HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ursodiol safely and effectively. See full prescribing information for ursodiol.
Ursodiol Tablets, USP
Initial U.S. Approval: 1997
INDICATIONS AND USAGE
Ursodiol tablets are bile acids indicated for the treatment of patients with primary biliary cirrhosis (1)
DOSAGE AND ADMINISTRATION
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Recommended adult dosage: 13-15 mg/kg/day administered in two to four divided doses with food (2.1)
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Scored ursodiol 500 mg tablet: scored tablet can be broken in halves to provide recommended dosage (2.2, 16.2)
DOSAGE FORMS AND STRENGTHS
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Ursodiol: 250 mg tablet (3)
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Ursodiol: 500 mg scored tablet (3)
CONTRAINDICATIONS
Known hypersensitivity or intolerance to ursodiol or any of the components of the formulation (4)
WARNINGS AND PRECAUTIONS
Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment (5)
ADVERSE REACTIONS
Most common adverse reactions reported with the use of ursodiol during worldwide postmarketing and clinical experience (≥1%) are, in alphabetical order: abdominal discomfort, abdominal pain, alopecia, diarrhea, nausea, pruritus, and rash (6)
To report SUSPECTED ADVERSE REACTIONS, contact Watson Laboratories, Inc. at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Bile Acid Sequestering Agents: May interfere with the action of ursodiol by reducing its absorption (7.1)
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Aluminum-based Antacids: May interfere with the action of ursodiol by reducing its absorption (7.2)
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Drugs that alter the metabolism of lipids or induce cholestasis may interfere with the action of ursodiol (7.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 05/2011
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