ESTRADIOL tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)

可用日期:

Physicians Total Care, Inc.

INN（国际名称）:

ESTRADIOL

组成:

ESTRADIOL 0.5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Estradiol Tablets, USP are 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. - Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. - Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). - 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 risk

產品總結:

Estradiol Tablets, USP are available as: Store at 20º to 25º C (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container.

授权状态:

Abbreviated New Drug Application

产品特点

ESTRADIOL - ESTRADIOL TABLET
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
11001016
(THREE PATIENT INFORMATION LEAFLETS ENCLOSED - TEAR AT PERFORATION)
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, estr