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Estrace®
Tablets
(estradiol tablets, USP)
See:
Estradiol Evista
Mircette
Activella Alora
Climara Pro
CombiPatch Delestrogen
Esclim Estraderm
Estring Evamist Vagifem Vivelle-Dot
All of these products are used to reduce symptoms
of menopause, including feelings of warmth in the face, neck, and chest; the
sudden intense episodes of heat and sweating known as "hot flashes"; dry, itchy
external genitals; and vaginal irritation. They are also prescribed for other
conditions that cause low levels of estrogen, and some doctors prescribe them
for teenagers who fail to mature at the usual rate.
Along with diet, calcium supplements, and exercise, Alora, Estraderm, Climara,
Vivelle, and Vivelle-Dot are prescribed to prevent osteoporosis, a condition in
which the bones become brittle and easily broken.
ESTRACE® (estradiol tablets, USP) for oral
administration contains 0.5,1 or 2 mg of micronized estradiol per tablet.
Estradiol (17b-estradiol) is a white, crystalline solid, chemically described as
estra-1,3,5,(10)-triene-3,17b-diol.It has an empirical formula of C18H24O2 and
molecular weight of 272.37.
ESTRACE Tablets, 0.5 mg, contain the following inactive ingredients: acacia,
dibasic calcium phosphate, lactose, magnesium stearate, colloidal silicon
dioxide, starch (corn),and talc.
ESTRACE Tablets,1 mg, contain the following inactive ingredients: acacia, D&C
Red No.27 (aluminum lake),dibasic calcium phosphate, FD&C Blue No.1 (aluminum
lake),lactose, magnesium stearate, colloidal silicon dioxide, starch (corn),and
talc.
ESTRACE Tablets,2 mg, contain the following inactive ingredients: acacia,
dibasic calcium phosphate, FD&C Blue No.1 (aluminum lake), FD&C Yellow No. 5 (tartrazine)
(aluminum lake), lactose, magnesium stearate, colloidal silicon dioxide, starch
(corn),and talc.
WARNINGS
1. ESTROGENS HAVE BEEN REPORTED TO
INCREASE THE RISK OF ENDOMETRIAL CARCINOMA IN POSTMENOPAUSAL WOMEN.
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 "natural"
estrogens are more or less hazardous than "synthetic" estrogens at
equiestrogenic doses.
2. ESTROGENS SHOULD NOT BE USED DURING PREGNANCY.
There is no indication for estrogen therapy during pregnancy or during the
immediate postpartum period. Estrogens are ineffective for the prevention or
treatment of threatened or habitual abortion. Estrogens are not indicated for
the prevention of postpartum breast engorgement.
Estrogen therapy during pregnancy is associated with an increased risk of
congenital defects in the reproductive organs of the fetus, and possibly other
birth defects. Studies of women who received diethylstilbestrol (DES) during
pregnancy have shown that female offspring have an increased risk of vaginal
adenosis, squamous cell dysplasia of the uterine cervix, and clear cell vaginal
cancer later in life; male offspring have an increased risk of urogenital
abnormalities and possibly testicular cancer later in life. The 1985 DES Task
Force concluded that use of DES during pregnancy is associated with a subsequent
increased risk of breast cancer in the mothers, although a causal relationship
remains unproven and the observed level of excess risk is similar to that for a
number of other breast cancer risk factors.
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