Tobi Podhaler

Safety and efficacy have not been demonstrated in patients <6yrs, in those with FEV1 <25% or >80% predicted, or patients colonized with B. cepacia. Auditory/vestibular dysfunction; monitor closely; if ototoxicity occurs, manage and discontinue if appropriate. Risk for ototoxicity (known maternal history of ototoxicity due to aminoglycoside use or mitochondrial DNA variants); consider alternative therapies. Renal dysfunction or neuromuscular disorders (eg, myasthenia gravis, Parkinson's disease); monitor closely. Monitor serum tobramycin levels in renal dysfunction patients or if treated with concomitant IV aminoglycosides. Consider discontinuing if nephrotoxicity occurs. Elderly. Embryo-fetal toxicity. Pregnancy. Nursing mothers: monitor infants.