Dosing and Time on Therapy
The lowest effective dose of PREMARIN should be used. That is why PREMARIN offers five dosage strengths, so your health care professional can choose the one that is right for you.
Because no two women are the same, PREMARIN offers a range of doses to meet the needs of different women, including two low-dose options, PREMARIN 0.3 mg and PREMARIN 0.45 mg.
You and your health care professional should determine the appropriate dose for you. You should see your doctor regularly while taking therapy to discuss the effects and to review your treatment plan.
How long will I be on therapy?
PREMARIN does not need to be taken for the rest of your life. The U.S. Food and Drug Administration (FDA) recommends that women who choose hormone therapy to manage menopausal symptoms should use the lowest effective dose for the shortest time, consistent with treatment goals and risks.
What if I miss a dose?
You'll achieve your best results with PREMARIN if you remember to take it every day, as prescribed by your health care professional. If you're taking PREMARIN and you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double your doses.
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.
