DEPO-PROVERA (medroxiprogesterone) 150m/ml x1 PreFilled Syringe

DEPO-PROVERA (medroxyprogesterone acetate) Pre-filled Syringe 150mg/ml.

Patient Education - English

• Generic Name: medroxyprogesterone (injectable)

• Pronounced: me DROX ee proe JES ter one

• Brand Names: Depo-Provera, Depo-Provera Contraceptive, Depo-SubQ Provera 104

What is the most important information I should know about medroxyprogesterone?

This medication can cause birth defects. Do not use medroxyprogesterone if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Do not use this medication if you are allergic to medroxyprogesterone, or if you have abnormal vaginal bleeding, breast cancer, liver disease, or a history of a stroke or blood clot.

Medroxyprogesterone may cause bone loss (osteoporosis) especially when used over long periods of time. Bone loss may not be reversible. Do not use this medication for longer than 2 years. Talk with your doctor about your specific risk of bone loss.

Medroxyprogesterone will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What is medroxyprogesterone?

Medroxyprogesterone is a form of progesterone, a female hormone that prevents ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Medroxyprogesterone is used as contraception to prevent pregnancy. It is also used to reduce pain cause by endometriosis.

Medroxyprogesterone is also used to ease pain and other symptoms in women with metastatic uterine or kidney cancer. This medication is not a cure for these conditions.

Medroxyprogesterone may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using medroxyprogesterone?

This medication may cause bone loss (osteoporosis) especially when used over long periods of time. Bone loss may not be reversible. Do not use this medication for longer than 2 years. Talk with your doctor about your specific risk of bone loss.

Medroxyprogesterone can cause birth defects. Do not use if this medication you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Do not use this medication if you are allergic to medroxyprogesterone, or if you have:

• abnormal vaginal bleeding;
• breast cancer;
• liver disease; or
• a history of a stroke or blood clot.

Before using this medication, tell your doctor if you have any of the following conditions. You may need a dose adjustment or special tests to safely use medroxyprogesterone.

• congestive heart failure;
• diabetes;
• seizures or epilepsy; or
• a history of depression.

Medroxyprogesterone passes into breast milk, but it is not known whether this could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use medroxyprogesterone?

Medroxyprogesterone is given as an injection into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Medroxyprogesterone may be given once per week or once every 3 months, depending on why you are using the medication. Follow your doctor's instructions.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

You may have breakthrough bleeding while using medroxyprogesterone. Tell your doctor if this bleeding continues or is very heavy.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using medroxyprogesterone.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

If you store this medication at home, keep it at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of medroxyprogesterone is not expected to produce life-threatening symptoms.

What should I avoid while using medroxyprogesterone?

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What are the possible side effects of medroxyprogesterone?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• fever;
• jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet; or
• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

• changes in your menstrual periods;
• headache, nervousness, dizziness, tired feeling;
• breast tenderness or discharge;
• changes in weight or appetite;
• mild stomach pain, bloating, nausea;
• back pain or pelvic pain;
• mild itching or skin rash;
• increased acne, hair growth, loss of scalp hair;
• sleep problems (insomnia);
• vaginal itching or discharge;
• decreased sex drive; or
• skin color changes or a hard lump where the injection was given.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect medroxyprogesterone?

Before using medroxyprogesterone, tell your doctor if you are also using aminoglutethimide (Cytadren).

This list is not complete and there may be other drugs that can interact with medroxyprogesterone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about medroxyprogesterone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.