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References

  1. The North American Menopause Society. Menopause Guidebook. 6th ed. Cleveland, OH: The North American Menopause Society; 2006.
  2. Divigel® [package insert]. Minneapolis, MN: Upsher-Smith Laboratories, Inc; 2007.
  3. EstroGel® [package insert]. Herndon, VA: ASCEND Therapeutics, Inc; 2007.
  4. Elestrin® [package insert]. Philadelphia, PA: Azur Pharma Inc; 2007.
  5. Estrasorb® [package insert]. Bristol, TN: Graceway Pharmaceuticals, LLC; 2008.
  6. Evamist™ [package insert]. St. Louis, MO: Ther-Rx Corporation; 2008.
  7. US Food and Drug Administration. Menopause and hormones. http://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118624.htm. Updated June 18, 2009. Accessed July 30, 2009.
  8. Cobin RH, Futterweit W, Ginzburg SB, et al; for the AACE Menopause Guidelines Revision Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of menopause. Endocr Pract. 2006;12(3):315-337.
  9. Samsioe G. Transdermal hormone therapy: gels and patches. Climacteric. 2004;7(4):347-356.
  10. Elestrin® [patient information]. Philadelphia, PA: Azur Pharma Inc; 2007.
  11. Hedrick RE, Ackerman RT, Koltun WD, Halvorsen MB, Lambrecht LJ. Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women. Menopause. 2009;16(1):132-140.
  12. Premarin® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2008.
  13. Prempro™ [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2008.
  14. Data on file, Upsher-Smith Laboratories, Inc.
  15. Deep vein thrombosis (DVT). In: The Merck Manual of Medical Information, 2nd Home Edition. http://www.merck.com/mmhe/print/sec03/ch036/ch036b.html. Reviewed February 2008. Accessed May 1, 2009.
  16. Office of the Surgeon General. Bone health and osteoporosis: a report of the surgeon general. http://www.surgeongeneral.gov/library/bonehealth/chapter_2.html. Published October 14, 2004. Accessed May 1, 2009.
  17. Fast facts on osteoporosis. National Osteoporosis Foundation Web site. http://www.nof.org/osteoporosis/diseasefacts.htm. Accessed May 1, 2009.
  18. National Osteoporosis Foundation. Bone Tool Kit. http://www.nof.org/awareness2/2007/images/Bone_Tool_Kit.pdf. Accessed May 1, 2009.
  19. Shanafelt TD, Barton DL, Adjei AA, Loprinzi CL. Pathophysiology and treatment of hot flashes. Mayo Clin Proc. 2002;77(11):1207-1218.
  20. Utian WH, Archer DF, Bachmann GA, et al; for North American Menopause Society. Estrogen and progestogen use in postmenopausal women: July 2008 position statement of The North American Menopause Society. Menopause. 2008;15(4, pt 1):582-602.
  21. Estrogen and estrogen with progestin therapies for postmenopausal women. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm135318.htm. Updated June 18, 2009. Accessed July 30, 2009.
  22. Facts About Menopausal Hormone Therapy. Bethesda, MD: National Heart, Lung, and Blood Institute, National Institutes of Health. NIH publication 05-5200. http://www.nhlbi.nih.gov/health/women/pht_facts.pdf. Published October 2002. Revised June 2005. Accessed April 23, 2009.
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Important Safety Information for Patients

The following are not all the possible risks for Divigel®. 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®, 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® 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. The less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, and ovarian cancer.

In Divigel® clinical trials, the most common side effects were inflammation of the nasal passages and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness and vaginal bleeding. Call your healthcare provider right away if you have any symptoms that concern you.

Estrogen products should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-654-2299.

©2010 Upsher-Smith Laboratories, Inc., Maple Grove, MN 55369

*Once-daily dosing of estradiol.