Depo-subQ Provera 104 (medroxyprogesterone) 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-subQ Provera 104 is used as contraception (birth control) to prevent pregnancy.

Depo-subQ Provera 104 is also used to reduce pain caused by endometriosis. Symptoms of endometriosis arise when cells normally inside your uterus grow outside the uterus. The cells respond to menstrual cycle hormones, and may cause painful periods, pelvic pain, and painful sex.

Depo-subQ provera 104 is given as a subcutaneous injection (shot given under the skin) every 3 months.

You should not use Depo-subQ Provera 104 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.

Depo-subQ Provera 104 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-subQ Provera 104 for longer than 2 years unless other birth control methods are not right for you.

Before taking this medicine

You may need to have a negative pregnancy test before you start Depo-subQ Provera 104.

You should not use Depo-subQ Provera 104 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.

Depo-subQ Provera 104 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-subQ Provera 104 for longer than 2 years unless other birth control methods are not right for you. Ask your doctor.

To make sure Depo-subQ provera 104 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-subQ Provera 104.

It may not be safe to breastfeed while using Depo-subQ Provera 104. Ask your doctor about any risk.

Depo-subQ Provera 104 is injected under the skin. A healthcare provider will give you Depo-subQ Provera 104 once every 3 months (12 to 14 weeks).

You may have breakthrough bleeding while using Depo-subQ Provera 104. Tell your doctor if this bleeding continues or is very heavy.

Depo-subQ Provera 104 can affect the results of certain medical tests. Tell any doctor who treats you that you are using Depo-subQ Provera 104.

Your doctor will need to see you on a regular basis while you are using Depo-subQ Provera 104. If you use this medicine long-term, your bone density may need to be checked during treatment.

Usual Adult Dose of Depo-subQ Provera 104 for Contraception:

Subcutaneous injection:
-104 mg once every 3 months (12 to 14 weeks) into the anterior thigh or abdomen.

Usual Pediatric Dose of Depo-subQ Provera 104 for Contraception:

Postmenarchal children and adolescents:
Subcutaneous injection:
-104 mg once every 3 months (12 to 14 weeks) into the anterior thigh or abdomen.

Comments:
First injection:
-Ensure the patient is not pregnant at the time of the first Depo-subQ Provera 104 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:
- The first Depo-subQ Provera 104 injection should be given within 7 days after the last day taking the last active contraceptive tablet, or after removing the patch or ring.

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 the injection long-term.

Usual Adult Dose of Depo-subQ Provera 104 for Endometriosis:

104 mg subcutaneously once every 3 months (12 to 14 weeks)
Duration of therapy: No longer than two years.

Comments:
-For sexually active women having regular menses, the first Depo-subQ Provera 104injection should only be given within the first 5 days of a normal menstrual period or at 6 weeks postpartum, if the patient is breast feeding.
-If the period between injections is more than 14 weeks, pregnancy should be ruled out prior to administering.
-The impact of long-term use of the Depo-subQ Provera 104 subcutaneous injection on bone mineral density (BMD) should be considered.
-If symptoms return after discontinuation of treatment, BMD should be evaluated prior to retreatment.

You may need to have a negative pregnancy test before you start Depo-subQ Provera 104.

You should not use Depo-subQ Provera 104 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.

Depo-subQ Provera 104 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-subQ Provera 104 for longer than 2 years unless other birth control methods are not right for you. Ask your doctor.

To make sure Depo-subQ provera 104 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-subQ Provera 104.

It may not be safe to breastfeed while using Depo-subQ Provera 104. Ask your doctor about any risk.

Depo-subQ Provera 104 will not be effective in preventing pregnancy if you do not receive an injection every 3 months.

If you plan to continue using Depo-subQ Provera 104, 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-subQ Provera 104 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-subQ Provera 104 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-subQ provera 104: 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-subQ provera 104 side effects may include:

• changes in your menstrual periods;

• weakness, feeling tired;

• stomach pain;

• feeling nervous;

• decreased sexual drive;

• weight gain;

• headache, dizziness; or

• lumps or dimpling in your skin where Depo-subQ Provera 104 injections were given.

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.