Zerbaxa

Zerbaxa

Manufacturer:

MSD

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ceftolozane 1 g, tazobactam 0.5 g
Indications/Uses
Complicated intra-abdominal infections caused by the following susceptible gm -ve & gm +ve microorganisms: Enterobacter cloacae, E. coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Strep anginosus, Strep constellatus, & Strep salivarius. Complicated UTI, including pyelonephritis, caused by the following susceptible gm -ve microorganisms: E. coli, Klebsiella pneumoniae, Proteus mirabilis. Hospital-acquired bacterial pneumonia & ventilator-associated bacterial pneumonia, caused by the following susceptible gm -ve microorganisms: Enterobacter cloacae, E. coli, H. influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens.
Dosage/Direction for Use
Patient ≥18 yr, CrCl >50 mL/min Complicated intra-abdominal infection 1.5 g (1 g ceftolozane/0.5 g tazobactam) every 8 hr w/ 1 hr infusion time for 4-14 days. Complicated UTI including pyelonephritis 1.5 g every 8 hr w/ 1 hr infusion time for 7 days. Hospital-acquired bacterial pneumonia & ventilator-associated bacterial pneumonia 3 g (2 g ceftolozane/1 g tazobactam) every 8 hr w/ 1 hr infusion time for 8-14 days. Patient ≥18 yr, CrCl 30-50 mL/min Complicated intra-abdominal infection & complicated UTI including pyelonephritis 750 mg (500 mg ceftolozane/250 mg tazobactam) IV every 8 hr w/ 1 hr infusion time. Hospital-acquired bacterial pneumonia & ventilator-associated bacterial pneumonia 1.5 g IV every 8 hr w/ 1 hr infusion. Patient ≥18 yr, CrCl 15-29 mL/min Complicated intra-abdominal infection & complicated UTI including pyelonephritis 375 mg (250 mg ceftolozane/125 mg tazobactam) IV every 8 hr w/ 1 hr infusion time. Hospital-acquired bacterial pneumonia & ventilator-associated bacterial pneumonia 750 mg IV every 8 hr w/ 1 hr infusion time. End stage renal disease on haemodialysis Complicated intra-abdominal infection & complicated UTI including pyelonephritis Loading dose: 750 mg, followed by a 150 mg (100 mg ceftolozane/50 mg tazobactam) maintenance dose every 8 hr for the remainder of the treatment of period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis). Hospital-acquired bacterial pneumonia & ventilator-associated bacterial pneumonia Loading dose: 2.25 g (1.5 g ceftolozane/0.75 g tazobactam), followed by a 450 mg (300 mg ceftolozane/150 mg tazobactam) maintenance dose every 8 hr for the remainder of the treatment of period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis).
Contraindications
Serious hypersensitivity to ceftolozane, tazobactam, piperacillin/tazobactam, or other members of the β-lactam class.
Special Precautions
Decreased efficacy in patients w/ baseline CrCl 30-50 mL/min. Discontinue in case of anaphylactic reaction. Clostridium difficile-associated diarrhoea. Development of positive direct Coombs test may occur. Patients w/ renal impairment. Pregnancy & lactation. Elderly.
Adverse Reactions
Complicated intra-abdominal infection & complicated UTI including pyelonephritis: Nausea, diarrhea, headache, pyrexia. Hospital-acquired bacterial pneumonia & ventilator-associated bacterial pneumonia: Hepatic transaminase increased, renal impairment/renal failure, diarrhea, intracranial hemorrhage, vomiting, C. difficile colitis.
Drug Interactions
Tazobactam: Increased plasma conc w/ OAT1 or OAT3 inhibitors (eg, probenecid).
MIMS Class
Cephalosporins
ATC Classification
J01DI54 - ceftolozane and beta-lactamase inhibitor ; Belongs to the class of other cephalosporins and penems. Used in the systemic treatment of infections.
Presentation/Packing
Form
Zerbaxa powd for conc for soln for infusion
Packing/Price
10 × 1's
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