Indications for TOBI Podhaler:
Management of cystic fibrosis patients with P. aeruginosa.
Adults and Children:
<6yrs: not established. For oral inhalation use only with Podhaler device; do not swallow caps. Give in alternate 28-day cycles (28 days on, 28 days off). ≥6yrs: Inhale contents of 4 caps 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 >80% 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 serum tobramycin levels in auditory or renal dysfunction patients, or if used with other aminoglycosides (or other nephrotoxic or ototoxic drugs) as needed. Discontinue if ototoxicity or 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 concomitant and/or sequential use with other neurotoxic, nephrotoxic, or ototoxic drugs.
Cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, headache; hearing loss, tinnitus, nephrotoxicity, bronchospasm.
Caps—8, 56, 224 (w. Podhaler device)