Ogen® brand of estropipate tablets, USP
1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF
ENDOMETRIAL CARCINOMA IN POST-MENOPAUSAL WOMEN.
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
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
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
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).
Each tablet contains: Colloidal
silicon dioxide, dibasic potassium phosphate, hydrogenated vegetable oil
wax, hydroxypropyl cellulose,
lactose, magnesium stearate, microcrystalline cellulose,
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.