ursodeoxycholic acid: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
ursodeoxycholic acid: clinical details
Prescribing considerations
- Confirm that indication, age and formulation are covered by the relevant product licence.
- For gallstone dissolution, confirm suitable radiolucent cholesterol stones, a functioning gallbladder and no recurrent biliary colic or obstruction.
- Review persistent diarrhoea and monitor advanced primary biliary cholangitis for deterioration or decompensation.
- For intrahepatic cholestasis of pregnancy, explain that use is non-licensed for the selected products and does not replace obstetric surveillance.
Contraindications and cautions
- Hypersensitivity to ursodeoxycholic acid, other bile acids or formulation excipients.
- Acute gallbladder or biliary-tract inflammation, biliary obstruction, frequent biliary colic, calcified stones or impaired gallbladder contractility.
- Unsuccessful portoenterostomy or failure to restore bile flow in children with biliary atresia.
- Cholurso contains soya lecithin and is contraindicated with peanut or soya hypersensitivity.
- The selected hard-capsule product has additional product-specific contraindications; check its wording.
Monitoring
- Liver enzymes and clinical status early in treatment and periodically thereafter.
- Response and hepatic deterioration in primary biliary cholangitis.
- Gallbladder imaging, including assessment for calcification, during gallstone dissolution treatment.
- Ciclosporin blood concentrations when used together.
- Bile acids, liver tests and obstetric risk assessment for intrahepatic cholestasis of pregnancy.
Clinical pharmacology
An orally absorbed hydrophilic bile acid that undergoes hepatic extraction, conjugation and enterohepatic circulation. It reduces biliary cholesterol saturation and displaces more hydrophobic bile acids.
Formulation and product differences
- Cholurso tablets contain soya lecithin.
- Selected hard capsules should be swallowed whole; alternative formulations are available if swallowing capsules is unsuitable.
- DEOXXA suspension must be shaken and can be administered through compatible feeding tubes.
- The suspension contains benzoic acid, propylene glycol, xylitol, a small amount of ethanol and sodium; neonatal and laxative-effect warnings apply.
- Licensed paediatric ages for cystic-fibrosis-associated hepatobiliary disease differ between suspension and solid formulations.
ursodeoxycholic acid preparations and strengths
Capsule
Route: Oral
Strengths: 250 mg
Oral suspension
Route: Oral
Strengths: 250 mg/5 mL
Tablet
Route: Oral
Strengths: 150 mg, 250 mg, 300 mg, 450 mg, 500 mg
ursodeoxycholic acid interactions
Check all prescribed, non-prescribed and complementary products. Important interactions include:
Colestyramine or colestipol
They bind ursodeoxycholic acid in the gut and reduce absorption; do not take them simultaneously.
Aluminium-containing antacids or smectite
They can reduce its effect; ask a pharmacist how to separate administration.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.