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.
MEDROXYPROGESTERONE ACETATE (CONTRACEPTIVE) - INTRAMUSCULAR
COMMON BRAND NAME(S): Depo-Provera
WARNING: This medication may cause serious bone loss. The risk of bone loss increases with longer use of this medication. This bone loss may be permanent even after you stop using medroxyprogesterone injection. This medication should not be used for longer than 2 years unless other birth control methods will not work for you. The years of adolescence and early adulthood are important for your body to build healthy bones. Use of this medication may increase the risk of broken bones when you are older. Discuss with your doctor the risks and benefits of this medication and other birth control choices. Keep all your medical/lab appointments. Your doctor may test your bone density while you are using this medication. Be sure to get enough vitamin D and calcium in your diet. Consult your doctor or pharmacist to determine whether you need calcium/vitamin D supplements to help keep your bones healthy. Use of this medication does not protect you against sexually transmitted diseases (e.g., HIV, hepatitis B, gonorrhea). Consult your doctor or pharmacist if you have any questions.
USES: This medication is used to prevent pregnancy. Medroxyprogesterone is like a natural hormone made by the body called progesterone. It works by preventing the growth and release of a mature egg (ovulation), and changing the womb to make it more difficult for an egg to meet sperm (fertilization) or for the fertilized egg to attach to the wall of the womb (implantation).
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information. If you have any questions, consult your doctor or pharmacist. The container should be shaken well before each injection. This medication is given by injection into a muscle (upper arm or buttock) as directed by your doctor once every 3 months (13 weeks). The first injection should be given during the first 5 days of your menstrual period to make sure you are not pregnant. If you have recently given birth, the first injection should be given within 5 days after delivery if you are not breast-feeding and during the sixth week after delivery if you are breast-feeding. Talk with your doctor about the best time to schedule your first injection. If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. It is very important that you have an injection every 3 months. If more than 13 weeks pass between injections, you may become pregnant. You may need a pregnancy test to make sure you are not pregnant before getting another injection. Other birth control methods (e.g., contraceptive sponge, diaphragm, condom) must be used to protect you from getting pregnant until you can get the next injection.
SIDE EFFECTS: Nausea, stomach cramping/bloating, dizziness, headache, tiredness, breast tenderness, decrease in breast size, acne, hair loss, or irritation/pain at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Your periods may be early or late, shorter or longer, or heavier or lighter than normal. You may also have some spotting between periods, especially during the first several months of use. Your periods may stop completely after you have been receiving this medication for about a year. If this occurs, your periods will normally return after you stop receiving this medication. If you miss a period and have missed an injection, or if more than 13 weeks pass between injections and you think you may be pregnant, see your doctor. 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 you have any serious side effects, including: mental/mood changes (e.g., depression), changes in sexual interest/ability, swelling of the ankles/feet, unusual/sudden weight gain, bone pain, unusual breast discharge/lumps in breast, abnormal severe/persistent vaginal bleeding, persistent nausea/vomiting, seizures, severe stomach/abdominal/pelvic pain, unusual weakness/tiredness, dark urine, yellowing skin/eyes. This drug may rarely cause blood clots. Get medical help right away if you notice any of the following rare but very serious side effects: chest/jaw/left arm pain, sudden shortness of breath, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden/severe headache, slurred speech, vision changes/problems, weakness on one side of the body. A very serious allergic reaction to this drug is rare. However, get medical help right away 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. 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 using 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, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have any of the following conditions: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), breast cancer, liver disease, current/suspected pregnancy, abnormal/unexplained vaginal bleeding. Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, abnormal breast exam, family history of breast cancer, cancer of the reproductive organs (e.g., cervix, uterus), frequent use of alcohol/tobacco, depression, diabetes, eating disorder (anorexia), heart disease (e.g., chest pain, heart failure), high blood pressure, kidney disease, high cholesterol, irregular/missed/light menstrual periods, migraine, personal/family history of bone disease (e.g., osteoporosis), seizures. Before having surgery, including dental surgery, tell your doctor or dentist that you are using this medication. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. It may take longer for you to get pregnant after you stop using this medication. Consult your doctor for more information. 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: acitretin, aminoglutethimide, amprenavir, anticonvulsants (e.g., phenytoin), corticosteroids (e.g., hydrocortisone, prednisone), isotretinoin, sodium tetradecyl sulfate, troleandomycin, warfarin. Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others. Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. This medication may interfere with certain laboratory tests (including certain hormone levels, thyroid tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you are using this medication.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., bone density) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Keep all appointments with your doctor and the laboratory. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Your doctor may also order bone density exams if you are using this long term. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.
MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.
Information last revised May 2012. Copyright(c) 2012 First Databank, Inc.