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Lupibile

Lupibile Dosage/Direction for Use

ursodeoxycholic acid

Manufacturer:

Globela Pharma
/
Sydler Remedies

Distributor:

Multicare
/
Multicare
Full Prescribing Info
Dosage/Direction for Use
Tab: The licensed dose is 6 to 12 mg/kg daily as a single bedtime dose or in 2 or 3 divided doses; obese patients may require up to 15 mg/kg daily. The daily dose may be divided unequally and the larger dose given before bedtime to counteract the increase in biliary cholesterol concentration seen overnight. The time required for dissolution of gallstones is likely to be between 6 and 24 months depending on stone size and composition. Treatment should be continued for 3 to 4 months after radiological disappearance of the stones.
A dose of 300 mg twice daily has been suggested for the prevention of gallstones in patients undergoing rapid weight loss. Ursodeoxycholic acid has also been given in reduced doses in combination with chenodeoxycholic acid.
Ursodeoxycholic acid is also used in primary biliary cirrhosis. The usual dose is 10 to 15 mg/kg daily in 2 to 4 divided doses. Ursodeoxycholic acid has been tried in the treatment of primary sclerosing cholangitis. The more hydrophilic derivative, tauroursodeoxycholic acid, has also been used.
FC tab: Recommended Dose: The recommended adult dosage for Ursodeoxycholic acid in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. The Ursodeoxycholic acid 500 mg is a white to off white colored caplet shaped film-coated tablets having break-line on one side and other side plain, can be broken in half to provide recommended dosage.
Dosing Considerations: Patient Monitoring: 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. 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.
Caution has to be exercised to maintain the bile flow of the patients taking UDCA.
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