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U.S. Department of Health and Human Services

Safety

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Tobi (tobramycin inhalation solution, USP) 300mg/5mL

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

September 2013

Summary View

PRECAUTIONS

Geriatric Use - new section added

ADVERSE REACTIONS

  • added ..... bronchospasm and hearing loss.
  • cross-references to the “WARNINGS – Ototoxicity” and “WARNINGS – Bronchospasm” sections have been added