daily.

Prophylaxis of gallstones in patients undergoing rapid weight loss
Adult: 300 mg bid.

Primary biliary cirrhosis
Adult: 10-16 mg/kg daily in 2-4 divided doses, may be taken once daily in the evening after the 1st 3 mth.
Should be taken with food.
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.
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.
Monitor LFTs mthly for the 1st 3 mth and every 6 mth thereafter.
Symptoms: Diarrhoea. Management: Symptomatic treatment w/ fluid and electrolyte balance restoration.
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.
Description: Ursodeoxycholic acid suppresses hepatic synthesis and secretion of cholesterol and also inhibits intestinal absorption of cholesterol.
Absorption: Absorbed from the GI tract.
Distribution: Plasma protein binding: Approx 70%.
Metabolism: Undergoes extensive enterohepatic recycling. Free and conjugated forms undergo 7α-dehydroxylation to lithocholic acid under the influence of intestinal bacteria; some of which are further conjugated and sulfated hepatically.
Excretion: Via faeces; urine (<1%). Half-life: Approx 4-6 days.
Chemical Structure

Chemical Structure Image
Ursodeoxycholic acid

Source: National Center for Biotechnology Information. PubChem Database. Ursodeoxycholic acid, CID=31401, https://pubchem.ncbi.nlm.nih.gov/compound/Ursodeoxycholic-acid (accessed on Jan. 23, 2020)

Store between 20-25°C.
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
Anon. Ursodiol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/02/2016.

Buckingham R (ed). Ursodeoxycholic acid. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/02/2016.

Joint Formulary Committee. Ursodeoxycholic acid. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/02/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Ursodiol. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 05/02/2016.

Ursodiol Capsule (Actavis Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/02/2016.

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