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linezolid injection in sodium chloride
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linezolid injection in sodium chloride Quick Finder
1 INDICATIONS AND USAGE
1.1 Nosocomial Pneumonia
Linezolid is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus...
2 DOSAGE AND ADMINISTRATION
2.1 General Dosage and Administration
The recommended dosage for linezolid injection for the treatment of infections is described in...
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.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Linezolid injection is contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other...
5 WARNINGS AND PRECAUTIONS
5.1 Myelosuppression
Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients...
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...
7 DRUG INTERACTIONS
7.1 Monoamine Oxidase Inhibitors
Linezolid is a reversible, nonselective inhibitor of monoamine oxidase [see...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
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...
11 DESCRIPTION
Linezolid injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Linezolid is an antibacterial drug [see Microbiology (12.4)]....
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Lifetime studies in animals have not been conducted to evaluate the carcinogenic...
14 CLINICAL STUDIES
14.1 Adults
Nosocomial Pneumonia
Adult patients with...
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...
17 PATIENT COUNSELING INFORMATION
Important Administration Instructions
Advise patients that linezolid injection may be taken with or...
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