"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
Depo-SubQ Provera 104™
(medroxyprogesterone acetate) Injectable Suspension 104 mg/0.65 mL
Women who use depo-subQ provera (medroxyprogesterone acetate) 104 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-subQ provera (medroxyprogesterone acetate) 104 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-subQ provera (medroxyprogesterone acetate) 104 should be used long-term (e.g., longer than 2 years) only if other methods of birth control are inadequate (see WARNINGS).
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
depo-subQ provera 104 contains medroxyprogesterone acetate (MPA), 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 205°and 209°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 17-hydroxy-6α-methylpregn-4ene-3,20-dione 17-acetate. The structural formula is as follows:
depo-subQ provera (medroxyprogesterone acetate) 104 for subcutaneous (SC) injection is available in pre-filled syringes (160 mg/mL), each containing 0.65 mL (104 mg) of medroxyprogesterone acetate sterile aqueous suspension.
Each 0.65 mL contains:
|Medroxyprogesterone acetate||104 mg|
|Sodium Chloride||5.200 mg|
|Polyethylene Glycol||18.688 mg|
|Polysorbate 80||1.950 mg|
|Monobasic Sodium Phosphate. H2O||0.451 mg|
|Dibasic Sodium Phosphate . 12H2O||0.382 mg|
|Water for Injection||qs|
When necessary, the 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,...
What are the precautions when taking medroxyprogesterone acetate (Depo-SubQ 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), unexplained vaginal bleeding, asthma, abnormal breast exam, personal or family history of cancer (especially breast or cervical cancer), daily use of alcohol/tobacco, depression, diabetes, eating disorder (anorexia), heart problems (such as heart failure, irregular heartbeat, previous heart attack), high blood pressure, kidney disease, liver disease (including...
Last reviewed on RxList: 7/27/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Depo-SubQ Provera Information
Depo-SubQ Provera - User Reviews
Depo-SubQ Provera User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
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.
Find out what women really need.