Label Changes for:

Cipro I.V. (ciprofloxacin) For Intravenous Infusion

January 2008

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


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

PRECAUTIONS

  • Photosensitivity/Phototoxicity
    • Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions...
  • Information for Patients
    • Patients should be advised: that photosensitivity/phototoxicity has been reported in patients receiving quinolones...

ADVERSE REACTIONS

  • Skin/Hypersensitivity
    • Photosensitivity/Phototoxicity Reaction
  • Postmarketing Adverse Events
    • Photosensitivity/Phototoxicity Reaction
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