Generic Name: conjugated estrogens/medroxyprogesterone (KON-joo-GAY-ted ES-troe-jenz/med-ROX-ee-proe-JES-ter-one)
Brand Name: Examples include Premphase and Prempro
Premphase should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Premphase. Talk with your doctor if you have questions about the benefits and risks of using Premphase.
Premphase should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Premphase.
Premphase is used for:
Treating menopausal symptoms (eg, hot flashes, vaginal dryness). It is used to prevent osteoporosis (weak bones) after menopause in certain patients. It may also be used for other conditions as determined by your doctor.
Premphase is a combination of estrogen and progestin hormones. It works by replacing these hormones in the body when the body does not make enough on its own.
Do NOT use Premphase if:
- you are allergic to any ingredient in Premphase
- you have had a severe reaction (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) after taking Premphase
- you are pregnant or think you may be pregnant
- you have known or suspected breast cancer or another estrogen-dependent cancer, or you have a history of breast cancer
- you have a history of liver problems or liver disease
- you have abnormal vaginal bleeding of an unknown cause
- you have active blood clots (eg, of the legs or lungs), a history of blood clots, or a condition which may increase your risk of blood clots
- you have had a stroke or heart attack
- you have had your uterus removed (hysterectomy)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Premphase:
Some medical conditions may interact with Premphase. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a condition called hereditary angioedema
- if you have a history of breast lumps, breast disease, or an abnormal mammogram, or if a member of your family has had breast cancer
- if you have a vaginal infection or a history of uterus problems (eg fibroids, endometriosis, abnormal vaginal bleeding, cancer)
- if you have a history of asthma, depression, diabetes, seizures, gallbladder disease, pancreatitis, heart problems, high blood cholesterol or triglyceride levels, high blood calcium levels, high blood pressure, low blood levels of parathyroid hormone, or the blood disease porphyria
- if you have a history of kidney or liver problems, yellowing of the skin or eyes, cancer, lupus, migraines, or thyroid problems
- if you smoke, use tobacco, are very overweight, will be having surgery, or will be confined to a bed or chair for a period of time
- if a member of your family has had high cholesterol or triglyceride levels, blood clots (eg, in the leg or lung), or lupus, or has been very overweight
Some MEDICINES MAY INTERACT with Premphase. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin), or protease inhibitors (eg, ritonavir) because they may increase the risk of Premphase's side effects
- Aminoglutethimide, aprepitant, barbiturates (eg, phenobarbital), carbamazepine, fosaprepitant, hydantoins (eg, phenytoin), rifamycins (eg, rifampin), or St. John's wort because they may decrease Premphase's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Premphase may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Premphase:
Use Premphase as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Premphase. Talk to your pharmacist if you have questions about this information.
- Take Premphase by mouth with food or right after a meal to prevent stomach upset.
- Eating grapefruit or drinking grapefruit juice may increase the risk of Premphase's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Premphase.
- Premphase works best if it is taken at the same time each day.
- Continue to take Premphase even if you feel well. Do not miss any doses.
- If you miss a dose of Premphase, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Premphase.
Important safety information:
- If you are only being treated for vaginal menopause symptoms, consider using products that are applied locally, such as vaginal creams, tablets, or rings, before using products that are taken by mouth or absorbed through the skin. Discuss any questions with your doctor.
- Nondrug therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
- Premphase may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker. If patches develop, consult your doctor about the use of sunscreen or protective clothing when your skin is exposed to the sun, sunlamps, or tanning booths.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- Premphase may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke (especially in women older than 35 years old).
- Follow your doctor's instructions for examining your own breasts. Report any lumps immediately.
- If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor at least 4 to 6 weeks beforehand. You may need to stop taking Premphase or take other special precautions for a period of time.
- Tell your doctor or dentist that you take Premphase before you receive any medical or dental care, emergency care, or surgery.
- Premphase may interfere with certain lab tests. Be sure your doctors and lab personnel know that you are using Premphase.
- Diabetes patients - Premphase may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including physical exams, cholesterol levels, and blood pressure, may be performed while you use Premphase. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Talk with your doctor regularly (eg, every 3 to 6 months) about whether you need to continue taking Premphase.
- Use Premphase with caution in the ELDERLY; they may be more sensitive to its effects.
- Premphase is not approved for use in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Premphase if you are pregnant. If you think you may be pregnant, contact your doctor right away. Premphase is found in breast milk. If you are or will be breast-feeding while you use Premphase, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Premphase:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Breast tenderness or pain; hair loss; headache; mild fluid retention; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal vaginal bleeding; breast lumps or pain; bulging eyes; calf or leg pain, swelling, redness, or tenderness; chest pain; coughing up blood; fainting; mental or mood changes (eg, depression); migraine headache; new or worsening memory problems; severe or persistent dizziness or headache; severe or persistent stomach pain or tenderness; shortness of breath; swelling of hands or feet; symptoms of heart attack (eg, chest, jaw, or arm pain; fainting; sudden, severe nausea or vomiting; unusual sweating; weakness); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); unusual vaginal discharge, itching, or odor; unusual weakness or fatigue; vision loss or other vision changes; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal vaginal bleeding; severe nausea and vomiting.Proper storage of Premphase:
Store Premphase at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Premphase out of the reach of children and away from pets.
- If you have any questions about Premphase, please talk with your doctor, pharmacist, or other health care provider.
- Premphase is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Premphase or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Premphase. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Premphase. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Premphase.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
More about Premphase (conjugated estrogens / medroxyprogesterone)
- Other brands: Prempro