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URSO 250® and URSO Forte® (ursodiol) tablets are indicated for the treatment of patients with primary biliary cirrhosis (PBC).
DOSAGE AND ADMINISTRATION
General Dosing Information
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.
Liver Function Tests
Liver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter [see WARNINGS AND PRECAUTIONS].
Scoring the URSO Forte Tablet
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 from whole tablets. [see Storage and Handling].
Dosage Forms And Strengths
- URSO 250: 250 mg tablet
- URSO Forte: 500 mg scored tablet
Storage And Handling
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).
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). Store at 20°C to 25°C (68°F to 77°F). Dispense in a tight container.
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 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: Aptalis Pharma US, Inc. 100 Somerset Corporate Boulevard Bridgewater, NJ 08807, USA. Revised: 6/2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/5/2013
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