Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Adverse drug reactions derived from spontaneous reports
Metabolism and Nutrition disorders section added
- Decreased appetite
- Concurrent and/or sequential use of TOBI with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and TOBI has not been evaluated.
Geriatric Use - new section added
- added ..... bronchospasm and hearing loss.
- cross-references to the “WARNINGS – Ototoxicity” and “WARNINGS – Bronchospasm” sections have been added