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ZYVOX®(linezolid)

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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 OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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...

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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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5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients...

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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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7 DRUG INTERACTIONS

7.1 Monoamine Oxidase Inhibitors

Linezolid is a reversible, nonselective inhibitor of monoamine oxidase [see

7.2...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data from...

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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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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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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

ZYVOX is an antibacterial drug [see

12.2 Pharmacodynamics

In a...

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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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14 CLINICAL STUDIES

14.1 Adults

Nosocomial Pneumonia

Adult patients with...

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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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17 PATIENT COUNSELING INFORMATION

Important Administration Instructions

Advise patients that ZYVOX may be taken with or without food....

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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