May 25, 2017
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Actigall

Actigall®
(ursodiol, USP) Capsules

SPECIAL NOTE

Gallbladder stone dissolution with Actigall treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of s tones within 5 years has been observed in up to 50% of patients who do dissolve their s tones on bile acid therapy. Patients should be carefully s elected for therapy with ursodiol, and alternative therapies should be considered.

DRUG DESCRIPTION

Actigall is a bile acid available as 300 mg capsules suitable for oral administration.

Actigall is ursodiol, USP (ursodeoxycholic acid), 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:

Actigall (ursodiol) Structural Formula Illustration

Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, and starch (corn). Gelatin capsules contain ferric oxide, gelatin, and titanium dioxide. The capsules are printed with edible ink containing black iron oxide.

Last reviewed on RxList: 7/13/2016
This monograph has been modified to include the generic and brand name in many instances.

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