Medical Editor: John P. Cunha, DO, FACOEP
- changes in the patient's voice
- decrease in lung function
- sore throat
- difficulty speaking
- diarrhea, and
- increased immunoglobins
Bethkis should be taken twice daily by mouth in repeated cycles of 28 days on, followed by 28 days off. Bethkis may interact with Edecrin (ethacrynic acid), Lasix (furosemide), urea, or mannitol. Bethkis should not be taken with drugs known to be toxic to structures within the ears, or drugs known to be toxic to nerves or nerve tissues. Bethkis may harm a fetus if taken while pregnant. Breastfeeding mothers should talk with their doctors to decide where to discontinue drug or continue breastfeeding.
Our Bethkis (tobramycin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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 BETHKIS in two placebo-controlled studies in 305 cystic fibrosis patients. Patients receiving BETHKIS ranged in age from 6 to 31 years.
In Study 1, an eight week study, 29 patients received BETHKIS 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.
More patients in the placebo group discontinued/dropped out of Study 1 than in the BETHKIS group (23% [7/30] vs 3.4% [1/29], respectively). Five patients in the placebo group compared to none in the BETHKIS group discontinued/dropped out because of treatment-emergent adverse events (TEAEs) such as pulmonary exacerbations and respiratory disorders.
In Study 2, a 24 week study, 161 patients received BETHKIS versus 85 patients who received placebo in alternating four week on-off cycles for three cycles. All patients were ≤ 46 years of age (mean age 14.8 years) and 45% were females. 41% of patients were 612 years old while 29% of patients were 13-17 years old. Only 30% were adults (>17 years). Eighty-seven percent (87%) of patients were chronically colonized with P. aeruginosam. Only 13% were either initially or intermittently colonized with P. aeruginosam during the study.
More patients in the placebo group discontinued/dropped out of Study 2 than in the BETHKIS group (9.4% [8/85] vs 4.3% [7/161], respectively). Of these, 3 patients in the BETHKIS group (1.9%) compared to 2 patients in the placebo group (2.4%) withdrew due to a TEAE. The most common TEAEs causing patients to discontinue from the study drug are respiratory, thoracic, and mediastinal disorders.
The most common adverse experiences reported were respiratory disorders, consistent with the underlying disease in the patient population being evaluated and these were similarly distributed between both BETHKIS- and placebo-treated patients. The following adverse reactions were reported in at least 5% of Bethkis-treated patients and at rates ≥ 2% more common compared to the placebo-treated patients: decreased forced expiratory volume, rales, red blood cell sedimentation rate increased, and dysphonia (Table 1).
Table 1: Patients with Selected Treatment-Emergent Adverse Reactions Occurring in ≥ 2% of BETHKIS Patients
|Forced expiratory volume decreased||59 (31%)||33 (29%)|
|Rales||36 (19%)||18 (16%)|
|Red blood cell sedimentation rate increased||16 (8%)||6 (5%)|
|Dysphonia||11 (6%)||2 (2%)|
|Wheezing||10 (5%)||4 (4%)|
|Pharyngolaryngeal pain||5 (3%)||2 (2%)|
|Bronchitis||5 (3%)||1 (1%)|
|Diarrhea||3 (2%)||1 (1%)|
|Immunoglobulins increased||3 (2%)||0|
The following adverse reactions have been identified during postapproval use of tobramycin inhalation solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous system disorders: Aphonia, dysgeusia
Respiratory, thoracic, and mediastinal disorders: Bronchospasm (see WARNINGS AND PRECAUTIONS, Bronchospasm), oropharyngeal pain
Metabolism and Nutrition Disorders: Decreased appetite
Read the entire FDA prescribing information for Bethkis (Tobramycin Inhalation Solution)
© Bethkis Patient Information is supplied by Cerner Multum, Inc. and Bethkis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.