Label Changes for:

Ciprofloxacin Tablets Ciprofloxacin IV for Inusion Vial Ciprofloxacin 0.2 % Solution in 5% Dextrose Ciprofloxacin Oral Suspension Cipro XR Tablets

October 2011

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009 and October 2011

 

October 2011

 

Ciprofloxacin Tablets

Ciprofloxacin IV for Inusion Vial

Ciprofloxacin 0.2 % Solution in 5% Dextrose

Ciprofloxacin Oral Suspension

Cipro XR Tablet

 

WARNINGS

Central Nervous System Effects/ Disorders
  • ... Increased intracranial pressure (including pseudotumor cerebri)

 

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. Read about the new physician labeling format.
 
 
April 2009

 

Summary View

 

Brand (Generic) Name

Sections Modified

Cipro (ciprofloxacin hydrochloride) Tablets

 

Cipro IV (ciprofloxacin) 1% Solution in Vials

 

Cipro IV (ciprofloxacin) 0.2% Solution in 5% Dextrose

 

Cipro (ciprofloxacin) Oral 

 

Cipro XR (ciprofloxacin extended-release tablets)

MEDICATION GUIDE

“new safety information” with the use of Cipro, particularly the increased risks of tendonitis and tendon rupture.

  • What is the most important information I should know about Cipro?
    • Tendon rupture or swelling of the tendon (tendinitis)

 

 

 

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