Depo-Provera is a form of progesterone, a female hormone that prevents ovulation (the release of an egg from an ovary). Medroxyprogesterone 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.

Depo-Provera CI is an intramuscular injection (shot injected into a muscle) and is used as a contraceptive to prevent pregnancy.

Depo-Provera does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs).

You should not use Depo-Provera if you have: undiagnosed vaginal bleeding, liver disease, breast cancer, if you are pregnant, or if you have ever had a stroke or blood clot.

Medroxyprogesterone can decrease the calcium stored in your bones, which may cause bone loss (osteoporosis) when the medicine is used over long periods of time. Bone loss may not be reversible.

You may be more likely to have a broken bone if your bones get weak from calcium loss, especially after menopause. You should not use Depo-Provera CI for longer than 2 years unless other birth control methods are not right for you.

Depo-Provera 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.

Before taking this medicine

You may need to have a negative pregnancy test before you start Depo-Provera.

You should not use Depo-Provera if you are pregnant, or if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;

• liver disease;

• breast cancer; or

• a history of stroke or blood clot.

Medroxyprogesterone can decrease the calcium stored in your bones, which may cause bone loss (osteoporosis) when the medicine is used over long periods of time. Bone loss may not be reversible.

You may be more likely to have a broken bone if your bones get weak from calcium loss, especially after menopause. You should not use Depo-Provera CI for longer than 2 years unless other birth control methods are not right for you. Ask your doctor.

To make sure Depo-Provera is safe for you, tell your doctor if you have ever had:

• light or irregular menstrual periods;

• risk factors for osteoporosis (such as low bone mineral density, a family history of osteoporosis, drinking large amounts of alcohol, or if you smoke);

• a breast lump, an abnormal mammogram, or bleeding from your nipples;

• kidney disease;

• high blood pressure;

• breast cancer (in you or a family member);

• diabetes;

• depression, or an eating disorder;

• seizures;

• asthma; or

• migraine headaches.

Tell your doctor right away if you become pregnant, or if you plan to become pregnant soon after you stop using Depo-Provera CI.

It may not be safe to breastfeed while using Depo-Provera. Ask your doctor about any risk.

Depo-Provera CI is injected into a muscle. A healthcare provider will give you Depo-Provera CI once every 3 months (13 weeks).

You may have breakthrough bleeding while using Depo-Provera CI. Tell your doctor if this bleeding continues or is very heavy.

Depo-Provera can affect the results of certain medical tests. Tell any doctor who treats you that you are using Depo-Provera CI.

Your doctor will need to see you on a regular basis while you are using Depo-Provera CI. If you use this medicine long-term, your bone density may need to be checked during treatment.

Usual Adult Dose of Depo-Provera for Contraception:

Intramuscular injection:
-150 mg once every 3 months (13 weeks) in the gluteal or deltoid muscle.

Usual Pediatric Dose of Depo-Provera for Contraception:

Postmenarchal children and adolescents:
Intramuscular injection:
-150 mg once every 3 months (13 weeks) in the gluteal or deltoid muscle.

Comments:
First injection:
-Ensure the patient is not pregnant at the time of the first injection.
-The first injection should be given only during the first 5 days of a normal menstrual period, within the first 5-days postpartum if not breast-feeding, and at the sixth postpartum week if breast-feeding.
Switching from other methods of contraception:
-IM injection: The first injection should be given on the day after the last active contraception tablet, or at the latest, on the day following the final inactive contraception tablet.
If the time interval between injections is greater than 13 weeks, pregnancy should be excluded before administering the drug.
-The efficacy of the IM suspension depends on adherence to the dosage schedule of administration.
The risk/benefit of loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, should be assessed when using Depo-Provera long-term.

You may need to have a negative pregnancy test before you start Depo-Provera.

You should not use Depo-Provera if you are pregnant, or if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;

• liver disease;

• breast cancer; or

• a history of stroke or blood clot.

Medroxyprogesterone can decrease the calcium stored in your bones, which may cause bone loss (osteoporosis) when the medicine is used over long periods of time. Bone loss may not be reversible.

You may be more likely to have a broken bone if your bones get weak from calcium loss, especially after menopause. You should not use Depo-Provera CI for longer than 2 years unless other birth control methods are not right for you. Ask your doctor.

To make sure Depo-Provera is safe for you, tell your doctor if you have ever had:

• light or irregular menstrual periods;

• risk factors for osteoporosis (such as low bone mineral density, a family history of osteoporosis, drinking large amounts of alcohol, or if you smoke);

• a breast lump, an abnormal mammogram, or bleeding from your nipples;

• kidney disease;

• high blood pressure;

• breast cancer (in you or a family member);

• diabetes;

• depression, or an eating disorder;

• seizures;

• asthma; or

• migraine headaches.

Tell your doctor right away if you become pregnant, or if you plan to become pregnant soon after you stop using Depo-Provera CI.

It may not be safe to breastfeed while using Depo-Provera. Ask your doctor about any risk.

Depo-Provera CI will not be effective in preventing pregnancy if you do not receive an injection every 3 months.

If you plan to continue using Depo-Provera CI, get the missed injection as soon as possible. Use a non-hormonal back-up birth control (such as a condom or diaphragm with spermicide) until you receive the missed injection.

You may need to have a negative pregnancy test before you receive a missed injection.

If more than 14 weeks have passed since your last Depo-Provera CI injection, you may be able to get pregnant. The longer you wait between injections, the more likely you are to get pregnant.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Depo-Provera CI 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.

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

Call your doctor at once if you have:

• menstrual periods that are heavier or longer than normal;

• severe pain in your lower stomach;

• swelling in your face, or your hands, ankles, and feet;

• pain, bleeding, oozing (pus), or skin changes where the injection was given;

• symptoms of depression (sleep problems, weakness, mood changes);

• liver problems - upper stomach pain, itching, tiredness, dark urine, jaundice (yellowing of the skin or eyes); or

• signs of a blood clot - sudden numbness or weakness, severe headache, chest pain, sudden cough, coughing up blood; problems with vision or speech, swelling or pain in an arm or leg.

Common Depo-Provera side effects may include:

• changes in your menstrual periods;

• weakness, feeling tired;

• stomach pain;

• feeling nervous;

• decreased sexual drive;

• weight gain;

• headache, dizziness; or

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can lower your blood levels of medroxyprogesterone and make it less effective in preventing pregnancy.

Tell your doctor about all your other medicines, especially:

• St. John's wort;

• sleep medicine;

• seizure medicine;

• medicine to treat an infection;

• HIV or AIDS medication;

• bosentan;

• modafinil; or

• mitotane.

This list is not complete and many other drugs may interact with medroxyprogesterone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.