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



DESCRIPTION

Ogen® brand of estropipate tablets, USP

WARNINGS

    1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA IN POST-MENOPAUSAL 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 equi-estrestropic 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 diethyl-stilbestrol (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 off-spring have an increased risk of urestropital 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.


OGEN (estropipate tablets), (formerly piperazine estrone sulfate), is a natural estrogenic substance prepared from purified crystalline estrone, solubilized as the sulfate and stabilized with piperazine. It is appreciably soluble in water and has almost no odor or taste properties which are ideally suited for oral administration. The amount of piperazine in OGEN is not sufficient to exert a pharmacological action. Its addition ensures solubility, stability, and uniform potency of the estrone sulfate. Chemically estropipate, molecular weight: 436.56, is represented by estra-1,3,5(10)- trien-1,7-one,3-(sulfooxy)-, compound with piperazine (1:1).

OGEN is available as tablets for oral administration containing either 0.75 mg (OGEN .625), 1.5 mg (OGEN 1.25), or 3 mg (OGEN 2.5) estropipate (Calculated as sodium estrone sulfate 0.625 mg. 1.25 mg. and 2.5 mg, respectively).

Inactive Ingredients:

Each tablet contains: Colloidal silicon dioxide, dibasic potassium phosphate, hydrogenated vegetable oil wax, hydroxypropyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and tromethamine.

OGEN .625 also contains: D&C Yellow No.10 and FD&C Yellow No.6.
OGEN 1.25 also contains: FD&C Yellow No.6.
OGEN 2.5 also contains: FD&C Blue No.2.






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