Bacterial infections:

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.

TOBI Podhaler Warnings/Precautions:

Safety and efficacy have not been demonstrated in patients <6yrs, in those with FEV1 <25% or >80% predicted, or patients 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. Renal dysfunction or neuromuscular disorders (eg, myasthenia gravis, Parkinson's disease); monitor closely. Monitor serum tobramycin levels in renal dysfunction patients or if treated with concomitant IV aminoglycosides. Consider discontinuing if nephrotoxicity occurs. Elderly. Embryo-fetal toxicity. Pregnancy. Nursing mothers: monitor infants.

TOBI Podhaler Classification:


TOBI Podhaler Interactions:

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.

Adverse Reactions:

Cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, headache; hearing loss, tinnitus, nephrotoxicity, bronchospasm.

Drug Elimination:

Renal. Half-life: ~3 hours.

How Supplied:

Caps—8, 56, 224 (w. Podhaler device)