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BETHKIS® (Tobramycin Inhalation Solution)

Patient and physician resources

The resources below have been made available so that you and your patients can increase your knowledge of BETHKIS. In the future, more resources will be added to provide more opportunities for you and your patients.

Boomer Esiason Foundation
www.esiason.org
Cystic Fibrosis Foundation
www.cff.org
CF Living
www.cfliving.com
Cystic Fibrosis Research Inc
www.cfri.org
CysticFibrosis.com
www.cysticfibrosis.com
Cystic Fibrosis Worldwide
www.cfww.org

 

Patient Welcome Brochure

An informative brochure is available to help you transition your patients to BETHKIS.

 

Important Safety Information

BETHKIS® (Tobramycin Inhalation Solution) 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.

Indication

BETHKIS 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.

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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