Source: FDA, National Drug Code (US) Revision Year: 2018
URSO 250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cirrhosis (PBC).
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 (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 (5.1)].
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 How Supplied/Storage and Handling (16.2)].
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 at 1.5 g/kg was lethal in hamsters. Symptoms of acute toxicity were salivation and vomiting in dogs, and ataxia, dyspnea, ptosis, agonal convulsions and coma in hamsters.
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 20ºC to 25ºC (68ºF to 77ºF). Due to the bitter taste, the halved segments should be stored separately from the whole tablets [see Dosage and Administration (2.2)].
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