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Label Changes for:

Zyvox (linezolid) TabletsZyvox (linezolid) IV InjectionZyvox (linezolid) for Oral Suspension

May 2013

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

May 2013

7 DRUG INTERACTIONS

7.2 Adrenergic and Serotonergic Agents
  • Linezolid has the potential for interaction with adrenergic and serotonergic agents. [see Warnings and Precautions (5.3, 5.6) and Clinical Pharmacology (12.3)]

 

December 2009

 

PRECAUTIONS 

Drug Interactions
  • update an observed reduction in linezolid plasma concentrations when co-administered with rifampin in a Phase 1 drug interaction study conducted in healthy volunteers

ADVERSE REACTIONS 

Postmarketing Experience
  • Superficial tooth discoloration and tongue discoloration have been reported with the use of linezolid. The tooth discoloration was removable with professional dental cleaning (manual descaling) in cases with known outcome.