Provera

Medroxyprogesterone



(me drox' ee proe jes' te rone)

Amen®¶
Curretab®¶
Cycrin®¶
Prodroxy®¶
Provera®
Premphase® (as a combination product containing Medroxyprogesterone Acetate and Conjugated Estrogens)
Prempro® (as a combination product containing Medroxyprogesterone Acetate and Conjugated Estrogens)

acetoxymethylprogesterone
methylacetoxyprogesterone

Medroxyprogesterone is used to treat abnormal menstruation (periods) or irregular vaginal bleeding. Medroxyprogesterone is also used to bring on a normal menstrual cycle in women who menstruated normally in the past but have not menstruated for at least 6 months and who are not pregnant or undergoing menopause (change of life). Medroxyprogesterone is also used to prevent overgrowth of the lining of the uterus (womb) and may decrease the risk of cancer of the uterus in patients who are taking estrogen. Medroxyprogesterone is in a class of medications called progestins. It works by stopping the growth of the lining of the uterus and by causing the uterus to produce certain hormones.

Medroxyprogesterone comes as a tablet to take by mouth. It is usually taken once a day on certain days of a regular monthly cycle. To help you remember to take medroxyprogesterone, take it at around the same time every day on the days you are scheduled to take it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take medroxyprogesterone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Medroxyprogesterone may control your condition but will not cure it. Continue to take medroxyprogesterone according to your monthly schedule even if you feel well. Do not stop taking medroxyprogesterone without talking to your doctor.

Before using medroxyprogesterone injection,

tell your doctor and pharmacist if you are allergic to medroxyprogesterone (Depo-Provera, depo-subQ provera 104, Provera, in Prempro, in Premphase) or any other medications.

tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and aminoglutethimide (Cytadren). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

tell your doctor if you or anyone in your family has or has ever had breast cancer or diabetes. Also tell your doctor if you have or have ever had problems with your breasts such as lumps, bleeding from your nipples, an abnormal mammogram (breast x-ray), or fibrocystic breast disease (swollen, tender breasts and/or breast lumps that are not cancer); unexplained vaginal bleeding;irregular or very light menstrual periods; excessive weight gain or fluid retention before your period; blood clots in your legs, lungs, brain, or eyes; stroke or mini-stroke; migraine headaches; seizures; depression; high blood pressure; heart attack;  asthma; or heart, liver, or kidney disease.

tell your doctor if you think you might be pregnant, you are pregnant, or you plan to become pregnant. If you become pregnant while using medroxyprogesterone injection, call your doctor immediately. Medroxyprogesterone may harm the fetus.

tell your doctor if you are breast-feeding. You may use medroxyprogesterone injection while you are breast-feeding as long as your baby is 6 weeks old when you receive your first injection. Some medroxyprogesterone may be passed to your baby in your breast milk but this has not been shown to be harmful. Studies of babies who were breast-fed while their mothers were using medroxyprogesterone injection showed that the babies were not harmed by the medication.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are using medroxyprogesterone injection.

you should know that your menstrual cycle will probably change while you are using medroxyprogesterone injection. At first, your periods will probably be irregular, and you may experience spotting between periods. If you continue to use this medication, your periods may stop completely. Your menstrual cycle will probably return to normal some time after you stop using this medication.

You should eat plenty of foods that are rich in calcium and vitamin D while you are receiving medroxyprogesterone injection to help decrease the loss of calcium from your bones. Your doctor will tell you which foods are good sources of these nutrients and how many servings you need each day. Your doctor also may prescribe or recommend calcium or vitamin D supplements.

If you miss an appointment to receive an injection of medroxyprogesterone, call your doctor. You may not be protected from pregnancy if you do not receive your injections on schedule. If you do not receive an injection on schedule, your doctor will tell you when you should receive the missed injection. Your doctor will probably administer a pregnancy test to be sure that you are not pregnant before giving you the missed injection. You should use a different method of birth control, such as condoms until you receive the injection that you missed.

Medroxyprogesterone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:



breasts that are tender or produce a liquid

changes in menstrual flow

irregular vaginal bleeding or spotting

acne

growth of hair on face

loss of hair on scalp

difficulty falling asleep or staying asleep

drowsiness

upset stomach

weight gain or loss

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:



pain, swelling, warmth, redness, or tenderness in one leg only

slow or difficult speech

dizziness or faintness

weakness or numbness of an arm or leg

shortness of breath

coughing up blood

sudden sharp or crushing chest pain

fast or pounding heartbeat

sudden vision changes or loss of vision

double vision

blurred vision

bulging eyes

missed periods

depression

yellowing of the skin or eyes

fever

hives

skin rash

itching

difficulty breathing or swallowing

swelling of the hands, feet, ankles, or lower legs
Some laboratory animals who were given medroxyprogesterone developed breast tumors. It is not known if medroxyprogesterone increases the risk of breast cancer in humans. Medroxyprogesterone may also increase the chance that you will develop a blood clot that moves to your lungs or brain. Talk to your doctor about the risks of taking this medication.
Medroxyprogesterone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them.  However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community.  See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking medroxyprogesterone.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
¶ This branded product is no longer on the market. Generic alternatives may be available.