Actigall (Ursodiol) - Indications and Dosage

INDICATIONS AND USAGE

1. Actigall 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 Actigall beyond 24 months is not established.

2. Actigall is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

DOSAGE AND ADMINISTRATION

Gallstone Dissolution

The recommended dose for Actigall 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 Actigall therapy to monitor gallstone response. If gallstones appear to have dissolved, Actigall therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1-3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment re-evaluation. If partial stone dissolution is not seen by 12 months of Actigall therapy, the likelihood of success is greatly reduced.

Gallstone Prevention

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

HOW SUPPLIED

Actigall Capsules are opaque white and pink capsules imprinted “ACTIGALL” on one half and “300 mg” on the other half of the capsule in black.

Bottles of 100 are supplied with child-resistant closures.
(NDC 52544-930-01)

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Dispense in tight container (USP).

Rx only

Watson Pharmaceuticals, Inc.
Corona, CA 92880 USA

Revised: July 2007

ACTGL07/07
S0707