Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)
ReadyMeds
ESTRADIOL
ESTRADIOL 1 mg
ORAL
PRESCRIPTION DRUG
Estradiol tablets are indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribed solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. 5. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). 6. Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies .) The mainstays for decreasing the
Estradiol Tablets USP, 0.5 mg, are round, white, scored tablets imprinted with WATSON 528 : supplied in bottles of 100 and 500. Estradiol Tablets USP, 1 mg, are round, gray, scored tablets imprinted with WATSON 487 : supplied in bottles of 100 and 500. Estradiol Tablets USP, 2 mg, are round, light green, scored tablets imprinted with WATSON 488 : supplied in bottles of 100 and 500. Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
ESTRADIOL- ESTRADIOL TABLET READYMEDS ---------- ESTRADIOL TABLETS USP ESTRADIOL TABLETS USP RX ONLY Revised: October 2009 12820-5 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, CLINICALSTUDIES.) 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 prog Citiți documentul complet