Label Changes for:

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

September 2013

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

September 2013

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
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