Cefotetan Compatibility and Stability
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
Compatibility and Stability of CEFOTAN Products
Frozen samples should be thawed at room temperature before use. After the periods mentioned below, any unused solutions or frozen material should be discarded. DO NOT REFREEZE.
NOTE: Solutions of CEFOTAN must not be admixed-with solutions containing aminoglycosides. If CEFOTAN and aminoglycosides are to be administered to the same patient, they must be administered separately and not as a mixed injection. DO NOT ADD SUPPLEMENTARY MEDICATION.
CEFOTEAN DISODIUM FOR INJECTION
CEFOTAN (cefotetan disodium for injection) reconstituted as described above (PREPARATION OF SOLUTION) maintains satisfactory potency for 24 hours at room temperature (25°C/77°F), for 96 hours under refrigeration (5°C/41°F), and for at least 1 week in the frozen state (-20°C/-4°F). After reconstitution and subsequent storage in disposable glass or plastic syringes, CEFOTAN (cefotetan disodium for injection) is stable for 24 hours at room temperature and 96 hours under refrigeration.
ADD-Vantage Vials
Ordinarily, ADD-Vantage Vials should be reconstituted only when it is certain that the patient is ready to receive the drug. However, ADD-Vantage Vials of CEFOTAN reconstituted as described in Preparation of Solution, for ADD-Vantage Vials, maintains satisfactory potency for 24 hours at room temperature (25°C/77°F).
(DO NOT REFRIGERATE OR FREEZE CEFOTAN IN ADD-VANTAGE VIALS.)
CEFOTETAN INJECTION
The thawed solution in Galaxy® plastic container (PL 2040) remains chemically stable for 48 hours at room temperature (25°C/77°F) or for 21 days under refrigeration (5°C/41°F).
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
References
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr027_cefotan_lbl.pdf