Prescription Drug Information: Ursodiol (Page 3 of 3)

OVERDOSAGE

Neither accidental nor intentional overdosing with ursodiol has been reported. Doses of ursodiol in the range of 16 to 20 mg/kg/day have been tolerated for 6 to 37 months without symptoms by seven patients. The LD 50 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 capsules treatment of radiolucent gallbladder stones is 8 to 10 mg/kg/day given in two or three divided doses.

Ultrasound images of the gallbladder should be obtained at 6 month intervals for the first year of ursodiol capsules therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol capsules 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 capsules therapy, the likelihood of success is greatly reduced.

Gallstone Prevention

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

HOW SUPPLIED:

Ursodiol Capsules, USP are available containing 300 mg of ursodiol, USP.

The 300 mg capsules are hard-shell gelatin capsules with a peach opaque cap and a white opaque body filled with white to off-white powder. The capsule is axially printed with MYLAN over 1730 in black ink on both the cap and body. They are available as follows:

NDC 51079-383-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-12267
12/15

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 51079-383-20

Ursodiol
Capsules, USP
300 mg

100 Capsules (10 x 10)

Each capsule contains:
Ursodiol, USP 300 mg

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Rx only

S-12266

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Ursodiol 300 mg Capsules Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
URSODIOL
ursodiol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-383
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
STARCH, CORN
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color orange (peach opaque) , white (white opaque) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code MYLAN;1730
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-383-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-383-01)
1 NDC:51079-383-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-383-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090530 01/25/2016 01/31/2023
Labeler — Mylan Institutional Inc. (039615992)

Revised: 11/2021 Mylan Institutional Inc.

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