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Divigel(R) (estradiol gel) 0.1 Percent Offers Lowest Approved Dose of Estradiol for Treatment of Moderate to Severe Hot Flashes Associated with Menopause
Date:5/5/2008

el is applied, it absorbs directly into the bloodstream without having to pass through the liver. Divigel(R) also offers dosing flexibility with three different strengths (0.25 mg estradiol/day, 0.5 mg estradiol/day and 1.0 mg estradiol/day) to individualize treatment for each woman.

Important Safety Information for Patients

The following are not all the possible risks for Divigel(R). Please read the full Patient Information leaflet and talk to your healthcare provider.

Estrogens increase the chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.

Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks, or strokes. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.

Do not use estrogens, with or without progestins, to prevent dementia. Using estrogens, with or without progestins, may increase your risk of dementia.

Do not use estrogen products, including Divigel(R), if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to any Divigel(R) ingredients, or think you may be pregnant.

The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, and hair loss. Less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart a
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SOURCE Upsher-Smith Laboratories, Inc.
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