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:
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 acetate | 150 mg |
| Polyethylene glycol 3350 | 28.9 mg |
| Polysorbate 80 | 2.41 mg |
| Sodium chloride | 8.68 mg |
| Methylparaben | 1.37 mg |
| Propylparaben | 0.150 mg |
| Water for injection | quantity 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 acetate | 150 mg |
| Polyethylene glycol 3350 | 28.5 mg |
| Polysorbate 80 | 2.37 mg |
| Sodium chloride | 8.56 mg |
| Methylparaben | 1.35 mg |
| Propylparaben | 0.147 mg |
| Water for injection | quantity sufficient |
| When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both. | |