Label Changes for:

Avelox Tablets and Injection

December 2008

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- December 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

  • QT prolongation

ADVERSE REACTIONS

ADVERSE EVENTS/Post-Marketing Adverse Event Reports

WARNINGS

.....In addition, moxifloxacin should be used with caution in patients with mild, moderate, or severe liver cirrhosis.

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