Label Changes for:
Levaquin (levofloxacin) Injection, for Intravenous Use
May 2008
Changes have been made to the WARNINGS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 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. |
| Sections Modified | Summary of Changes to Contraindications and Warnings |
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WARNINGS AND PRECAUTIONS Tendon Effects ...Postmarketing surveillance reports indicate that this risk is increased in patients receiving concomitant corticosteroids and in patients over 65 years of age. Levaquin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon... Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals Levaquin is indicated in pediatric patients (less than 18 years of age) only for the prevention of inhalational anthrax (post-exposure)... |
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
PATIENT COUNSELING INFORMATION
PATIENT PACKAGE INSERT
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Label approved 05/05/2008 is not available on Drugs@FDA
