The fixed combination of ceftazidime-avibactam sodium is available as a powder in single-use vials containing 2.5 g (ceftazidime 2 g as the pentahydrate plus avibactam 0.5 g as the sodium salt).3004 Each vial also contains sodium carbonate 239.6 mg.3004
Each 2.5-g vial should be reconstituted with 10 mL of sterile water for injection, sodium chloride 0.9%, dextrose 5%, Ringers injection, lactated, or solutions containing any combination of dextrose and sodium chloride with concentrations not exceeding 2.5 and 0.45%, respectively;3004; 3005 the vial contents should be mixed gently to ensure complete dissolution.3004 Each mL of the resultant reconstituted solution contains approximately 167 mg of ceftazidime plus 42 mg of avibactam.3004 The reconstituted solution is not suitable for direct injection and must be diluted prior to infusion.3004
For adult and pediatric patients weighing 40 kg or more, the manufacturers instructions for preparing various dosages of ceftazidime-avibactam with final ceftazidime and avibactam concentrations of 8 to 40 and 2 to 10 mg/mL, respectively, from the reconstituted solution are as follows:3004
For 2.5 g (ceftazidime 2 g plus avibactam 0.5 g), withdraw the entire vial contents (i.e., 12 mL) and add to an infusion bag to achieve a total volume of 50 to 250 mL in a compatible diluent.
For 1.25 g (ceftazidime 1 g plus avibactam 0.25 g), withdraw 6 mL and add to an infusion bag to achieve a total volume of at least 50 mL (but less than 250 mL) in a compatible diluent.
For 940 mg (ceftazidime 750 mg plus avibactam 190 mg), withdraw 4.5 mL and add to an infusion bag to achieve a total volume of at least 50 mL (but less than 250 mL) in a compatible diluent.
For pediatric patients weighing less than 40 kg, the appropriate volume of the reconstituted solution to achieve the prescribed dose should be withdrawn from the vial and diluted in a compatible diluent to final ceftazidime and avibactam concentrations of 8 to 40 and 2 to 10 mg/mL, respectively.3004
The same diluent should be used for both reconstitution and further dilution unless the drug was reconstituted with sterile water, in which case any compatible diluent should be used for further dilution.3004 The diluted solution for infusion should be mixed gently to ensure complete dissolution and visually inspected for particulate matter and discoloration.3004
Sodium Content
Each 2.5-g vial contains approximately 6.4 mEq (146 mg) of sodium.3004
Trade Name(s)
Avycaz
Ceftazidime-avibactam sodium is administered by intravenous infusion over 2 hours following dilution of the reconstituted solution in a suitable infusion solution.3004
Intact vials should be stored at controlled room temperature and protected from light by storing in the original carton.3004 Ceftazidime-avibactam sodium is a white to yellow powder that ultimately forms a clear to light yellow solution upon reconstitution and subsequent dilution.3004 After reconstitution with an appropriate diluent as instructed, the drug may be stored for no longer than 30 minutes prior to dilution.3004 Following dilution, the drug should be used within 12 hours when stored at room temperature; alternatively, the diluted solution may be stored up to 24 hours at 2 to 8°C and then should be used within 12 hours of subsequent storage at room temperature.3004
For a list of references cited in the text of this monograph, search the monograph titled References.