Tobramycin Side Effects

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Bronchospasm [see Warnings and Precautions ( 5.1 )] Ototoxicity [see Warnings and Precautions ( 5.2 )] Nephrotoxicity [see Warnings and Precautions ( 5.3 )] Neuromuscular Disorders [see Warnings and Precautions ( 5.4 )] Embryo-fetal Toxicity [see Warnings and Precautions ( 5.5 )] Concomitant Use of Systemic Aminoglycosides [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (incidence >5%) are increased cough, pharyngitis, increased sputum, dyspnea, hemoptysis, decreased lung function, voice alteration, taste perversion and rash.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc.

at 1-855-839-8195 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tobramycin inhalation solution was studied in two Phase 3 clinical studies involving 258 cystic fibrosis patients ranging in age from 6 to 48 years.

Patients received tobramycin inhalation solution in alternating periods of 28 days on and 28 days off drug in addition to their standard cystic fibrosis therapy for a total of 24 weeks.

Table 1 lists the percent of patients with selected adverse reactions that occurred in >5% of tobramycin inhalation solution patients during the two Phase 3 studies.

Table 1: Percent of Patients With Selected Adverse Reactions Occurring in >5% of Tobramycin Inhalation Solution Patients Adverse Reaction Tobramycin Inhalation Solution (n=258) % Placebo (n=262) % Cough Increased Pharyngitis Sputum Increased Dyspnea Hemoptysis Lung Function Decreased 1 Voice Alteration Taste Perversion Rash 46.1 38.0 37.6 33.7 19.4 16.3 12.8 6.6 5.4 47.3 39.3 39.7 38.5 23.7 15.3 6.5 6.9 6.1 1 Includes reported decreases in pulmonary function tests or decreased lung volume on chest radiograph associated with intercurrent illness or study drug administration.

Selected adverse reactions that occurred in less than or equal to 5% of patients treated with tobramycin inhalation solution: Ear and Labyrinth Disorders: Tinnitus Musculoskeletal and Connective Tissue Disorders: Myalgia Infections and Infestations: Laryngitis Voice Alteration and Tinnitus Voice alteration and tinnitus were the only adverse reactions reported by significantly more tobramycin inhalation solution-treated patients.

Thirty-three patients (13%) treated with tobramycin inhalation solution complained of voice alteration compared to 17 (7%) placebo patients.