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Important Safety Information | Prescribing Information
Menopause is a series of natural biological changes that occur when your ovaries stop producing the hormone estrogen, and fertility ends. Menopause can take place over time, or can begin immediately after surgery that removes both the uterus and the ovaries. (This is called a total hysterectomy and bilateral oophorectomy.) The information in this section can help you understand the changes associated with either cause.
The time when natural menopause begins will be different for every woman. For most women, natural menopause occurs between the ages of 45 and 55, typically around age 51. This is when the ovaries normally stop producing estrogen. It is this drop in the body's estrogen levels that causes the "change of life" known as menopause—the time when monthly menstrual periods end. Once you have not had a period for 12 consecutive months, you have reached menopause.
Common menopausal symptoms include hot flashes, night sweats, and vaginal symptoms that may vary in frequency and intensity.
When menopause is the result of the surgical removal of the ovaries—as part of a hysterectomy—the sudden drop in estrogen levels is known as surgical menopause.
After surgical menopause, your body's primary source of estrogen is gone. This means you no longer have menstrual periods. The sudden estrogen loss can lead to many of the same menopausal symptoms that women face in natural menopause, like hot flashes, night sweats, and vaginal symptoms.
After surgical menopause, symptoms like hot flashes can suddenly occur and may be more severe for women in surgical menopause than those undergoing natural menopause.
In either type of menopause—surgical or natural—it's important to talk to your doctor or other health care professional about the best ways to keep healthy during this time of change.
What is the most important information you should know about PREMARIN (estrogens), PREMPRO (a combination of estrogens and a progestin), or PREMARIN Vaginal Cream (a cream of estrogens)?
Report any unusual vaginal bleeding right away while you are using these products. 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 out the cause.
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 estrogens.
PREMARIN® (conjugated estrogens tablets, USP) is used after menopause to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).
PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets) is used after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).
PREMARIN® (conjugated estrogens) Vaginal Cream is used after menopause to treat dryness, itching, and burning, in and around the vagina.
PREMARIN and PREMPRO should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. If using PREMARIN or PREMPRO only to treat your symptoms of vaginal dryness, consider topical therapies first. If you do not have symptoms, non-estrogen treatments should be carefully considered before taking PREMARIN and PREMPRO solely for the prevention of postmenopausal osteoporosis.
In a clinical trial, the most commonly reported (>5%) side effects that occurred more frequently with PREMARIN than with placebo were vaginitis due to yeast or other causes, vaginal bleeding, painful menstruation, and leg cramps.
In a clinical trial, the most commonly reported (>5%) side effects that occurred more frequently with PREMPRO 0.45 mg/1.5 mg and PREMPRO 0.625 mg/2.5 mg than with placebo were breast pain/enlargement, vaginitis due to yeast or other causes, leg cramps, vaginal spotting/bleeding, and painful menstruation. In a clinical trial, there was no difference in the commonly reported (>5%) side effects for women taking PREMPRO 0.3 mg/1.5 mg compared to those taking placebo.
The most commonly reported side effects of PREMARIN Vaginal Cream include vaginal discomfort or pain, breast pain, vaginitis, and itching.
PREMARIN, PREMPRO, and 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 in the past year, have or had blood clots, have liver problems, are allergic to any of the ingredients in PREMARIN, PREMPRO, or PREMARIN Vaginal Cream, or think you may be pregnant. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
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