 are prescription medications used to treat moderate to severe hot flashes and vaginal dryness, burning, and irritation after menopause. Prempro and Premphase are also used to reduce the risk of getting osteoporosis. These medicines both contain estrogen and progesterone hormones, which are necessary for many processes in the body and ovulation and menstruation.Prempro and Premphase come in tablet form to be taken once daily, with or without food. Both Prempro and Premphase contain the same hormones, but the dosage... "Pin It")
Prempro / Premphase Overview
Prempro/Premphase (generic: conjugated estrogens/medroxyprogesterone) are prescription medications used to treat moderate to severe hot flashes and vaginal dryness, burning, and irritation after menopause. Prempro and Premphase are also used to reduce the risk of getting osteoporosis. These medicines both contain estrogen and progesterone hormones, which are necessary for many processes in the body and ovulation and menstruation.
Prempro and Premphase come in tablet form to be taken once daily, with or without food. Both Prempro and Premphase contain the same hormones, but the dosage is different for each medication. Prempro contains a lower amount of hormones in each tablet and is taken every day throughout the year. Premphase contains a higher amount of both hormones and an alternating schedule of 14 days of taking just estrogen is followed by 14 days of taking both estrogen and progesterone.
Commons side effects of Prempro/Premphase include headache, breast pain, and irregular vaginal bleeding.
Uses of Prempro / Premphase
Prempro/Premphase are prescription medications used to treat moderate to severe hot flashes and other changes in and around the vagina after menopause.
These medications may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Side Effects of Prempro / Premphase
Serious, but less common side effects include:
- Heart attack
- Stroke
- Blood clots
- Dementia
- Breast cancer
- Cancer of the lining of the uterus (womb)
- Cancer of the ovary
- High blood pressure
- High blood sugar
- Gallbladder disease
- Liver problems
- Enlargement of benign tumors of the uterus (“fibroids”)
- Mental depression
- Severe allergic reaction
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
- New breast lumps
- Unusual vaginal bleeding
- Changes in vision or speech
- Sudden new severe headaches
- Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
- Swollen lips, tongue and face
Less serious, but common side effects include:
- Headache
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach or abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
- Fluid retention
- Vaginal yeast infection
Prempro / Premphase Interactions
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- St. John's Wort (Hypericum perforatum)
- phenobarbital
- carbamazepine
- rifampin
- erythromycin
- clarithromycin
- ketoconazole
- itraconazole
- ritonavir
This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.
Prempro / Premphase Precautions
Important Information about the use of combinations of estrogens and progestin (Prempro and Premphase):
- Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function)
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
- Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
- Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia
- Using estrogen-alone may increase your chance of getting cancer of the uterus (womb)
- Using estrogen-alone may increase your chances of getting strokes or blood clots
- Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
- You and your healthcare provider should talk regularly about whether you still need treatment with Prempro or Premphase
Do not take Prempro or Premphase if you have had your uterus (womb) removed (hysterectomy). Prempro and Premphase contain a progestin to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not take Prempro or Premphase.
Do not take Prempro or Premphase if you:
- Have unusual vaginal bleeding
- Currently have or have had certain cancers. Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Prempro or Premphase.
- Had a stroke or heart attack
- Currently have or have had blood clots
- Currently have or have had liver problems
- Have been diagnosed with a bleeding disorder
- Are allergic to Prempro or Premphase or any of their ingredients
- Think you may be pregnant
Prempro / Premphase Food Interactions
Grapefruit and grapefruit juice may interact with Prempro and Premphase and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Inform MD
Tell your healthcare provider
- If you have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- About all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- About all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Prempro or Premphase works. Prempro or Premphase may also affect how your other medicines work.
- If you are going to have surgery or will be on bedrest. You may need to stop taking estrogens and progestins.
- If you are breastfeeding. The hormones in Prempro and Premphase can pass into your milk.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Prempro / Premphase and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant. Prempro and Premphase should not be used during pregnancy.
Prempro / Premphase and Lactation
Tell your doctor if you are breastfeeding or plan to breastfeed. Prempro and Premphase should not be used while breastfeeding.
Prempro / Premphase Usage
- Take one Prempro or Premphase tablet at the same time each day
- If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your normal schedule. Do not take 2 doses at the same time.
- Estrogens should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Prempro or Premphase.
Prempro / Premphase Dosage
Take Prempro or Premphase exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.
Prempro therapy consists of a single tablet to be taken once daily.
Prempro / Premphase Overdose
If you take too much Prempro or Premphase, call your local Poison Control Center or seek emergency medical attention right away.
Forms of Prempro / Premphase
Prempro contains the same conjugated estrogens found in Premarin, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components, including sodium sulfate conjugates, 17α-dihydroequilin, 17α-estradiol and 17β-dihydroequilin. Prempro also contains either 1.5, 2.5, or 5 mg of medroxyprogesterone acetate.
Prempro 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets also contain calcium phosphate tribasic, microcrystalline cellulose, lactose monohydrate, hypromellose, magnesium stearate, polyethylene glycol, sucrose, hydroxypropyl cellulose, Eudragit NE 30D, povidone, titanium dioxide, yellow iron oxide, and black iron oxide.
Prempro 0.625 mg/2.5 mg and 0.625 mg/5 mg tablets also contain calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glyceryl monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, sucrose, povidone, titanium dioxide, black iron oxide, and FD&C Blue No. 2 or red ferric oxide.
Other Requirements
What can I do to lower my chances of getting a serious side effect with Prempro or Premphase?
- Talk with your healthcare provider regularly about whether you should continue taking Prempro or Premphase
- See your healthcare provider right away if you get vaginal bleeding while taking Prempro or Premphase
- Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something elseIf members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
- If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart diseaseAsk your healthcare provider for ways to lower your chances of getting heart disease.
Store these medications at room temperature.
Keep all medications out of the reach of children.
Prempro / Premphase FDA Warning
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER and PROBABLE DEMENTIA
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.
The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Breast Cancer
The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer.
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins.
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.
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.
The WHI estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg), relative to placebo.
The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.
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.
