General Information

 URSO 250 and URSO Forte (ursodiol) tablets are bile acids.

URSO 250 and URSO Forte are indicated for the treatment of patients with primary biliary cholangitis

The recommended adult dosage is 13-15 mg/kg/day administered in two to four divided doses with food.

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 in a dose related manner, to become the major biliary acid, replacing/displacing toxic concentrations of endogenous hydrophobic bile acids that tend to accumulate in cholestatic liver disease. In addition to the replacement and displacement of toxic bile acids, other mechanisms of action include cytoprotection of the injured bile duct epithelial cells (cholangiocytes) against toxic effects of bile acids, inhibition of apotosis of hepatocytes, immunomodulatory effects, and stimulation of bile secretion by hepatocytes and cholangiocytes.

Side Effects

Adverse effects associated with the use of URSO and URSO FORTE may include, but are not limited to, the following:

• abdominal discomfort
• abdominal pain
• alopecia
• diarrhea
• nausea
• pruritus
• rash

Clinical Trial Results

The approval rested primarily on the results of two Phase III trials conducted in approximately 300 patients. A two-year 180-patient study performed by the Mayo Clinic dosed patients at 13-15 mg/kg per day with Urso tablets 250 mg four times daily. Among patients receiving Urso, 23% were considered treatment failures compared to 47% in the placebo group.