Label Changes for:
Zyvox (linezolid) TabletsZyvox (linezolid) IV InjectionZyvox (linezolid) for Oral Suspension
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)
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)]
- update an observed reduction in linezolid plasma concentrations when co-administered with rifampin in a Phase 1 drug interaction study conducted in healthy volunteers
- 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.