Label Changes for:

Cipro XR (ciprofloxacin extended-release tablets)

January 2008

Changes have been made to the PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT 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 Reactions
  • Postmarketing Adverse Experience
    • Photosensitivity/Phototoxicity Reaction

PATIENT PACKAGE INSERT

  • What are the possible side effects of Cipro XR?
    • Sun sensitivity (photosensitivity), which can appear as skin eruption or severe sunburn, can occur in some patients taking quinolone antibiotics after exposure to sunlight or artificial ultraviolet (UV) light (e.g., tanning beds). Cipro XR has been infrequently associated with photosensitivity...
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