What is PREMARIN?
PREMARIN is a hormone therapy that contains a combination of estrogens. It can help you manage the symptoms of menopause, including hot flashes, night sweats, and vaginal dryness, as well as reduce your chances of developing osteoporosis (thin, weak bones).
PREMARIN is for women without a uterus (hysterectomy) who have moderate to severe menopausal symptoms—hot flashes, night sweats, and vaginal dryness.
When your only menopausal symptom is vaginal dryness, your health care professional may recommend you use a topical vaginal product, such as PREMARIN Vaginal Cream.
It is best to take PREMARIN at the lowest possible effective dose for the shortest period of time. For this reason, PREMARIN comes in five dosage strengths so that you and your physician can determine which dose is best for you. Studies have shown that PREMARIN was effective in relieving the hot flashes, night sweats, and vaginal dryness related to menopause, and can also help to prevent osteoporosis.
For women who have not had a hysterectomy and are experiencing moderate to severe menopausal symptoms, PREMARIN can also be used in combination with a progestin tablet, or your health care professional may recommend PREMPRO, another member of the PREMARIN Family, which contains both estrogen and progestin.
Is PREMARIN right for me?
If your menopausal symptoms are moderate to severe, PREMARIN may be an appropriate treatment option for you. Every woman is different, but as many as half of the women in menopause will experience some moderate to severe symptoms during the first few years of menopause. You and your health care professional can decide which approach to managing menopausal symptoms may be right for you.
A good first step toward understanding your symptoms is to complete the Menopausal Symptoms Assessor. It will only take a few minutes and, when you're finished, you'll have a symptom profile to print out and bring with you when you talk to your doctor or health care professional.
If your only symptoms are vaginal, such as dryness, burning, and itching, which can make intimacy uncomfortable or painful, your health care professional may recommend a topical therapy. He or she may prescribe PREMARIN Vaginal Cream. It is equally important to review your family history with your health care professional prior to beginning therapy with PREMARIN. If there is a family history of heart disease, breast cancer, stroke, blood clots, or osteoporosis, be sure to tell your health care professional.
Important Safety Information
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)?
Estrogens increase the chance of getting cancer of the uterus.
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.
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 chance of getting 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 who have 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 menopausal changes in and around the vagina and to treat painful intercourse caused by menopausal changes of the vagina.
PREMARIN, PREMPRO, and PREMARIN Vaginal Cream should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. If you are using or are considering using PREMARIN or PREMPRO only to treat your symptoms of vaginal dryness, consider topical therapies first. If you are using or are considering using PREMARIN and PREMPRO only to prevent osteoporosis due to menopause, talk with your health care professional about whether a different treatment or medicine without estrogens might be better for you.
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, have or had blood clots or 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.
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 headache, infection, abdominal pain, back pain, accidental injury, and vaginitis.
