Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
ESTRADIOL HEMIHYDRATE (UNII: CXY7B3Q98Z) (ESTRADIOL - UNII:4TI98Z838E)
A-S Medication Solutions
VAGINAL
PRESCRIPTION DRUG
Estradiol Vaginal Cream 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Estradiol Vaginal Cream 0.01% should not be used in women with any of the following conditions: - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of cancer of the breast. - Known or suspected estrogen-dependent neoplasia. - Active DVT, PE or history of these conditions. - Active arterial thromboembolic disease (for example, stroke, MI) or a history of these conditions. - Known anaphylactic reaction or angioedema to Estradiol Vaginal Cream 0.01%. - Known liver dysfunction or disease. - Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. - Known or suspected pregnancy.
Product: 50090-3645 NDC: 50090-3645-0 42.5 g in a TUBE, WITH APPLICATOR / 1 in a CARTON
Abbreviated New Drug Application
ESTRADIOL- ESTRADIOL CREAM A-S MEDICATION SOLUTIONS ---------- ESTRADIOL VAGINAL CREAM, USP 0.01% WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA 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 PROBABLE 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]-alone, relative to placebo [see CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS]. The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an 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, PROBABLE 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 tre Прочетете целия документ