ESTRADIOL / NORETHINDRONE ACETATE- estradiol and norethindrone acetate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Estradiol (UNII: 4TI98Z838E) (Estradiol - UNII:4TI98Z838E), Norethindrone Acetate (UNII: 9S44LIC7OJ) (Norethindrone - UNII:T18F433X4S)

Available from:

Breckenridge Pharmaceutical, Inc.

INN (International Name):

Estradiol

Composition:

Estradiol 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol/Norethindrone Acetate Tablets are indicated for:   Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. Estradiol/Norethindrone Acetate Tablets are contraindicated in women with any of the following conditions: - Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.2)] - Breast cancer or history of breast cancer [see Warnings and Precautions (5.2)] - Estrogen-dependent neoplasia [see Warnings and Precautions (5.2)] - Active DVT, PE, or history of these conditions [see Warnings and Precautions (5.1)] - Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions [see Warnings and Precauti

Product summary:

Estradiol/Norethindrone Acetate Tablets 1 mg/0.5 mg are available as white, convex, coated tablets debossed with "B" on one side and "474" on the other side. (NDC 51991-474-28). It is supplied as 28 tablets in a calendar blister pack dispenser. Estradiol/Norethindrone Acetate Tablets 0.5 mg/0.1 mg are available as white, convex, coated tablets debossed with "B" on one side and "623" on the other side. (NDC 51991-623-28). It is supplied as 28 tablets in a calendar blister pack dispenser. Store in a dry place protected from light. Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL / NORETHINDRONE ACETATE- ESTRADIOL AND NORETHINDRONE
ACETATE TABLET, FILM COATED
BRECKENRIDGE PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTRADIOL/NORETHINDRONE ACETATE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR ESTRADIOL/ NORETHINDRONE ACETATE TABLETS.
ESTRADIOL / NORETHINDRONE ACETATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER,
AND ENDOMETRIAL CANCER
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
ESTROGEN PLUS PROGESTIN THERAPY
THE WOMEN'S HEALTH INITIATIVE (WHI) ESTROGEN PLUS PROGESTIN SUBSTUDY
REPORTED
INCREASED RISKS OF DEEP VEIN THROMBOSIS (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 WHI MEMORY STUDY (WHIMS) ESTROGEN PLUS PROGESTIN ANCILLARY STUDY
OF WHI
REPORTED AN INCREASED RISK OF PROBABLE DEMENTIA IN POSTMENOPAUSAL
WOMEN 65
YEARS OF AGE AND OLDER (5.3)
DO NOT USE ESTROGEN PLUS PROGESTOGEN THERAPY FOR THE PREVENTION OF
CARDIOVASCULAR
DISEASE OR DEMENTIA (5.1, 5.3)
ESTROGEN-ALONE THERAPY
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO USE
UNOPPOSED ESTROGENS (5.2)
THE WHI ESTROGEN-ALONE SUBSTUDY REPORTED INCREASED RISKS OF STROKE AND
DVT (5.1)
THE WHIMS ESTROGEN-ALONE ANCILLARY STUDY OF WHI REPORTED AN INCREASED
RISK OF
PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE AND OLDER
(5.3)
DO NOT USE ESTROGEN-ALONE THERAPY FOR THE PREVENTION OF CARDIOVASCULAR
DISEASE OR
DEMENTIA (5.2, 5.3)
RECENT MAJOR CHANGES
Boxed Warning
08/2021
INDICATIONS AND USAGE
Estradiol/Norethindrone Acetate Tablets are an estrogen and progestin
combination indicated in a woman
with a uterus 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 Menop