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Medically reviewed by Drugs. Last updated on June 1, 2021. Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions Adverse Reactions/Side Effects Drug Interactions Use In Specific Populations Overdosage Description Clinical Pharmacology Nonclinical Toxicology Clinical Studies How Supplied/Storage and Handling Patient Counseling Information. Indications and Usage for Ursodiol, cabgolin 0.25 mg antiestrogens cabaser. Ursodiol tablets, USP 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC). Ursodiol Dosage and Administration. The recommended adult dosage for Ursodiol tablets, USP 250 mg and 500 mg 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 (?-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 (5. Scoring the Ursodiol Tablets, USP 500 mg. The Ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage. To break Ursodiol 500 mg 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. Dosage Forms and Strengths. Ursodiol: 250 mg tablet Ursodiol: 500 mg scored tablet. Patients with complete biliary obstruction and known hypersensitivity or intolerance to Ursodiol or any of the components of the formulation. Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment. Abnormal Liver Function Tests. Liver function tests (?-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. This monitoring will allow the early detection of a possible deterioration of the hepatic function. Treatment discontinuation should be considered if the above parameters increase to a level considered clinically significant in patients with stable historical liver function test levels. Caution has to be exercised to maintain the bile flow of the patients taking Ursodiol.
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