Estradioldrug info
84 HR estradiol 0.00156 MG/HR Transdermal System [Dotti]
What it is used for
DOTTI is indicated for: DOTTI 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 May 14, 2024. 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
DOTTI (estradiol transdermal system, USP) contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of DOTTI are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm 2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 - triene-3,17β-diol.
The structural formula is: The molecular formula of estradiol, USP is C 18 H 24 0 2. The molecular weight is 272.39 g/mol. DOTTI is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are polyester and ethylene vinyl acetate copolymer film an adhesive formulation containing estradiol USP, 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. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP. 1 2
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 14, 2024. 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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