Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Common adverse reactions (more than 5%) occurring more frequently in Tobramycin Inhalation Solution patients are forced expiratory volume decreased, rales, red blood cell sedimentation rate increased, and dysphonia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Tobramycin Inhalation Solution in two placebo-controlled studies in 305 cystic fibrosis patients.
Patients receiving Tobramycin Inhalation Solution ranged in age from 6 to 31 years.
In Study 1, an eight week study, 29 patients received Tobramycin Inhalation Solution versus 30 patients who received placebo for a total of four weeks on drug and four weeks off drug.
All patients were ≤ 30 years of age (mean age 12.6 years) and 46% were females.
52.5% of patients were 6 to 12 years of age while 30.5% of patients were 13-17 years old.
Only 16.5% of patients were adults (> 17 years old).
Eighty percent (80%) of patients were chronically colonized with Pseudomonas aeruginosa while 20.3% of patients were initially or intermittently colonized with Pseudomonas aeruginosa during the study.
5 WARNINGS AND PRECAUTIONS Caution should be exercised when prescribing Tobramycin Inhalation Solution to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction.
( 5.1 , 5.2 , 5.3 and 5.5 ) Aminoglycoside may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.
( 5.3 ) Bronchospasm can occur with inhalation of Tobramycin Inhalation Solution.
( 5.4 ) Audiograms, serum concentration, and renal function should be monitored as appropriate.
( 5.2 and 5.5 ) Fetal harm can occur when aminoglycosides are administered to a pregnant woman.
Like all medications, Tobramycin Inhalation can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: