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Depo Provera

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Depo Provera

DEPO-PROVERA CI
(medroxyprogesterone acetate)

Depo Provera

WARNING

LOSS OF BONE MINERAL DENSITY

Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible.

It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.

Depo-Provera Contraceptive Injection should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate. [(See WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Depo-Provera CI contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white; odorless crystalline powder that is stable in air and that melts between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.

The chemical name for medroxyprogesterone acetate is pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6α-).

The structural formula is as follows:

DEPO-PROVERA CI (medroxyprogesterone acetate)  Structural Formula Illustration

Depo-Provera CI for intramuscular (IM) injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL.

Each mL contains:

Medroxyprogesterone acetate 150 mg
Polyethylene glycol 3350 28.9 mg
Polysorbate 80 2.41 mg
Sodium chloride 8.68 mg
Methylparaben 1.37 mg
Propylparaben 0.150 mg
Water for injection quantity sufficient
When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

What are the possible side effects of medroxyprogesterone (Depo-Provera, Depo-Provera Contraceptive, Depo-SubQ Provera 104)?

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

Call your doctor at once if you have any of these serious side effects:

  • menstrual periods that are heavier or longer than normal;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • chest pain, sudden cough, wheezing, rapid breathing,...

Read All Potential Side Effects and See Pictures of Depo Provera »

What are the precautions when taking medroxyprogesterone (Depo Provera)?

Before using medroxyprogesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have any of the following conditions: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), breast cancer, liver disease, current/suspected pregnancy, abnormal/unexplained vaginal bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, abnormal breast exam, family history of breast cancer, cancer of the reproductive organs (e.g., cervix, uterus), frequent use of alcohol/tobacco,...

Read All Potential Precautions of Depo Provera »

Last reviewed on RxList: 8/31/2011
This monograph has been modified to include the generic and brand name in many instances.

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Depo Provera - User Reviews

Depo Provera User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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