Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ESTRADIOL ACETATE (UNII: 5R97F5H93P) (ESTRADIOL - UNII:4TI98Z838E)
Allergan, Inc.
ESTRADIOL ACETATE
ESTRADIOL 0.05 mg in 1 d
PRESCRIPTION DRUG
New Drug Application
FEMRING- ESTRADIOL ACETATE RING ALLERGAN, INC. ---------- 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 Olvassa el a teljes dokumentumot