Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Pediatrics/Neonatology | Pulmonary/Respiratory Diseases | Hepatology (Liver, Pancreatic, Gall Bladder) | Genetic Disease
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved December 1997
Treatment Area: cystic fibrosis
Tobi (tobramycin) has been approved as an inhaled antibiotic for
the treatment of cystic fibrosis. It is indicated to treat
Pseudomonas aeruginose infections, a common cause of lung
infections in cystic fibrosis patients. The drug has been available
intravenously since 1975.
Clinical trials demonstrated an increase in patients' lung
function to be as much as 11% during six months of treatment. Of
the approximate 500 patients studied, hospital admission were
reduced by 26% and stays averaged 5.1 days for Tobi patients
compared with 8.1 for placebo patients.
The main side effects were hoarseness and tinnitus. Eight Tobi
patients had 16 episodes of tinnitus, while there were none in the
placebo group. There was no evidence of hearing loss, but the FDA
cautioned that tinnitus could be a preliminary indication of