Generic Name and Formulations:
Tobramycin 300mg/4mL; amps; soln for inhalation; preservative-free.
Chiesi USA, Inc.
Indications for BETHKIS:
Management of cystic fibrosis patients with P. aeruginosa.
Adults and Children:
<6yrs: not established. Use the correct nebulizer/compressor. Give in alternate 28-day cycles (28 days on, 28 days off). ≥6yrs: 300mg (1 amp) by oral inhalation over 15 minutes twice daily, as close to every 12 hours as possible (must be at least 6 hours apart). Give last when using multiple inhalation therapies.
Safety and efficacy have not been demonstrated in patients with FEV1 <40% or >80% predicted, or those colonized with B. cepacia. Known or suspected auditory, vestibular, or renal dysfunction. Myasthenia gravis. Parkinson’s disease. Bronchospasm. 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. Monitor renal function as needed. Elderly. Pregnancy (Cat.D). Nursing mothers: not recommended.
Concomitant ethacrynic acid, furosemide, urea, IV mannitol: not recommended. Avoid concurrent and/or sequential use with other oto-, nephro-, or neurotoxic drugs. Do not mix in nebulizer with dornase alfa.
Decrease in FEV1, rales, increase in RBC sedimentation rate, dysphonia, wheezing, epistaxis, bronchitis, tonsillitis; ototoxicity, vertigo, nephrotoxicity.
Single-use amps (4mL)—28, 56