Ursodeoxycholic Acid

What it is and how it works

Ursodeoxycholic acid is a naturally occurring hydrophilic bile acid that reduces cholesterol secretion into bile and intestinal cholesterol absorption, lowering biliary cholesterol saturation and allowing gradual dissolution of cholesterol gallstones. In cholestatic liver disease it replaces more toxic hydrophobic bile acids, protects hepatocytes and cholangiocytes and stimulates bile flow.

Indications

Dissolution of small radiolucent cholesterol gallstones in patients with a functioning gallbladder; primary biliary cholangitis; other cholestatic conditions such as cholestasis of pregnancy and hepatobiliary disorders of cystic fibrosis (according to specialist use).

Dosage and administration (summary)

Orally: for gallstone dissolution about 8–12 mg/kg daily as a single dose at bedtime or in divided doses, for up to 2 years; for primary biliary cholangitis about 12–16 mg/kg daily in divided doses, continued long term.

Contraindications

Radio-opaque (calcified) gallstones; non-functioning gallbladder; acute inflammation of the gallbladder or biliary tract; obstruction of the biliary tract; frequent biliary colic; inflammatory bowel disease affecting bile acid enterohepatic circulation (in some product labels).

Warnings and precautions

Monitor liver function tests regularly, particularly during the first months of treatment, and assess gallstone dissolution by imaging. In advanced primary biliary cholangitis, worsening of liver function has rarely been reported. Absorption is reduced by bile acid sequestrants and aluminium-containing antacids; it may affect ciclosporin absorption.

Pregnancy

Avoid in the first trimester unless essential; used under specialist supervision for intrahepatic cholestasis of pregnancy.

Storage and supply

Store below 25 °C, protected from moisture.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.