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linezolid injection in sodium chloride Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Nosocomial Pneumonia

1.2 Community-acquired Pneumonia

1.3 Complicated Skin and Skin Structure Infections

1.4 Vancomycin-resistant Enterococcus faecium Infections

1.5 Limitations of Use

1.6 Usage

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

2.2 Intravenous Administration

2.3 Compatibilities

2.4 Incompatibilities

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Hypersensitivity

4.2 Monoamine Oxidase Inhibitors

5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression

5.2 Peripheral and Optic Neuropathy

5.3 Serotonin Syndrome

5.4 Mortality Imbalance in an Investigational Study in Patients with Catheter-Related Bloodstream Infections, Including Those with Catheter-Site Infections

5.5 Clostridioides difficile-Associated Diarrhea

5.6 Potential Interactions Producing Elevation of Blood Pressure

5.7 Lactic Acidosis

5.8 Convulsions

5.9 Hypoglycemia

5.10 Development of Drug-Resistant Bacteria

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Monoamine Oxidase Inhibitors

7.2 Adrenergic and Serotonergic Agents

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Adults

14.2 Pediatric Patients

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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