Tobi Podhaler

  • Bacterial infections

Tobi Podhaler Generic Name & Formulations

General Description

Tobramycin 28mg; per cap; dry pwd for oral inhalation; with Podhaler device.

Pharmacological Class


How Supplied

Caps—8, 56, 224 (w. Podhaler device)

Mechanism of Action

Tobramycin acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death.

Tobi Podhaler Indications


Management of cystic fibrosis patients with P. aeruginosa.

Tobi Podhaler Dosage and Administration

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 Contraindications

Not Applicable

Tobi Podhaler Boxed Warnings

Not Applicable

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 Pharmacokinetics


Binding of tobramycin to serum proteins is negligible.


Renal. Half-life: ~3 hours.

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.

Tobi Podhaler Adverse Reactions

Adverse Reactions

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

Tobi Podhaler Clinical Trials

See Literature

Tobi Podhaler Note

Not Applicable

Tobi Podhaler Patient Counseling

See Literature