pms-Ursodiol C Dosage/Direction for Use

Dosing Considerations: The monitoring of pms-URSODIOL C in the management of cholestatic liver diseases should be based on the biochemical parameters of cholestasis, 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.
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 under Precautions).
Caution has to be exercised to maintain the bile flow of the patients taking UDCA.
Recommended Dose and Dosage Adjustment: The recommended adult dosage for pms-URSODIOL C (ursodiol) in the treatment of PBC is 13 mg/kg/day to 15 mg/kg/day administered in two to four divided doses with food.
Health Canada has not authorized an indication for pediatric use.
Missed Dose: If a dose is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the dose missed and take the next regularly scheduled dose. Do not take a double dose.