Urso & PBC

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Chemically both Actigall & URSO 250 are made from ursodiol/ursodeoxycholic

acid....

DESCRIPTION

URSO® is a bile acid available as 250 mg film-coated tablets for oral

administration.

URSO® is ursodiol (ursodeoxycholic acid), a naturally occurring bile acid

found in small quantities in normal human bile and in larger quantities in

the biles of certain species of bears. It is a bitter- tasting white powder

consisting of crystalline particles freely soluble in ethanol and glacial

acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and

practically insoluble in water. The chemical name of ursodiol is 324H40O4).

Ursodiol has a molecular weight of 392.56. Its structure is shown below.

Inactive ingredients: microcrystalline cellulose, povidone, sodium starch

glycolate, magnesium stearate, ethylcellulose, dibutyl sebacate, carnauba

wax, hydroxypropyl methylcellulose, PEG 3350, PEG 8000, cetyl alcohol, sodium

lauryl sulfate, and hydrogen peroxide.

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During chronic administration of ursodiol, it becomes a major biliary and

plasma bile acid. At a chronic dose of 13-15 mg/kg/day, ursodiol constitutes

30-50% of biliary and plasma bile acids.

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INDICATIONS AND USAGE

URSO® (ursodiol) tablets are indicated for the treatment of patients with

primary biliary cirrhosis.

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DOSAGE AND ADMINISTRATION

The recommended adult dosage for URSO® in the treatment of PBC is 13-15

mg/kg/day administered in four divided doses with food.

HOW SUPPLIED

Each URSO® film-coated tablet, white, imprinted with " 785 " , contains 250 mg

of ursodiol.

Joanne C. (PBC) List Moderator

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