• Bacterial infections

Bethkis Generic Name & Formulations

General Description

Tobramycin 300mg/4mL; amps; soln for inhalation; preservative-free.

Pharmacological Class


How Supplied

Single-use amps (4mL)—28, 56


Generic Availability


Mechanism of Action

Tobramycin, an aminoglycoside antibacterial, acts primarily by disrupting protein synthesis in the bacterial cell which eventually leads to death of the cell. Tobramycin has activity against a wide range of gram-negative bacteria including P. aeruginosa.

Bethkis Indications


Management of cystic fibrosis patients with P. aeruginosa.

Bethkis Dosage and Administration

Adults and Children

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

Bethkis Contraindications

Not Applicable

Bethkis Boxed Warnings

Not Applicable

Bethkis Warnings/Precautions


Safety and efficacy have not been demonstrated in patients with FEV1 <40% or >80% predicted, or those 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. Consider performing an audiogram at baseline (esp. at risk of auditory dysfunction). Monitor serum tobramycin levels only via venipuncture in patients with renal dysfunction or those treated with concomitant parenteral tobramycin. Discontinue if nephrotoxicity occurs; may restart when serum tobramycin <2mcg/mL. Neuromuscular disorders (eg, myasthenia gravis, Parkinson’s disease). Renal impairment. Elderly. Embryo-fetal toxicity. Pregnancy. Nursing mothers: monitor infants.

Bethkis Pharmacokinetics


The bioavailability of Bethkis may vary because of individual differences in nebulizer performance and airway pathology.


Following administration of Bethkis, tobramycin remains concentrated primarily in the airways. Binding of tobramycin to serum proteins is negligible.


Renal. Half-life: ~4.4 hours.

Bethkis Interactions


Avoid concurrent and/or sequential use with other oto-, nephro-, or neurotoxic drugs. Concomitant ethacrynic acid, furosemide, urea, IV mannitol: not recommended. Risk of prolonged respiratory paralysis with concomitant neuromuscular blockers. Do not mix in nebulizer with dornase alfa.

Bethkis Adverse Reactions

Adverse Reactions

Decrease in FEV1, rales, increase in RBC sedimentation rate, dysphonia, wheezing, epistaxis, bronchitis, tonsillitis; ototoxicity, vertigo, nephrotoxicity, bronchospasm.

Bethkis Clinical Trials

See Literature

Bethkis Note

Not Applicable

Bethkis Patient Counseling

See Literature