Ursodiol

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Substrate of
  • Induces
  • Drug Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Ursofalk; Belgium: Ursochol, Ursofalk; Czech Republic: Ursosan; Estonia: Ursofalk; Finland: Adursal; France: Ursolvan; Germany: Cholacid, Cholofalk, Ursochol, Ursofalk; Greece: Ursofalk; Hungary: Ursofalk; Ireland: Ursofalk; Italy: Acido Ursodesossicolico, Biliepar, Coledos, Desocol, Deursil, Dissolursil, Fraurs, Lentorsil, Ursacol, Ursilon, Ursobil, Ursodamor, Ursodiol, Ursofalk, Ursoflor, Ursolac, Uroslisin, Ursoproge; Luxembourg: Ursochol, Ursofalk; Netherlands: Ursochol; Poland: Biliepar, Ursocam, Ursofalk, Ursopol; Portugal: Destolit, Ursofalk; Spain: Ursobilane, Ursochol, Ursofalk; Sweden: Ursofalk; UK: Destolit, Urdox, Ursodeoxycholic Acid, Ursofalk, Ursogal.

North America

Canada: Urso, Ursodiol; USA: Actigall, Urso.

Asia

Japan: Buraue, Gokumisin, Precoat, Reptor, Shikinol, Ubiron, Urdenacin, Urdeston, Urdex, Ursamic, Urso.

Drug combinations

Chemistry

Ursodiol: C~24~H~40~O~4~. Mw: 392.57. (1) Cholan-24-oic acid, 3,7-dihydroxy-, (3α,5β,7β)-; (2) 3α,7β-Dihydroxy-5β-cholan-24-oic acid. CAS-128-13-2 (1988).

Pharmacologic Category

Gastrointestinal Drugs; Cholelitholytic Agents; Gallstone Dissolution Agent. (ATC-Code: A05AA02).

Mechanism of action

Decreases cholesterol content of bile and bile stones by reducing secretion of cholesterol from liver and fractional reabsorption of cholesterol by intestines. Mechanism of action in primary biliary cirrhosis not clearly defined.

Therapeutic use

Gallbladder stone dissolution. Prevention of gallstones in obese patients experiencing rapid weight loss. Primary biliary cirrhosis.

Pregnancy and lactiation implications

Use caution during pregnancy or lactation.

Unlabeled use

Liver transplantation.

Contraindications

Hypersensitivity to ursodiol, bile acids, or any component of the formulation. Not to be used with cholesterol, radiopaque, bile pigment stones, or stones >20 mm in diameter. Allergy to bile acids.

Warnings and precautions

Use with caution in chronic liver disease. Complete dissolution of gallbladder stone may not occur and recurrence of stones within 5 years observed in 50% of patients. Use with caution in patients with a nonvisualizing gallbladder.

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