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warnings
WARNINGS Caution should be exercised when prescribing tobramycin inhalation solution to patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction. Patients receiving concomitant parenteral aminoglycoside therapy should be monitored as clinically appropriate. Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use tobramycin inhalation solution during pregnancy, or become pregnant while taking tobramycin inhalation solution should be apprised of the potential hazard to the fetus. Ototoxicity Ototoxicity, as measured by complaints of hearing loss or by audiometric evaluations, did not occur with tobramycin inhalation solution therapy during clinical studies. However, transient tinnitus occurred in eight tobramycin inhalation solution-treated patients versus no placebo patients in the clinical studies. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution (see ADVERSE REACTIONS ). Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness. In postmarketing experience, patients receiving tobramycin inhalation solution have reported hearing loss. Some of these reports occurred in patients with previous or concomitant treatment with systemic aminoglycosides. Patients with hearing loss frequently reported tinnitus. Nephrotoxicity Nephrotoxicity was not seen during tobramycin inhalation solution clinical studies but has been associated with aminoglycosides as a class. If nephrotoxicity occurs in a patient receiving tobramycin inhalation solution, tobramycin therapy should be discontinued until serum concentrations fall below 2 mcg/mL. Muscular Disorders Tobramycin inhalation solution should be used cautiously in patients with neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, since aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. Bronchospasm Bronchospasm can occur with inhalation of tobramycin inhalation solution. In clinical studies of tobramycin inhalation solution, changes in FEV 1 measured after the inhaled dose were similar in the tobramycin inhalation solution and placebo groups. Bronchospasm should be treated as medically appropriate.
ADVERSE REACTIONS Tobramycin inhalation solution was generally well tolerated during two clinical studies in 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. Voice alteration and tinnitus were the only adverse experiences 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. Eight patients from the tobramycin inhalation solution group (3%) reported tinnitus compared to no placebo patients. All episodes were transient, resolved without discontinuation of the tobramycin inhalation solution treatment regimen, and were not associated with loss of hearing in audiograms. Tinnitus is one of the sentinel symptoms of cochlear toxicity, and patients with this symptom should be carefully monitored for high frequency hearing loss. The numbers of patients reporting vestibular adverse experiences such as dizziness were similar in the tobramycin inhalation solution and placebo groups. Nine (3%) patients in the tobramycin inhalation solution group and nine (3%) patients in the placebo group had increases in serum creatinine of at least 50% over baseline. In all nine patients in the tobramycin inhalation solution group, creatinine decreased at the next visit. Table 1 lists the percent of patients with treatment-emergent adverse experiences (spontaneously reported and solicited) that occurred in >5% of tobramycin inhalation solution patients during the two Phase III studies. Table 1: Percent of Patients With Treatment Emergent Adverse Experiences Occurring in >5% of Tobramycin Inhalation Solution, USP Patients Adverse Event 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 Asthenia 35.7 39.3 Rhinitis 34.5 33.6 Dyspnea 33.7 38.5 Fever Includes subjective complaints of fever. 32.9 43.5 Lung Disorder 31.4 31.3 Headache 26.7 32.1 Chest Pain 26.0 29.8 Sputum Discoloration 21.3 19.8 Hemoptysis 19.4 23.7 Anorexia 18.6 27.9 Lung Function Decreased Includes reported decreases in pulmonary function tests or decreased lung volume on chest radiograph associated with intercurrent illness or study drug administration. 16.3 15.3 Asthma 15.9 20.2 Vomiting 14.0 22.1 Abdominal Pain 12.8 23.7 Voice Alteration 12.8 6.5 Nausea 11.2 16.0 Weight Loss 10.1 15.3 Pain 8.1 12.6 Sinusitis 8.1 9.2 Ear Pain 7.4 8.8 Back Pain 7.0 8.0 Epistaxis 7.0 6.5 Taste Perversion 6.6 6.9 Diarrhea 6.2 10.3 Malaise 6.2 5.3 Lower Respiratory Tract Infection 5.8 8.0 Dizziness 5.8 7.6 Hyperventilation 5.4 9.9 Rash 5.4 6.1 Adverse drug reactions (<5%) occurring more frequently with tobramycin inhalation solution in the placebo-controlled studies and assessed as drug-related in ≥1% of patients: Ear and labyrinth disorders Tinnitus (3.1%, vs 0% for placebo) Musculoskeletal and connective tissue disorders Myalgia (4.7%, vs 2.7% for placebo) Infections and infestations Laryngitis (4.3%, vs 3.1% for placebo) Adverse drug reactions derived from spontaneous reports 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. Ear and labyrinth disorders Hearing loss (see WARNINGS –Ototoxicity) Skin and subcutaneous tissue disorders Hypersensitivity, pruritus, urticaria, rash Nervous system disorders Aphonia, dysgeusia Respiratory, thoracic, and mediastinal disorders Bronchospasm (see WARNINGS –Bronchospasm), oropharyngeal pain, sputum increased, chest pain Metabolism and Nutrition Disorders Decreased appetite