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LINEZOLID Oral Suspension (GREENSTONE LLC)

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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.

LINEZOLID Oral Suspension (GREENSTONE LLC) 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 formulations for the treatment of infections is described in...

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3 DOSAGE FORMS AND STRENGTHS

Linezolid for Oral Suspension: dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of...

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4 CONTRAINDICATIONS

4.1 Hypersensitivity

Linezolid formulations are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the...

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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 for Oral Suspension contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-...

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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 for Oral Suspension is available as a dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension...

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17 PATIENT COUNSELING INFORMATION

Important Administration Instructions

Advise patients that linezolid 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.greenstonellc.com.

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