Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)
Preferred Pharmaceuticals Inc.
ESTRADIOL
ESTRADIOL 1 mg
ORAL
PRESCRIPTION DRUG
Estradiol Tablets USP are indicated in the: Estrogens should not be used in individuals with any of the following conditions:
Abbreviated New Drug Application
ESTRADIOL- ESTRADIOL TABLET PREFERRED PHARMACEUTICALS INC. ---------- ESTRADIOL TABLETS USP RX ONLY 332 333 334 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 at equivalent estrogen doses. (See WARNINGS, MALIGNANT NEOPLASMS, _ENDOMETRIAL CANCER_.) CARDIOVASCULAR AND OTHER RISKS Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, CARDIOVASCULAR DISORDERS.) 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.) 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 or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, CLINICAL STUDIES.) 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 trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should Olvassa el a teljes dokumentumot