Ursodiol (Ursodeoxycholic Acid)(ur soe dye’ ole)
Actigall, URSO 250, URSO DS (CAN), URSO Forte
PREGNANCY CATEGORY B
Drug class
Gallstone-solubilizing drug
Therapeutic Actions
A naturally occurring bile acid that suppresses hepatic synthesis of cholesterol and inhibits intestinal absorption of cholesterol, leading to a decreased cholesterol concentration in the bile and a bile that is cholesterol solubilizing and not cholesterol precipitating.
Indications
Treatment of select patients with radiolucent, noncalcified gallstones less than 20 mm in diameter in gallbladders for whom elective surgery is contraindicated (capsules)
Prevention of gallstone formation in obese patients experiencing rapid weight loss
Treatment of primary biliary cirrhosis (tablets only)
Unlabeled uses: Cholestasis-associated pruritus, biliary atresia in infants, enhancement of fatty acid metabolism in children with cystic fibrosis
Contraindications and Cautions
Contraindicated with allergy to bile salts, calcified stones, radiopaque stones or radiolucent bile pigment stones, unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, biliary GI fistula (cholecystectomy required), pregnancy.
Use cautiously with lactation, hepatic impairment.
Available Forms
Capsules—300 mg; tablets—250, 500 mg
Dosages
Adults
Solubilization of gallstones: 8–10 mg/kg/day PO given in two to three divided doses. Resolution of the gallstones requires months of therapy; condition needs to be monitored with ultrasound at 6-mo and 1-yr intervals. (capsules)
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