estrogel

The U.S estrogel. Food and Drug Administration (FDA) has approved EstroGel (estradiolgel) for the treatment of moderate to severe vasomotor symptoms, as well asvulvar and vaginal atrophy associated with the menopause.
EstroGel is a clear, odorless, hydro-alcoholic gel that provides for deliveryof estradiol for estrogen replacement in a non-patch transdermal form.

Transdermal delivery of EstroGel will ensure the body receives a consistentand continuous supply of estrogen estrogel. Applied once daily on one arm from wristto shoulder, EstroGel avoids first pass metabolism in the liver and minimizesapplication site skin irritation estrogel. The gel dries in as little as two to fiveminutes.

EstroGel will be prescribed at a 1.25g (0.75 mg estradiol) daily dose estrogel. EstroGelis packaged in a non-aerosol, metered-dose pump that is designed to deliver1.25g (0.75 mg estradiol) of gel per compression.

Clinical Trials
Data supporting the efficacy and tolerability of EstroGel in reducing the frequencyand severity of moderate-to-severe vasomotor symptoms was demonstrated in a12-week, double-blind, randomized, placebo-controlled, multicenter study estrogel. Thestudy analyzed the effects of EstroGel on 145 healthy, postmenopausal womensuffering from moderate-to-severe hot flashes.

Important Information
The use of unopposed estrogens in non-hysterectomized women increases the riskof endometrial cancer estrogel. Estrogens with or without progestins should not be usedfor the prevention of cardiovascular disease estrogel. The Women's Health Initiative(WHI) study reported increased risks of myocardial infarction, stroke, invasivebreast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausalwomen (50 to 79 years of age) during 5 years of treatment with oral conjugatedestrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg)relative to placebo estrogel. Other doses of conjugated estrogens with medroxyprogesteroneand other combinations and dosage forms of estrogens and progestins were notstudied in the WHI clinical trials, and in the absence of comparable data, theserisks should be assumed to be similar estrogel. Because of these risks, estrogens withor without progestins should be prescribed at the lowest effective doses andfor the shortest duration consistent with treatment goals and risks for theindividual woman.

Estrogens are contraindicated for patients with known or suspected pregnancy,breast cancer, active thrombophlebitis, or thromboembolic disorders.

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