Medroxyprogesterone 100 Mg Tablet - Oral

Pronunciation: meh-DROX-ee-pro-JESS-tur-own

Common Brand Name(s): Provera

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Warning

Very serious side effects have been reported in women after menopause who have used medroxyprogesterone along with another drug (estrogen) during combination hormone replacement therapy. Treatment can rarely cause heart disease (for example, heart attacks), stroke, serious blood clots (possibly in the lungs and legs), dementia, and breast cancer. These risks appear to depend on the length of treatment and other factors. Therefore, combination hormone therapy should be used for the shortest possible length of time at the lowest effective dose so that the benefits are obtained while the chance of serious side effects from long-term treatment is minimized. Discuss the risks and benefits of this drug during your cancer treatment with your doctor.

If you use this medication for an extended period, you should have a complete physical exam at regular intervals (for example, once a year) or as directed by your doctor. See Notes section.

Uses

Medroxyprogesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is used to treat cancer of the uterus lining (endometrial cancer). It is also used to treat certain types of breast cancer in women after menopause. Medroxyprogesterone helps to slow down the growth of the tumors.

How To Use

Read the Patient Information Leaflet provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth as directed by your doctor. The dosage is based on your medical condition and response to therapy.

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.

It may take up to 2-3 months to see a response to this medication.

Side Effects

Nausea, bloating, increased appetite, breast tenderness/swelling, headache, change in vaginal discharge, mood swings, dizziness, drowsiness, or weight gain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur:

  • unusual vaginal bleeding (e.g., spotting, breakthrough bleeding)
  • mental/mood changes (e.g., depression, memory loss)
  • swelling of the hands/feet
  • unusual fullness of the face
  • frequent/burning/painful urination
  • breast lumps
  • dark patches on the skin or face (melasma)
  • yellowing eyes/skin
  • unusual tiredness

This medication may rarely cause very serious (possibly fatal) problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs or legs, blindness). Seek immediate medical attention if you experience any of the following:

  • chest/jaw/left arm pain
  • weakness on one side of the body
  • slurred speech
  • sudden vision changes (e.g., blurred/double vision, loss of vision, bulging eyes)
  • confusion
  • sudden severe headache
  • severe dizziness
  • fainting
  • trouble breathing
  • coughing up blood
  • pain/redness/swelling/weakness of the arms/legs
  • calf pain/swelling that is warm to the touch

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking medroxyprogesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soybeans), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

  • history of blood clots
  • history of bleeding in the brain
  • liver disease
  • vaginal bleeding of unknown cause
  • a loss of pregnancy with some tissue remaining in the uterus ("missed abortion")
  • recent stroke or heart attack (within 1 year)

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • family medical history (especially breast lumps and cancer)
  • kidney disease
  • obesity
  • heart disease (e.g., past heart attacks, coronary artery disease, congestive heart failure)
  • high blood pressure
  • seizures
  • migraine headaches
  • asthma
  • high blood levels of cholesterol/fats
  • high blood levels of calcium
  • a certain blood disorder (porphyria)
  • depression
  • strokes
  • vision loss caused by blood vessel disease in the eye

If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and if you have any symptoms of high blood sugar such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (such as on a long plane flight). You may need to stop the medication for a time or take special precautions because of the increased risk for blood clots. Ask your doctor for more details.

Do not smoke. Smoking combined with this medication further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

This medication must not be used during pregnancy because it may harm an unborn baby, especially during the first 4 months of pregnancy. If you become pregnant or think you may be pregnant, inform your doctor right away.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

  • aminoglutethimide
  • drugs affecting liver enzymes that remove medroxyprogesterone from your body (such as carbamazepine, phenobarbital, phenytoin, rifamycins including rifampin, St. John's wort)

This medication can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use this medication.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe nausea and vomiting.

Notes

Do not share this medication with others.

Keep all appointments with your doctor and the laboratory. You should have a complete physical examination that includes blood pressure measurements and breast/pelvic examinations at regular intervals as directed by your doctor. Follow your doctor's instructions on how to examine your own breasts and report any lumps right away. You should also be regularly screened for cervical cancer (for example, by having a Pap test) and have periodic mammograms as determined by your doctor. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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