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 ImageLabel 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

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