Urso (Ursodiol) - Indications and Dosage

INDICATIONS AND USAGE

URSO 250^® and URSO Forte^® (ursodiol) tablets are indicated for the treatment of patients with primary biliary cirrhosis.

DOSAGE AND ADMINISTRATION

The recommended adult dosage for URSO 250^® and URSO Forte^® in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient's need at the discretion of the physician.

The URSO Forte^® scored tablet can be broken in halves to provide recommended dosage.

To break URSO Forte^® scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately.

Half-tablets (scored URSO Forte^® 500 mg tablets broken in half) maintain acceptable quality for up to 28 days when stored in the current packaging (bottles) at 25^°C (77^°F).

HOW SUPPLIED

Each URSO 250^® elliptical, biconvex, film-coated tablet, white, engraved with "URS785", contains 250 mg of ursodiol. Available in bottles of 100 tablets (NDC 58914-785-10) and 500 tablets (NDC 58914-785-50).

Each URSO Forte^® elliptical, biconvex, scored, film-coated tablet, white, engraved with "URS790", contains 500 mg of ursodiol. Available in bottles of 100 tablets (NDC 58914-790-10) and 500 tablets (NDC 58914-790-50).

Store at 20^°C to 25^°C (68^°F to 77^°F). Dispense in a tight container.

Manufactured in Canada for:
Axcan Scandipharm Inc.
22 Inverness Center Parkway
Birmingham, AL 35242
USA
www.axcan.com

URSO 250^® and URSO Forte^® are registered trademarks used under license by Axcan Scandipharm Inc.

Revision date: March 10, 2008

Printed in Canada.