Medroxyprogesterone Acetate Suspension for injection [Contraception]

What is this medicine?

MEDROXYPROGESTERONE (me DROX ee proe JES te rone) contraceptive injections prevent pregnancy. They provide effective birth control for 3 months. Depo-subQ Provera 104 is also used for treating pain related to endometriosis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• frequently drink alcohol
• asthma
• blood vessel disease or a history of a blood clot in the lungs or legs
• bone disease such as osteoporosis
• breast cancer
• diabetes
• eating disorder (anorexia nervosa or bulimia)
• high blood pressure
• HIV infection or AIDS
• kidney disease
• liver disease
• mental depression
• migraine
• seizures (convulsions)
• stroke
• tobacco smoker
• vaginal bleeding
• an unusual or allergic reaction to medroxyprogesterone, other hormones, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Depo-Provera Contraceptive injection is given into a muscle. Depo-subQ Provera 104 injection is given under the skin. These injections are given by a health care professional. You must not be pregnant before getting an injection. The injection is usually given during the first 5 days after the start of a menstrual period or 6 weeks after delivery of a baby.

A patient information sheet for the product will be given with each injection. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. These injections have been used in female children who have started having menstrual periods.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Try not to miss a dose. You must get an injection once every 3 months to maintain birth control. If you cannot keep an appointment, call and reschedule it. If you wait longer than 13 weeks between Depo-Provera contraceptive injections or longer than 14 weeks between Depo-subQ Provera 104 injections, you could get pregnant. Use another method for birth control if you miss your appointment. You may also need a pregnancy test before receiving another injection.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• bosentan

This medicine may also interact with the following medications:

• aminoglutethimide
• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin
• aprepitant
• barbiturate medicines such as phenobarbital or primidone
• bexarotene
• carbamazepine
• medicines for seizures like ethotoin, felbamate, oxcarbazepine, phenytoin, topiramate
• modafinil
• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug does not protect you against HIV infection (AIDS) or other sexually transmitted diseases.

Use of this product may cause you to lose calcium from your bones. Loss of calcium may cause weak bones (osteoporosis). Only use this product for more than 2 years if other forms of birth control are not right for you. The longer you use this product for birth control the more likely you will be at risk for weak bones. Ask your health care professional how you can keep strong bones.

You may have a change in bleeding pattern or irregular periods. Many females stop having periods while taking this drug.

If you have received your injections on time, your chance of being pregnant is very low. If you think you may be pregnant, see your health care professional as soon as possible.

Tell your health care professional if you want to get pregnant within the next year. The effect of this medicine may last a long time after you get your last injection.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breast tenderness or discharge
• breathing problems
• changes in vision
• depression
• feeling faint or lightheaded, falls
• fever
• pain in the abdomen, chest, groin, or leg
• problems with balance, talking, walking
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne
• fluid retention and swelling
• headache
• irregular periods, spotting, or absent periods
• temporary pain, itching, or skin reaction at site where injected
• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This does not apply. The injection will be given to you by a health care professional.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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.