SPL Set ID: e86fbda8-00e4-4d54-841a-59dea6c15e70

Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate, USP as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53 g/mol. The structural formula is represented below: Methylprednisolone sodium succinate, USP is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone sodium succinate for injection, USP is available in below formulations: Formulations 40 mg (Single-Dose Vial) —Each mL (when mixed) contains methylprednisolone sodium succinate, USP equivalent to 40 mg methylprednisolone, USP. Also contains benzyl alcohol; lactose hydrous, 25 mg; monobasic sodium phosphate anhydrous, 1.6 mg; and dibasic sodium phosphate dried, 17.46 mg. 125 mg (Single-Dose Vial) —Each 2 mL (when mixed) contains methylprednisolone sodium succinate, USP equivalent to 125 mg methylprednisolone, USP. Also contains benzyl alcohol; monobasic sodium phosphate anhydrous, 1.6 mg; and dibasic sodium phosphate dried, 17.4 mg. IMPORTANT - Use only Bacteriostatic Water for Injection with Benzyl Alcohol when reconstituting Methylprednisolone Sodium Succinate for Injection, USP. Use within 48 hours after mixing. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8. 1