Brand Name
Zevtera
Generic Name
Ceftobiprole Medocaril
View Brand Information FDA approval date: March 21, 2025
Classification: Cephalosporin Antibacterial
Form: Injection
What is Zevtera (Ceftobiprole Medocaril)?
ZEVTERA is a cephalosporin antibacterial indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections , including those with right-sided infective endocarditis.
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Brand Information
ZEVTERA (ceftobiprole medocaril sodium)
1DOSAGE FORMS AND STRENGTHS
ZEVTERA (ceftobiprole medocaril sodium for injection) is available in a single-dose vial as a white, yellowish to slightly brownish, cake to broken cake or powder containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole) for reconstitution.
2CONTRAINDICATIONS
ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in the Warnings and Precautions section:
- Increased Mortality in Ventilator-Associated Bacterial Pneumonia Patients [
- Hypersensitivity Reactions
- Seizures and Other Central Nervous System Reactions
- Clostridioides difficile-Associated Diarrhea [see
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Postmarketing Experience
The following adverse reactions and altered laboratory tests have been identified during post-approval use of ZEVTERA and ceftobiprole outside of the United States, or other cephalosporin-class antibacterial drugs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Altered Laboratory Tests: Positive direct Coombs' test, false-positive test for urinary glucose.
Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia.
Hepatobiliary disorders: Hepatic dysfunction including cholestasis
Immune system disorders: Drug fever, serum sickness-like reaction
Nervous system disorders: Myoclonus
Renal and urinary disorders: Renal dysfunction, toxic nephropathy
Vascular disorders: Hemorrhage, hypertension
Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia.
Hepatobiliary disorders: Hepatic dysfunction including cholestasis
Immune system disorders: Drug fever, serum sickness-like reaction
Nervous system disorders: Myoclonus
Renal and urinary disorders: Renal dysfunction, toxic nephropathy
Vascular disorders: Hemorrhage, hypertension
4OVERDOSAGE
There is no information on clinical signs and symptoms associated with an overdose of ZEVTERA. For patients who receive doses greater than the recommended dosage regimen and have unexpected adverse reactions associated with ZEVTERA, discontinue ZEVTERA, treat symptomatically, and institute general supportive treatment.
ZEVTERA can be removed by hemodialysis. However, no information is available on the use of hemodialysis to treat overdose
5DESCRIPTION
ZEVTERA (ceftobiprole medocaril sodium for injection) contains sodium salt of ceftobiprole medocaril, a, semisynthetic, cephalosporin antibacterial, for intravenous use. Chemically, ceftobiprole medocaril is (6
Figure 1 Chemical Structure of ceftobiprole medocaril
ZEVTERA vials contain 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole). The powder for injection is a white, yellowish to slightly brownish sterile powder. Each vial includes inactive ingredient citric acid monohydrate (26.3 mg/vial) as a buffer component and sodium hydroxide (q.s.) as a pH adjustment agent. Each vial of ZEVTERA contains approximately 32 mg of sodium.
The pH of the reconstituted solution is 4.5–5.5.
6PRINCIPAL DISPLAY PANEL - 667 mg Vial Box
NDC# 68547-578-10
Rx Only
ZEVTERA
For intravenous use only.
