Ursodiol (Page 4 of 4)

OVERDOSAGE

Neither accidental nor intentional overdosing with ursodiol has been reported. Doses of ursodiol in the range of 16 — 20 mg/kg/day have been tolerated for 6 to 37 months without symptoms by 7 patients. The LD₅₀ for ursodiol in rats is over 5000 mg/kg given over 7 to 10 days and over 7500 mg/kg for mice. The most likely manifestation of severe overdose with ursodiol would probably be diarrhea, which should be treated symptomatically.

DOSAGE AND ADMINISTRATION

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.).

HOW SUPPLIED

Product: 68151-2987

NDC: 68151-2987-0 1 CAPSULE in a PACKAGE

Ursodiol 300 mg capsules

Label Image

URSODIOL ursodiol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-2987(NDC:0591-3159) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength URSODIOL (URSODIOL) URSODIOL 300 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE FERRIC OXIDE RED GELATIN MAGNESIUM STEARATE STARCH, CORN FERROSOFERRIC OXIDE

Product Characteristics Color WHITE (opaque white) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code WATSON;3159 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68151-2987-0 1 CAPSULE in 1 PACKAGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA AUTHORIZED GENERIC NDA019594 12/31/1987

Labeler — Carilion Materials Management (079239644)

Establishment
Name	Address	ID/FEI	Operations
Carilion Materials Management		079239644	REPACK (68151-2987)

Revised: 08/2016 Carilion Materials Management