Estradioldrug info
84 HR estradiol 0.00104 MG/HR Transdermal System [Vivelle]
What it is used for
Vivelle-Dot is indicated for: Vivelle-Dot is an estrogen indicated for:
Treatment of moderate to severe vasomotor symptoms due to menopause
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause Limitations of Use When prescribing solely for the treatment of moderate to severe vaginal atrophy, first consider the use of topical vaginal products.
Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure
Prevention of postmenopausal osteoporosis Limitations of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1.1 Treatment of
Moderate to Severe Vasomotor Symptoms Due to Menopause.
1.2 Treatment of
Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.
1.3 Treatment of
Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure.
1.4 Prevention of
Postmenopausal Osteoporosis Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 17, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Vivelle-Dot (estradiol transdermal system) contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of Vivelle-Dot are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm 2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 - triene-3,17β-diol.
The structural formula is: The molecular formula of estradiol is C 18 H 24 0 2. The molecular weight is 272.39 g/mol. Vivelle-Dot is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are a translucent polyolefin film an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. ----- Backing ----- Adhesive Containing Estradiol ----- Protective Liner The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive. estradiolstructuralformula vivelledotlayerimage
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 17, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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