URSODEOXYCHOLIC ACID

Mode of action
Unclear; alters bile acid composition resulting in greater concentration of ursodeoxycholic acid; increases bile acid
output and bile flow. Some evidence for immunological mechanisms.
Indications
Chronic cholestatic liver diseases (e.g. primary biliary cirrhosis (PBC), primary sclerosing cholangitis, cholestasis
related to cystic fibrosis).
Contraindications
Acute cholecystitis/cholangitis or bile duct obstruction.

Specific considerations

Children: Limited data; children with PBC may have an initial deterioration in symptoms which may be alleviated by
dose reduction and slow titration of dose.
Pregnancy: Limited data; is used for cholestasis of pregnancy but information on efficacy is lacking; ADEC
category B3.
Breastfeeding: Limited data; consult specialist advisory service.
Adverse effects
Common: diarrhoea
Infrequent: increased itch, increased cholestasis, nausea, vomiting, sleep disturbance.
Dosage
Adult: PBC and chronic cholestatic diseases other than cystic fibrosis, 10–15 mg/kg/day in 2–4 divided doses.
Cystic fibrosis, up to 20 mg/kg/day.
Child: 15–20 mg/kg/day in 2–3 divided doses.
Practice points
use in PBC improves liver function tests but effect on mortality is unclear; changes in liver function tests are
not a clear measurement of efficacy; further studies are required to establish efficacy in PBC
use in primary sclerosing cholangitis improves liver function tests but does not significantly improve
symptoms, histology or survival

little information available on efficacy in cystic fibrosis.
Products
URSODEOXYCHOLIC ACID TABS 100 MG (URSA®)