"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
ESTROGEN (estropipate) S INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogen (estropipate) s 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 the use of “natural” estrogen (estropipate) s result in a different endometrial risk profile than “synthetic” estrogen (estropipate) s at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogen (estropipate) s with and without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular disorders.)
The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogen (estropipate) s (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (see CLINICAL PHARMACOLOGY, Clinical Studies.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogen (estropipate) s plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen (estropipate) alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Other doses of conjugated estrogen (estropipate) s with medroxyprogesterone acetate, and other combinations and dosage forms of estrogen (estropipate) s and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogen (estropipate) s with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
OGEN (estropipate tablets), (formerly piperazine estrone sulfate), is a natural estrogen (estropipate) ic 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 (estropipate) 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-17-one,3-(sulfooxy)-, compound with piperazine (1:1). The structural formula may be represented as follows:
OGEN (estropipate) 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, hydrogen (estropipate) ated vegetable oil wax, hydroxypropyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and tromethamine.
OGEN (estropipate) .625 also contains: D&C Yellow No. 10 and FD&C Yellow No. 6.
OGEN (estropipate) 1.25 also contains: FD&C Yellow No. 6.
OGEN (estropipate) 2.5 also contains: FD&C Blue No. 2.
What are the possible side effects of estropipate (Ogen 0.625, Ogen 1.25, Ogen 2.5)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- pain or swelling in your lower leg;
What are the precautions when taking estropipate (Ogen)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels,...
Last reviewed on RxList: 4/30/2009
This monograph has been modified to include the generic and brand name in many instances.
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