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ZYVOX®(linezolid)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
ZYVOX® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Nosocomial Pneumonia
ZYVOX is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 General Dosage and Administration
The recommended dosage for ZYVOX formulations for the treatment of infections is described in Table...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
ZYVOX I.V. Injection: 200 mg/100 mL (2 mg/mL) and 600 mg/300 mL (2 mg/mL) linezolid single-dose, ready-to-use flexible plastic infusion bags in a foil laminate overwrap.
ZYVOX 600 mg Tablet...
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Contraindications
4 CONTRAINDICATIONS
4.1 Hypersensitivity
ZYVOX formulations are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Myelosuppression
Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients...
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Adverse Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Monoamine Oxidase Inhibitors
Linezolid is a reversible, nonselective inhibitor of monoamine oxidase [see...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
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Overdosage
10 OVERDOSAGE
In the event of overdosage, supportive care is advised, with maintenance of glomerular filtration. Hemodialysis may facilitate more rapid elimination of linezolid. In a Phase 1 clinical trial, approximately 30...
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Description
11 DESCRIPTION
ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
ZYVOX is an antibacterial drug [see Microbiology (12.4)].
...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Lifetime studies in animals have not been conducted to evaluate the carcinogenic...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Adults
Nosocomial Pneumonia
Adult patients with...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 Injection
ZYVOX I.V. Injection is available in single-dose, ready-to-use flexible plastic infusion bags in a foil laminate...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Important Administration Instructions
Advise patients that ZYVOX may be taken with or without food....
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Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.