Generic Name and Formulations:
Tobramycin 300mg/5mL; amps; soln for inhalation; preservative-free.
Novartis Pharmaceuticals Corp
Indications for TOBI:
Management of cystic fibrosis patients with P. aeruginosa.
Adults and Children:
<6yrs: not studied. Use the correct nebulizer/compressor. Administer by inhalation over a 15-minute period. Give in alternate 28-day cycles (28 days on, 28 days off). ≥6yrs: 300mg (1 amp) twice daily, as close to every 12hrs as possible (must be at least 6hrs apart). Give last when using multiple inhalation therapies.
Safety and efficacy have not been demonstrated in patients <6yrs, in those with FEV1 <25% or >75% predicted, or patients colonized with B. cepacia. Known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. Myasthenia gravis. Parkinson's disease. Consider performing an audiogram at baseline (esp. at risk of auditory dysfunction). Monitor for high frequency hearing loss if tinnitus occurs. Monitor serum tobramycin levels in renal dysfunction patients or if treated with concomitant IV tobramycin. Discontinue if nephrotoxicity occurs; may restart when serum tobramycin <2µg/mL. Monitor renal function as needed. Elderly. Pregnancy (Cat.D). Nursing mothers: not recommended.
Concomitant ethacrynic acid, furosemide, urea, IV mannitol: not recommended. Diuretics may increase toxicity. Avoid concurrent or sequential use of other oto-, neuro-, or nephrotoxic drugs. Do not mix in nebulizer with dornase alfa.
Voice alteration, tinnitus (follow-up if occurs), bronchospasm.
Single-use amps (5mL)—56
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