Safety

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

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

October 2015

Summary View

ADVERSE REACTIONS

Adverse drug reactions derived from spontaneous reports

Metabolism and Nutrition disorders section added
  • Decreased appetite

 

April 2014

Summary View

PRECAUTIONS

Drug Interactions
  • 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.

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

 

Page Last Updated: 11/13/2015
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