Ursodiol (ursodeoxycholic acid)

Generic Name : ursodiol (ursodeoxycholic acid) Brand Name: Actigall, URSO, URSO 250, URSO Forte, URSO DS (CAN) Classification: Gallsone-solubilizing drug Pregnancy Category B

Dosage & Route

ADULTS

Solubilization of gallstones: 810 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. Treatment of biliary cirrhosis: 1315 mg/kg/day PO administered in two to four divided doses with food; readjust dosage based on patient response (URSO). Prevention of gallstones: 300 mg PO bid or 810 mg/kg/day PO in two to three divided doses.

PEDIATRIC PATIENTS

Safety and efficacy not established.

Therapeutic actions
Indications

Treatment of selected patients with radiolucent, noncalcified gallstones in gallbladders for whom elective surgery is contraindicated Prevention of gallstone formation in obese patients experiencing rapid weight loss Treatment of primary biliary cirrhosis (tablets only) Unlabeled uses: Cholestasis-associated pruritus, primary sclerosing cholangitis

Adverse effects
fever, chills, body aches, flu symptoms; stomach pain, nausea, diarrhea, constipation; dizziness, tired feeling; back pain; runny or stuffy nose, cold symptoms; or

headache.

Contraindications
Contraindicated with allergy to bile salts, hepatic impairment, 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.

Nursing considerations
Assessment

History: Allergy to bile salts, hepatic impairment, calcified stones, radiopaque stones or radiolucent bile pigment stones, unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, biliary-GI fistula, pregnancy, lactation Physical: Liver evaluation, abdominal examination; affect, orientation; skin color, lesions; LFTs, hepatic and biliary radiological studies, biliary ultrasound

Interventions

Assess patient carefully for suitability of ursodiol therapy. Alternative therapy should be reviewed before using ursodiol. Give drug in two to three divided doses. Do not administer drug with aluminum-based antacids. If such drugs are needed, administer 23 hr after ursodiol. Schedule patients for periodic oral cholecystograms or ultrasonograms to evaluate drug effectiveness at 6-mo intervals until resolution, then every 3 mo to monitor stone formation. Stones recur within 5 yr in more than 50% of patients. If gallstones appear to have dissolved, continue treatment for 3 mo and perform follow-up ultrasound. Monitor LFTs periodically. Carefully assess patient if any change in liver function occurs.

Teaching points

Take drug two to four times a day. Take the drug as long as prescribed. It may be needed for a long time. This drug may dissolve your gallstones; it does not cure the problem that caused the stones, and in many cases, the stones can recur. Medical follow-up care is important. Arrange to receive periodic X-rays or ultrasound tests of your gallbladder; you also will need periodic blood tests to evaluate your response to this drug. Keep follow-up appointments.

Do not take with any aluminum-based antacids.