国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)
NuCare Pharmaceuticals,Inc.
ESTRADIOL
ESTRADIOL 0.1 mg in 1 d
TRANSDERMAL
PRESCRIPTION DRUG
Estradiol transdermal system is indicated for: Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. Estradiol transdermal system 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 a history of these conditions - Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions - Known anaphylactic reaction or angioedema or hypersensitivity with estradiol transdermal system - Known liver impairment or disease - Known protein C, protein S, or antithrombin de
Estradiol transdermal system, 0.1 mg per day – each 10.0 cm 2 system contains 1.56 mg of estradiol USP for nominal* delivery of 0.1 mg of estradiol per day. NDC 68071-3326-8 Packet of 8 Storage and Handling Store at controlled room temperature at 25°C (77°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.
New Drug Application Authorized Generic
ESTRADIOL- ESTRADIOL PATCH, EXTENDED RELEASE NUCARE PHARMACEUTICALS,INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ESTRADIOL TRANSDERMAL SYSTEM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESTRADIOL TRANSDERMAL SYSTEM. ESTRADIOL TRANSDERMAL SYSTEM INITIAL U.S. APPROVAL: 1996 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 DEVELOPING PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE OR 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 DVT, PULMONARY EMBOLISM (PE), STROKE AND MYOCARDIAL INFARCTION (MI) (5.1) THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF INVASIVE BREAST CANCER (5.2) THE WHIMS ESTROGEN PLUS PROGESTIN ANCILLARY STUDY OF WHI REPORTED AN INCREASED RISK OF DEVELOPING PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE OR OLDER (5.3) INDICATIONS AND USAGE Estradiol transdermal system is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1) Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause ( 1.2) Limitation of Use: When prescribing solely for the treatment of moderate to severe vaginal atrophy, topical vaginal products should be considered. Treatment o 阅读完整的文件