WARNING
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 the 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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DESCRIPTION
Estrace tablets for oral administration contain
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.
Its molecular formula is C18H24O2
and its molecular weight is 272.39. 0.5 mg: Estrace 0.5
mg tablets contain the following inactive ingredients: acacia,
dibasic calcium phosphate, lactose, magnesium stearate,
colloidal silicon dioxide, starch (corn), and talc. 1 mg:
Estrace 1 mg tablets 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. 2 mg: Estrace 2 mg tablets 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.
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