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 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 Dr.
REDDY’S LABORATORIES Inc., at 1-888-375-3784 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 46.1 47.3 Pharyngitis 38.0 39.3 Sputum Increased 37.6 39.7 Dyspnea 33.7 38.5 Hemoptysis 19.4 23.7 Lung Function Decreased 1 16.3 15.3 Voice Alteration 12.8 6.5 Taste Perversion 6.6 6.9 Rash 5.4 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.
Voice alteration was more common in the on-drug periods.
5 WARNINGS AND PRECAUTIONS Bronchospasm: Can occur with inhalation of tobramycin inhalation solution.
Treat as medically appropriate, if it occurs.
( 5.1 ) Ototoxicity: Tinnitus and hearing loss have been reported in patients receiving tobramycin inhalation solution.
If noted, manage as medically appropriate, including potentially discontinuing tobramycin inhalation solution.
( 5.2 ) Nephrotoxicity: Has been associated with aminoglycosides as a class.
Like all medications, Tobramycin Inhalation Solution 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: