Provera

GENERIC NAME: MEDROXYPROGESTERONE (me-DROX-ee-proe-JESS-te-rone)

COMMON USES: This medicine is a progestin hormone used to prevent pregnancy. It may also be used to manage pain associated with endometriosis. It may also be used to treat other conditions as determined by your doctor.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. This medicine comes with a patient information leaflet. Read it carefully. This medicine is usually administered as an injection at your doctor's office, hospital, or clinic. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine is sometimes used at home as an injection. If you are using this medicine at home, a healthcare professional will provide detailed instructions for its appropriate use. Ask any questions that you may have about this medicine or giving injections. Do not use this medicine if it contains particles, is cloudy or discolored, or if the vial or syringe is cracked or damaged. This medicine is given every 3 months (13 weeks). It is very important that you return to your doctor's office for your next injection promptly at the end of the 3 month interval. STORE THIS MEDICINE as directed on the prescription label. KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and pets. Use this medicine regularly to receive the most benefit from it. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor as soon as possible.

CAUTIONS: DO NOT USE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. This medicine does not stop the spread of HIV infection (AIDS) or other sexually transmitted diseases. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors. DO NOT USE this medicine for longer than 2 years without checking with your doctor. Laboratory and/or medical tests may be performed to monitor your progress or to check for side effects. You should have a physical examination regularly as directed by your doctor while you are using this medicine. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. THIS MEDICINE MAY AFFECT CERTAIN LAB TEST RESULTS. Make sure laboratory personnel and your doctors know you are taking this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. This medicine may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping this medicine. Discuss any concerns with your doctor or pharmacist. This medicine may cause dizziness, drowsiness, lightheadedness, or vision changes. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE MAY CAUSE dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths. THIS MEDICINE MAY CAUSE A DECREASE IN THE AMOUNT OF CALCIUM in your bones. A decrease in bone calcium is of most concern if you have the following risk factors: adolescence, bone disease, anorexia nervosa (an eating disorder), a strong family history of osteoporosis, if you take certain medicines (eg, for epilepsy or steroids), or if you drink a lot of alcohol or smoke cigarettes often. If you need a birth control method for more than 2 years, your health care provider may switch you to another method or test you for weak bones. When this medicine is stopped, the calcium in bones begins to come back. Your health care provider may recommend that you take calcium or vitamin D to help lower the amount of calcium lost from your bones. FOR WOMEN: DO NOT USE THIS MEDICINE if you are pregnant. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. THIS MEDICINE IS EXCRETED IN BREAST MILK. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check your blood sugar level closely and ask your doctor before adjusting the dose of your diabetes medicine.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include changes in menstrual flow, including breakthrough bleeding, spotting, or missed periods; weight gain; headache; weakness or tiredness; stomach pain or discomfort; nausea; trouble sleeping; dizziness; drowsiness; hot flashes; acne; nervousness; hair loss; decreased interest in sex; breast pain or tenderness. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience mental or mood changes (eg, depression); unusual vaginal discharge or irritation; or swelling of your hands, legs, ankles, or feet. IF YOU MISS A MENSTRUAL PERIOD and think that you may be pregnant, contact your doctor immediately. CHECK WITH YOUR DOCTOR IMMEDIATELY if you experience breast lumps or nipple bleeding; dark urine; fast heartbeat; fever; pale stools; unusually heavy or continuous vaginal bleeding; seizures; sudden or severe headache; sudden or severe vomiting or dizziness; fainting; sudden loss of coordination; slurred speech; sudden loss of vision or changes in vision; weakness, numbness, or pain in the arms or legs; chest pain; sudden shortness of breath; coughing up blood; pain, swelling, or tenderness in the calf; severe stomach pain or tenderness; yellowing of the eyes/skin; or pain, pus, or bleeding at the injection site. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: WARNING: This medicine may decrease the amount of calcium in your bones. The longer you use this medicine, the more calcium you are likely to lose. The calcium may not return completely once you stop using this medicine. Loss of bone calcium may cause weak bones (osteoporosis). This could increase the risk of bone fracture, especially after menopause. It is not known if using this medicine during adolescence or early adulthood will increase your chances of developing osteoporosis later in life. This medicine should be used as a long-term birth control method (more than 2 years) only if other birth control methods are not right for you. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking aminoglutethimide, aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), nonnucleoside reverse transcriptase inhibitor (NNRTI) (eg, nevirapine), oxcarbazepine, phenytoin, rifampin, steroids, St. John's wort, or topiramate. Inform your doctor of any other medical conditions, including a history of certain bone problems (metabolic bone disease), anorexia, chronic alcohol or tobacco use, seizures, migraines, asthma, heart problems (eg, congestive heart failure), high blood pressure, kidney problems, mental or mood problems (eg, depression), diabetes, menstrual changes (eg, irregular or lighter menstrual periods), fibrocystic breast disease, lumps in your breast, bleeding from the nipples, abnormal mammogram, cancer, family history of breast cancer, family history of osteoporosis, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have unexplained vaginal bleeding, or a history of breast cancer, stroke or bleeding in the brain, liver problems, blood clots (including clots in the leg or the lung), problems with blood vessels, or problems with blood vessels in your brain. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are pregnant or think you may be pregnant. This medicine should not be used to diagnose pregnancy. USE OF THIS MEDICINE IN CHILDREN BEFORE the first menstrual period is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately.

ADDITIONAL INFORMATION: FOLLOW YOUR DOCTOR'S INSTRUCTIONS for taking calcium and vitamin D while you are using this medicine. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.