Finished product reference
Ceftolozane / Tazobactam
Injection, Powder · Parenteral · 1 g/500 mg
- List code
- 53498
- Salt form
- Sulfate
What it is and how it works
Mechanism of Action ZERBAXA is an antibacterial drug .
Indications
(ceftolozane and tazobactam) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible microorganisms in adult and pediatric patients (at least 32 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole. Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis. Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP). Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Dosage and administration (summary)
Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 1 hour in adult patients. Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 1 hour in pediatric patients (at least 32 weeks gestational age) with cIAI or cUTI. Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 2 hours in pediatric patients (at least 32 weeks gestational age) with HABP/VABP.
Contraindications
is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane and tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class. ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane and tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class.
Warnings and precautions
Decreased efficacy was observed in a Phase 3 cIAI trial in a subgroup of patients with baseline CrCl of 30 to 50 mL/min. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA accordingly. Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs. Exercise caution in patients with known hypersensitivity to beta-lactam antibacterial drugs. If an anaphylactic reaction to ZERBAXA occurs, discontinue the drug and institute appropriate therapy.
Pregnancy
Pregnancy Risk Summary There are no data available on ZERBAXA, ceftolozane or tazobactam use in pregnant women to allow assessment of a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Storage and supply
Storage and Handling ZERBAXA vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F) and protected from light. Storage after reconstitution and dilution is described elsewhere in the labeling .
Source: Ceftolozane And Tazobactam (Zerbaxa) — US FDA prescribing information, 2026-05-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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