Imipenem cilastatin compatibility reconstitution and stability

Imipenem Cilastatin
PRIMAXIN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
Compatibility, Reconstitution, and Stability
Directions For Use
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Compatibility, Reconstitution, and Stability

Compatibility And Stability

Before Reconstitution:

The dry powder should be stored at a temperature below 25°C (77°F).

Reconstituted Solutions:

Solutions of PRIMAXIN I.V. range from colorless to yellow. Variations of color within this range do not affect the potency of the product.

Vials

PRIMAXIN I.V., as supplied in single use vials and reconstituted with the following diluents (see PREPARATION OF SOLUTION), maintains satisfactory potency for 4 hours at room temperature or for 24 hours under refrigeration (5°C). Solutions of PRIMAXIN I.V. should not be frozen.

0.9% Sodium Chloride Injection

5% or 10% Dextrose Injection

5% Dextrose and 0.9% Sodium Chloride Injection

5% Dextrose Injection with 0.225% or 0.45% saline solution

5% Dextrose Injection with 0.15% potassium chloride solution

Mannitol 5% and 10%

ADD-Vantage® vials

PRIMAXIN I.V., as supplied in single dose ADD‑Vantage® vials and reconstituted with the following diluents (see PREPARATION OF SOLUTION), maintains satisfactory potency for 4 hours at room temperature.

0.9% Sodium Chloride Injection

5% Dextrose Injection

PRIMAXIN I.V. should not be mixed with or physically added to other antibiotics. However, PRIMAXIN I.V. may be administered concomitantly with other antibiotics, such as aminoglycosides.

References

Adapted from the FDA Package Insert.