"March 14, 2013 -- Hormone replacement therapy is the most effective treatment for symptoms like hot flashes, and the benefits are likely to outweigh the risks, major medical societies say.
The statement was published in the April issue "...
- Patient Information:
Details with Side Effects
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. Postmenopausal women 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 before covering the site with clothing. The site should not be washed for at least one hour. Application of Evamist to other skin surfaces has not been adequately studied. Evamist should not be applied to skin surfaces other than the forearm.
Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to estradiol from Evamisttreated skin. Women should cover the Evamist application site with clothing if another person may come into contact with that area of skin after the spray dries. Additional precautions to minimize unintentional secondary exposure are outlined in Patient Counseling Information [see PATIENT INFORMATION] and in the Patient Information Leaflet at the end of the prescribing information.
Dosage Forms And Strengths
Evamist is an estradiol transdermal spray. One spray consists of 90 mcL that contains 1.53 mg of estradiol.
Storage And Handling
Evamist (NDC 64011-215-41) 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 dried.
Store at 25°C (77°F) with excursion permitted to 15° to 30°C (59° to 86°F). Do not freeze.
Revised 10/2011. Manufactured by DPT San Antonio, TX 78215 for Ther-Rx Corporation St. Louis, MO 63044
Last reviewed on RxList: 11/10/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Evamist Information
Evamist - User Reviews
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