DEPO-SUBQ PROVERA 104® Description

(medroxyprogesterone acetate)

11 DESCRIPTION

Depo-subQ provera 104 contains medroxyprogesterone acetate (MPA), a derivative of progesterone, as its active ingredient. MPA is a white to off-white, odorless crystalline powder that is stable in air and that melts between 205°C 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 MPA 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 use is available in pre-filled syringes, each containing 0.65 mL (104 mg) of sterile medroxyprogesterone acetate injectable suspension.

Each 0.65 mL contains the following inactive ingredients:

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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Description

11 DESCRIPTION

Depo-subQ provera 104 contains medroxyprogesterone acetate (MPA), a derivative of progesterone, as its active ingredient. MPA is a white to off-white, odorless crystalline powder that is stable in air and that melts between 205°C 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 MPA 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 use is available in pre-filled syringes, each containing 0.65 mL (104 mg) of sterile medroxyprogesterone acetate injectable suspension.

Each 0.65 mL contains the following inactive ingredients:

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.

Medication Guide

Health Professional Information

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