conjugated estrogens and medroxyprogesterone

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Pronunciation: KON joo GAY ted ES troe jenz and me DOX ee proe JES ter one

Brand: Premphase, Prempro

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 harm an unborn baby or cause birth defects. Do not use if you are pregnant.

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

Have regular physical exams and mammograms, 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 are conjugated estrogens and medroxyprogesterone?

Conjugated estrogens and medroxyprogesterone 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.

The combination of conjugated estrogens and medroxyprogesterone 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).

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 not listed in this medication guide.

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;
  • a bleeding or blood-clotting disorder;
  • liver disease; or
  • any type of breast, uterine, or hormone-dependent cancer.

To make sure you can safely take conjugated estrogens and medroxyprogesterone, tell your doctor if you have any of these other conditions:

  • 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); or
  • gallbladder disease.

Conjugated estrogens increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. The medroxyprogesterone contained in this medication may lower this risk. If your uterus has not been removed, talk with your doctor about your specific risk of developing uterine cancer while taking conjugated estrogens and medroxyprogesterone.

Long-term use of conjugated estrogens and medroxyprogesterone may increase your risk of breast cancer, heart attack, stroke, or blood clot. 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.

FDA pregnancy category X. This medication can harm an unborn baby or 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 effective 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 exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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 mammograms, and self-examine your breasts for lumps on a monthly basis while using this medication.

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

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking conjugated estrogens and medroxyprogesterone.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using conjugated estrogens and medroxyprogesterone.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms 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 severe headache, confusion, problems with vision, speech, or balance;
  • pain, swelling, warmth, or redness in one or both legs;
  • 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 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 conjugated estrogens and medroxyprogesterone?

Tell your doctor about all other medicines you use, especially:

  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • a thyroid medication such as levothyroxine (Synthroid, Levoxyl, Levothroid and others);
  • insulin or diabetes medicine taken by mouth;
  • rifampin (Rifadin, Rifater, Rifamate, Rimactane);
  • ketoconazole (Nizoral) or itraconazole (Sporanox);
  • seizure medicines such as phenytoin (Dilantin), carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or primidone (Mysoline);
  • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
  • antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

This list is not complete and other drugs may interact with conjugated estrogens and medroxyprogesterone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about conjugated estrogens and medroxyprogesterone.

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.

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