国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)
Physicians Total Care, Inc.
ESTRADIOL
ESTRADIOL 0.97 mg in 48 [USP'U]
TRANSDERMAL
PRESCRIPTION DRUG
Estradiol Transdermal System Continuous Delivery (Once-Weekly), USP is indicated in the: - Treatment of moderate to severe vasomotor symptoms associated with the menopause. - Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - Prevention of postmenopausal osteoporosis. 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. The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elementa
Estradiol Transdermal System, 0.025 mg/day Continuous Delivery (Once-Weekly), USP – each 7.75 cm2 system contains 0.97 mg of estradiol USP NDC 54868-5009-0 Individual Carton of 4 systems NDC 54868-4811-0 Individual Carton of 4 systems NDC 54868-4813-0 Individual Carton of 4 systems Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Do not store unpouched. Apply immediately upon removal from the protective pouch. MYLAN PHARMACEUTICALS INC. Morgantown, WV 26505 REVISED AUGUST 2008 ETS:R16
Abbreviated New Drug Application
ESTRADIOL - ESTRADIOL PATCH PHYSICIANS TOTAL CARE, INC. ---------- PRESCRIBING INFORMATION Estradiol Transdermal System Continuous Delivery (Once- Weekly), USP ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer.) CARDIOVASCULAR AND OTHER RISKS Estrogens with and without progestins should not be used for the prevention of cardiovascular disease or dementia. (See WARNINGS, Cardiovascular disorders and Dementia.) The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.) The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, Clinical Studies and WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.) Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical tria 阅读完整的文件