ar, colorless, hydroalcoholic 0.06% estradiol gel supplied in a non-aerosol, metered-dose pump. The pump consists of an LDPE inner liner encased in rigid plastic with a resealable polypropylene cap. Three pump sizes are available, a 93-gram, a 50-gram, and a 25-gram. Each individually packaged 93-gram pump contains 93 grams of gel and is capable of delivering 64 metered 1.25-g doses. Each individually packaged 50-gram pump contains 50 grams of gel and is capable of delivering 32 metered 1.25-g doses. Each individually packaged 25-gram pump contains 25 grams of gel and is capable of delivering 14 metered 1.25-g doses.
NDC: 0051-1028-58…………………….... (93-gram pump)
NDC: 17139-617-40…………………….... (50-gram pump)
NDC: 17139-617-20……………………... (25-gram sample pump)
NDC: 0051-1028-20…………………….... (25-gram sample pump)
Keep out of reach of children.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)
[See USP Controlled Room Temperature].
Manufactured for:
ASCEND Therapeutics, Inc.
Herndon, VA 20170
By Laboratoires Besins International
Montrouge, France
5000718
E01306
Utilizes EHGTM Technology
©2008 ASCEND Therapeutics, Inc.
PATIENT INFORMATION
(Updated 2008)
EstroGel®
(estradiol gel)
Read this PATIENT INFORMATION before you start using EstroGel, and read the patient information each time you refill your EstroGel prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms and their treatment.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW
ABOUT EstroGel (AN ESTROGEN HORMONE)?
• Estrogens increase the chance of getting cancer of the uterus.
Report any unusual vaginal bleeding right away while you are using EstroGel. 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 the cause.
• Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes or dementia.
Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.
Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women age 65 or older. You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel.
What is EstroGel?
EstroGel is a clear, colorless gel medicine that contains estradiol (an estrogen hormone) which is absorbed through the skin into the bloodstream.
How is EstroGel used?
EstroGel is used after menopause to:
• Reduce moderate to severe hot flashes
Estrogens are hormones made by a woman’s ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estro
