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DEPO-subQ PROVERA 104® (medroxyprogesterone acetate) Description

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 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-4-ene-3, 20-dione 17-acetate. The structural formula is as follows:

Chemical Structure

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 104 mg
Methylparaben 1.040 mg
Propylparaben 0.098 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
Methionine 0.975 mg
Povidone 3.250 mg
Water for Injection qs

When necessary, the pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

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