Kitabis Pak

  • Bacterial infections

Kitabis Pak Generic Name & Formulations

General Description

Tobramycin 300mg/5mL; per amp; soln for oral inhalation; preservative-free.

Pharmacological Class


How Supplied

Kit—1 (nebulizer + 56 single-dose amps)


Generic Availability


Mechanism of Action

Tobramycin is an aminoglycoside antibacterial produced by Streptomyces tenebrarius. It acts primarily by disrupting protein synthesis, leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death.

Kitabis Pak Indications


Management of cystic fibrosis patients with P. aeruginosa.

Kitabis Pak Dosage and Administration

Adults and Children

<6yrs: not established. 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.

Kitabis Pak Contraindications

Not Applicable

Kitabis Pak Boxed Warnings

Not Applicable

Kitabis Pak 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. Auditory/vestibular dysfunction; monitor closely; if ototoxicity occurs, manage and discontinue if appropriate. Consider obtaining audiometric evaluations and serum tobramycin levels. 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 nephrotoxic drugs or IV aminoglycosides. Consider discontinuing if nephrotoxicity occurs. Elderly. Embryo-fetal toxicity. Pregnancy. Nursing mothers: monitor infant.

Kitabis Pak Pharmacokinetics


Average sputum concentration: 1237 mcg/g (ranging from 35–7414 mcg/g).

Average serum concentration 1 hour after inhalation: 0.95 mcg/mL.


Following administration, tobramycin remains concentrated primarily in the airways.

Plasma protein binding: negligible.


Renal. Half-life: 2–3 hours.

Kitabis Pak 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.

Kitabis Pak Adverse Reactions

Adverse Reactions

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

Kitabis Pak Clinical Trials

See Literature

Kitabis Pak Note

Not Applicable

Kitabis Pak Patient Counseling

See Literature