Bethkis

Safety and efficacy have not been demonstrated in patients with FEV₁ <40% or >80% predicted, or those 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. Consider performing an audiogram at baseline (esp. at risk of auditory dysfunction). Monitor serum tobramycin levels only via venipuncture in patients with renal dysfunction or those treated with concomitant parenteral tobramycin. Discontinue if nephrotoxicity occurs; may restart when serum tobramycin <2mcg/mL. Neuromuscular disorders (eg, myasthenia gravis, Parkinson’s disease). Renal impairment. Elderly. Embryo-fetal toxicity. Pregnancy. Nursing mothers: monitor infants.