Provera


Provera

     * Generic Name: medroxyprogesterone acetate tablets
     * Brand Name: Provera


     * What is medroxyprogesterone?
     * What are the possible side effects of medroxyprogesterone?
     * What is the most important information I should know about
       medroxyprogesterone?
     * What should I discuss with my healthcare provider before taking
       medroxyprogesterone?
     * How should I take medroxyprogesterone?
     * What happens if I miss a dose?
     * What happens if I overdose?
     * What should I avoid while taking medroxyprogesterone?
     * What other drugs will affect medroxyprogesterone?
     * Where can I get more information?

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 purposes not listed in this
   medication guide.

What are the possible side effects of medroxyprogesterone?

   Get emergency medical help if you have signs of an allergic reaction:
   hives; difficulty breathing; swelling of your face, lips, tongue, or
   throat.

   Call your doctor at once if you have:
     * vaginal bleeding if you have already gone through
       menopause;
     * a light-headed 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);
     * swelling in your hands, ankles, or feet;
     * heart attack symptoms--chest pain or pressure, pain spreading to
       your jaw or shoulder, nausea, sweating;
     * signs of a stroke--sudden numbness or weakness (especially on
       one side of the body), sudden severe headache, slurred speech,
       problems with vision or balance;
     * signs of a blood clot in the lung--chest pain, sudden cough,
       wheezing, rapid breathing, coughing up blood; or
     * signs of a blood clot in your leg--pain, swelling, warmth, or
       redness in one or both legs.

   Common side effects may include:
     * spotting or breakthrough bleeding;
     * changes in your menstrual periods;
     * vaginal itching or discharge;
     * breast tenderness or discharge;
     * headache, dizziness, feeling nervous or depressed;
     * bruising or swelling of your veins;
     * premenstrual type symptoms (bloating, fluid retention, mood
       changes);
     * sleep problems (insomnia);
     * itching, rash, acne, hair growth, loss of scalp hair;
     * stomach discomfort, bloating, nausea;
     * weight gain; or
     * vision changes and difficulty wearing contact lenses.

   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 is the most important information I should know about
medroxyprogesterone?

   You should not use this medicine 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 should not be used to prevent heart disease,
   stroke, or dementia. This medicine may actually increase your risk of
   developing these conditions. Long-term use of medroxyprogesterone may
   increase your risk of breast cancer, heart attack, stroke, or
   blood clot. Talk with your doctor about your individual risk.

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

   Medroxyprogesterone can cause birth defects. Do not use if this
   medicine you are pregnant. Tell your doctor right away if you become
   pregnant during treatment.

   You should not use this medicine 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.

   To make sure medroxyprogesterone is safe for you, tell your doctor if
   you have:
     * 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 may increase your risk of developing a condition
   that can lead to uterine cancer. To help lower this risk, your doctor
   may prescribe a progestin for you to take with medroxyprogesterone.
   Report any unusual vaginal bleeding right away.

   Medroxyprogesterone can pass into breast milk and may harm a nursing
   baby. Tell 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 medicine, 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?

   Follow all directions on your prescription label. Do not take this
   medicine in larger or smaller amounts or for longer than recommended.

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

   Store at room temperature away from moisture and heat.

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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.

What should I avoid while taking medroxyprogesterone?

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

   This medicine can pass into body fluids (urine, feces, vomit).
   Caregivers should wear rubber gloves while cleaning up a patient's body
   fluids, handling contaminated trash or laundry or changing diapers.
   Wash hands before and after removing gloves. Wash soiled clothing and
   linens separately from other laundry.

What other drugs will affect medroxyprogesterone?

   Other drugs may interact with medroxyprogesterone, including
   prescription and over-the-counter medicines, vitamins, and herbal
   products. Tell each of your health care providers about all medicines
   you use now and any medicine you start or stop using.

Where can I get more information?

   Your pharmacist can provide more information about medroxyprogesterone.
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