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linezolid injection in sodium chloride

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linezolid injection in sodium chloride 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

Linezolid is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus...

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2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

The recommended dosage for linezolid injection for the treatment of infections is described in...

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3 DOSAGE FORMS AND STRENGTHS

Linezolid injection: 600 mg/300 mL (2 mg/mL) linezolid in single-dose, ready-to-use flexible plastic VisIV™ container in a foil laminate overwrap.

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4 CONTRAINDICATIONS

4.1 Hypersensitivity

Linezolid injection is 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

Linezolid injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Linezolid 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

Linezolid injection is available in a single-dose, ready-to-use flexible plastic container (VisIV™ Container) in a foil laminate overwrap. The container is available in the following...

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17 PATIENT COUNSELING INFORMATION

Important Administration Instructions

Advise patients that linezolid injection may be taken with or...

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Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

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