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
| 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.
|
