FEMRING estradiol acetate

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Allergan, Inc.

INN (International Name):

ESTRADIOL ACETATE

Sammensetning:

ESTRADIOL 0.05 mg in 1 d

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application

Preparatomtale

FEMRING- ESTRADIOL ACETATE RING
ALLERGAN, INC.
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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)
DOSAGE FORMS AND STRENGTHS
Femring (0.05 mg/day): Ea