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TOBI
Bacterial infections
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Drug Name:

TOBI Rx

Generic Name and Formulations:
Tobramycin 300mg/5mL; per amp; soln for oral inhalation; preservative-free.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

Indications for TOBI:

Management of cystic fibrosis patients with P. aeruginosa.

Adults and Children:

<6yrs: not established. Use the correct nebulizer/compressor. Administer by oral inhalation over a 15-minute period. Give in alternate 28-day cycles (28 days on, 28 days off). ≥6yrs: 300mg (1 amp) twice daily, as close to every 12hrs as possible (must be at least 6hrs apart). Give last when using multiple inhalation therapies.

Warnings/Precautions:

Safety and efficacy have not been demonstrated in patients <6yrs, in those with FEV1 <25% or >75% predicted, or patients colonized with B. cepacia. Known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. Myasthenia gravis. Parkinson's disease. Consider obtaining audiometric evaluations at baseline (esp. at risk of auditory dysfunction). Monitor for high frequency hearing loss if tinnitus occurs. Monitor serum tobramycin levels in renal dysfunction patients or if treated with concomitant nephrotoxic drugs. Consider discontinuing if nephrotoxicity occurs. Monitor renal function as needed. Elderly. Pregnancy. Nursing mothers: monitor infant.

Pharmacological Class:

Aminoglycoside.

Interactions:

Concomitant ethacrynic acid, furosemide, urea, IV mannitol: not recommended. Diuretics may increase toxicity. Avoid concurrent or sequential use with other oto-, neuro-, or nephrotoxic drugs. Monitor with concomitant systemic aminoglycosides. Do not mix in nebulizer with dornase alfa.

Adverse Reactions:

Increased cough, pharyngitis, increased sputum, dyspnea, hemoptysis, decreased lung function, voice alteration, taste perversion, rash; tinnitus (monitor if occurs), bronchospasm.

Generic Availability:

YES

How Supplied:

Single-dose amps (5mL)—56

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