Consumer Information

Prempro

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Treatment & Uses
Side Effects
Treating Overdose
Safety Information
Before Using

Generic Name: conjugated estrogens and medroxyprogesterone (KON joo GAY ted ES troe jenz and me DOX ee proe JES ter one)
Brand Names: Premphase, Prempro

What is Prempro?

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Prempro contains a combination of conjugated estrogens and medroxyprogesterone. Conjugated estrogens are a mixture of estrogen hormones. Estrogen is a female sex hormone produced by the ovaries that is necessary for many processes in the body.

Medroxyprogesterone is also a female hormone, usually called "progesterone." It is important for the regulation of ovulation and menstruation.

Prempro is used to treat the symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation, and to prevent thinning of the bones (osteoporosis).

Prempro should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Prempro may also be used for other purposes not listed in this medication guide.

Important information about Prempro

Do not use Prempro if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), liver disease, abnormal vaginal bleeding, or a hormone-related cancer such as breast or uterine cancer. This medication can cause birth defects in an unborn baby. Do not use Prempro if you are pregnant.

Long-term treatment with Prempro may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using Prempro long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Prempro.

Prempro should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Before taking Prempro

Do not use Prempro if you have:

a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);
abnormal vaginal bleeding that a doctor has not checked;
liver disease; or
any type of breast, uterine, or hormone-dependent cancer.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Prempro:

high blood pressure, heart disease, or circulation problems;
a personal or family history of stroke;
endometriosis;
liver or kidney disease;
asthma;
epilepsy or other seizure disorder;
migraines;
diabetes;
underactive thyroid;
high cholesterol or triglycerides;
high or low levels of calcium in your blood;
porphyria;
systemic lupus erythematosus (SLE);
gallbladder disease; or
if you have had your uterus removed (hysterectomy).

Conjugated estrogens increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using conjugated estrogens may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using Prempro.

Long-term conjugated estrogens treatment may increase your risk of stroke or blood clots. Talk with your doctor about your individual risks before using conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue treatment with Prempro.

FDA pregnancy category X. Prempro can cause birth defects. Do not use Prempro if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Conjugated estrogens and medroxyprogesterone can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. Do not give Prempro to anyone under 18 years old without the advice of a doctor.

How should I take Prempro?

Take Prempro exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medication with a full glass of water.

Prempro comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

You may take this medication with or without food. Try to take the medicine at the same time each day.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Prempro.

It is important to take this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Prempro. You may need to stop using the medicine for a short time.

Prempro can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store Prempro at room temperature away from moisture and heat. Keep the medicine container tightly closed.

What happens if I miss a dose?

Take the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

What should I avoid while taking Prempro?

Do not smoke while using Prempro. Smoking can increase your risk of blood clots, stroke, or heart attack caused by this medicine.

Prempro side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Prempro: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have any of these serious side effects:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
pain or swelling in your lower leg;
abnormal vaginal bleeding;
migraine headache;
pain, swelling, or tenderness in your stomach;
confusion, problems with memory or concentration;
jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet; or
a breast lump.

Less serious Prempro side effects may include:

mild nausea, vomiting, bloating, stomach pain;
breast pain, tenderness, or swelling;
freckles or darkening of facial skin;
acne, increased hair growth, loss of scalp hair;
changes in weight or appetite;
problems with contact lenses;
vaginal itching or discharge;
changes in your menstrual periods, decreased sex drive; or
headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Prempro?

Before taking Prempro, tell your doctor if you are taking any of the following medicines:

St. John's wort;
carbamazepine (Carbatrol, Tegretol)
phenobarbital (Luminal, Solfoton);
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
ritonavir (Norvir);
ketoconazole (Nizoral) or itraconazole (Sporanox); or
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin, E-Mycin), itraconazole (Sporanox) or ketoconazole (Nizoral).

This list is not complete and there may be other drugs that can interact with Prempro. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about Prempro.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.