Vagifem
Vagifem®
estradiol vaginal tablets
DRUG DESCRIPTION
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ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA. Three independent, case controlled studies have reported an increased risk of endometrial cancer in post-menopausal women exposed to exogenous estrogens for more than one year. This risk was independent of the other known risk factors for endometrial cancer. These studies are further supported by the finding that incident 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 expanding use of estrogens during the last decade. The three case-controlled studies reported that the risk of endometrial cancer in estrogen users was about 4.5 to 13.9 times greater than in nonusers. The risk appears to depend on both duration of treatment and on estrogen dose. In view of these findings, 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 semi-annual basis, to determine the need for continued therapy. Close clinical surveillance of all women taking estrogens is important. In all cases of undiagnosed persistent or reoccurring 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 equi-estrogenic doses. |
VAGIFEM® (estradiol vaginal tablets) are small, white, film-coated tabletes containing 25.8µg of estradiol hemihydrate equivalent to 25µg of estradiol.
Each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate, maize starch and magnesium stearate. The film coating contains hydroxypropyl methylcellulose and polyethylene glycol. Each white tablet is 6 mm in diameter and is placed in a disposable applicator.
Each tablet-filled applicator is packaged separately in a blister pack. 17(beta)-estradiol hemihydrate is a white, almost white or colorless crystalline solid, chemically described as estra-1,3,5 (10)-triene-3, 17 diol.
The chemical formula is C 18 H 24 O 2 • ½H 2 O with a molecular weight of 281.4. The structural formula is:

Generic Name: Estradiol
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