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

General Dosing Information

The recommended adult dosage for URSO 250 (urso (ursodiol) diol) ® and URSO (ursodiol) 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.

Scoring the URSO (ursodiol) Forte Tablet

The URSO (ursodiol) Forte scored tablet can be broken in halves to provide recommended dosage.

To break URSO (ursodiol) 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 from whole tablets. [see HOW SUPPLIED/Storage and Handling].

Dosage Forms And Strengths

• URSO 250 (urso (ursodiol) diol) : 250 mg tablet
• URSO (ursodiol) Forte: 500 mg scored tablet

Storage And Handling

URSO 250 (ursodiol)

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

URSO (ursodiol) Forte

Each URSO (ursodiol) Forte elliptical, biconvex, scored, film-coated tablet, white, engraved with “URS790”, contains 500 mg of urso (ursodiol) diol. Available in bottles of 100 tablets (NDC 58914-790-10). Store at 20°C to 25°C (68°F to 77°F). Dispense in a tight container.

Half-tablets (scored URSO (ursodiol) Forte 500 mg tablets broken in half) maintain acceptable quality for up to 28 days when stored in the current packaging (bottles) at 20°C to 25°C (68°F to 77°F). Due to the bitter taste, the halved segments should be stored separately from the whole tablets [see DOSAGE AND ADMINISTRATION].

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

Last reviewed on RxList: 12/28/2009
This monograph has been modified to include the generic and brand name in many instances.