BETHKIS® (Tobramycin Inhalation Solution) is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia.
Important Safety Information
BETHKIS is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
Bronchospasm can occur with inhalation of BETHKIS. Bronchospasm and wheezing should be treated as medically appropriate.
Caution should be exercised when prescribing BETHKIS to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. Audiograms, serum concentration, and renal function should be monitored as appropriate.
Avoid concurrent and/or sequential use of BETHKIS with other drugs with neurotoxic or ototoxic potential.
BETHKIS should not be administered concurrently with ethacrynic acid, furosemide, urea, or mannitol.
Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.
Fetal harm can occur when aminoglycosides are administered to a pregnant woman. Apprise women of the potential hazard to the fetus.
Common adverse reactions (more than 5%) occurring more frequently in BETHKIS patients are forced expiratory volume decreased, rales, red blood cell sedimentation rate increased, and dysphonia.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full prescribing information.
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References: 1. BETHKIS [package insert]. Cary, NC: Chiesi USA, Inc.; 2014. 2. TOBI [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2009. 3. Chuchalin A, Csiszér E, Gyurkovics K, et al. A formulation of aerosolized tobramycin (Bramitob®) in the treatment of patients with cystic fibrosis and Pseudomonas aeruginosa infection: a double-blind, placebo-controlled, multicenter study. Pediatr Drugs. 2007;9(suppl 1):21-31. 4. Poli G, Acerbi D, Pennini R, et al. Clinical pharmacology study of Bramitob, a tobramycin solution for nebulization, in comparison with Tobi®. Pediatr Drugs. 2007;9(suppl 1):3-9. 5. Data on file. Chiesi USA, Inc. 6. Lenoir G, Antypkin YG, Miano A, et al. Efficacy, safety, and local pharmacokinetics of highly concentrated nebulized tobramycin in patients with cystic fibrosis colonized with Pseudomonas aeruginosa. Pediatr Drugs. 2007;9(suppl 1):11-20.