Depo Medrol
Depo-Medrol®
(methylprednisolone acetate) injectable suspension, USP
Not For Intravenous Use
DRUG DESCRIPTION
DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, in alcohol, in chloroform, and in methanol, and slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11β)-and the molecular weight is 416.51. The structural formula is represented below:
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DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intrasynovial, soft tissue or intralesional injection. It is available in three strengths: 20 mg/mL; 40 mg/mL; 80 mg/mL.
| Each mL of these preparations contains: | |||
| Methylprednisolone acetate | 20 mg | 40 mg | 80 mg |
| Polyethylene glycol 3350 | 29.5 mg | 29.1 mg | 28.2 mg |
| Polysorbate 80 | 1.97 mg | 1.94 mg | 1.88 mg |
| Monobasic sodium phosphate | 6.9 mg | 6.8 mg | 6.59 mg |
| Dibasic sodium phosphate USP | 1.44 mg | 1.42 mg | 1.37 mg |
| Benzyl alcohol added as a preservative | 9.3 mg | 9.16 mg | 8.88 mg |
Sodium Chloride was added to adjust tonicity.
When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.
The pH of the finished product remains within the USP specified range; ie, 3.5 to 7.0.
Generic Name: Methylprednisolone
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