INCURIN- estriol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Estriol (UNII: FB33469R8E) (Estriol - UNII:FB33469R8E)

Available from:

Merck Sharp & Dohme Corp.

INN (International Name):

Estriol

Composition:

Estriol 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATION: INCURIN® Tablets are indicated for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.

Product summary:

HOW SUPPLIED: INCURIN® Tablets contain 1 mg of estriol in each tablet and are supplied in foil-sealed blister packs of 30 single-scored tablets. Two carton sizes containing either 30 tablets (one blister pack) or 90 tablets (three blister packs) are available.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

INCURIN- ESTRIOL TABLET
MERCK SHARP & DOHME CORP.
----------
INCURIN TABLETS
(ESTRIOL)
APPROVED BY FDA UNDER NADA # 141-325
FOR ORAL USE IN DOGS ONLY
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A
LICENSED VETERINARIAN.
DESCRIPTION: INCURIN (estriol) Tablets contain 1 mg of estriol per
tablet.
USP Chemical Name: Estra-1,3,5(10)-triene-3,16,17-triol, (16 ,17 )-.
USP Molecular Weight: 288.38
USP Solubility: Soluble in acetone, in chloroform, in dioxane, in
ether, and in vegetable
oils; sparingly soluble in alcohol; insoluble in water.
INDICATION: INCURIN Tablets are indicated for the control of
estrogen-responsive
urinary incontinence in ovariohysterectomized female dogs.
DOSAGE AND ADMINISTRATION: The dose of INCURIN Tablets is not
dependent
upon body weight. All dogs should receive an initial dose of 2 mg
INCURIN Tablets (2
tablets) orally once per day for a minimum of 14 days. After urinary
incontinence is
controlled, the lowest effective daily dose of INCURIN Tablets should
be determined by
decreasing the dose in a step-wise manner from 2 mg once daily (2
tablets) to 1 mg
once daily (1 tablet), then 0.5 mg once daily (1/2 tablet) depending
upon the response of
the individual dog. There should be a minimum of 7 days between each
dose adjustment.
After the lowest daily dose that controls urinary incontinence is
identified, the dose may
be decreased further by administering once every two days. Dogs should
not receive
more than 2 mg INCURIN Tablets per day (2 tablets). If the dog does
not respond to 2
mg of INCURIN Tablets per day, the diagnosis should be re-assessed.
WARNINGS:
HUMAN WARNINGS: Not for human use. Keep out of the reach of children.
Women who
are of child-bearing age or those who are breastfeeding should use
caution when
administering INCURIN Tablets. Wash your hands with soap and water
after
®
®
α
β
®
®
®
®
®
®
®
administration to avoid exposure to the drug. Consult a physician in
case of accidental
ingestion by humans.
ANIMAL WARNINGS: Some estrogens have been as