Monograph Details
|
|
Infections & Infestations
> Bacterial infections
|
|
TOBI |
| Manufacturer |
|
Chiron Corporation |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Aminoglycoside. |
| Generic Name |
|
Tobramycin 300mg/5mL; amps; soln for inhalation; preservative-free. |
| Indications |
|
Management of cystic fibrosis patients with P. aeruginosa. |
| Adults and Children |
|
<6yrs: see literature. Use the correct nebulizer/compressor. Give in alternate 28-day cycles (28 days on, 28 days off). ≥6yrs: 300mg (1 amp) by inhalation over 10–15 minutes twice daily, as close to every 12 hrs as possible (must be at least 6 hrs apart). Give last when using multiple inhalation therapies. |
| Precautions |
Safety and efficacy not established in patients colonized with B. cepacia or in those with baseline FEV1 <25% or >75% predicted. Auditory, vestibular, renal, or neuromuscular dysfunction. Monitor renal function; withhold if nephrotoxicity occurs (may restart when serum tobramycin ≤2micrograms/mL). Do audiogram and reevaluate if auditory dysfunction (eg, tinnitus) or vestibular toxicity (eg, vertigo) occurs. Monitor for high frequency hearing loss if tinnitus occurs. Monitor serum tobramycin levels or if used with other aminoglycosides or other nephrotoxic drugs. Pregnancy (Cat.D). Nursing mothers.
|
| Interactions |
|
Concomitant ethacrynic acid, furosemide, urea, mannitol: not recommended. Diuretics may increase toxicity. Avoid concurrent or sequential use of other oto- or nephrotoxic drugs. Do not mix in nebulizer with dornase alfa. |
| Adverse Reactions |
|
Voice alteration, tinnitus (follow-up if occurs), bronchospasm. |
| How Supplied |
|
Single-use amps (5mL)—56 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
