Ceftolozane/Tazobactam

DEA Class; Rx

Common Brand Names; Zerbaxa

Indicated for use in combination with metronidazole for complicated intra-abdominal infections (cIAI) cause by Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius

Indicated for complicated urinary tract infections (cUTI), including pyelonephritis, caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa

Indicated for treatment of adults aged ≥18 years with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Serratia marcescens

Hypersensitivity to any of the components

>10% (HABP/VABP)

Increased hepatic transaminase (11.9%)

1-10% (cIAI or cUTI)

• Nausea (2.8-7.9%)
• Headache (2.5-5.8%)
• Diarrhea (1.9-6.2%)
• Pyrexia (1.7-5.6%)
• Constipation (1.9-3.9%)
• Insomnia (1.3-3.5%)
• Vomiting (1.1-3.3%)
• Hypokalemia (0.8-3.3%)
• ALT increased (1.7-1.5%)
• AST increased (1-1.7%)
• Anemia (0.4-1.5%)
• Thrombocytosis (0.4-1.9%)
• Abdominal pain (0.8-1.2%)
• Anxiety (0.2-1.9%)
• Dizziness (0.8-1.1%)
• Hypotension (0.4-1.7%)
• Atrial fibrillation (0.2-1.2%)
• Rash (0.9-1.7%)

Clinical cure rates lower in patients with baseline CrCl of 30 to ≤50 mL/min when compared with other antibiotics in clinical trials; monitor CrCl at least daily in patients with changing renal function and adjust dosage accordingly

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported with beta-lactam antibacterial agents; before initiating therapy make careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactams; if this product is to be given to a patient with a cephalosporin, penicillin, or other beta-lactam allergies, exercise caution because cross-sensitivity has been established; if an anaphylactic reaction occurs, discontinue drug and institute appropriate therapy

Prescribing antibiotics in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria

There are no data available on ceftolozane/tazobactam or its individual components regarding use in pregnant women to assess drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

There are no data on presence of either drug component in human milk; there are no data on effects of either drug component on breastfed infant, or on milk production

Ceftolozane/tazobactam

IV injection, powder for reconstitution

• 1.5g/vial (ie, 1.5g = 1g ceftolozane plus 0.5g tazobactam)
• Dose based on sum weight of each ingredient