How many milliliters of sterile water for injection are required to reconstitute a hydrocortisone sodium succinate vial?

Reconstitution of Hydrocortisone Sodium Succinate

For a 100 mg vial of hydrocortisone sodium succinate, add not more than 2 mL of sterile water for injection (or bacteriostatic water for injection or bacteriostatic sodium chloride injection). 1

Reconstitution Details

The FDA-approved drug label provides explicit instructions for preparing hydrocortisone sodium succinate for injection:

• Volume required: Add not more than 2 mL of diluent to the 100 mg vial
• Acceptable diluents:
  • Bacteriostatic Water for Injection
  • Bacteriostatic Sodium Chloride Injection
  • Sterile Water for Injection (preservative-free)

1

Important Technical Considerations

Stability after reconstitution: Once reconstituted with the 2 mL of diluent, the solution remains stable for at least 4 hours at room temperature and can be administered directly or by IV piggyback. 1 The reconstituted pH ranges from 7 to 8. 1

Extended storage: If kept at controlled room temperature (20-25°C), unused reconstituted solution should be discarded after 12 hours. Under refrigeration, it may be kept for up to 24 hours before discarding. 1

For IV infusion: After initial reconstitution with 2 mL, this solution may then be further diluted in 100-1000 mL of 5% dextrose in water, isotonic saline, or 5% dextrose in isotonic saline (unless the patient is sodium-restricted). 1

Critical Safety Note

Heat sensitivity: This product is sensitive to heat and should not be autoclaved when sterilizing the exterior of the vial. 1 The reconstituted solution should only be used if it is clear. 1