FEMRING- estradiol acetate ring

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ESTRADIOL ACETATE (UNII: 5R97F5H93P) (ESTRADIOL - UNII:4TI98Z838E)

Tilgjengelig fra:

Millicent US, Inc.

Administreringsrute:

VAGINAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Femring 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 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 Femring - Known liver impairment or disease - Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders - Known or suspected pregnancy Femring 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 progestins as an oral contraceptive inadvertently during early pregnancy. Femring should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast

Produkt oppsummering:

Each Femring (estradiol acetate vaginal ring) is individually packaged in a pouch consisting of one side medical grade paper and the other side polyester/polyethylene laminate. N 72495-201-05 Femring 0.05 mg/day (estradiol acetate vaginal ring) is available in single units. N 72495-202-10 Femring 0.10 mg/day (estradiol acetate vaginal ring) is available in single units. Store at 25º C (77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature]. Do not store unpouched. Insert immediately upon removal from the protective pouch.

Autorisasjon status:

New Drug Application

Preparatomtale

FEMRING- ESTRADIOL ACETATE RING
MILLICENT US, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FEMRING SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FEMRING.
FEMRING® (ESTRADIOL ACETATE VAGINAL RING)
INITIAL U.S. APPROVAL: 1975
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 PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS
OF AGE AND
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
STROKE, 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 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)
RECENT MAJOR CHANGES
Warnings and Precautions, Malignant Neoplasms ( 5.2) 11/2017
INDICATIONS AND USAGE
Femring is an estrogen indicated for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (
1.1)
Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to
Menopause ( 1.2)
DOSAGE AND ADMINISTRATION
One ring inserted into the vagina for 3 months. Patients should be
started at the lowest dose. ( 2.1, 2.2)
DOSA