DEPO-PROVERA® CI Description

(medroxyprogesterone acetate injectable suspension, for intramuscular use)

11 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:

Chemical Structure

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

For Depo-Provera CI vials, each mL of sterile aqueous suspension contains:
Medroxyprogesterone acetate150 mg
Polyethylene glycol 335028.9 mg
Polysorbate 802.41 mg
Sodium chloride8.68 mg
Methylparaben1.37 mg
Propylparaben0.150 mg
Water for injectionquantity sufficient
When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
For Depo-Provera CI prefilled syringes, each mL of sterile aqueous suspension contains:
Medroxyprogesterone acetate150 mg
Polyethylene glycol 335028.5 mg
Polysorbate 802.37 mg
Sodium chloride8.56 mg
Methylparaben1.35 mg
Propylparaben0.147 mg
Water for injectionquantity sufficient
When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

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Description

11 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:

Chemical Structure

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

For Depo-Provera CI vials, each mL of sterile aqueous suspension contains:
Medroxyprogesterone acetate150 mg
Polyethylene glycol 335028.9 mg
Polysorbate 802.41 mg
Sodium chloride8.68 mg
Methylparaben1.37 mg
Propylparaben0.150 mg
Water for injectionquantity sufficient
When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
For Depo-Provera CI prefilled syringes, each mL of sterile aqueous suspension contains:
Medroxyprogesterone acetate150 mg
Polyethylene glycol 335028.5 mg
Polysorbate 802.37 mg
Sodium chloride8.56 mg
Methylparaben1.35 mg
Propylparaben0.147 mg
Water for injectionquantity sufficient
When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
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