Depo-SubQ Provera
Depo-SubQ Provera 104
(medroxyprogesterone acetate) Injectable Suspension 104 mg/0.65 mL
Women who use depo-subQ provera 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 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 104 should be used long-term (e.g., longer than 2 years) only if other methods of birth control are inadequate (see WARNINGS, section 1).
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
DRUG DESCRIPTION
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 205º and 209ºC. 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-4-ene-3,20-dione 17-acetate. The structural formula is as follows:
 |
depo-subQ provera 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 Methylparaben Propylparaben Sodium Chloride Polyethylene Glycol Polysorbate 80 Monobasic Sodium Phosphate. H2O Dibasic Sodium Phosphate. 12H2O Methionine Povidone Water for Injection |
104 mg 1.040 mg 0.098 mg 5.200 mg 18.688 mg 1.950 mg 0.451 mg 0.382 mg 0.975 mg 3.250 mg qs |
| When necessary, the pH is adjusted with sodium hydroxide or hydrochloric acid, or both. | |
Generic Name: Medroxyprogesterone Acetate
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Depo-SubQ Provera
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