Ursodeoxycholic acid is a tertiary bile acid with the ability to reduce cholesterol saturation of bile that may lead to the formation of cholesterol-containing gallstone and to improve any bile flow impairment.
Indications/Uses
For patients with radiolucent, noncalcified gallbladder stone <20 mm in greatest diameter, in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reactions to general anesthesia or for patients who refuse surgery.
Dosage/Direction for Use
Treatment of Radiolucent Gallstone: Recommended Dose: 8-10 mg/kg body weight/day in 2 or 3 divided doses (usually, 300 mg in the morning and night).
X-ray or USG examination should be obtained at 6-month interval for the 1st year of therapy to monitor gallstone response.
Minimum duration of therapy to dissolve gallstone is 3 months. Treatment should be continued for the next 3 months to dissolve another fragments which are not detected by x-ray or USG. If gallstone dissolution is not seen by 12 months of therapy, the treatment may be ineffective.
In cases of fragmentation of gallstones with cholelithotripsy, Ursochol should be administered 2 weeks prior to intervention and the treatment should be continued until 3 months after dissolution of gallstones. Although the symptoms subside immediately after the starting of treatment and the patients achieve stone dissolution, dosing should not be reduced or discontinued.
Contraindications
Impaired kidney function and cholecystitis or enterocolitis.
Oral contraceptives as it may encourage the risk of gallstone formation.
Repeated biliary colic; acute gastritis which result in enterocolitis. Pregnancy.
Ursodeoxycholic acid will not dissolve calcified cholesterol gallstone, radiopaque or radiolucent bile pigment stones. Hence, Ursochol is contraindicated in such patients.
Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction or biliary fistula.
Allergy to bile acids.
Special Precautions
Safety of Ursochol use beyond 24 months has not been established.
Gallstone dissolution by ursodeoxycholic acid should only be used in cases of radiolucent stones (without x-ray proof-coating) in patients with functioning gall bladder. The best rate of dissolution has been reached in the case of a small, suspended stone with ≤10 mm in diameter. Ursodeoxycholic acid should not be given to patients with frequent bile colic, bladder and biliary tract inflammation, and bile acid malabsorption (ie, small and large intestine inflammation eg, Crohn's disease).
Gallstone dissolution by ursodeoxycholic acid requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who dissolve their stones on bile acid therapy. Patients should be carefully selected and alternative treatment should be considered. Use in children: The safety and effectiveness in pediatric patients has not been established.
Do not use in combination with antacids and cholestyramine (bile-acid sequestering agents).
Concomitant use with estrogen pill may encourage gallstone formation.
Storage
Store at room temperature (25°-30°C). Keep in a dry place.
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