Ursochol Special Precautions

Safety of Ursochol use beyond 24 months has not been established.
Gallstone dissolution by ursodeoxycholic acid should only be used in cases of radiolucent stones (without x-ray proof-coating) in patients with functioning gall bladder. The best rate of dissolution has been reached in the case of a small, suspended stone with ≤10 mm in diameter. Ursodeoxycholic acid should not be given to patients with frequent bile colic, bladder and biliary tract inflammation, and bile acid malabsorption (ie, small and large intestine inflammation eg, Crohn's disease).
Gallstone dissolution by ursodeoxycholic acid requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who dissolve their stones on bile acid therapy. Patients should be carefully selected and alternative treatment should be considered.
Use in children: The safety and effectiveness in pediatric patients has not been established.