Patient Information
Medroxyprogesterone Acetate Injectable Suspension, USP
Contraceptive Injection
Read this Patient Information carefully before you decide if Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP is right for you. This information does not take the place of talking with your gynecologist or other healthcare professional who specializes in women's health. If you have any questions about MPA Injectable Suspension, USP, ask your healthcare professional. You should also learn about other birth control methods to choose the one that is best for you.
What is the most important information I should know about MPA Injectable Suspension, USP?
MPA Injectable Suspension, USP can cause serious side effects, including:
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- Use of MPA Injectable Suspension, USP may cause you to lose calcium stored in your bone and decrease your bone mass. The longer you use MPA Injectable Suspension, USP, the greater your loss of calcium from your bones. Your bones may not recover completely when you stop using MPA Injectable Suspension, USP.
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- If you use MPA Injectable Suspension, USP continuously for a long time (for more than 2 years), it may increase the risk of weak, porous bones (osteoporosis) that could increase the risk of broken bones, especially after menopause.
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- You should not use MPA Injectable Suspension, USP for more than two years unless you cannot use other birth control methods.
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- It is not known if your risk of developing osteoporosis is greater if you are a teenager or young adult when you start to use MPA Injectable Suspension, USP. (see "What are the possible side effects of MPA Injectable Suspension, USP?").
MPA Injectable Suspension, USP is intended to prevent pregnancy. MPA Injectable Suspension, USP does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
What is MPA Injectable Suspension, USP?
MPA Injectable Suspension, USP is a progestin hormone birth control method that is given by injection (a shot) to prevent pregnancy.
How well does MPA Injectable Suspension, USP work?
Your chance of getting pregnant depends on how well you follow the directions for taking your MPA Injectable Suspension, USP. The more carefully you follow the directions (such as returning every 3 months for your next injection), the less chance you have of getting pregnant.
In clinical studies, about 1 out of 100 women got pregnant during the first year that they used MPA Injectable Suspension, USP.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
How should I take MPA Injectable Suspension, USP?
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- MPA Injectable Suspension, USP is given by your healthcare professional as a shot into your muscle (intramuscular injection). The shot is given in your buttock or upper arm 1 time every 3 months. At the end of the 3 months, you will need to return to your healthcare professional for your next injection in order to continue your protection against pregnancy.
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- To make sure that you are not pregnant before you take MPA Injectable Suspension, USP, the first injection should be given only:
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- during the first 5 days of a normal menstrual period, or
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- within the first 5 days after giving birth, if you are not breastfeeding, or
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- at the 6th week after giving birth, if you are feeding your baby only breastmilk.
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- MPA Injectable Suspension, USP may be given at other times than those listed above, but you will likely need to have a pregnancy test first to show that you are not pregnant.
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- During treatment with MPA Injectable Suspension, USP, you should see your healthcare professional every year for a blood pressure check and other healthcare needs.
Who Should Not Use MPA Injectable Suspension, USP?
Do not use MPA Injectable Suspension, USP if you:
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- have bleeding from your vagina that has not been explained
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- have breast cancer now or in the past, or think you have breast cancer
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- have had a stroke
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- ever had blood clots in your arms, legs or lungs
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- have problems with your liver or liver disease
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- are allergic to medroxyprogesterone acetate or any of the other ingredients in MPA Injectable Suspension, USP. See the end of this leaflet for a complete list of ingredients in MPA Injectable Suspension, USP.
What should I tell my healthcare professional before taking MPA Injectable Suspension, USP?
Before taking MPA Injectable Suspension, USP, tell your healthcare professional if you have:
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- risk factors for weak bones (osteoporosis) such as bone disease, use alcohol or smoke regularly, anorexia nervosa, or a strong family history of osteoporosis
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- irregular or lighter than usual menstrual periods
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- breast cancer now or in the past, or think you have breast cancer
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- a family history of breast cancer
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- an abnormal mammogram (breast X-ray), lumps in your breasts, or bleeding from your nipples
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- kidney problems
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- high blood pressure
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- had a stroke
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- had blood clots in your arms, legs or lungs
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- migraine headaches
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- asthma
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- epilepsy (convulsions or seizures)
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- diabetes
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- depression or a history of depression
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- any other medical conditions
If you are breastfeeding or plan to breastfeed, MPA Injectable Suspension, USP can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you take MPA Injectable Suspension, USP.
Tell your healthcare professional about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
MPA Injectable Suspension, USP and certain other medicines may affect each other, causing serious side effects. Sometimes the doses of other medicines may need to be changed while you are taking MPA Injectable Suspension, USP.
Some medicines may make MPA Injectable Suspension, USP less effective at preventing pregnancy, including those listed below.
Especially tell your healthcare professional if you take:
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- medicine to help you sleep
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- bosentan
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- medicine for seizures
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- griseofulvin
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- an antibiotic
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- medicine for HIV (AIDS)
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- St. John's wort
Know the medicines you take. Keep a list of your medicines with you to show your healthcare professional or pharmacist before you first start taking MPA Injectable Suspension, USP or when you get a new medicine.
Follow your healthcare professional's instructions about using a back-up method of birth control if you are taking medicines that may make MPA Injectable Suspension, USP less effective.
What are the possible side effects of MPA Injectable Suspension, USP?
MPA Injectable Suspension, USP can cause serious side effects, including:
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- Effect on the bones: See ”What is the most important information I should know about MPA Injectable Suspension, USP?”.
- Teenage years are the most important years to gain bone strength. The decrease in calcium in your bones is of most concern if you are a teenager or have the following problems:
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- bone disease
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- an eating disorder (anorexia nervosa)
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- a strong family history of osteoporosis
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- you take a drug that can lower the amount of calcium in your bones (drugs for epilepsy or steroid drugs)
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- you drink a lot of alcohol (more than 2 drinks a day)
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- you smoke
- If you need a birth control method for more than 2 years, your healthcare professional may switch you to another birth control method instead of using MPA Injectable Suspension, USP. If you continue using MPA Injectable Suspension, USP, your healthcare professional may ask you to have a bone test, especially if you have other risks for weak bones.
- When MPA Injectable Suspension, USP is stopped, your bones may start to regain calcium. However, in a study of teenage girls who used MPA Injectable Suspension, USP for more than 2 years, their hip bones did not completely recover by 5 years after they stopped using MPA Injectable Suspension, USP. Taking calcium and Vitamin D and exercising daily may lessen the loss of calcium from your bones.
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- possible increased risk of breast cancer. Women who use MPA Injectable Suspension, USP may have a slightly increased risk of breast cancer compared to non-users.
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- blood clots in your arms, legs, lungs, and eyes
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- stroke
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- a pregnancy outside of your uterus (ectopic pregnancy). Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death.
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- allergic reactions. Severe allergic reactions have been reported in some women using MPA Injectable Suspension, USP.
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- loss of vision or other eye problems
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- migraine headaches
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- depression
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- convulsions or seizures
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- liver problems
Call your healthcare professional right away if you have:
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- sharp chest pain, coughing up blood, or sudden shortness of breath (indicating a possible clot in the lung)
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- sudden severe headache or vomiting, dizziness or fainting, problems with your eyesight or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
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- severe pain or swelling in the calf (indicating a possible clot in the leg)
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- sudden blindness, partial or complete (indicating a possible clot in the blood vessels of the eye)
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- unusually heavy vaginal bleeding
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- severe pain or tenderness in the lower abdominal area
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- persistent pain, pus, or bleeding at the injection site
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- yellowing of the eyes or skin
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- hives
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- difficulty breathing
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- swelling of the face, mouth, tongue or neck
The most common side effects of MPA Injectable Suspension, USP include:
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- irregular vaginal bleeding, such as lighter or heavier menstrual bleeding, or continued spotting
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- weight gain. You may experience weight gain while you are using MPA Injectable Suspension, USP. About two-thirds of the women who used MPA Injectable Suspension, USP in the clinical trials reported a weight gain of about 5 pounds during the first year of use. You may continue to gain weight after the first year. Women who used MPA Injectable Suspension, USP for 2 years gained an average of 8 pounds over those 2 years.
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- abdominal pain
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- headache
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- weakness
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- tiredness
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- nervousness
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- dizziness
Tell your healthcare professional if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of MPA Injectable Suspension, USP. For more information, ask your healthcare professional or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088.
What other information should I know before choosing MPA Injectable Suspension, USP?
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- Pregnancy. When you take MPA Injectable Suspension, USP every 3 months, your chance of getting pregnant is very low. You could miss a period or have a light period and not be pregnant. If you miss 1 or 2 periods and think you might be pregnant, see your healthcare professional as soon as possible. You should not use MPA Injectable Suspension, USP if you are pregnant. However, MPA Injectable Suspension, USP taken by accident during pregnancy does not seem to cause birth defects.
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- Nursing Mothers. Although MPA Injectable Suspension, USP can be passed to the nursing baby in the breast milk, no harmful effects on babies have been found. MPA Injectable Suspension, USP does not stop the breasts from producing milk, so it can be used by nursing mothers. However, to minimize the amount of MPA Injectable Suspension, USP that is passed to the baby in the first weeks after birth, you should wait until your baby is 6 weeks old before you start using MPA Injectable Suspension, USP for birth control.
How will MPA Injectable Suspension, USP change my periods?
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- Change in normal menstrual cycle. The side effect reported most frequently by women who use MPA Injectable Suspension, USP for birth controls is a change in their normal menstrual cycle. During the first year of using MPA Injectable Suspension, USP, you might have one or more of the following changes:
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- irregular or unpredictable bleeding or spotting
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- an increase or decrease in menstrual bleeding
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- no bleeding at all. In clinical studies of MPA Injectable Suspension, USP, 55% of women reported no menstrual bleeding (amenorrhea) after one year of use and 68% of women reported no menstrual bleeding after two years of use.
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- Missed period. During the time you are using MPA Injectable Suspension, USP for birth controls, you may skip a period, or your periods may stop completely. If you have been receiving your shot of MPA Injectable Suspension, USP regularly every 3 months, then you are probably not pregnant. However, if you think that you may be pregnant, see your healthcare professional
Unusually heavy or continuous bleeding is not a usual effect of MPA Injectable Suspension, USP and if this happens you should see your healthcare professional right away.
With continued use of MPA Injectable Suspension, USP, bleeding usually decreases and many women stop having periods completely. When you stop using MPA Injectable Suspension, USP your menstrual period will usually, in time, return to its normal cycle.
What if I want to become pregnant?
Because MPA Injectable Suspension, USP is a long-acting birth control method, it takes some time after your last shot for its effect to wear off. Most women who try to get pregnant after using MPA Injectable Suspension, USP get pregnant within 18 months after their last shot. The length of time you use MPA Injectable Suspension, USP has no effect on how long it takes you to become pregnant after you stop using it.
General Information about MPA Injectable Suspension, USP
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. This leaflet summarizes the most important information about MPA Injectable Suspension, USP. If you would like more information, talk with your healthcare professional. You can ask your healthcare professional for information about MPA Injectable Suspension, USP that is written for healthcare professionals.
What are the ingredients in MPA Injectable Suspension, USP?
Active ingredient: medroxyprogesterone acetate
Inactive ingredients: polyethylene glycol 3350, polysorbate 80, sodium chloride, methylparaben, propylparaben, and water for injection. When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Distributed by:
Prasco Laboratories
Mason, OH 45040 USA
LAB-1463-4.0
Revised: August 2024