FEMHRT- norethindrone acetate/ethinyl estradiol tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

זמין מ:

Allergan, Inc.

INN (שם בינלאומי):

NORETHINDRONE ACETATE

הרכב:

NORETHINDRONE ACETATE 0.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

   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 medication should be carefully considered. femhrt 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 to femhrt - Known liver impairment or disease - Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders - Known or suspected pregnancy  femhrt should not be used during pregnancy [see  Contraindications (4) ]. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestin

leaflet_short:

femhrt (norethindrone acetate/ethinyl estradiol tablets) is available in the following strengths and package sizes: N 0430-0145-14  Blister card of 28 oval white tablets containing 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol; imprinted with WC on one side and 145 on the other. Store at 25º C (77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature].

מצב אישור:

New Drug Application

מאפייני מוצר

FEMHRT- NORETHINDRONE ACETATE/ETHINYL ESTRADIOL TABLET
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
_FEMHRT_ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR _FEMHRT_.
_FEMHRT_® (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL TABLETS)
INITIAL U.S. APPROVAL: 1968
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER
AND
PROBABLE DEMENTIA
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
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 WOMEN’S HEALTH INITIATIVE (WHI) ESTROGEN PLUS PROGESTIN
SUBSTUDY REPORTED INCREASED RISKS OF
STROKE, DEEP VEIN THROMBOSIS (DVT), PULMONARY EMBOLISM (PE), AND
MYOCARDIAL INFARCTION (MI) (5.1)
• THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED AN INCREASED
RISK 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)
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 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)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 11/2017
INDICATIONS AND USAGE
_FEMHRT_ is an estrogen plus progestin indicated in a woman with a
uterus for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
(1.1)
Prevention of Postmenopausal Osteoporosis (1.2)
DOSAGE AND ADMINISTRATION
One tablet taken orally once daily (2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
Oval white tablet contain