How does CEFTOBIPROLE MEDOCARIL SODIUM work?

CEFTOBIPROLE MEDOCARIL SODIUM works through the following mechanism: 12.1 Mechanism of Action ZEVTERA is an antibacterial drug [see Microbiology (12.4) ].

What are the most common side effects of CEFTOBIPROLE MEDOCARIL SODIUM?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for CEFTOBIPROLE MEDOCARIL SODIUM. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is CEFTOBIPROLE MEDOCARIL SODIUM the same as ZEVTERA?

ZEVTERA is a brand name for CEFTOBIPROLE MEDOCARIL SODIUM. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

CEFTOBIPROLE MEDOCARIL SODIUM

Q: What is CEFTOBIPROLE MEDOCARIL SODIUM used for?

CEFTOBIPROLE MEDOCARIL SODIUM (brand name ZEVTERA) is a Electrolyte / Mineral indicated for 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 ).

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%

Community Discussions

No community discussions found for CEFTOBIPROLE MEDOCARIL SODIUM yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → CEFTOBIPROLE MEDOCARIL SODIUM openFDA label JSON → CEFTOBIPROLE MEDOCARIL SODIUM FAERS adverse-event reports → CEFTOBIPROLE MEDOCARIL SODIUM ClinicalTrials.gov → completed Phase 2+ trials of CEFTOBIPROLE MEDOCARIL SODIUM

Compare With

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Formulations

Dosage Forms

Tablet

Route

Intravenous