Ceftazidime/Avibactam

DEA Class; Rx

Common Brand Names; Avycaz

Indicated in combination with metronidazole for complicated intra-abdominal infections (cIAIs) caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae, Klebsiella oxytoca, Citrobacter freundii complex, and Pseudomonas aeruginosa

Indicated for complicated urinary tract infections (cUTIs) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Citrobacter freundii complex, Proteus mirabilis, and Pseudomonas aeruginosa

Indicated for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible gram negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.

Known serious hypersensitivity to avibactam, ceftazidime, or other cephalosporins

1-10% (cIAI plus metronidazole)

Diarrhea (8%)

Nausea (7%)

Vomiting (5%)

Headache (3%)

Dizziness (2%)

Abdominal pain (1%)

1-10% (cUTI in pediatric patients)

Vomiting (>3%)

Diarrhea (>3%)

Rash (>3%)

Infusion site phlebitis (>3%)

1-10% (cUTI)

Diarrhea (3%)

Nausea (3%)

Constipation (2%)

Upper abdominal pain (1%)

1-10% (HABP/VABP)

Nausea (3%)

Pruritus (2%)

In clinical trials, cure rates were lower in patients with baseline moderate renal impairment (CrCl 30-50 mL/min) who were treated for cIAI with ceftazidime/avibactam plus metronidazole (45% cure rate) compared with meropenem (74% cure rate); during the clinical trial, the ceftazidime/avibactam dose was 33% lower than what is currently recommended for patients with moderate renal impairment (see Dosage Modifications); follow current dosage adjustment recommendations for renal impairment

Serious and occasionally fatal anaphylactic reactions and serious skin reactions have been reported with beta-lactam antibacterials; caution in patients with history of allergy to cephalosporins, penicillins, or carbapenems; exercise caution if this product is to be given to a penicillin or other beta-lactam-allergic patient; cross sensitivity among beta-lactam antibacterial drugs established; discontinue drug if allergic reaction occurs

Seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported with ceftazidime, especially in the setting of renal impairment; adjust dose according to CrCl (see Dosage Modifications)

Confirm suspected bacterial infection when prescribing ceftazidime/avibactam to avoid the risk of developing drug-resistant bacteria; prescribing antibiotics in absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria

There are no adequate and well-controlled studies of ceftazidime/avibactam, ceftazidime, or avibactam in pregnant women

Ceftazidime is excreted in human milk in low concentrations