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



WARNING

Vaginal Cream and Ring

1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA IN POSTMENOPAUSAL 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 equiestrogenic 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 diethylstilbestrol (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 offspring have an increased risk of urogenital abnormalities and possibly testicular cancer later in life. The 1985 DES Task Force concluded that the 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.

Estradiol Vaginal Tablets: 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 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.


DESCRIPTION

Vaginal Cream

Estradiol (17b-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5(10)-triene-3,17b diol.

It has an empirical formula of C18H24O2 and molecular weight of 272.37.

Estrace vaginal cream contains 0.1 mg estradiol per gram in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, glyceryl monostearate, hydroxypropyl methylcellulose, 2208 4000 cps, sodium lauryl sulfate, methylparaben, edetate disodium and tertiary-butylhydroquinone.

Vaginal Ring

Estring is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, Estring releases estradiol, approximately 7.5 mcg/24 hours, in a consistent stable manner over 90 days. Estring Has the Following Dimensions: Outer diameter 55 mm; cross-sectional diameter 9 mm; core diameter 2 mm. One Estring should be inserted into the upper third of the vaginal vault, to be worn continuously for three months.

Estradiol is chemically described as estra-1,3,5(10)-triene-3,17b-diol. The molecular formula of estradiol is C18H24O2.

The molecular weight of estradiol is 272.39.

Vaginal Tablets

Vagifem is a small, white, film-coated tablet containing 25.8 mcg of estradiol hemihydrate equivalent to 25 mcg 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.

17b-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 C18H24O2·½ H2O with a molecular weight of 281.4.

CATEGORIES, BRAND NAMES

CATEGORIES: Atrophy, vagina; Atrophy, vulva; Carcinoma, breast, adjunct; Carcinoma, prostate, adjunct; Hypoestrogenism; Hypogonadism, female; Kraurosis vulvae; Menopause; Osteoporosis, prevention; Ovarian failure; Vaginitis, atrophic; Pregnancy Category X; FDA Approval Pre 1982; FDA Approved 1975 Jul; Top 200 Drugs

FDA Drug Classes: Estrogens

BRAND NAMES:

BRAND NAMES: Alora; Climara; Climara Forte; Climaderm; Dermestril; Estrace; Estracomb TTS; Estraderm; Estraderm MX; Estraderm TTS; Estrapak 50; Estreva; Estrifam; Estring; Estrofem; Estrofem 2; Estrofem Forte; Evorel; Femtran; Fempatch; Ginedisc; GynPolar; Menorest; Oesclim; Oestradiol Berco; Progynon; Progynova; Sandrena Gel; Sisare Gel; Systen; Tradelia; Vagifem; Vivelle; Zumenon
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Climara Forte (New-Zealand)
Climaderm (Mexico)
Dermestril (Germany; Italy)
Estracomb TTS (Hong-Kong)
Estraderm MX (Australia)
Estraderm TTS (Austria; Bahamas; Bahrain; Barbados; Belgium; Belize; Benin; Bermuda; Bulgaria; Burkina-Faso; Colombia; Curacao; Cyprus; Czech-Republic; Egypt; England; Ethiopia; France; Gambia; Germany; Ghana; Greece; Guinea; Guyana; Hungary; Indonesia; Iran; Iraq; Israel; Israel; Italy; Ivory-Coast; Jamaica; Japan; Jordan; Kenya; Korea; Kuwait; Lebanon; Liberia; Libya; Malawi; Malaysia; Mali; Mauritania; Mauritius; Morocco; Netherland-Antilles; Netherlands; New-Zealand; Niger; Nigeria; Oman; Philippines; Portugal; Puerto-Rico; Qatar; Republic-Of-Yemen; Russia; Saudi-Arabia; Senegal; Seychelles; Sierra-Leone; South-Africa; South-Africa; Spain; Sudan; Surinam; Switzerland; Syria; Taiwan; Tanzania; Trinidad; Tunia; Turkey; Uganda; United-Arab-Emirates; Zambia; Zimbabwe)
Estrapak 50 (Ecuador)
Estreva (Italy)
Estrifam (Germany)
Estrofem (Austria; Belgium; Benin; Bulgaria; Burkina-Faso; Czech-Republic; Denmark; Ethiopia; Finland; France; Gambia; Ghana; Guinea; Hong-Kong; Ivory-Coast; Kenya; Liberia; Malawi; Malaysia; Mali; Mauritania; Mauritius; Morocco; Netherlands; New-Zealand; Niger; Nigeria; Philippines; Senegal; Seychelles; Sierra-Leone; South-Africa; South-Africa; Sudan; Switzerland; Taiwan; Tanzania; Thailand; Tunia; Uganda; Zambia; Zimbabwe)
Estrofem 2 (Thailand)
Estrofem Forte (Benin; Burkina-Faso; Ethiopia; Gambia; Ghana; Guinea; Ivory-Coast; Kenya; Liberia; Malawi; Mali; Mauritania; Mauritius; Morocco; Niger; Nigeria; Senegal; Seychelles; Sierra-Leone; South-Africa; Sudan; Tanzania; Tunia; Uganda; Zambia; Zimbabwe)
Evorel (Germany; Israel)
Femtran (New-Zealand)
Ginedisc (Colombia; Mexico; Peru)
GynPolar (Germany)
Menorest (Germany; Italy; South-Africa)
Oesclim (France)
Oestradiol Berco (Germany)
Progynon (Sweden)
Progynova (Norway)
Sandrena Gel (Germany)
Sisare Gel (Germany)
Systen (Mexico)
Tradelia (Germany)
Zumenon (Austria; Belgium; England; Netherlands)

COST OF THERAPY: 64.56 (Osteoporosis; Tablet; 0.5 mg; 1/day; 300 days)





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