pms-Ursodiol C

pms-Ursodiol C Indications/Uses

ursodeoxycholic acid




Full Prescribing Info
pms-URSODIOL C (ursodiol), also known as ursodeoxycholic acid (UDCA) is indicated for the management of cholestatic liver diseases, such as primary biliary cirrhosis (PBC).
Cholestatic liver diseases are characterized by a decrease in bile secretion and bile flow. Caution has to be exercised to maintain the bile flow of the patients taking UDCA.
The diagnosis of cholestatic liver diseases is based on the biochemical signs of cholestasis (such as an increase in alkaline phosphatase, γ-GT, bilirubin), and also an increase in IgM levels and the presence of antimitochondrial antibodies in PBC.
The monitoring of pms-URSODIOL C in the management of cholestatic liver diseases should be based on the biochemical parameters of cholestasis, as described previously, as well as on signs of hepatic cytolysis (such as AST, ALT) which are very often associated with cholestasis during the progression of the diseases.
Serum liver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin level should be monitored every month for three months after start of therapy, and every six months thereafter. Improved serum liver function tests (e.g. AST, ALT) do not always correlate with improved disease status. In addition to identifying responsive and non-responsive patients, this monitoring will allow the early detection of a possible deterioration of the hepatic function. 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, generally increase in ALT, AST levels three times the baseline value and increase in total bilirubin to twice the baseline value, confirmed by repeated tests (see Dosing Considerations: Patient Monitoring under Dosage & Administration; Hepatic/Biliary/Pancreatic under Precautions).
pms-URSODIOL C is not indicated for the treatment of decompensated cirrhosis.
Geriatrics: 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.
Pediatrics: The safety and effectiveness of ursodiol in children have not been established.
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