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Evamist

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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?

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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.