URSO 250 / FORTE Film-coated tablet (2018)

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Allergan, Inc.

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1. Indications and Usage

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

2. Dosage and Administration

2.1 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 ...

3. Dosage Forms and Strengths

URSO 250: 250 mg tablet URSO Forte: 500 mg scored tablet

4. Contraindications

Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation.

5. Warnings and Precautions

Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment. 5.1 Abnormal Liver Function Tests Liver function ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during postapproval use of ursodiol. Because these reactions are reported voluntarily from a ...

7. Drug Interactions

7.1 Bile Acid Sequestering Agents Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of URSO 250 and URSO Forte by reducing its absorption. 7.2 Aluminum-based ...

8.1. Pregnancy

Reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times ...

8.3. Nursing Mothers

It is not known whether ursodiol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when URSO 250 and URSO Forte are administered to a nursing mother. ...

8.4. Pediatric Use

The safety and effectiveness of URSO 250 and URSO Forte in pediatric patients have not been established.

10. Overdosage

There have been no reports of accidental or intentional overdosage with ursodiol. Single oral doses of ursodiol at 10 g/kg in mice and dogs, and 5 g/kg in rats were not lethal. A single oral dose of ursodiol ...

11. Description

URSO 250 (ursodiol, 250 mg) is available as a film-coated tablet for oral administration. URSO Forte (ursodiol, 500 mg) is available as a scored film-coated tablet for oral administration. Ursodiol (ursodeoxycholic ...

12.1. Mechanism of Action

Ursodiol, a naturally occurring hydrophilic bile acid, derived from cholesterol, is present as a minor fraction of the total human bile acid pool. Oral administration of ursodiol increases this fraction ...

12.2. Pharmacodynamics

Lithocholic acid, when administered chronically to animals, causes cholestatic liver injury that may lead to death from liver failure in certain species unable to form sulfate conjugates. Ursodiol is 7-dehydroxylated ...

12.3. Pharmacokinetics

Ursodiol (UDCA) is normally present as a minor fraction of the total bile acids in humans (about 5%). Following oral administration, the majority of ursodiol is absorbed by passive diffusion and its absorption ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In two 24-month oral carcinogenicity studies in mice, ursodiol at doses up to 1,000 mg/kg/day (3,000 mg/m²/day) was not tumorigenic. Based on body surface area, for a 50 kg person of average height (1.46 ...

14. Clinical Studies

14.1 Efficacy of Ursodeoxycholic Acid A dministered at 13 to 15 mg/kg/day in 3 or 4 Divided Doses to PBC Patients A U.S., multicenter, randomized, double-blind, placebo-controlled study was conducted to ...

16.1. How Supplied

16.1 URSO 250 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). 16.2 URSO Forte ...

16.2. Storage and Handling

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 ...

17. Patient Counseling Information

17.1 Appropriate Treatments Patients with the following conditions should be instructed to receive appropriate management measures: variceal bleeding, hepatic encephalopathy, ascites, in need of an urgent ...