Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
ESTRADIOL ACETATE (UNII: 5R97F5H93P) (ESTRADIOL - UNII:4TI98Z838E)
Physicians Total Care, Inc.
ESTRADIOL ACETATE
ESTRADIOL ACETATE 0.1 mg in 24 [USP'U]
VAGINAL
PRESCRIPTION DRUG
Femring therapy is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms due to menopause. 2. Treatment of moderate to severe vulvar and vaginal atrophy due to menopause. Femring should not be used 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 deep vein thrombosis, pulmonary embolism or history of these conditions. - Active arterial thromboembolic disease (for example, stroke and myocardial infarction) or a history of these conditions. - Known liver dysfunction or disease. - Known or suspected pregnancy.
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. NDC 54868-6030-0 Femring® 0.10 mg/day (estradiol acetate vaginal ring) is available in single units. Relabeling of "Additional Barcode" by Physicians Total Care, Inc. Tulsa, OK 74146
New Drug Application
FEMRING - ESTRADIOL ACETATE RING PHYSICIANS TOTAL CARE, INC. ---------- WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA FOR ESTROGEN-ALONE THERAPY ENDOMETRIAL CANCER There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. (See WARNINGS, MALIGNANT NEOPLASMS, _ENDOMETRIAL_ _CANCER_.) CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS and DEMENTIA.) The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS.) The Women’s Health Initiative Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, DEMENTIA and PRECAUTIONS, GERIATRIC USE.) In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the Прочитать полный документ