Label Changes for:
Tobi (tobramycin inhalation solution, USP) 300mg/5mL
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)
Geriatric Use - new section added
- added ..... bronchospasm and hearing loss.
- cross-references to the “WARNINGS – Ototoxicity” and “WARNINGS – Bronchospasm” sections have been added