Prescribing Information
SPECIAL NOTE
Gallbladder stone dissolution with ursodiol treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who do dissolve their stones on bile acid therapy. Patients should be carefully selected for therapy with ursodiol, and alternative therapies should be considered.
DESCRIPTION
Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration.
Ursodiol, USP (ursodeoxycholic acid) is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below:
Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, and starch (corn). Gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing black iron oxide.
