medroxyprogesterone 104 mg/0.65 mL subcutaneous syringe

Generic name:
Medroxyprogesterone acetate (contraceptive) - subcutaneous

Pronunciation
(med-ROX-ee-proe-JES-ter-one AS-e-tate)

Brand name(s)
Depo-SubQ Provera

This medication may cause serious bone loss which may not return to normal after you stop using it. The risk of bone loss increases with longer use of this medication and smoking. An important time when your bones continue to build up is during your teenage and young adult years. Use of this medication may increase the risk of weak/brittle bones (osteoporosis), which can lead to broken bones when you are older. Talk with your doctor about the risks and benefits of this medication and other birth control choices.

This medication should not be used longer than 2 years for birth control or for treatment of endometriosis unless other methods/treatments will not work for you.

This medication is used to prevent pregnancy. Medroxyprogesterone is like a natural hormone made by the body.

Medroxyprogesterone is also used to treat endometriosis. It works by lowering the amount of certain hormones in the body and decreasing the growth of abnormal tissues that cause endometriosis. This helps reduce pain and other symptoms.

Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Read the Patient Information Leaflet if available from your pharmacist before you start using medroxyprogesterone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin as directed by your doctor, usually once every 3 months. The injection is given in the stomach area or upper thigh. Before starting this medication, you must have a negative pregnancy test. The first injection is usually given during the first 5 days of your menstrual period or 6 weeks after the delivery of your baby if you are breastfeeding. Follow your doctor's exact instructions if you are switching from another birth control method. Repeat the same dose every 12 to 14 weeks.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder. If more than 14 weeks pass between injections, you could become pregnant. Use a form of non-hormonal birth control (such as condoms, diaphragm, spermicide) to prevent pregnancy until you can get the next injection. Your doctor may direct you to first have a pregnancy test before your next injection.

Nausea, bloating, headache, changes in appetite, weight gain, tiredness, swelling, acne, hot flashes, breast tenderness, or irritation/pain at the injection site may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Your periods may stop completely after you have been using this medication for about a year. If this occurs, your periods will normally return after you stop using this medication. If you miss a period and have missed an injection, or if more than 14 weeks pass between injections and you think you might be pregnant, contact your doctor for a pregnancy test.

Remember that this medication has been prescribed because your doctor 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:

• nausea/vomiting that doesn't stop
• mental/mood changes (such as new/worsening depression)
• changes in sexual interest/ability
• swelling of the ankles/feet
• bone pain
• unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding)
• severe stomach/abdominal/pelvic pain
• unusual weakness/tiredness
• dark urine
• yellowing skin/eyes
• seizure

This medication may increase your risk of breast cancer. Tell your doctor right away if you have symptoms such as a lump in the breast, nipple discharge. Ask your doctor for more details.

Rarely, people using this medication have had very serious (possibly fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs, legs, or eyes). Get medical help right away if you have:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

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 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.

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.

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

• blood clots (for example, in the legs, eyes, lungs)
• unexplained vaginal bleeding
• asthma
• abnormal breast exam
• personal or family history of cancer (especially breast or cervical cancer)
• daily use of alcohol/tobacco
• depression
• diabetes
• eating disorder (anorexia)
• heart problems (such as heart failure, irregular heartbeat, previous heart attack)
• high blood pressure
• kidney disease
• liver disease (including tumors)
• high cholesterol or triglyceride (blood fat) levels
• migraines
• seizures
• stroke or "mini" stroke (transient ischemic attack)
• personal or family history of bone disease (such as osteoporosis)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

It may take longer for you to become pregnant after you stop using this medication. Consult your doctor.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

This drug passes into breast milk. Consult your doctor before breastfeeding.

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.

A product that may interact with this drug is:

• 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), ritonavir, St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine), among others.

Tell your doctor when you start any new drug, and discuss if you should use reliable backup 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 lab tests (such as certain hormone levels, blood tests for clotting factors, thyroid/liver function tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam, pelvic exam, Pap smear) should be done while you are using this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details. 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. Ask your doctor or pharmacist about calcium/vitamin D supplements to help keep your bones healthy.

It is important to get each dose of this medication as scheduled. If you miss a dose and more than 14 weeks have passed between injections, ask your doctor right away for instructions. You will need a pregnancy test to make sure you are not pregnant before getting another injection. Other birth control methods (such as spermicide, condoms) must be used to protect you from getting pregnant until you can get the next injection.

Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

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.