Label Changes for:
Noroxin (norfloxacin) 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) – September and October 2011
October 2011
WARNINGS
Central Nervous System Effects/ Disorders:
- added......Convulsions have been reported in patients receiving norfloxacin. Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychoses have been reported in patients receiving drugs in this class.
September 2011
MEDICATION GUIDE
- increased risk of tendon rupture or swelling of the tendon (tendinitis) from the use of fluoroquinolones.
