CEFTOBIPROLE MEDOCARIL SODIUM

Electrolyte / Mineral

Brand names: ZEVTERA

Intravenous

Mechanism of Action

12.1 Mechanism of Action ZEVTERA is an antibacterial drug [see Microbiology (12.4) ]

Indications

1 INDICATIONS AND USAGE ZEVTERA is a cephalosporin antibacterial indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB)

including those with right-sided infective endocarditis ( 1.1 )

Adult patients with acute bacterial skin and skin structure infections (ABSSSI) ( 1.2 )

including those with right-sided infective endocarditis

Streptococcus pyogenes

Streptococcus pneumoniae

Contraindications

• 4 CONTRAINDICATIONS ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA
• or to other members of the cephalosporin class [see Warnings and Precautions (5.2) ]. ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA
• or to other members of the cephalosporin class ( 4 ).

FDA Warnings

5 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
Generally, deaths were associated with complications of infection or underlying co-morbidities
2 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials [see Adverse Reactions (6
Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs

Known Side Effects

2 documented side effects by frequency

Rash

0.1-1%

Diarrhea

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous