Evamist- Spray-on estrogen treats hot flushes

Company:

Ther-Rx

Pharmacologic class:

Estrogen

Active ingredient:

Estradiol 1.53 mg/spray; transdermal spray.

Indication:

Moderate-to-severe vasomotor symptoms of menopause.

Pharmacology:

The addition of exogenous estrogens helps to alleviate the vasomotor symptoms that are associated with declining estrogen levels. Evamist 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. One spray of Evamist contains 1.53 mg estradiol.

Clinical trials:

In a 12-week, randomized, double-blind, placebo-controlled clinical trial, a total of 454 postmenopausal women were randomized and received at least one dose of Evamist or placebo. Efficacy was determined as a statistically significant and clinically significant (at least two per day or 14 per week difference) reduction in hot flush frequency and a statistically significant reduction in severity for Evamist vs. placebo. One, two, or three daily sprays of Evamist were shown to be better than placebo for relief of frequency and severity of moderate-to-severe vasomotor symptoms at week 4 and week 12.

Adults:

Prime pump before first use. Apply to clean, dry, unbroken skin on the inside of the forearm between the elbow and wrist. Initially one spray daily; may increase to two to three sprays if needed; do not spray in the same area. Re-evaluate periodically. Allow spray to dry before dressing; do not wash area for at least 30 minutes after application.

Children:

Not applicable.

Contraindications:

Breast or estrogen-dependent carcinoma. Undiagnosed abnormal vaginal bleeding. Thromboembolic disorders (e.g., stroke or MI within one year, deep venous thrombosis, pulmonary embolism). Thrombophlebitis. Liver dysfunction or disease. Pregnancy (Cat. X).

Precautions:

Use shortest duration and lowest dose consistent with treatment goals and risks. Not for prevention of cardiovascular disease (CVD) or dementia. Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Renal dysfunction. Gall bladder disease.

Hypertriglyceridemia. Hypothyroidism. Hypercoagulability. Conditions aggravated by fluid retention. Bone disease associated with hypercalcemia. Do initial complete physical; repeat annually (include BP, mammogram, Pap smear). Discontinue if visual disturbances or jaundice occurs, and during immobilization, and at least four to six weeks before surgery associated with thromboembolism. Manage risk factors for CVD and venous thromboembolism appropriately. May aggravate asthma, diabetes, epilepsy, migraine, porphyria, systemic lupus erythematosus, hepatic hemangiomas. May interfere with lab tests (e.g., thyroid, parathyroid, glucose tolerance, HDL/LDL). Product is flammable. Nursing mothers.

Interactions:

Avoid applying sunscreen one hour after. May need higher doses of thyroid replacement therapy. May be antagonized by CYP3A4 inducers. May be potentiated by CYP3A4 inhibitors.

Adverse reactions:

Headache, breast/nipple pain, nausea, back pain, nasopharyngitis.

How supplied:

Pump—8.1 mL (56 sprays/pump).

For more information, call 877.567.7676 or visit www.Evamist.com

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