ESTRADIOL patch, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 0.1 mg in 1 d

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol transdermal system is indicated for:   Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.   Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. Estradiol transdermal system is contraindicated in women with any of the following conditions: - Undiagnosed abnormal genital bleeding - Known, suspected or history of breast cancer - Known or suspected estrogen-dependent neoplasia - Active DVT, PE, or a history of these conditions - Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions - Known anaphylactic reaction or angioedema or hypersensitivity with estradiol transdermal system - Known liver impairment or disease - Known protein C, protein S, or antithrombin de

Product summary:

Estradiol transdermal system, 0.1 mg per day – each 10.0 cm 2 system contains 1.56 mg of estradiol USP for nominal* delivery of 0.1 mg of estradiol per day. NDC 68071-3326-8 Packet of 8 Storage and Handling Store at controlled room temperature at 25°C (77°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

ESTRADIOL- ESTRADIOL PATCH, EXTENDED RELEASE
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTRADIOL TRANSDERMAL SYSTEM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESTRADIOL
TRANSDERMAL SYSTEM.
ESTRADIOL TRANSDERMAL SYSTEM
INITIAL U.S. APPROVAL: 1996
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER
AND
PROBABLE DEMENTIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ESTROGEN-ALONE THERAPY
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO USES UNOPPOSED
ESTROGENS (5.2)
ESTROGEN-ALONE THERAPY SHOULD NOT BE USED FOR THE PREVENTION OF
CARDIOVASCULAR DISEASE OR DEMENTIA
(5.1, 5.3)
THE WOMEN’S HEALTH INITIATIVE (WHI) ESTROGEN-ALONE SUBSTUDY REPORTED
INCREASED RISKS OF STROKE AND
DEEP VEIN THROMBOSIS (DVT) (5.1)
THE WHI MEMORY STUDY (WHIMS) ESTROGEN-ALONE ANCILLARY STUDY OF WHI
REPORTED AN INCREASED RISK OF
DEVELOPING PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE
OR OLDER (5.3)
ESTROGEN PLUS PROGESTIN THERAPY
ESTROGEN PLUS PROGESTIN THERAPY SHOULD NOT BE USED FOR THE PREVENTION
OF CARDIOVASCULAR DISEASE OR
DEMENTIA (5.1, 5.3)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
DVT, PULMONARY EMBOLISM
(PE), STROKE AND MYOCARDIAL INFARCTION (MI) (5.1)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
INVASIVE BREAST CANCER (5.2)
THE WHIMS ESTROGEN PLUS PROGESTIN ANCILLARY STUDY OF WHI REPORTED AN
INCREASED RISK OF DEVELOPING
PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE OR OLDER
(5.3)
INDICATIONS AND USAGE
Estradiol transdermal system is an estrogen indicated for:
Treatment of moderate to severe vasomotor symptoms due to menopause (
1.1)
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy
due to menopause ( 1.2)
Limitation of Use: When prescribing solely for the treatment of
moderate to severe vaginal atrophy, topical vaginal
products should be considered.
Treatment o