ZEVTERA 500 MG
Generic Name/API: ceftobiprole medocaril sodium for injection
Manufacturer: Nipro Pharma Corporation
Dosage Forms & Strength & Pack Size:
For injection: 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole) as a lyophilized powder for reconstitution in a single-dose vial (3).
Storage:
Store ZEVTERA vials refrigerated at 2 °C to 8 °C (36 °F to 46 °F) protected from light. Store in carton until time of use.
ZEVTERA must be reconstituted and then further diluted prior to administration by intravenous infusion. Store reconstituted and diluted solution of ZEVTERA as described elsewhere in the labeling [see Dosage and Administration (2.7)].
What is Zevtera
Zevtera (ceftobiprole medocaril) is an injectable cephalosporin antibiotic that may be used to treat:
- Staphylococcus aureus bloodstream infections (bacteremia) (SAB) in adults, including those with right-sided infective endocarditis
- Acute bacterial skin and skin structure infections (ABSSSI) in adults
- Community-acquired bacterial pneumonia (CABP) in adults and children aged 3 months and older.
WARNINGS AND PRECAUTIONS
Increased Mortality with Unapproved use in Ventilator-Associated
Bacterial Pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not
been established and the use of ZEVTERA for VABP is not approved (5.1).
Hypersensitivity Reactions: Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment (5.2).
Seizures and other adverse central nervous system (CNS) reactions have been associated with the use of ZEVTERA. If seizures or other CNS adverse reactions occur, evaluate patients to determine whether ZEVTERA should be discontinued (5.3).
Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA. Evaluate if diarrhea occurs (5.4).
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