Usual Adult Dose for Intraabdominal Infection

1.5 g IV every 8 hours
Duration of therapy: 4 to 14 days

Comments:

• Metronidazole (500 mg IV every 8 hours) should be administered concomitantly.

Use: In combination with metronidazole, for the treatment of complicated intraabdominal infections due to susceptible Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, K pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, S constellatus, S salivarius

Usual Adult Dose for Pyelonephritis

1.5 g IV every 8 hours
Duration of therapy: 7 days

Use: For the treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible E coli, K pneumoniae, P mirabilis, P aeruginosa

Usual Adult Dose for Urinary Tract Infection

1.5 g IV every 8 hours
Duration of therapy: 7 days

Use: For the treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible E coli, K pneumoniae, P mirabilis, P aeruginosa

Usual Adult Dose for Nosocomial Pneumonia

3 g IV every 8 hours
Duration of therapy: 8 to 14 days

Uses: For the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) due to susceptible E cloacae, E coli, Haemophilus influenzae, K oxytoca, K pneumoniae, P mirabilis, P aeruginosa, Serratia marcescens

Usual Pediatric Dose for Intraabdominal Infection

Birth to less than 18 years: 30 mg/kg IV every 8 hours
Maximum dose: 1.5 g/dose
Duration of therapy: 5 to 14 days

Comments:

• Metronidazole should be administered concomitantly.

Use: In combination with metronidazole, for the treatment of complicated intraabdominal infections due to susceptible E cloacae, E coli, K oxytoca, K pneumoniae, P mirabilis, P aeruginosa, B fragilis, S anginosus, S constellatus, S salivarius

Usual Pediatric Dose for Pyelonephritis

Birth to less than 18 years: 30 mg/kg IV every 8 hours
Maximum dose: 1.5 g/dose
Duration of therapy: 7 to 14 days

Use: For the treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible E coli, K pneumoniae, P mirabilis, P aeruginosa

Usual Pediatric Dose for Urinary Tract Infection

Birth to less than 18 years: 30 mg/kg IV every 8 hours
Maximum dose: 1.5 g/dose
Duration of therapy: 7 to 14 days

Use: For the treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible E coli, K pneumoniae, P mirabilis, P aeruginosa

Renal Dose Adjustments

Adult Patients:

• Complicated intraabdominal infections and complicated urinary tract infections (including pyelonephritis):
• Estimated CrCl 30 to 50 mL/min: 750 mg IV every 8 hours
• Estimated CrCl 15 to 29 mL/min: 375 mg IV every 8 hours
• HABP/VABP:
• Estimated CrCl 30 to 50 mL/min: 1.5 g IV every 8 hours
• Estimated CrCl 15 to 29 mL/min: 750 mg IV every 8 hours

Pediatric Patients (birth to less than 18 years):

• Estimated GFR 50 mL/min/1.73 m2 or less: Not recommended.

Comments:

• CrCl estimated using the Cockcroft-Gault formula; estimated GFR using an age-appropriate equation for use in the pediatric population
• CrCl should be monitored at least daily in patients with changing renal function and dose should be adjusted accordingly.
• Dose adjustment has not been established in pediatric patients with estimated GFR 50 mL/min/1.73 m2 or less.

Liver Dose Adjustments

No adjustment recommended.

Precautions

CONTRAINDICATIONS:
Known serious hypersensitivity to either active component, piperacillin-tazobactam, or other members of the beta-lactam class

Safety and efficacy have not been established in patients younger than 18 years with HABP/VABP.

Consult WARNINGS section for additional precautions.

Dialysis

Adult Patients:

• Complicated intraabdominal infections and complicated urinary tract infections (including pyelonephritis):
• ESRD on hemodialysis: 750 mg IV as a single loading dose followed by 150 mg IV every 8 hours for remainder of treatment period
• HABP/VABP:
• ESRD on hemodialysis: 2.25 g IV as a single loading dose followed by 450 mg IV every 8 hours for remainder of treatment period

Comments:

• On hemodialysis days, dose should be administered at the earliest possible time after completion of dialysis.

Other Comments

3 g ceftolozane-tazobactam contains 2 g ceftolozane and 1 g tazobactam
2.25 g ceftolozane-tazobactam contains 1.5 g ceftolozane and 0.75 g tazobactam
1.5 g ceftolozane-tazobactam contains 1 g ceftolozane and 0.5 g tazobactam
750 mg ceftolozane-tazobactam contains 500 mg ceftolozane and 250 mg tazobactam
450 mg ceftolozane-tazobactam contains 300 mg ceftolozane and 150 mg tazobactam
375 mg ceftolozane-tazobactam contains 250 mg ceftolozane and 125 mg tazobactam
150 mg ceftolozane-tazobactam contains 100 mg ceftolozane and 50 mg tazobactam

Administration advice:

• Administer all doses by IV infusion over 1 hour.
• Duration of therapy should be guided by severity and site of infection and the clinical and bacteriological progress of the patient.

Storage requirements:

• Prior to reconstitution: Store refrigerated at 2C to 8C (36F to 46F); protect from light.
• After reconstitution with appropriate diluent: May hold the reconstituted solution for 1 hour before transfer and dilution in appropriate infusion bag; do not freeze.
• After dilution of reconstituted solutions with appropriate diluents: Prepared infusion bags are stable for 24 hours when stored at room temperature or 7 days when stored refrigerated at 2C to 8C (36F to 46F); do not freeze.

Reconstitution/preparation techniques:

• Must be reconstituted and then diluted; the manufacturer product information should be consulted.

IV compatibility:

• Compatible diluents for reconstitution: Sterile water for injection; 0.9% Sodium Chloride for Injection, USP
• Compatible diluents for dilution: 0.9% Sodium Chloride for Injection, USP; 5% Dextrose Injection, USP
• Compatibility with other agents has not been established; this drug should not be mixed with other agents or physically added to solutions containing other agents.

General:

• The dose is expressed as the total of ceftolozane content plus tazobactam content.
• To reduce the development of drug-resistant organisms and maintain effective therapy, antibiotics should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
• Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.

Monitoring:

• Renal: CrCl in patients with changing renal function (at least daily); renal function in elderly patients

Patient advice:

• Avoid missing doses and complete the entire course of therapy.
• Consult healthcare provider if severe watery or bloody diarrhea develops.