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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (E's) » Ethinyl Estradiol



DESCRIPTION

WARNINGS

1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK RATIO OF ENDOMETRIAL CARCINOMA.

Three independent case control studies have reported an increased risk ratio of endometrial cancer in postmenopausal women exposed to exogenous estrogens for prolonged periods.1-3 This risk ratio was independent of the other risk factors for endometrial cancer These studies are further supported by the report that incidence rates of endometrial cancer have increased sharply since 1969 in eight different areas of the United States with population-based cancer reporting systems an increase which may be related to the rapidly expanding1 use of estrogens during the last decade.4

The three case control studies reported that the risk ratio of endometrial cancer in estrogen users was about 4.5 to 13.9 times greater than in nonusers. The risk ratio appears to depend on both duration of treatment1 and on estrogen dose.3 In view of these reports, when estrogens are used for the treatment of menopausal symptoms, the lowest dose that will control symptoms should be utilized and medication should be discontinued as soon as possible. When prolonged treatment is medically indicated, the patient should be reassessed on at least a semiannual basis to determine the need for continued therapy. Although the evidence must be considered preliminary, one study suggests that cyclic administration of low doses of estrogen may carry less risk than continuous administration3; it therefore appears prudent to utilize such a regimen.

Close clinical surveillance of all women taking estrogens is important. In all cases of undiagnosed persistent or recurring abnormal vaginal bleeding, adequate diagnostic measures should be undertaken to rule out malignancy.

There is no evidence at present that "natural" estrogens are more or less hazardous than "synthetic" estrogens at equiestrogenic doses.

2. ESTROGENS SHOULD NOT BE USED DURING PREGNANCY.

The use of estrogens during early pregnancy may seriously damage the offspring. It has been reported that females exposed in utero to diethylstilbestrol, a nonsteroidal estrogen, may have an increased risk of developing in later life a form of vaginal or cervical cancer that is ordinarily extremely rare. This risk has been estimated statistically as not greater than 4 per 1000 exposures. In certain studies a high percentage of such exposed women (from 30% to 90%) have been found to have vaginal adenosis, epithelial changes of the vagina and cervix. Although these changes are histologically benign, it is not known whether they are precursors of malignancy Although similar data are not available table with the use of other estrogens, it cannot be presumed they would not induce similar changes. Exposure to diethylstilbestrol has also been associated with adverse effects on reproductive performance, including increased rates of spontaneous abortion, ectopic pregnancy, premature deliveries, and perinatal deaths.

Several reports suggest an associati on between intrauterine fetal exposure to female sex hormones and congenital anomalies, including congenital heart defects and limb reducti on defects. One case control study estimated a 4.7-fold increased risk of limb reduction defects in infants exposed in utero to sex hormones (oral contraceptives, hormone withdrawal tests for pregnancy or attempted treatment for threatened abortion). Some of these exposures were very short and involved only a few days of treatment. The data suggests that the risk of limb reduction defects in exposed fetuses is somewhat less than 1 per 1000.

In the past, estrogens have been used during pregnancy in an attempt to treat threatened or habitual abortion. There is considerable evidence that estrogens are ineffective for these indications.

If ESTINYL Tablets are used during pregnancy or if the patient becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus, and the advisability of pregnancy continuation.


ESTINYL Tablets contain ethinyl estradiol, USP, a potent synthetic estrogen, having the chemical name 19-Nor- 17apregna-1,3,5(10)-trien-20-yne-3,17-diol; the chemical formula C20H24O2; molecular weight of 296.41.

Ethinyl estradiol is a white to creamy white odorless crystalline powder. It is insoluble in water, soluble in alcohol, chloroform, ether, and vegetable oils.

Biologically estrogens may be defined as compounds capable of stimulating female secondary sex characteristics. Chemically, there are different groups of estrogens, depending on whether they are natural or synthetic steroidal or non- steroidal. Natural human estrogens are ultimately formed from either androstenedione or testosterone as immediate precursors. Ethinyl estradiol is a synthetic, steroidal estrogen. ESTINYL, for oral administration, is available in tablets containing 0.02, 0.05 or 0.5 mg ethinyl estradiol, USP.

The inactive ingredients for ESTINYL Tablets 0.02 mg include: acacia, butylparaben, calcium phosphate, calcium sulfate, carnauba wax, corn starch, FD & C Blue No. 2 Al Lake FD & C Yellow No. 5, FD & C Yellow No. 5 Al Lake, FD & C Yellow No. 6 Al Lake, gelatin, lactose, magnesium stearate, potato starch, sodium phosphate, sugar, and white wax. May also contain talc.

The inactive ingredients for ESTINYL Tablets 0.05 mg include: acacia, butylparaben, calcium phosphate, calcium sulfate, carnauba wax, corn starch, FD & C Blue No. 1, FD & C Red No. 3, gelatin, lactose, magnesium stearate, potato starch, sodium phosphate, and whi te wax. May also contain talc.

The inactive ingredients for ESTINYL Tablets 0.5 mg include: corn starch, FD& C Yellow No. 6, lactose, magnesium stearate, and sodium phosphate.





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