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Evamist®
(estradiol) Transdermal Spray
See:
Estradiol Evista
Mircette
Activella Alora
Climara Pro
CombiPatch Delestrogen
Esclim Estraderm
Estring Estrace Tablets
Vagifem Vivelle-Dot
All of these products are used to reduce symptoms
of menopause, including feelings of warmth in the face, neck, and chest; the
sudden intense episodes of heat and sweating known as "hot flashes"; dry, itchy
external genitals; and vaginal irritation. They are also prescribed for other
conditions that cause low levels of estrogen, and some doctors prescribe them
for teenagers who fail to mature at the usual rate.
Along with diet, calcium supplements, and exercise, Alora, Estraderm, Climara,
Vivelle, and Vivelle-Dot are prescribed to prevent osteoporosis, a condition in
which the bones become brittle and easily broken.
Evamist (estradiol) transdermal spray is designed to deliver estradiol to the
blood circulation following topical application to the skin of a rapidly drying
solution from a metered-dose pump.
Evamist is a homogeneous solution of 1.7% estradiol USP (active ingredient) in
alcohol USP and octisalate USP formulated to provide sustained release of the
active ingredient into the systemic circulation.
Estradiol USP is a white crystalline powder, chemically described as
estra-1,3,5(10)-triene-3,17 β-diol. It has an empirical formula of C18H24O2•˝
H2O and molecular weight of 281.4.
Each metered-dose pump contains 8.1 mL and is designed to accurately deliver 56
sprays of 90 mcL each after priming. One spray of Evamist contains 1.53 mg
estradiol. The metered-dose pump should be held upright and vertical for
spraying. Before a new applicator is used for the first time, the pump should be
primed by spraying 3 times into the cover.
One, two or three sprays are applied daily to adjacent non-overlapping 20 cm2
areas on the inner surface of the arm between the elbow and the wrist and
allowed to dry.
WARNINGS
Endometrial Cancer
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
[see WARNINGS and PRECAUTIONS].
Cardiovascular and Other Risks
Estrogens with or without progestins
should not be used for the prevention of cardiovascular disease or dementia [see
WARNINGS and PRECAUTIONS and and CLINICAL STUDIES].
The Women's Health Initiative (WHI) estrogen alone substudy reported increased
risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79
years of age) during 6.8 years and 7.1 years, respectively, of treatment with
daily oral conjugated estrogens (CE 0.625 mg), relative to placebo [see WARNINGS
and PRECAUTIONS and CLINICAL STUDIES].
The estrogen plus progestin WHI substudy reported increased risk of myocardial
infarction, stroke, invasive breast cancer, pulmonary emboli, and DVT in
postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with
daily oral CE 0.625 mg combined with medroxyprogesterone acetate (MPA 2.5 mg),
relative to placebo [see WARNINGS and PRECAUTIONS and CLINICAL STUDIES].
The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI,
reported increased risk of developing probable dementia in postmenopausal women
65 years of age or older during 5.2 years of treatment with daily CE 0.625 mg
alone and during 4 years of treatment with daily CE 0.625 mg combined with MPA
2.5 mg, relative to placebo. It is unknown whether this finding applies to
younger postmenopausal women
[see WARNINGS and PRECAUTIONS, Use in Specific Populations and CLINICAL
STUDIES].
In the absence of comparable data, these risks should be assumed to be similar
for other doses of CE and MPA and other combinations and dosage forms of
estrogens and progestins. Because of these risks, estrogens with or without
progestins should be prescribed at the lowest effective doses and for the
shortest duration consistent with treatment goals and risks for the individual
woman.
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