Overview
11 DESCRIPTION ZERBAXA (ceftolozane and tazobactam) is an antibacterial combination product consisting of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Ceftolozane sulfate is a semi-synthetic antibacterial drug of the beta-lactam class for parenteral administration.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action ZERBAXA is an antibacterial drug [see Clinical Pharmacology (12.4) ] . 12.2 Pharmacodynamics As with other beta-lactam antibacterial agents, the percent time of dosing interval that the plasma concentration of ceftolozane exceeds the minimum inhibitory concentration (MIC) of the infecting organism has been shown to be the best predictor of efficacy in animal models of infection. The percent time of dosing interval that the plasma concentration of tazobactam exceeds a threshold concentration has been determined to be the parameter that best predicts the efficacy of tazobactam in in vitro and in vivo models.
Indications
- 1 INDICATIONS AND USAGE ZERBAXA (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. ( 1.1 ) Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis. ( 1.
Common Doses
- 500 mg
- 1.5 g
- 1 g
- 0.5 g
Dosage
2 DOSAGE AND ADMINISTRATION Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 1 hour in adult patients. ( 2.1 ) 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. ( 2.2 ) 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. ( 2.2 ) Recommended Dosage of ZERBAXA by Infection in Adult Patients ( 2.
Contraindications
- 4 CONTRAINDICATIONS 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. 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. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The following serious reactions are described in greater detail in the Warnings and Precautions section: Hypersensitivity reactions [see Warnings and Precautions (5.2) ] Clostridioides difficile -associated diarrhea [see Warnings and Precautions (5.3) ] Adult cIAI, cUTI and HABP/VABP Patients : The most common adverse reactions in adult patients (≥5% in either the cIAI or cUTI indication) are nausea, diarrhea, headache, and pyrexia. ( 6.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.