Pharmacists

Primary Biliary Cirrhosis (PBC)

500 mg URSO Forte^® Scored

URSO Forte^® Scored Purchasing Information

Size	100 count
Strengths	500 mg
Storage	Store at 68°F to 77°F. Dispense in a tight container.

Product Information

Size	100 tablets
NDC Code	58914-790-10
Price	Lower price mg per mg versus URSO 250^®1.

Packaging Specifications

Size (Tablets)	100
Inner Pack	1
Case Pack	70 bottles
Case	16.16" x 12.8" x 11.6"
Case Cube	1.58
Case Cube	19.769

The scored tablet change only affects the product description. URSO FORTE^® Scored purchasing information, product information and packaging specifications remain the same. URSO 250^® is still available.

Important Safety Information

URSO Forte^® Scored (ursodiol) tablets are indicated for the treatment of patients with primary biliary cirrhosis. URSO Forte^® Scored and URSO 250^® are contraindicated in patients with hypersensitivity or intolerance to ursodiol or any components of the formulation. In clinical trials, all of the related treatment emergent adverse events (TEAEs) were considered to be mild in severity.

The most common (>5%) TEAEs were asthenia (11.7%), dyspepsia (10%), peripheral edema (8.3%), hypertension (8.3%), nausea (8.3%), GI disorders (5%), chest pain (5%), and pruritus (5%). Less frequent events included diabetes mellitus, cyst and breast neoplasm, abdominal pain, anorexia, esophagitis, elevated creatinine, elevated blood glucose, leukopenia, peptic ulcer, and skin rash. Hypertension and thrombocytopenia (1 case each) were also reported after 7 years follow-up.

Precautions

Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specifi c treatment.

Drug Interactions

Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of URSO 250^® and URSO Forte^® Scored by reducing its absorption. Aluminum-based antacids have been shown to absorb bile acids in vitro and may be expected to interfere with URSO 250^® and URSO Forte^® Scored in the same manner as the bile acid sequestering agents. Estrogens, oral contraceptives and clofi brate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion, and encourage cholesterol gallstone formation and hence may counteract the effectiveness of URSO 250^® and URSO Forte^® Scored.

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Reference: 1. Axcan PharmaTM WAC Price List, August 2007.

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