Premphase® (as a combination product containing Medroxyprogesterone Acetate and Conjugated Estrogens)
Prempro® (as a combination product containing Medroxyprogesterone Acetate and Conjugated Estrogens)
WHY is this medicine prescribed?
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.
HOW should this medicine be used?
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.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking medroxyprogesterone,
tell your doctor and pharmacist if you are allergic to medroxyprogesterone (Provera, Depo-Provera), any other medications, or corn.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention 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 have or have ever had cancer of the breasts or female organs; unexplained vaginal bleeding; a missed abortion (a pregnancy that ended when the unborn child died in the uterus but was not expelled from the body); blood clots in your legs, lungs, brain, or eyes; stroke or mini-stroke; seizures; migraine headaches; depression; asthma; diabetes; or heart, kidney, or liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking medroxyprogesterone, call your doctor immediately. Medroxyprogesterone should never be used to test for pregnancy or to prevent miscarriage during the first few months of pregnancy. Medroxyprogesterone has not been shown to prevent miscarriage and may harm the fetus.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking medroxyprogesterone.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
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
growth of hair on face
loss of hair on scalp
difficulty falling asleep or staying asleep
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
yellowing of the skin or eyes
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 ( Web Site ) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
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 ( Web Site) 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. Web Site
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What OTHER INFORMATION should I know?
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.
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