pms-Ursodiol C Special Precautions

Carcinogenesis and Mutagenesis: Ursodiol has no carcinogenic, mutagenic or teratogenic effects in laboratory animals treated at higher doses than those intended for therapy in humans, and after long-term treatment (see Pharmacology: Toxicology: Non-Clinical Toxicology: General Toxicology: Carcinogenicity, Mutagenicity, and Reproductive and Developmental Toxicology under Actions).
Gastrointestinal: Bezoars in Patients with Risk for Intestinal Stenosis or Stasis: There have been very rare post-marketing reports of bezoars leading to obstructive symptoms that require surgical interventions in ursodiol-treated patients with medical conditions that predispose to intestinal stenosis or stasis (e.g., surgical enteroanastomoses, Crohn's disease).
Hepatic/Biliary/Pancreatic: Patients with variceal bleeding, hepatic encephalopathy, ascites, or in need of an urgent liver transplant, should receive appropriate specific treatment. Caution should be exercised when UDCA is administered in a setting of partial biliary obstruction of extra-hepatic origin.
Monitoring and Laboratory Tests: Lithocholic acid, one of the metabolites of ursodeoxycholic acid is hepatotoxic unless it is effectively detoxified in the liver. Therefore, the following tests are important for patient monitoring: Serum liver function tests (γ-GT, alkaline phosphatase, AST, ALT), and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter. Serial monitoring will allow for the early detection of a possible deterioration of the hepatic function. Serum levels of these parameters usually decrease rapidly. Improved serum liver tests (e.g., AST, ALT) do not always correlate with improved disease status. For patients who have a recent history of adequate biochemical response to the treatment, UDCA discontinuation should be considered when serum liver function tests increase to a level considered clinically significant (see Dosing Considerations: Patient Monitoring under Dosage & Administration).
Caution has to be exercised to maintain the bile flow of the patients taking UDCA.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in Children: No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
Use in the Elderly: No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.