pms-Ursodiol C

pms-Ursodiol C Special Precautions

ursodeoxycholic acid

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Full Prescribing Info
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: Carcinogenicity, Mutagenicity, and Reproduction and Teratology under Actions).
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 Hepatic/Biliary/Pancreatic as previously mentioned; Dosing Considerations: Patient Monitoring under Dosage & Administration).
Caution has to be exercised to maintain the bile flow of the patients taking UDCA.
Use in Children: The safety and effectiveness of ursodiol in children has not been established.
Use in the Elderly: Appropriate studies with ursodiol have not been performed in the geriatric population. However, geriatric-specific problems that would limit the use or usefulness of ursodiol in the elderly are not expected.
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