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Zerbaxa

Zerbaxa

ceftolozane + tazobactam

Manufacturer:

MSD

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ceftolozane 1 g, tazobactam 0.5 g
Indications/Uses
In combination w/ metronidazole for the treatment of complicated intra-abdominal infections (cIAI), 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. Treatment of complicated UTI (cUTI), including pyelonephritis, caused by the following susceptible gm -ve microorganisms: E. coli, Klebsiella pneumoniae, Proteus mirabilis. Treatment of hospital-acquired bacterial pneumonia & ventilator-associated bacterial pneumonia (HABP/VABP), 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
Administer by IV infusion over 1 hr. Patient ≥18 yr w/ CrCl >50 mL/min cIAI 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) every 8 hr for 4-14 days, in combination w/ IV metronidazole 500 mg every 8 hr. cUTI, including pyelonephritis 1.5 g every 8 hr for 7 days. HABP/VABP 3 g (2 g/1 g) every 8 hr for 8-14 days. Patient ≥18 yr w/ CrCl 30-50 mL/min cIAI & cUTI, including pyelonephritis 750 mg (500 mg/250 mg) every 8 hr. HABP/VABP 1.5 g every 8 hr. Patient ≥18 yr w/ CrCl 15-29 mL/min cIAI & cUTI, including pyelonephritis 375 mg (250 mg/125 mg) every 8 hr. HABP/VABP 750 mg every 8 hr. Patient ≥18 yr w/ ESRD on hemodialysis On hemodialysis days, administer dose at the earliest possible time following completion of dialysis. cIAI & cUTI, including pyelonephritis Single loading dose of 750 mg, followed by maintenance dose of 150 mg (100 mg/50 mg) every 8 hr for the remainder of the treatment period. HABP/VABP Single loading dose of 2.25 g (1.5 g/0.75 g), followed by maintenance dose of 450 mg (300 mg/150 mg) every 8 hr for the remainder of the treatment period.
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. Monitor CrCl at least daily in patients w/ changing renal function & adjust dose accordingly. Caution in patients w/ cephalosporin, penicillin, or other β-lactam allergy due to cross-sensitivity. Discontinue if an anaphylactic reaction occurs. Risk of Clostridioides difficile-associated diarrhea. Prescribing in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication risks the development of drug-resistant bacteria. While available studies w/ multiple cephalosporins cannot definitively establish absence of risk, published data have not identified an association of cephalosporin use during pregnancy w/ major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Consider developmental & health benefits of breastfeeding along w/ mother's clinical need for Zerbaxa & any potential adverse effects on breastfed child from Zerbaxa or from underlying maternal conditions. Safety & effectiveness in ped patients have not been established. Adjust dose for elderly patients based on renal function.
Adverse Reactions
cIAI & cUTI, including pyelonephritis: Nausea, diarrhea, headache, pyrexia. HABP/VABP: Increased hepatic transaminase, renal impairment/failure, diarrhea, intracranial hemorrhage, vomiting, Clostridioides difficile colitis.
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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