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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 (transdermal)



WARNING

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 currently no evidence that "natural" estrogens are more or less hazardous than "synthetic" estrogens at equiestrogenic doses.

2. ESTROGENS SHOULD NOT BE USED DURING PREGNANCY: 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. 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.


DESCRIPTION

Estradiol (17b-estradiol) is a white, crystalline powder, 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.

Estraderm

The Estraderm system is designed to release 17b-estradiol through a rate-limiting membrane continuously upon application to intact skin.

Two systems are available to provide nominal in vivo delivery of 0.05 or 0.1 mg of estradiol per day via skin of average permeability (interindividual variation in skin permeability is approximately 20%) Each corresponding system having a contact surface area of 10 or 20 cm2 contains 4 or 8 mg of estradiol and 0.3 or 0.6 ml of alcohol, respectively. The composition of the systems per unit area is identical.

The Estraderm system comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a transparent polyester film, (2) a drug reservoir of estradiol and alcohol gelled with hydroxypropyl cellulose, (3) an ethylene-vinyl acetate copolymer membrane, and (4) an adhesive formulation of light mineral oil and polyisobutylene. A protective liner (5) of siliconized polyethylene terephthalate film is attached to the adhesive surface and must be removed before the system can be used.

The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive. Alcohol is also released from the system during use.

Climara

Climara, estradiol transdermal system, is designed to release 17b-estradiol continuously upon application to intact skin. Four (6.5, 12.5, 18.75, and and 25.0 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.05, 0.075, or or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 6.5, 12.5, 18.75, or 25.0 cm2, and contains 2.04, 3.9, 5.85, or 7.8 mg of estradiol respectively. The composition of the systems per unit area is identical.

The Climara system comprises two layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are a translucent polyethylene film, and an acrylate adhesive matrix containing estradiol. A protective liner of siliconized or fluoropolymer-coated polyester film is attached to the adhesive surface and must be removed before the system can be used.

The active component of the system is 17b-estradiol. The remaining components of the system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive.

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; Femsept; Ginedisc; GynPolar; Lindisc; Meno-MPA; Menorest; Oesclim; Progynon; Progynova; Sandrena Gel; Sisare Gel; Systen; Tradelia; Vivelle; Zumenon
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Climara Forte (New-Zealand)
Climaderm (Colombia; Mexico)
Dermestril (Germany; Israel; 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; 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; 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; Mali; Mauritania; Mauritius; Morocco; Netherlands; New-Zealand; Niger; Nigeria; Philippines; Senegal; Seychelles; Sierra-Leone; 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)
Femsept (France)
Ginedisc (Colombia; Mexico; Peru)
GynPolar (Germany)
Lindisc (Colombia)
Meno-MPA (Israel)
Menorest (Germany; Italy; South-Africa)
Oesclim (France)
Progynon (Sweden)
Progynova (Norway)
Sandrena Gel (Australia; Germany)
Sisare Gel (Germany)
Systen (Mexico)
Tradelia (Germany)
Zumenon (Australia; Austria; Belgium; England; Netherlands)

COST OF THERAPY: $78.00 (Osteoporosis; Tablet; 0.5 mg; 1/day; 300 days)





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