Avycaz (ceftazidime-avibactam)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved February 2015

Specific Treatments:

complicated intra-abdominal and urinary tract infections

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General Information

Avycaz (ceftazidime-avibactam) is a combination of a cephalosporin and a beta-lactamase inhibitor.

Avycaz in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Providencia stuartii, Enterobacter cloacae, Klebsiella oxytoca, and Pseudomonas aeruginosa in patients 18 years or older.

Avycaz is also indicated for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Citrobacter freundii, Proteus spp., and Pseudomonas aeruginosa in patients 18 years or older.

Avycaz is supplied as a solution for intravenous infusion. The recommended dosage of Avycaz is 2.5 grams (2 grams ceftazidime and 0.5 grams avibactam) administered every 8 hours by intravenous (IV) infusion over 2 hours. For treatment of cIAI, metronidazole should be given concurrently.

Clinical Results

FDA Approval

The FDA approval of Avycaz was supported in part by the previous findings of the efficacy and safety of ceftazidime for the treatment of cIAI and cUTI. The contribution of avibactam to Avycaz was primarily established in vitro and in animal models of infection. Avycaz was studied in two phase II randomized, blinded, active-controlled, multicenter trials, one each in cIAI and cUTI, including pyelonephritis. These trials were not designed with any formal hypotheses for inferential testing against the active comparators. 

Side Effects

Adverse effects associated with the use of Avycaz may include, but are not limited to, the following:

  • vomiting
  • nausea
  • constipation
  • anxiety

Mechanism of Action

The ceftazidime component of Avycaz is a cephalosporin antibacterial drug with in vitro activity against certain gram-negative and gram-positive bacteria. The bactericidal action of ceftazidime is mediated through binding to essential penicillin-binding proteins (PBPs). The avibactam component of Avycaz is a non-betalactam beta-lactamase inhibitor that inactivates some beta-lactamases and protects ceftazidime from degradation by certain beta-lactamases. Avibactam does not decrease the activity of ceftazidime against ceftazidimesusceptible organisms. 

Additional Information

For additional information regarding Avycaz or complicated intra-abdominal and urinary tract infections, please visit https://www.avycaz.com/