Kitabis Pak

Safety and efficacy have not been demonstrated in patients <6yrs, in those with FEV₁ <25% or >75% predicted, or patients colonized with B. cepacia. Auditory/vestibular dysfunction; monitor closely; if ototoxicity occurs, manage and discontinue if appropriate. Consider obtaining audiometric evaluations and serum tobramycin levels. 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 nephrotoxic drugs or IV aminoglycosides. Consider discontinuing if nephrotoxicity occurs. Elderly. Embryo-fetal toxicity. Pregnancy. Nursing mothers: monitor infant.