medroxyprogesterone (oral)

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

You should not use this medication if you are pregnant, or if you have liver disease, a hormone-related cancer such as breast or uterine cancer, a history of stroke or blood clot, or abnormal vaginal bleeding that has not been checked by a doctor.

Medroxyprogesterone will not prevent heart disease, breast cancer, or dementia, and may actually increase the risk of developing these conditions in post-menopausal women. Medroxyprogesterone may also increase the risk of uterine or ovarian cancer in some women. Long-term treatment with estrogens and progestins (such as medroxyprogesterone) may also increase your risk of heart attack, blood clot, or stroke.

Talk to your doctor about your specific risks and benefits of taking this medication, 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.

What is medroxyprogesterone?

Medroxyprogesterone is a progestin (a form of progesterone), a female hormone that helps regulate ovulation (the release of an egg from an ovary) and menstrual periods.

Medroxyprogesterone is used to treat conditions such as absent or irregular menstrual periods, or abnormal uterine bleeding. Medroxyprogesterone is also used to decrease the risk of endometrial hyperplasia (a condition that may lead to uterine cancer) while taking estrogens.

Medroxyprogesterone is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

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

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

FDA pregnancy category X. Medroxyprogesterone can cause birth defects. Do not use if this medication you are pregnant. Tell your doctor right away if you become pregnant during treatment.

You should not use this medication if you are allergic to medroxyprogesterone, or if you have:

• abnormal vaginal bleeding that has not been diagnosed;
• a hormone-related cancer such as breast or uterine cancer;
• liver disease; or
• a history of stroke or blood clot.

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

• heart disease, congestive heart failure, recent stroke or heart attack
• high blood pressure;
• high cholesterol or triglycerides;
• low levels of calcium in your blood;
• severe pelvic pain;
• recent miscarriage or abortion;
• epilepsy;
• asthma;
• migraine headaches;
• a thyroid disorder;
• kidney disease,
• diabetes; or
• lupus.

Medroxyprogesterone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Medroxyprogesterone will not prevent heart disease, breast cancer, or dementia, and may actually increase the risk of developing these conditions in post-menopausal women. Medroxyprogesterone may also increase the risk of uterine or ovarian cancer in some women. Long-term treatment with estrogens and progestins (such as medroxyprogesterone) may also increase your risk of heart attack, blood clot, or stroke.

Talk to your doctor about your specific risks and benefits of taking this medication, 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.

How should I take medroxyprogesterone?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Medroxyprogesterone is usually given for only a few days in a row each month. You may need to start taking the medication on a certain day of your menstrual cycle, depending on why you are taking medroxyprogesterone. Follow your doctor's instructions.

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

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are taking medroxyprogesterone.

Store medroxyprogesterone at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. 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, stomach pain, breast tenderness, dizziness, drowsiness, or vaginal bleeding.

What should I avoid while taking medroxyprogesterone?

Avoid smoking while you are taking this medication. Smoking greatly increases your risk of blood clots.

What are the possible side effects of 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.

Call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;
• pain or swelling in one or both legs;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• vaginal bleeding if you have already gone through menopause;
• feeling like you might pass out;
• a breast lump;
• symptoms of depression (sleep problems, dizziness, mood changes, headache);
• fever;
• jaundice (yellowing of the skin or eyes); or
• swelling in your hands, ankles, or feet.

Less serious side effects may include:

• spotting or breakthrough bleeding;
• changes in your menstrual periods;
• vaginal itching or discharge;
• breast tenderness or discharge;
• mild itching or skin rash;
• increased acne, hair growth, loss of scalp hair;
• sleep problems (insomnia);
• changes in appetite or weight,
• mild stomach pain, bloating, nausea; or
• skin color changes.

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 medroxyprogesterone?

There may be other drugs that can interact with medroxyprogesterone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about medroxyprogesterone.