Label Changes for:
Noroxin (norfloxacin) Tablets
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
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.
- increased risk of tendon rupture or swelling of the tendon (tendinitis) from the use of fluoroquinolones.