September 1, 2014
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Drug Factsheets

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Depo-Provera

(medroxyprogesterone acetate injection)

DIN (Drug Identification Number)

00585092 DEPO-PROVERA STERILE AQUEOUS SUSPENSION 150MG/ML
00030848 DEPO-PROVERA STERILE AQUEOUS SUSPENSION 50MG/ML

What side effects are possible with Depo-Provera?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain or cramping
  • acne
  • back ache
  • breast swelling or tenderness
  • brown spots on exposed skin, possibly long-lasting
  • changes in menstrual bleeding:
    • increased amounts of menstrual bleeding occurring at regular monthly periods
    • heavier uterine bleeding between regular monthly periods
    • lighter uterine bleeding between menstrual periods
    • stopping of menstrual periods
  • constipation
  • decreased bone mineral density
  • diarrhea
  • dizziness
  • fatigue
  • heartburn
  • hot flashes
  • loss or gain of body, facial, or scalp hair
  • loss of sexual desire
  • mild headache
  • mood changes
  • nausea and vomiting
  • nervousness
  • pain or irritation at place of injection
  • painful periods
  • rapid heartbeat
  • swelling of face, ankles, or feet
  • trouble sleeping
  • unusual tiredness or weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • signs of depression (such as feeling sad, losing interest in things you used to enjoy, weight changes, changes in sleep habits, feelings of guilt or worthlessness, thoughts of suicide)
  • skin rashes
  • unexpected or increased flow of breast milk
  • yellowing of the skin or eyes, which could be signs of liver damage

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • abdominal or stomach pain (sudden, severe, or continuing)
  • shortness of breath (sudden or unexplained)
  • signs of blood clots (e.g., coughing up of blood, pains in chest, groin, or leg (especially in calf of leg), swelling or redness in the legs)
  • signs of heart attack (e.g., sudden chest pain; pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
  • signs of stroke (e.g., confusion; sudden or severe headache; sudden loss of coordination; sudden change in vision; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Depo-Provera?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Blood clots: This medication has been associated with blood clots developing in the bloodstream. These blood clots may form anywhere in the body but are more noticeable when they occur in the large muscles, lung, brain (stroke), or heart (heart attack). If you experience pain in the chest or leg, unexplained shortness of breath, blurred vision or slurred speech, contact your doctor immediately.

Certain conditions such as long-term bed confinement may make blood clots more likely. Discuss with your doctor the risks and benefits of temporarily stopping this medication if you are scheduled for surgery, and let all doctors involved in your care know that you are taking this medication.

Bone loss: The amount of bone loss depends on how long the woman uses this medication. This bone loss may not be completely reversible. You should discuss these risks with your doctor. This risk for bone effects may be greatest in early adulthood and adolescence.

Medroxyprogesterone causes bone loss, and adolescent women whose bones are still forming and have not yet reached their peak bone mass should discuss any concerns with their doctor. It is not known if this will influence peak bone mass and increase the risk of osteoporosis in the future. If you are considering using this medication, discuss the risks and benefits with your doctor.

Cancer: For some women, there may be an increased risk of breast cancer associated with the use of medroxyprogesterone acetate injection. Long-term studies showed no increased risk of ovarian, liver, or cervical cancer. Talk to your doctor if you have any concerns about this medication.

Cigarette smoking: There is an increased risk of negative side effects on the heart and blood vessels in women who smoke and are using medroxyprogesterone acetate. If you smoke, discuss the benefits of stopping smoking with your doctor or pharmacist. There are tools that are available to make this easier.

Diabetes: Some women receiving medroxyprogesterone experience decreased blood glucose control. For this reason, women with diabetes should carefully monitor their blood glucose while receiving medroxyprogesterone acetate. Discuss with your doctor the ideal frequency with which you should check your blood glucose.

Fertility: Research indicates there is no evidence that medroxyprogesterone causes infertility. It may take some time for the injection to wear off, and most women must wait about 6 to 8 months after the last injection to start ovulating, having regular periods, and be able to become pregnant.

Fluid retention: Since progestogens may cause some degree of fluid retention, conditions such as epilepsy, migraine, asthma, or reduced heart or kidney function might be influenced by this medication.Women who have any of these conditions should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

High blood pressure: The fluid retention mentioned above can contribute to increased blood pressure. Women who are treating high blood pressure or may be at risk of developing high blood pressure should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Irregular menstrual patterns: Menstrual patterns commonly change following the use of medroxyprogesterone. This includes irregular or unpredictable bleeding or spotting or, rarely, heavy or continuous bleeding. If undiagnosed vaginal bleeding occurs, or if abnormal bleeding persists or is severe, consult your doctor.

As women continue to use medroxyprogesterone, fewer experience irregular bleeding patterns and more do not menstruate at all. By Month 12, about 55% of women no longer have periods, and by Month 24, about 68% of women using medroxyprogesterone do not have periods. Because of the prolonged effect of the medication, re-establishment of menstruation may be delayed and difficult to predict.

Liver disease: Women who at risk of or who have liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. The doctor will probably monitor liver function with regular blood tests. If you develop signs of liver disease (such as yellowing of the skin or eyes; or swelling, pain, or tenderness in the upper abdominal area), contact your doctor as soon as possible.

Migraine and headache: The onset or worsening of a migraine or the development of new types of recurrent, persistent, or severe headaches should be reported to your doctor.

Sexually transmitted infections: This medication does not protect against sexually transmitted infections, including HIV/AIDS. For protection against these, use latex condoms.

Weight changes: Weight gain may be associated with the use of medroxyprogesterone. The majority of studies report an average weight gain of 2.5 kg at the end of one year, but only 2% of women stopped treatment due to excessive weight gain.

Pregnancy: This medication should not be used by pregnant women. To help ensure a woman is not pregnant at the time of the first injection, it is recommended that the first injection be given only within the first 5 days of the onset of a normal menstrual period, or only within the first 5 days after childbirth if the mother is not breast-feeding.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking medroxyprogesterone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. Medroxyprogesterone is not intended to be used in young women before menstruation begins (menarche).

What other drugs could interact with Depo-Provera?

There may be an interaction between medroxyprogesterone acetate injection and any of the following:

  • aminoglutethimide
  • aprepitant
  • barbiturates (e.g., phenobarbital, butalbital)
  • certain antiseizure medications (e.g., carbamazepine, lamotrigine, phenytoin)
  • certain benzodiazepines (e.g., alprazolam, clonazepam, diazepam)
  • cholestyramine
  • cyclosporine
  • griseofulvin
  • isotretinoin
  • mycophenolate
  • nevirapine
  • rifabutin
  • rifampin
  • tranexamic acid
  • tretinoin
  • voriconazole

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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