Ursolin Special Precautions

Monitoring: Abnormalities in liver enzymes have not been associated with ursodiol therapy and in fact, ursodiol has been shown to decrease liver enzyme levels in liver disease. However, patients given with ursodiol should have AST and ALT measured at the initiation of therapy and thereafter as indicated by the particular clinical circumstances.
Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant should receive appropriate specific treatment.
Hepatic effects: Ursodiol therapy has not been associated with liver damage. Lithocholic acid, a naturally occurring bile acid, is known to be a liver - toxic metabolite. This bile acid is formed in the gut from ursodiol less efficiently and in smaller amounts than that seen from chenodiol. Lithocholic acid is detoxified in the liver by sulfation and although man appears to be an efficient sulfater, it is possible that some patients may have a congenital or acquired deficiency in sulfation, thereby predisposing them to lithocholate-induced liver damage.
Use in Children: The safety and effectiveness of ursodiol in pediatric patients have not been established.