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Ursodiol (Ursodiol) - Indications and Dosage



Watchful Waiting

Watchful waiting has the advantage that no therapy may ever be required. For patients with silent or minimally symptomatic stones, the rate of development of moderate-to-severe symptoms or gallstone complications is estimated to be between 2% and 6% per year, leading to a cumulative rate of 7% - 27% in 5 years. Presumably the rate is higher for patients already having symptoms.


For patients with symptomatic gallstones, surgery offers the advantage of immediate and permanent stone removal, but carries a high risk in some patients. About 5% of cholecystectomized patients have residual symptoms or retained common duct stones. The spectrum of surgical risk varies as a function of age and the presence of disease other than cholelithiasis.

Mortality Rates for Cholecystectomy in the U.S.

(National Halothane Study, JAMA 1966; 197:775-8)

27,600 Cholecystectomies

(Smoothed Rates)

Deaths/1000 Operations***

Figure 1
Mortality Rates for Cholecystectomy in the US

Low Risk Patients*

Age (yrs)


Cholecystectomy Common Duct Exploration
Women 0-49 .54 2.13
50-69 2.80 10.10
Men 0-49 1.04 4.12
50-69 5.41 19.23
High Risk Patients**
Women 0-49 12.66 47.62
50-69 17.24 58.82
Men 0-49 24.39 90.91
50-69 33.33 111.11

* In good health or with moderate systemic disease.

** With severe or extreme systemic disease.

*** Includes both elective and emergency surgery.

Women in good health or who have only moderate systemic disease and are under 49 years of age have the lowest surgical mortality rate (0.054); men in all categories have a surgical mortality rate twice that of women. Common duct exploration quadruples the rates in all categories. The rates rise with each decade of life and increase tenfold or more in all categories with severe or extreme systemic disease.


  1. Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 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 reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established.
  2. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.


Gallstone Dissolution

The recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8 - 10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.

Gallstone Prevention

The recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).


Ursodiol Capsules USP, 300 mg are opaque white and pink capsules, filled with white powder. They are imprinted

“Є503” in black ink on cap and body and are supplied in bottles of 180. NDC 42291-850-18 and 1000 42291-850-10.

Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense contents in tight, light-resistant container as defined in the USP.

Keep out of reach of children.

Manufactured for:
Pulaski, TN 38478

Mfg. Iss. 05/10
AV Rev. 05/14 (P)

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