A-Hydrocort (Hydrocortisone Sodium Succinate) - Description and Clinical Pharmacology

Hydrocortisone Sodium Succinate

for Injection, USP

R_x only

For Intravenous or Intramuscular Administration

DESCRIPTION

A-Hydrocort sterile powder contains hydrocortisone sodium succinate as the active ingredient. 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. The chemical name 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:

Hydrocortisone sodium succinate is an anti-inflammatory adrenocortical steroid. This highly water-soluble sodium succinate ester of hydrocortisone permits the immediate intravenous administration of high doses of hydrocortisone in a small volume of diluent and is particularly useful where high blood levels of hydrocortisone are required rapidly.

A-Hydrocort sterile powder is available for intravenous or intramuscular administration.

100 mg − Vials containing hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone, also 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate anhydrous.

When necessary, the pH was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.

For intravenous or intramuscular injection, vial should be reconstituted with Bacteriostatic Water for Injection or Bacteriostatic Sodium Chloride.

For intravenous infusion, vial should be reconstituted with Bacteriostatic Water for Injection.

CLINICAL PHARMACOLOGY

Hydrocortisone sodium succinate has the same metabolic and anti-inflammatory actions as hydrocortisone. When given parenterally and in equimolar quantities, the two compounds are equivalent in biologic activity. Following the intravenous injection of hydrocortisone sodium succinate, demonstrable effects are evident within one hour and persist for a variable period. Excretion of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours. This preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection.