Estring
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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.



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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