From the Guidelines
Ceftazidime/avibactam (Avycaz) from Pfizer is stable for 12 hours at room temperature or 24 hours under refrigeration (2-8°C) after reconstitution, as indicated by the most recent and highest quality study available 1. For intravenous administration, the reconstituted solution should be further diluted in an appropriate infusion solution (typically 0.9% sodium chloride or 5% dextrose) before use. Once diluted for infusion, the solution remains stable for 12 hours at room temperature or 24 hours if refrigerated. Any unused portion should be discarded after these time periods as the product contains no preservatives. This limited stability window is due to the gradual degradation of both active components, particularly avibactam, which can lose potency over time when in solution. The beta-lactam structure of ceftazidime is also susceptible to hydrolysis in aqueous solutions, especially at higher temperatures. For optimal efficacy, it's essential to administer the medication within these stability timeframes to ensure patients receive the full therapeutic benefit of both antimicrobial components.
Some key points to consider:
- The stability of ceftazidime/avibactam is affected by temperature and storage conditions.
- The solution should be used within the recommended time frame to ensure efficacy and safety.
- The product contains no preservatives, and any unused portion should be discarded after the recommended storage period.
- The gradual degradation of avibactam and the susceptibility of ceftazidime to hydrolysis contribute to the limited stability window.
It's crucial to follow the recommended storage and handling procedures for ceftazidime/avibactam to maintain its potency and ensure optimal treatment outcomes, as supported by the guidelines and recommendations from reputable sources 1.
From the FDA Drug Label
The diluted AVYCAZ solution in the infusion bags may be stored under refrigeration at 2 to 8°C (36 to 46°F) up to 24 hours following dilution and used within 12 hours of subsequent storage at room temperature. Following dilution of the constituted solutions with the appropriate diluents, AVYCAZ solutions in the infusion bags are stable for 12 hours when stored at room temperature Following dilution of the constituted solutions with the appropriate diluents, AVYCAZ solutions in the infusion bags may also be refrigerated at 2 to 8°C (36 to 46°F) for up to 24 hours; and then should be used within 12 hours of subsequent storage at room temperature.
The stability of Ceftazidime/avibactam preparation from Pfizer is as follows:
- Room temperature: 12 hours
- Refrigeration (2 to 8°C): up to 24 hours, then use within 12 hours of subsequent storage at room temperature 2
From the Research
Stability of Ceftazidime/Avibactam Preparation
- The stability of ceftazidime/avibactam in elastomeric infusion devices was evaluated in a study published in 2024 3.
- The study found that after 14 days of fridge storage and subsequent 24 hours exposure to 32°C, the mean percentage of ceftazidime remaining was between 75.5% and 85.4%, and the mean percentage of avibactam remaining was between 83.2% and 93.1%.
- The study concluded that ceftazidime/avibactam may be acceptable to administer as a continuous 12 hourly infusion in those territories where degradation of ≤10% is deemed acceptable.
- However, the study noted that the preparation did not meet the strict UK criteria for ≤5% degradation.
Factors Affecting Stability
- The study found that the degradation of both ceftazidime and avibactam was <10% for at least 12 hours of the running phase, if stored in a fridge for not more than 72 hours prior to in-use temperature exposure 3.
- The cumulative amount of pyridine generated in the devices ranged from 10.4 mg at low dose to 76.9 mg at high dose.
- The study suggests that the stability of ceftazidime/avibactam may be affected by factors such as storage conditions, dose, and device type.
Clinical Relevance
- Ceftazidime/avibactam is a valuable treatment option for serious Gram-negative bacterial infections, including those caused by multidrug-resistant organisms 4.
- The stability of ceftazidime/avibactam is an important consideration in the clinical setting, as it may impact the efficacy and safety of the treatment.
- Further studies are needed to fully evaluate the stability of ceftazidime/avibactam in different clinical settings and to determine the optimal storage and handling conditions for the preparation.