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
- 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.
- Treatment of biliary cirrhosis: 13–15 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 8–10 mg/kg/day PO in two to three divided doses.
- Safety and efficacy not established.
- 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
- fever, chills, body aches, flu symptoms;
- stomach pain, nausea, diarrhea, constipation;
- dizziness, tired feeling;
- back pain;
- runny or stuffy nose, cold symptoms; or
- 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.
- 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
- 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 2–3 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.
- 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.