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Evamist
Overview
What is Evamist?
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()-triene-3,17β-diol. It has an empirical
formula of CHO·1/2 HO and molecular weight of 281.4.
The structural formula is:
Each metered-dose pump contains 8.1 mL and is designed to accurately deliver
75 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
cm areas on the inner surface of the arm between the
elbow and the wrist and allowed to dry.
What does Evamist look like?
What are the available doses of Evamist?
Evamist is an estradiol transdermal spray. One spray delivers 90 mcL that
contains 1.53 mg of estradiol.
What should I talk to my health care provider before I take Evamist?
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How should I use Evamist?
Evamist (estradiol transdermal spray) is an estrogen indicated for the treatment
of moderate to severe vasomotor symptoms due to menopause.
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What interacts with Evamist?
Sorry No Records found
What are the warnings of Evamist?
Sorry No Records found
What are the precautions of Evamist?
Sorry No Records found
What are the side effects of Evamist?
Sorry No records found
What should I look out for while using Evamist?
Evamist should not be used in women with any of the following
conditions:
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 .
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of
cardiovascular disease or dementia .
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
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 .
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 .
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.
What might happen if I take too much Evamist?
Overdosage of estrogen may cause nausea and vomiting, breast tenderness,
dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur
in women. Treatment of overdose consists of discontinuation of Evamist together
with institution of appropriate symptomatic care.
How should I store and handle Evamist?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Evamist () is supplied as a homogeneous solution of estradiol USP, octisalate USP and alcohol USP. The liquid formulation of Evamist is packaged in a glass vial fitted with a metered-dose pump. The unit is encased in a plastic housing with a conical bell opening that controls the distance, angle, and area of application of the metered-dose spray. Each metered-dose pump contains 8.1 mL and is designed to accurately deliver 75 sprays of 90 mcL after priming. One spray contains 1.53 mg estradiol.Keep out of reach of children.Alcohol and alcohol-based liquids are flammable. Avoid fire, flame or smoking until the spray has driedStore at 25°C (77°F) with excursion permitted to 15° to 30°C (59° to 86°F). Do not freeze.Evamist () is supplied as a homogeneous solution of estradiol USP, octisalate USP and alcohol USP. The liquid formulation of Evamist is packaged in a glass vial fitted with a metered-dose pump. The unit is encased in a plastic housing with a conical bell opening that controls the distance, angle, and area of application of the metered-dose spray. Each metered-dose pump contains 8.1 mL and is designed to accurately deliver 75 sprays of 90 mcL after priming. One spray contains 1.53 mg estradiol.Keep out of reach of children.Alcohol and alcohol-based liquids are flammable. Avoid fire, flame or smoking until the spray has driedStore at 25°C (77°F) with excursion permitted to 15° to 30°C (59° to 86°F). Do not freeze.Evamist () is supplied as a homogeneous solution of estradiol USP, octisalate USP and alcohol USP. The liquid formulation of Evamist is packaged in a glass vial fitted with a metered-dose pump. The unit is encased in a plastic housing with a conical bell opening that controls the distance, angle, and area of application of the metered-dose spray. Each metered-dose pump contains 8.1 mL and is designed to accurately deliver 75 sprays of 90 mcL after priming. One spray contains 1.53 mg estradiol.Keep out of reach of children.Alcohol and alcohol-based liquids are flammable. Avoid fire, flame or smoking until the spray has driedStore at 25°C (77°F) with excursion permitted to 15° to 30°C (59° to 86°F). Do not freeze.Evamist () is supplied as a homogeneous solution of estradiol USP, octisalate USP and alcohol USP. The liquid formulation of Evamist is packaged in a glass vial fitted with a metered-dose pump. The unit is encased in a plastic housing with a conical bell opening that controls the distance, angle, and area of application of the metered-dose spray. Each metered-dose pump contains 8.1 mL and is designed to accurately deliver 75 sprays of 90 mcL after priming. One spray contains 1.53 mg estradiol.Keep out of reach of children.Alcohol and alcohol-based liquids are flammable. Avoid fire, flame or smoking until the spray has driedStore at 25°C (77°F) with excursion permitted to 15° to 30°C (59° to 86°F). Do not freeze.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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Non-Clinical Toxicology
Evamist should not be used in women with any of the following conditions: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 .
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia .
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
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 .
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 .
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.
Oxycodone is metabolized in part to oxymorphone via the cytochrome p450 isoenzyme CYP2D6. While this pathway may be blocked by a variety of drugs (e.g., certain cardiovascular drugs and antidepressants), such blockade has not yet been shown to be of clinical significance with this agent. However, clinicians should be aware of this possible interaction.
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Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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