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FDA Approves Low-dose Regimen of PREMARIN Vaginal Cream to Treat Moderate to Severe Postmenopausal Dyspareunia – Painful Sexual Intercourse : Agency Grants New Indication for Bothersome Vaginal Symptom Associated with Menopause
Date:11/13/2008

in either regimen.

"This new indication for PREMARIN Vaginal Cream, with a low volume of 0.5 g and two different dosing regimens – 21 days on/7 days off or twice weekly – gives health care professionals and women a new option in treating moderate to severe dyspareunia due to menopause," says Eileen Helzner, M.D., Assistant Vice President, Global Medical Affairs, Wyeth Pharmaceuticals.

PREMARIN Vaginal Cream is only available by prescription.

Important Safety Information

What is the most important information you should know about PREMARIN Vaginal Cream (a cream of estrogens)?

Estrogens may increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are using PREMARIN Vaginal Cream. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care 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 chances 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 years or older. You and your health care provider should talk regularly about whether you still need treatment with PREMARIN Vaginal Cream. PREMARIN Vaginal Cream is used after menopause to treat menopausal changes in and around the vagina and to treat painful intercourse caused by menopausal changes of the vagina.

PREMARIN Vaginal Cream should not be used if you have unusual vaginal bleeding, have or had cancer of the breast or uterus, had a stroke or heart attack, have or had blood clots or liver problems, are allergic to any of the ingredients in PREMARIN Vaginal Cream, or think you may be pregnant.

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