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SOLU-CORTEF® WITHOUT PRESERVATIVE (hydrocortisone sodium succinate) Description

DESCRIPTION

SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.

100 mg Plain

Vials containing hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone, 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate dried. SOLU-CORTEF 100 mg plain does not contain diluent (see DOSAGE AND ADMINISTRATION, Preparation of Solutions).

ACT-O-VIAL® System (Single-Dose Vial) in four strengths:
100 mg
ACT-O-VIAL
250 mg
ACT-O-VIAL
500 mg
ACT-O-VIAL
1000 mg
ACT-O-VIAL
Each 2 mL
contains
(when mixed):
Each 2 mL
contains
(when mixed):
Each 4 mL
contains
(when mixed):
Each 8 mL
contains
(when mixed):
Hydrocortisone
  sodium succinate
equiv. to
100 mg
Hydrocortisone
equiv. to
250 mg
Hydrocortisone
equiv. to
500 mg
Hydrocortisone
equiv. to
1000 mg
Hydrocortisone
Monobasic sodium
  phosphate anhydrous
0.8 mg2 mg4 mg8 mg
Dibasic sodium
  phosphate dried
8.73 mg21.8 mg44 mg87.32 mg

The diluent, as part of the packaging presentation for the ACT-O-VIAL® system, is comprised of Water for Injection only, and does not contain any preservative.

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.

The chemical name for hydrocortisone sodium succinate is pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11β)- and its molecular weight is 484.52.

The structural formula is represented below:

Chemical Structure

Hydrocortisone sodium succinate is a white or nearly white, odorless, hygroscopic amorphous solid. It is very soluble in water and in alcohol, very slightly soluble in acetone, and insoluble in chloroform.

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