"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.
(Generic versions may still be available.)
(estradiol) Transdermal System
Continuous delivery for twice-weekly application
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 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.
The Esclim™ estradiol transdermal system contains estradiol in a polymeric adhesive. The system is designed to release 17Ò²estradiol continuously upon application to intact skin.
Five systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via skin of average permeability. Each corresponding system having an active surface area of 11, 16.5, 22, 33, or 44 cm2 contains 5, 7.5, 10, 15, or 20 mg of estradiol USP, respectively.
The composition of the systems per unit area is identical.
Estradiol USP (17Ò²estradiol) is a white, crystalline powder, chemically described as estra-1, 3, 5 (10)triene3, 17Ò²diol. The structural formula is:
The molecular formula of estradiol is C18 H24 O2. The molecular weight is 272.39.
Esclim (estradiol transdermal) transdermal systems are composed of a soft, flexible, rectangular foam backing material with rounded corners, covered on 1 side with a self-adhesive polymer matrix which contains estradiol and pharmacologically inactive components. The adhesive surface is covered by a transparent protective release liner as shown in the diagram below.
The active component of the system is estradiol. The remaining components of the system (EVA copolymers, ethylcellulose, octyldodecanol, dipropylene glycol, polyester protective release liner) are pharmacologically inactive.
Last reviewed on RxList: 1/12/2005
This monograph has been modified to include the generic and brand name in many instances.
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