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Evamist (Estradiol Transdermal) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Evamist (estradiol transdermal spray) is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

DOSAGE AND ADMINISTRATION

General Dosing Information

When estrogen is prescribed for a postmenopausal woman with a uterus, generally, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin.

Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example at 3-month to 6-month intervals) to determine if treatment is still necessary.

Treatment of Moderate to Severe Vasomotor Symptoms

Evamist therapy should be initiated with one spray per day. Dosage adjustment should be guided by the clinical response.

Before applying the first dose from a new applicator, the pump should be primed by spraying 3 sprays with the cover on. The container should be held upright and vertical for spraying.

One, two or three sprays are applied each morning to adjacent, non-overlapping areas on the inner surface of the forearm, starting near the elbow. Sprays should be allowed to dry for approximately 2 minutes and the site should not be washed for 30 minutes. Application of Evamist to other skin surfaces has not been adequately studied. Evamist should not be applied to skin surfaces other than the forearm.

DOSAGE FORM AND STRENGTH

Evamist is an estradiol transdermal spray. Each spray delivers 90 mcL which contains 1.53 mg of estradiol.

HOW SUPPLIED / STORAGE AND HANDLING

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 56 sprays of 90 mcL after priming. Each 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 dried

Store at 25°C (77°F) with excursion permitted to 15 to 30°C (59 to 86°F). Do not freeze.

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