Elestrin estradiol gel 0.06%

Menopause
and Treatment Options

The Symptoms of Menopause

What is My Body Going Through? How Can I Go Through It More Comfortably?

Suffering through numerous intolerable hot flashes daily? Waking up in the middle of the night in a sweat? Losing sleep? These are just some of the ways menopause can disrupt your life. While not every woman going through menopause experiences symptoms, many do. Common symptoms include:1

  • Hot flashes
  • Irregular periods
  • Vaginal dryness
  • Trouble sleeping
  • Mood swings
  • Thinning hair

Elestrin is only approved by the US Food and Drug Administration (FDA) for treatment of moderate-to-severe hot flashes associated with menopause. The effectiveness of treating other menopausal symptoms with Elestrin has not been shown.

About Hot Flashes and Night Sweats

Hot flashes and night sweats, also known as vasomotor symptoms, are among the most disruptive of menopausal symptoms. They are caused by the decrease in estrogen level that naturally occurs in your body with aging. These symptoms produce a feeling of heat and redness, primarily on your face and neck. Your skin feels hot. You often sweat. When hot flashes occur at night, they're known as night sweats.

Hot flashes can come on fast, be very intense for a few minutes, then gradually weaken and go away. They can occur anywhere from a few times a day to up to 15 times a day or more. How often hot flashes occur and how severe they are varies from person to person.

The good news is that many women may find relief from hot flashes and night sweats with hormone therapy.

To understand how severe your hot flashes and night sweats are—and whether you might benefit from treatment—assess your symptoms using an easy tool. You can also print out the results of this survey to share with your healthcare provider.

All estrogen therapy has risks. Please see important safety information at the bottom of this page.

Indication

Elestrin is indicated for the treatment of moderate-to-severe hot flashes and night sweats associated with menopause.

Important Safety Information

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia (decline in memory or thinking skills). Estrogen and progestin therapy has shown an increased risk of breast cancer, heart attack, and blood clots. Estrogen therapy, with or without progestins, increases the risk of stroke and dementia. Estrogen therapy alone increases the risk of cancer of the uterus (womb).

Elestrin should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past; currently have or have had blood clots; currently have or have had liver problems; or think you may be or know that you are pregnant.

The most frequently reported adverse events in clinical trials were nose and throat irritation, breast tenderness, upper respiratory tract infection, and irregular menstrual bleeding.

You and your healthcare provider should discuss whether Elestrin is right for you or whether you still need treatment with Elestrin.

Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Please see full Prescribing Information, including Boxed Warning and Patient Information Sheet.

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

For more information, call 1-800-890-3098.

Reference

  1. North American Menopause Society. Menopause Guidebook: Helping Women Make Informed Healthcare Decisions Around Menopause and Beyond, 6th ed. Available at: http://www.menopause.org/edumaterials/guidebook/guidebook.aspx. Accessed July 16, 2010.