Ursodiol Therapy

URSODIOL

DRUGDEX® Evaluations

DOSING/ADMINISTRATION

Adult Dosing[pic 1]

Normal Dosage

Oral route

Chemodissolution of bile duct stone

a) Patient Selection - Gallstone Dissolution

1) The following guidelines are suggested in the selection of patients for ursodiol therapy 

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a) Ursodiol therapy is only applicable to patients with gallstones in which cholesterol is the main component. Ursodiol will not dissolve pigment stones and these patients are not candidates for therapy. In addition, the drug will not dissolve stones containing calcium and is contraindicated for stones having a radiopaque component.

b) In general, patients who have had frequent attacks of biliary colic should not be treated with ursodiol therapy; surgery is indicated for these patients.

c) A non-functioning gallbladder, as determined by oral cholecystograms, is not a contraindication to therapy. In studies by the manufacturer, patients with nonvisualizing gallbladders prior to therapy had stone dissolution that was similar to those with visualizing gallbladders.

d) A stone diameter of less than 20 mm is usually associated with a favorable response to therapy; however, larger stones may dissolve if they are free of calcium or pigment elements.

e) Determination of cholesterol content of stones is mandatory. If stones appear radiolucent, small, and smoothly rounded, they are usually cholesterol stones as seen on x-ray. Success rates of 50% to 80% can be expected after treatment in patients with these types of stones. The recommended initial ursodiol dose is 10 milligrams/kilogram/day, given in 3 divided doses.

f) The first follow-up filming (or ultrasound scanning) should be performed at six months. In about 25% of patients, stones will have disappeared at this time. However, if there is no reduction, therapy should be discontinued if: (1) the patient has been taking medication regularly and there is no contraindication to cholecystectomy, (2) the patient has not been taking the medication regularly and cannot be relied upon to follow the regimen. Continuation of therapy is indicated if: (1) cholecystectomy is contraindicated and the patient is taking the medication regularly, or (2) a previously non-compliant patient promises to adhere to the regimen. Further imaging of the gallbladder should be performed at 6 month intervals and continued as long as reduction in size is demonstrable, until stones dissolve completely.

g) Therapy should be continued for an additional 3 months after documentation of complete disappearance of stones.

h) Ursodiol therapy can be considered for patients of any age or body weight. The likelihood of gallstone dissolution is not dependent on age, sex, weight, degree of obesity or serum cholesterol 

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b) Dosing

1) The recommended oral dosage of ursodiol for the treatment of radiolucent, non-calcified gallstones of less than 20 mm in diameter is 8 to 10 milligrams/kilogram/day in 2 to 3 divided doses. Ultrasound images are recommended at 6-month intervals during the first year of therapy to monitor gallstone response. Therapy should be continued If gallstones appear to have dissolved, and dissolution should be confirmed on repeat ultrasound within 1 to 3 months