Zerbaxa

Zerbaxa

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ceftolozane 1 g, tazobactam 0.5 g
Indications/Uses
Infections caused by designated susceptible microorganisms in complicated intra-abdominal infections (cIAI) (in combination w/ metronidazole), complicated UTI (cUTI) including pyelonephritis & nosocomial pneumonia including ventilator-associated pneumonia (VAP) in patients ≥18 yr.
Dosage/Direction for Use
Patient ≥18 yr w/ CrCl >50 mL/min cIAI 1.5 g every 8 hr w/ 1 hr infusion time for 4-14 days in conjunction w/ metronidazole 500 mg IV every 8 hr. cUTI including pyelonephritis 1.5 g every 8 hr w/ 1 hr infusion time for 7 days. Nosocomial pneumonia including VAP 3 g every 8 hr w/ 1 hr infusion time for 8-14 days. Renal impairment: CrCl 30-50 mL/min cIAI & cUTI including pyelonephritis 750 mg IV every 8 hr w/ 1 hr infusion time. Nosocomial pneumonia including VAP 1.5 g IV every 8 hr w/ 1 hr infusion time. CrCl 15-29 mL/min cIAI & cUTI pyelonephritis 375 mg IV every 8 hr w/ 1 hr infusion time. Nosocomial pneumonia including VAP 750 mg IV every 8 hr w/ 1 hr infusion time. ESRD on hemodialysis cIAI & cUTI including pyelonephritis 750 mg single loading dose followed by 150 mg maintenance dose every 8 hr for the remainder of treatment period. Nosocomial pneumonia including VAP 2.25 g single loading dose followed by 450 mg maintenance dose every 8 hr for the remainder of treatment period.
Contraindications
Hypersensitivity to ceftolozane, tazobactam, or any cephalosporins. Severe hypersensitivity (eg, anaphylactic & severe skin reaction) to other type of β-lactams (eg, penicillins or carbapenems).
Special Precautions
Cross-sensitivity to other cephalosporins, penicillins or other β-lactams. Constituted soln is not for direct inj. Clostridium difficile-associated diarrhea (CDAD) may occur; if possible, discontinue antibacterials not directed against Clostridium difficile if CDAD is confirmed; manage fluid & electrolyte levels & supplement protein intake. Risk of developing drug-resistant bacteria in the absence of a proven or strongly suspected bacterial infection. Immunocompromised patients & those w/ severe neutropenia. Frequently monitor patients w/ renal impairment at baseline. Pregnancy & lactation. Childn & adolescent <18 yr. Elderly.
Adverse Reactions
Anemia, thrombocytosis; atrial fibrillation; abdominal pain, constipation, diarrhea, nausea, vomiting; infusion site reactions, pyrexia; increased ALT & AST; hypokalemia; dizziness, headache; anxiety, insomnia; rash; hypotension. Clostridium difficile colitis; increased transaminases.
Drug Interactions
Tazobactam: Plasma conc may be increased by 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 inj
Packing/Price
10 × 1's
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