Finished product reference
Ceftazidime / Avibactam
Injection, Powder · Parenteral · 2 g/0.5 g
- List code
- 52547
- Salt form
- Sodium
What it is and how it works
Mechanism of Action AVYCAZ is an antibacterial drug [ see Clinical Pharmacology ].
Indications
is a combination of ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible Gram-negative microorganisms in adult and pediatric patients (at least 31 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole Complicated Urinary Tract Infections (cUTI), including Pyelonephritis Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVYCAZ and other antibacterial drugs, AVYCAZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.
Dosage and administration (summary)
Dosage of AVYCAZ in Adult Patients with Creatinine Clearance (CrCl) greater than 50 mL/min Infection Dose Frequency Infusion Time cIAI * , cUTI including Pyelonephritis, and HABP/VABP AVYCAZ 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) Every 8 hours 2 hours * Used in conjunction with metronidazole 0.5 g intravenously every 8 hours in adult cIAI patients Dosage of AVYCAZ in Pediatric Patients aged 2 years to less than 18 years with Estimated Glomerular Filtration Rate (eGFR) greater than 50 mL/min/1.73 m 2 and in Pediatric Patients less than 2 years of age without Renal Impairment Infection Age Range Dose Infusion Time/ Frequency cIAI * , cUTI including Pyelonephritis, HABP/VABP 2 …
Contraindications
is contraindicated in patients with known serious hypersensitivity to the components of AVYCAZ (ceftazidime and avibactam), avibactam containing products, or other members of the cephalosporin class . AVYCAZ is contraindicated in patients with known serious hypersensitivity to the components of AVYCAZ (ceftazidime and avibactam), avibactam-containing products or other members of the cephalosporin class.
Warnings and precautions
Decreased Clinical Response in A dult cIAI P atients with B aseline CrC l of 30 to L ess T han or E qual to 50 mL/ min : Monitor CrCl at least daily in adult and pediatric patients with changing renal function and adjust the dosage of AVYCAZ accordingly. Hypersensitivity R eactions : Includes anaphylaxis and serious skin reactions. Cross sensitivity may occur in patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue AVYCAZ.
Pregnancy
Pregnancy Risk Summary There are no adequate and well-controlled studies of AVYCAZ, ceftazidime, or avibactam in pregnant women. Neither ceftazidime nor avibactam were teratogenic in rats at doses 40 and 9 times the recommended human clinical dose.
Storage and supply
2.5 grams (ceftazidime and avibactam) for injection is supplied as a white to yellow sterile powder for constitution in single-dose, clear glass vial containing: ceftazidime 2 grams and avibactam 0.5 grams. Vials are supplied as individual vial (NDC # 0456-2700-01) and in cartons containing 10 vials (NDC # 0456-2700-10).
Source: Ceftazidime, Avibactam (Avycaz) — US FDA prescribing information, 2025-04-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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