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. 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.
Avoid concurrent and/or sequential use with other oto-, nephro-, or neurotoxic drugs. Concomitant ethacrynic acid, furosemide, urea, IV mannitol: not recommended. Risk of prolonged respiratory paralysis with concomitant neuromuscular blockers. 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, bronchospasm.
Renal. Half-life: ~4.4 hours.
Generic Drug Availability:
Single-use amps (4mL)—28, 56