SPL Set ID: 2035f00e-2299-473a-b004-cb93f541cfa9

Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate 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. Methylprednisolone sodium succinate USP is the sodium salt of methylprednisolone hemisuccinate USP, which is formed in situ, with the aid of sodium hydroxide. 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. 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 a sterile, white color lyophilized cake, available in preservative and preservative-free formulations: 40 mg (Single-Dose Vial): Each mL (when mixed with 1 mL of Water for Injection USP) contains 53 mg of methylprednisolone sodium succinate USP equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; 25 mg lactose hydrous. This package does not contain diluent. Each mL (when mixed with 1 mL of Bacteriostatic Water for Injection USP) contains 53 mg of methylprednisolone sodium succinate USP equivalent to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; 25 mg lactose hydrous. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 125 mg (Single-Dose Vial): Each 2 mL (when mixed with 2 mL of Water for Injection USP) contains 165.74 mg of methylprednisolone sodium succinate USP equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. Each 2 mL (when mixed with 2 mL of Bacteriostatic Water for Injection USP) contains 165.74 mg of methylprednisolone sodium succinate USP equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative. 500 mg (Multiple-Dose Vial): Each 8 mL (when mixed with 8 mL of Bacteriostatic Water for Injection USP) contains 663 mg of methylprednisolone sodium succinate USP equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent ( Bacteriostatic water ) contains benzyl alcohol as a preservative. 2 grams (Single-Dose Vial): Each 30.6 mL (when mixed with 30 mL of Bacteriostatic Water for Injection USP) contains 2.65 grams of methylprednisolone sodium succinate USP equivalent to 2 grams methylprednisolone; also 25.6 mg monobasic sodium phosphate anhydrous; 278 mg dibasic sodium phosphate dried. This package does not contain diluent. Recommended diluent ( Bacteriostatic water ) contains benzyl alcohol as a preservative. IMPORTANT — Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol as described above 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. Methylprednisolone Sodium Succinate Chemical Structure