Zavicefta (Ceftazidime and Avibactam Sodium) | CIAI | DengYue

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)

Guidelines for the Use of Ceftazidime and Avibactam Sodium

• 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

Interactions

• 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.