Ceftazidime and Avibactam Sodium Application Scope

Recommended for adults (and eligible pediatric patients) for:

Complicated intra‑abdominal infections (cIAI) – must be used with metronidazole
Complicated urinary tract infections (cUTI), including pyelonephritis
Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
Bacteremia associated with the above infections

Ceftazidime and Avibactam Sodium Characteristics

Ingredients:
- Active:
  - Ceftazidime pentahydrate eq. 2 g ceftazidime per vial
  - Avibactam sodium eq. 0.5 g avibactam per vial
- Excipient:
  - Sodium carbonate (anhydrous)
Properties:
- White to yellow powder for concentrate for infusion
- Fixed 4:1 ratio of ceftazidime:avibactam
- Antibacterial: cephalosporin + β-lactamase inhibitor targeting resistant Gram-negative pathogens
Packaging Specification: 2g/0.5g; packs of 1 or 10 vials
Storage: Store ≤ 30 °C in original package, protected from light
Expiry Date: Shelf life: 36 months from manufacture; expiry is last day of stated month
Executive Standard: Manufactured per EU SmPC, FDA and WHO essential medicines guidelines
Approval Number: EMA EPAR – first authorized June 2016; FDA approval in 2015
Date of Revision: EU SmPC updated October 21, 2024
Manufacturer: Pfizer Ireland Pharmaceuticals (AstraZeneca in EU)

Dosage and Administration:
- Adults (CrCl ≥50 mL/min):
  - 2 g ceftazidime + 0.5 g avibactam IV over 2 h every 8 h
    - cIAI: 5–14 days (with metronidazole)
    - cUTI: 5–10 days
    - HAP/VAP: 7–14 days
- Renal impairment adjustments apply for CrCl < 50 mL/min
- Pediatric dosing for ≥ 3 months – weight-based, same infusion regimen
Adverse Reactions:
- Common: Nausea, diarrhea, fever, headache, infusion-site reactions
- Serious:
  - Hypersensitivity/anaphylaxis, Clostridioides difficile-associated diarrhea, seizures, encephalopathy (esp. renal impairment)
Contraindications: Hypersensitivity to ceftazidime, avibactam, β-lactams or excipients
Precautions:
- Monitor renal function frequently; adjust dosage accordingly
- Not to be used empirically: reserved for infections with limited/no alternatives
- Watch for neurotoxicity in renal impairment

Drug Interactions:
No significant CYP interactions documented.
Dose adjustments required in renal impairment.
Potential neuromuscular and CNS interactions in renal/liver dysfunction — monitor carefully.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.