HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
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 injection in sodium chloride
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
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 injection in sodium chloride Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Nosocomial Pneumonia
Linezolid is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus...
Did you find an answer to your question?
Yes
No
Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 General Dosage and Administration
The recommended dosage for linezolid injection for the treatment of infections is described in...
Did you find an answer to your question?
Yes
No
Dosage Forms and Strengths
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.
Did you find an answer to your question?
Yes
No
Contraindications
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Linezolid injection is contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other...
Did you find an answer to your question?
Yes
No
Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Myelosuppression
Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients...
Did you find an answer to your question?
Yes
No
Adverse Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...
Did you find an answer to your question?
Yes
No
Drug Interactions
7 DRUG INTERACTIONS
7.1 Monoamine Oxidase Inhibitors
Linezolid is a reversible, nonselective inhibitor of monoamine oxidase [see...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
Did you find an answer to your question?
Yes
No
Overdosage
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...
Did you find an answer to your question?
Yes
No
Description
11 DESCRIPTION
Linezolid injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N...
Did you find an answer to your question?
Yes
No
Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Linezolid is an antibacterial drug [see Microbiology (12.4)]....
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Lifetime studies in animals have not been conducted to evaluate the carcinogenic...
Did you find an answer to your question?
Yes
No
Clinical Studies
14 CLINICAL STUDIES
14.1 Adults
Nosocomial Pneumonia
Adult patients with...
Did you find an answer to your question?
Yes
No
How Supplied/Storage and Handling
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...
Did you find an answer to your question?
Yes
No
Medication Guide
17 PATIENT COUNSELING INFORMATION
Important Administration Instructions
Advise patients that linezolid injection may be taken with or...
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.