SPL Set ID: ae524bdb-9fd0-49f9-802d-465a374c175b

Methylprednisolone Sodium Succinate for Injection, USP, Sterile Powder 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, USP, 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. 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, USP, is available in two strengths and packages for intravenous or intramuscular administration: 40 mg (Single-Dose Vial) —Each mL (when mixed) contains Methylprednisolone Sodium Succinate, USP equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; and 25 mg lactose hydrous. 125 mg (Single-Dose Vial) —Each 2 mL (when mixed) contains Methylprednisolone Sodium Succinate, USP equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. IMPORTANT — Use only Water for Injection USP or Bacteriostatic Water for Injection USP 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. chemical structure