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SOLU-MEDROL® (methylprednisolone sodium succinate) Description

DESCRIPTION

SOLU-MEDROL Sterile Powder 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.

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:

Chemical Structure

Methylprednisolone sodium succinate 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.

SOLU-MEDROL is available in preservative and preservative-free formulations:

Preservative-free Formulations
40 mg Act-O-Vial System (Single-Dose Vial)—Each mL (when mixed) contains methylprednisolone sodium succinate 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 Act-O-Vial System (Single-Dose Vial)—Each 2 mL (when mixed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also
1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried.
500 mg Act-O-Vial System (Single-Dose Vial)—Each 4 mL (when mixed) contains methylprednisolone sodium succinate equivalent to 500 mg methylprednisolone; also
6.4 mg monobasic sodium phosphate anhydrous; and 69.6 mg dibasic sodium phosphate dried.
1 gram Act-O-Vial System (Single-Dose Vial)—Each 8 mL (when mixed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also
12.8 mg monobasic sodium phosphate anhydrous; and 139.2 mg dibasic sodium phosphate dried.
Formulations preserved with Benzyl Alcohol
500 mg Vial—Each 8 mL (when mixed as directed) contains methylprednisolone sodium succinate 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.
1 gram Vial—Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; 139.2 mg dibasic sodium phosphate dried.
This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains benzyl alcohol as a preservative.
2 gram Vial—Each 30.6 mL (when mixed as directed) contains methylprednisolone sodium succinate 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.
2 gram Vial with Diluent—Each 30.6 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 2 grams methylprednisolone; also 25.6 mg monobasic sodium phosphate anhydrous; 278 mg dibasic sodium phosphate dried.
The packaged diluent (Bacteriostatic Water for Injection) contains benzyl alcohol as a preservative.
IMPORTANT — Use only the accompanying diluent
or Bacteriostatic Water For Injection with
Benzyl Alcohol when reconstituting SOLU-MEDROL.
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 and the tonicities are, for the 40 mg per mL solution, 0.50 osmolar; for the 125 mg per 2 mL solution, 0.40 osmolar; for the 1 gram per 8 mL solution, 0.44 osmolar; for the 2 gram per 30.6 mL solutions, 0.42 osmolar. (Isotonic saline = 0.28 osmolar.)

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