Premphase

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Premphase, Prempro, |Premphase

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Premphase

Generic Name: conjugated estrogens and medroxyprogesterone (ESS troe jenz and me DROX ee proe JESS te rone)
Brand Names: Premphase, Prempro

What are 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.

Together, conjugated estrogens and medroxyprogesterone are 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).

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

Conjugated estrogens and medroxyprogesterone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about conjugated estrogens and medroxyprogesterone?

Do not use this medication 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 conjugated estrogens and medroxyprogesterone if you are pregnant.

Long-term treatment with conjugated estrogens and medroxyprogesterone may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using this medication 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 conjugated estrogens and medroxyprogesterone.

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

What should I discuss with my healthcare provider before taking conjugated estrogens and medroxyprogesterone?

Do not use this medication 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.

Before using conjugated estrogens and medroxyprogesterone, tell your doctor if you are allergic to any drugs, or if you have:

  • 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).

If you have any of these conditions, you may not be able to use conjugated estrogens and medroxyprogesterone, or you may need a dosage adjustment or special tests during treatment.

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 conjugated estrogens and medroxyprogesterone.

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 this treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use conjugated estrogens and medroxyprogesterone 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 this medication to anyone under 18 years old without the advice of a doctor.

How should I take conjugated estrogens and medroxyprogesterone?

Take this medication 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.

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

The 28-day Premphase treatment consists of two differently colored pills, 14 of each color. Carefully follow the patient instructions about which pills to take on days 1 through 14 and which pills to take on days 15 through 28.

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 conjugated estrogens and medroxyprogesterone.

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 conjugated estrogens and medroxyprogesterone. You may need to stop using the medicine for a short time.

This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using conjugated estrogens and medroxyprogesterone.

Store this medication 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. Symptoms of a conjugated estrogens and medroxyprogesterone overdose may include nausea, vomiting, or vaginal bleeding.

What should I avoid while taking conjugated estrogens and medroxyprogesterone?

Do not smoke while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by conjugated estrogens and medroxyprogesterone.

What are the possible side effects of conjugated estrogens and medroxyprogesterone?

Get emergency medical help if you have any of these signs of an allergic reaction: 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.

Continue taking the medication and talk to your doctor if you have any of these less serious side effects:

  • 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.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect conjugated estrogens and medroxyprogesterone?

Before taking conjugated estrogens and medroxyprogesterone, 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).

If you are using any of these drugs, you may not be able to use conjugated estrogens and medroxyprogesterone, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect conjugated estrogens and medroxyprogesterone. 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 has information about conjugated estrogens and medroxyprogesterone written for health professionals that you may read.

What does my medication look like?

Conjugated estrogens and medroxyprogesterone are available with a prescription under the brand names Prempro and Premphase. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Prempro 0.625 mg of conjugated estrogens and 2.5 mg of medroxyprogesterone--two blister cards, each containing 14 oval, peach-colored tablets

  • Premphase--one blister card of 14 oval, maroon tablets, each containing 0.625 mg of conjugated estrogens, to be taken on days 1 through 14; and a second blister card of 14 oval, light-blue tablets, each containing 0.625 mg of conjugated estrogens and 5 mg of medroxyprogesterone, to be taken on days 15 through 28.

  • 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.
Copyright 1996-2006 Cerner Multum, Inc. Version: 6.04. Revision Date: 9/29/06 4:44:20 PM.



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