Adult Dosing

Complicated intra-abdominal infections (cIAI)

• 1.5 g IV q8hours x4-14 days

Complicated Urinary Tract Infections

• 1.5 g IV q8hours x7 days

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• In combination with metronidazole is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by Gram-negative and Gram-positive microorganisms
• Complicated urinary tract infections, including pyelonephrits

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment (Based on CrCl)

• 30 to 50 mL/min: 750 mg (500 mg and 250 mg) IV q8hours
• 15 to 29 mL/min: 375 mg (250 mg and 125 mg) IV q8hours
• End-stage renal disease /hemodialysis: 750 mg x 1, then 150 mg q8hours

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

• Clinical cure rates lower in patients with baseline CrCl of 30 to 50 mL/min when compared with other antibiotics
• Serious, and sometimes fatal, hypersensitivity (anaphylactic) reactions including shock have been reported in patients receiving beta-lactam antibacterial drugs. Prior to initiating therapy, obtain a detailed history concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams. Discontinue therapy if anaphylactic reaction occurs
• Clostridium difficile associated diarrhea (CDAD), which may range in severity from mild diarrhea to fatal colitis, may occur during or after antibiotic treatment. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile. In case of suspected or confirmed C. difficile infection, discontinue ongoing antibiotic therapy and initiate fluid and electrolyte management, protein supplementation, appropriate antibiotic treatment, and surgical evaluation as indicated
• Avoid use of ceftolozane/tazobactam in the absence of confirmed or strongly suspected bacterial infection or a prophylactic indication to prevent drug-resistance

Pregnancy Category:B

Breastfeeding: No information is available on the clinical use of ceftolozane and tazobactam during breastfeeding. No serious adverse effects have been reported for other cephalosporin antibiotics during breastfeeding. Occasionally disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush have been reported with cephalosporins, but these effects have not been adequately evaluated. Ceftolozane and tazobactam is acceptable to use during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 23 January 2010). Manufacturer advises caution while administering to nursing mothers.

• CNS: Headache, insomnia, dizziness
• CV: Hypotension, atrial fibrillation
• GI: Nausea, diarrhea, constipation, vomiting, abdominal pain
• METABOLIC: Hypokalemia
• HEMA: Thrombocytosis
• LABTEST: ALT increased, AST increased
• PHYSIATRY: Anxiety
• DERM: Rash
• MISC: Pyrexia

Ceftolozane

• Bactericidal; inhibits cell wall mucopeptide synthesis
• Metabolism: Unknown
• Excreted in urine (>95% unchanged)
• Half-life: 2.8-3.1 hours

Tazobactam

• Extended-spectrum penicillin; inhibits bacterial beta-lactamase enzyme and broadens the spectrum of piperacillin
• Metabolized by liver; CYP450: Unknown
• Excreted in urine (80% unchanged)
• Half-life: 1 hour

US Trade Name(s)

• Zerbaxa

US Availability

Zerbaxa (ceftolozane/tazobactam)

• INJ: 1.5g/vial [1g/0.5 g]/vial

Canadian Trade Name(s)

• Zerbaxa

Canadian Availability

Zerbaxa (ceftolozane/tazobactam)

• INJ: 1.5g/vial [1g/0.5 g]/vial

UK Trade Name(s)

• Zerbaxa

UK Availability

Zerbaxa (ceftolozane/tazobactam)

• INJ: 1.5g/vial [1g/0.5 g]/vial

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Antibiotic Combinations

Infectious Disease

Antibiotic Combinations