TOBRAMYCIN- tobramycin_solution

Tobramycin inhalation solution is an aminoglycoside antibacterial [see Clinical Pharmacology ( 12. 4 Tobramycin inhalation solution contains tobramycin, a cationic polar molecule that does not readily cross epithelial membranes. 1 2 Sputum Concentrations Thirty minutes after inhalation of the first 300 mg dose of tobramycin inhalation solution, the maximum geometric mean concentration of tobramycin was 814 mcg/g (ranging from 23 to 2843 mcg/g) in sputum. High variability of tobramycin concentration in sputum was observed. Three hours after inhalation started, sputum tobramycin concentrations declined to approximately 15% of those observed at 30 minutes. After four weeks of therapy with tobramycin inhalation solution average mean sputum tobramycin concentrations obtained 10 minutes following administration were 717 mcg/g. Distribution Following administration of tobramycin inhalation solution, tobramycin remains concentrated primarily in the airways. Binding of tobramycin to serum proteins is negligible. Elimination Tobramycin is not metabolized. The elimination half-life of tobramycin from serum is approximately two hours after intravenous (IV) administration. The elimination half-life following the inhalation of tobramycin inhalation solution is approximately 4. Assuming tobramycin absorbed following inhalation behaves similarly to tobramycin following intravenous administration, systemically absorbed tobramycin is eliminated principally by glomerular filtration. Unabsorbed tobramycin following inhalation is likely eliminated in expectorated sputum. Mechanism of Action Tobramycin, an aminoglycoside antibacterial, acts primarily by disrupting protein synthesis in the bacterial cell which eventually leads to death of the cell. Tobramycin has activity against a wide range of gram-negative bacteria including P. aeruginosa Mechanism of Resistance The predominant mechanism of resistance to tobramycin in P. aeruginosa P. aeruginosa Cross Resistance Cross resistance between aminoglycosides exists but the cross resistance is variable. Development of Resistance Treatment for six months with tobramycin inhalation solution in one clinical trial did not affect the susceptibility of the majority of P. aeruginosa Susceptibility Testing The clinical microbiology laboratory should provide cumulative results of the in vitro Susceptibility Testing Techniques Dilution Techniques Quantitative methods can be used to determine the minimum inhibitory concentration (MIC) of tobramycin that will inhibit the growth of the bacteria being tested. The MIC provides an estimate of the susceptibility of bacteria to tobramycin. The MIC should be determined using a standardized procedure. 3, 5 Diffusion Techniques Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure requires the use of standardized inoculum concentrations. 4, 5 Susceptibility Test Interpretive Criteria In vitro in vitro Quality Control Parameters for Susceptibility Testing In vitro Table 2: Acceptable Quality Control Ranges for Tobramycin Bacteria MIC Range (mcg/mL) Disk Diffusion Zone Diameter (mm) Pseudomonas aeruginosa ATCC 27853 0. 25 to 1 19 to 25 Other No trends in the treatment-emergent isolation of other bacterial respiratory pathogens such as Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans, Staphylococcus aureus Candida spp.

Tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa 1 Burkholderia cepacia [see Clinical Studies ( 14 Tobramycin inhalation solution is an inhaled aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa 1 Safety and efficacy have not been demonstrated in patients under the age of six years, patients with a forced expiratory volume in one second (FEV 1 Burkholderia cepacia 1.

DOSAGE AND ADMINISTRATION
For oral inhalation only ( 2. 1 Administer the entire contents of one ampule twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug. 1 Tobramycin inhalation solution is for oral inhalation only [see Dosage and Administration ( 2. 2 The 300 mg/4 mL dose of tobramycin inhalation solution is the same for patients regardless of age or weight. Tobramycin inhalation solution has not been studied in patients less than six years old. If patients miss a dose, they should take it as soon as possible anytime up to 6 hours prior to their next scheduled dose. If less than 6 hours remain before the next dose, wait until their next scheduled dose. Tobramycin inhalation solution is administered by oral inhalation using a hand-held PARI LC PLUS Reusable Nebulizer with a PARI Vios Air compressor over an approximately 15 minute period and until sputtering from the output of the nebulizer has occurred for at least one minute. Tobramycin inhalation solution should not be diluted or mixed with dornase alfa or other medications in the nebulizer. Tobramycin inhalation solution is not Further patient instructions on how to administer tobramycin inhalation solution are provided in the Patient’s Instructions for Use [see Patient Counseling Information ( 17 Tobramycin inhalation solution should not be used if it is cloudy, if there are particles in the solution, or if it has been stored at room temperature for more than 28 days.
INSTRUCTIONS FOR USE
Tobramycin (toe" bra mye'' sin) Inhalation Solution, USP Follow the instructions below for taking tobramycin inhalation solution. If you have any questions, ask your healthcare provider or pharmacist. Tobramycin inhalation solution is available as a 28-day supply containing 56 ampules including 14 foil pouches and as a 14-day supply containing 28 ampules including 7 foil pouches. Each foil pouch contains 4 tobramycin inhalation solution ampules. Supplies you will need to take tobramycin inhalation solution (See Figure A): 1 ampule of tobramycin inhalation solution PARI LC PLUS reusable nebulizer PARI Vios compressor tubing to connect the nebulizer and compressor clean paper or cloth towels nose clips (optional) (Figure A) Tobramycin inhalation solution is used only in a PARI LC PLUS re-usable Nebulizer connected to a PARI LC PLUS Vios air compressor. Make sure you know how to use your nebulizer machine before you use it to breathe in tobramycin inhalation solution. Do not Tobramycin inhalation solution comes in a sealed foil pouch. Do not open a sealed pouch until you are ready to use a dose of tobramycin inhalation solution. After opening the pouch, unused ready-to-use ampules should be returned to, and stored in, the pouch. Getting ready: Put your PARI LC PLUS Reusable Nebulizer Top and Bottom (Nebulizer Cup) Assembly, Inspiratory Valve Cap, Mouthpiece with Valve, and Tubing on a clean and dry surface. Wash your hands with soap and water. Preparing your tobramycin inhalation solution dose: Step 1: (Figure B) Step 2: (Figure C) Step 3: Do not squeeze the ampule until you are ready to squeeze all the medicine into the Nebulizer Cup. (Figure D) Step 4: (See Figure E). Set the Top aside on a clean, dry surface. (Figure E) Step 5: (Figure F) Step 6: Nebulizer Cup Top in a clock-wise direction until it is tight. (See Figure G). (Figure G) Step 7: (Figure H) Step 8: Inspiratory Valve Cap should fit tightly. (Figure I) Step 9: (Figure J) Step 10: (Figure K) Step 11: Intake on the bottom of the Nebulizer Cup (See Figure L). Make sure to keep the Nebulizer Cup upright. (Figure L) Giving your tobramycin inhalation solution dose: Step 12: from the Mouthpiece (Figure N). If you do not see a steady mist coming from the mouthpiece, check all tubing connections and make sure that the compressor is working the right way. (Figure M) (Figure N) Step 13: Mouthpiece between your teeth and on top of your tongue and breathe normally only through your mouth (See Figure O). Nose clips may help you breathe only through your mouth and not through your nose. (Figure O) Step 14: 1 minute and the Nebulizer Cup is empty. After your tobramycin inhalation solution dose: Step 15: Care and Use of Your PARI Vios registered Follow the manufacturer’s instructions for care and use of your compressor. How should I store tobramycin inhalation solution? Store tobramycin inhalation solution in the refrigerator at 36°F to 46°F (2°C to 8°C) until needed. After removing from the refrigerator, or if refrigeration is not available, tobramycin inhalation solution foil pouches (opened or unopened) may be stored at room temperature up to If tobramycin inhalation solution is not stored in the refrigerator but at room temperature up to 77 °F (25 °C) it may turn dark. If tobramycin inhalation solution turns dark, it does not change how well tobramycin inhalation solution works. Tobramycin inhalation solution can still be used as long as it is stored at room temperature up to Do not use tobramycin inhalation solution after the expiration date printed on the ampule. Keep tobramycin inhalation solution ampules in the foil pouch and away from light. Return unopened ampules to the foil pouch Keep tobramycin inhalation solution and all medicines out of the reach of children. This Patient Information and Instructions for Use have been approved by the U. Food and Drug Administration. Brands listed are the trademark of their respective owners. Manufactured In England By: Norton Healthcare Limited T/A IVAX Pharmaceuticals UK Manufactured For: Teva Pharmaceuticals USA, Inc. 2/2020 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1.

Common adverse reactions (more than 5%) occurring more frequently in tobramycin inhalation solution patients are forced expiratory volume decreased, rales, red blood cell sedimentation rate increased, and dysphonia. 1 To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www. gov/medwatch. 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 tobramycin inhalation solution in two placebo-controlled studies in 305 cystic fibrosis patients. Patients receiving tobramycin inhalation solution ranged in age from 6 to 31 years. In Study 1, an eight week study, 29 patients received tobramycin inhalation solution 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. 5% of patients were 6 to 12 years of age while 30. 5% of patients were 13 to 17 years old. 5% of patients were adults (>17 years old). Eighty percent (80%) of patients were chronically colonized with Pseudomonas aeruginosa Pseudomonas aeruginosa More patients in the placebo group discontinued/dropped out of Study 1 than in the tobramycin inhalation solution group (23% [7/30] vs 3. 4% [1/29], respectively). Five patients in the placebo group compared to none in the tobramycin inhalation solution 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 tobramycin inhalation solution 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 6 to 12 years old while 29% of patients were 13 to 17 years old. Only 30% were adults (>17 years). Eighty-seven percent (87%) of patients were chronically colonized with P. aeruginosa P. aeruginosa More patients in the placebo group discontinued/dropped out of Study 2 than in the tobramycin inhalation solution group (9. 4% [8/85] vs 4. 3% [7/161], respectively). Of these, 3 patients in the tobramycin inhalation solution 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 tobramycin inhalation solution- and placebo-treated patients. The following adverse reactions were reported in at least 5% of tobramycin inhalation solution-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 Tobramycin Inhalation Solution Patients Adverse Reactions Tobramycin Inhalation Solution N=190 (%) Placebo N=115 (%) 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%) Epistaxis 6 (3%) 0 Pharyngolaryngeal pain 5 (3%) 2 (2%) Bronchitis 5 (3%) 1 (1%) Tonsillitis 4 (2%) 0 Diarrhea 3 (2%) 1 (1%) Eosinophilia 3 (2%) 0 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. Ear and labyrinth disorders: [see Warnings and Precautions ( 5. 1 Skin and subcutaneous tissue disorders: Nervous system disorders: Respiratory, thoracic, and mediastinal disorders: [see Warnings and Precautions ( 5. 4 Metabolism and Nutrition Disorders:.

Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

Aminoglycosides can cause fetal harm when administered to a pregnant woman. 1 Nursing mothers: discontinue drug or nursing, taking into consideration the importance of the drug to a mother. 2 Risk Summary Aminoglycosides can cause fetal harm. Published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [Warnings and Precautions (5. [see Clinical Pharmacology ( 12. 3 (see Clinical Considerations) (see Data) The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Cystic fibrosis may increase the risk for preterm delivery. Data Animal Data No reproduction toxicology studies have been conducted with inhaled tobramycin. However, subcutaneous administration of tobramycin at doses of up to 100 (rat) or 20 (rabbit) mg/kg/day during organogenesis was not associated with adverse developmental outcomes. Subcutaneous doses of tobramycin >= 40mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. Ototoxicity was not evaluated in offspring during nonclinical reproductive toxicity studies with tobramycin. Risk Summary There are no data on the presence of tobramycin in either human or animal milk, the effects on the breastfed infant, or the effects on milk production following oral inhalation of tobramycin inhalation solution. Limited published data on other formulations of tobramycin in lactating women indicate that tobramycin is present in human milk. However, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology ( 12. 3 (see Clinical Considerations). Clinical Considerations Tobramycin may cause intestinal flora alteration. Advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). The safety and efficacy of tobramycin inhalation solution have not been studied in pediatric cystic fibrosis patients under six years of age. Clinical studies of tobramycin inhalation solution did not include patients aged 65 years and over. Tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see Warnings and Precautions ( 5. 5 Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure of tobramycin. The risk of adverse reactions to this drug may be greater in patients with impaired renal function. Patients with serum creatinine > 2mg/dL and blood urea nitrogen (BUN) > 40mg/dL have not been included in clinical studies and there are no data in this population to support a recommendation for or against dose adjustment [see Warnings and Precautions ( 5. 5 Serum concentrations of tobramycin in patients with renal dysfunction, or patients treated with concomitant parenteral tobramycin should be monitored at the discretion of the treating physician.

Concurrent and/or sequential use of tobramycin inhalation solution with other drugs with neurotoxic, nephrotoxic or ototoxic potential should be avoided. 1 Tobramycin inhalation solution should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. 2 Concurrent and/or sequential use of tobramycin inhalation solution with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. Therefore, tobramycin inhalation solution should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and tobramycin inhalation solution has not been evaluated.

OVERDOSAGE
No overdoses have been reported with tobramycin inhalation solution in clinical trials. Signs and symptoms of acute toxicity from overdosage of intravenous tobramycin might include dizziness, tinnitus, vertigo, loss of high-tone hearing acuity, respiratory failure, neuromuscular blockade, and renal impairment. Administration by inhalation results in low systemic bioavailability of tobramycin. Tobramycin is not significantly absorbed following oral administration. Tobramycin serum concentrations may be helpful in monitoring overdosage. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment. In the case of any overdosage, the possibility of drug interactions with alterations in drug disposition should be considered.
NONCLINICAL TOXICOLOGY
A two-year rat inhalation toxicology study to assess carcinogenic potential of an inhaled solution of tobramycin has been completed. Rats were exposed to tobramycin for up to 1.5 hours per day for 95 weeks. Serum levels of tobramycin up to 35 mcg/mL were measured in rats, 35x the average 1 mcg/mL exposure levels observed in cystic fibrosis patients in clinical trials. There was no drug-related increase in the incidence of any variety of tumors. Additionally, tobramycin has been evaluated for genotoxicity in a battery of in vitro in vivo Subcutaneous administration of up to 100 mg/kg of tobramycin did not affect mating behavior or cause impairment of fertility in male or female rats.
CLINICAL STUDIES
Two, double-blind, randomized, placebo-controlled, parallel group clinical studies (Study 1 and Study 2), which randomized and dosed 306 patients, were conducted in cystic fibrosis patients with P. aeruginosa The compressors in the placebo-controlled studies and the bridging study differed from the PARI VIOS compressor to be used with tobramycin inhalation solution. In vitro All subjects enrolled in both efficacy studies had baseline FEV 1 1 P. aeruginosa Burkholderia cepacia P. aeruginosa Study 1 Study 1 was a double-blind, single cycle study that randomized 59 patients to receive tobramycin inhalation solution (n=29) or placebo (n=30) for one cycle of treatment (28 days on treatment followed by 28 days off treatment). All patients were <=30 years of age (mean age 12. 6 years) and 46% were females. All randomized patients were included in the primary analysis except for one patient who had missing baseline information. Tobramycin inhalation solution significantly improved lung function compared with placebo as measured by the absolute change in FEV 1 1 1 1 Study 2 Study 2 was a randomized, double-blind, 3-cycle, placebo-controlled trial. A total of 247 eligible patients were randomized 2:1 to receive three cycles of tobramycin inhalation solution (n=161) or placebo (n=86). As in Study 1, each cycle comprised 28 days on treatment followed by 28 days off treatment. All patients were <=46 years of age (mean age 14. 8 years) and 44. 9% were females. In this study, two randomized patients in the placebo group were not included in the primary efficacy analysis; one withdrew consent without taking any trial medication and the other withdrew due to an adverse drug reaction. Tobramycin inhalation solution significantly improved lung function compared with placebo as measured by the absolute change in FEV 1 1 1 1 Figure 1: FEV 1 Population In Study 2, 9. 9% of patients treated with tobramycin inhalation solution and 24. 7% of patients who received placebo had unplanned hospitalizations due to the disease. Also in Study 2, 6. 2% of patients treated with tobramycin inhalation solution and 16. 5% of placebo patients received parenteral tobramycin.
REFERENCES
Neu HC. Tobramycin: an overview. [Review]. J Infect Dis. 1976;Suppl 134:S3-19. Weber A, Smith A, Williams-Warren J, et al. Nebulizer delivery of tobramycin to the lower respiratory tract. Pediatr Pulmonol. 1994;17(5):331-9. Clinical and laboratory Standards Institute (CLSI) Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically: Approved Standard -9 th CLSI Performance Standards for Antimicrobial Susceptibility Testing: 22 nd CLSI Performance standards for Antimicrobial Disk Susceptibility Tests: Approved standard -11 th PARI Vios Aerosol Delivery System with LC Plus Nebulizer: Instructions for Use. PARI Respiratory Equipment, Inc. 2010; 310D0028 Rev A 6-10.
PATIENT INFORMATION
Tobramycin (toe" bra mye'' sin) Inhalation Solution, USP for oral inhalation use What is tobramycin inhalation solution? Tobramycin inhalation solution is a prescription medicine that is used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa It is not known if tobramycin inhalation solution is safe and effective: in children under 6 years of age in people who have decreased lung volume or a forced expiratory volume in one second (FEV 1 in people who are colonized with a bacterium called Burkholderia cepacia Do not take tobramycin inhalation solution See the end of this Patient Information for a complete list of ingredients in tobramycin inhalation solution. Before you take tobramycin inhalation solution, tell your healthcare provider about all of your medical conditions, including if you: have or have had hearing problems (including noises in your ears such as ringing or hissing), hearing loss, or your mother has had hearing problems after taking an aminoglycoside. have been told you have certain gene variants (a change in the gene) related to hearing abnormalities inherited from your mother. have dizziness have or have had kidney problems have or have had problems with muscle weakness such as myasthenia gravis or Parkinson’s disease have or have had breathing problems such as wheezing, coughing, or chest tightness are pregnant or plan to become pregnant. Tobramycin inhalation solution is in a class of medicines that can harm your unborn baby and may be connected with complete deafness in babies at birth. The deafness affects both ears and cannot be changed. are breastfeeding or plan to breastfeed. It is not known if tobramycin passes into your breast milk. Tobramycin, the medicine in tobramycin inhalation solution may cause the following symptoms in your breastfed baby: loose or bloody stools yeast infection in the mouth or throat (thrush) diaper rash Call your baby’s healthcare provider if your breastfed baby has any of these problems. are receiving aminoglycoside therapy by injection or through a vein (intravenous) while taking tobramycin inhalation solution. Your blood levels of tobramycin will be checked. Tell your healthcare provider about all the medicines you take, How should I take tobramycin inhalation solution? See the step-by-step Instructions for Use Take tobramycin inhalation solution exactly as your healthcare provider tells you to. Do not The usual dose of tobramycin inhalation solution for adults and children over 6 years of age is: 1 single-dose ampule of tobramycin inhalation solution inhaled 2 times each day using your hand-held PARI LC PLUS Reusable Nebulizer with a PARI Vios air compressor. Each dose of tobramycin inhalation solution should be taken as close to 12 hours apart as possible. You should not take your dose of tobramycin inhalation solution less than 6 hours apart. Tobramycin inhalation solution is taken as a breathing treatment (inhalation) with a hand-held PARI LC Reusable Nebulizer with a PARI Vios air compressor. Do not Do not mix or dilute tobramycin inhalation solution with dornase alfa or other medicines in your nebulizer system. Each treatment of tobramycin inhalation solution should take about 15 minutes. Tobramycin inhalation solution should be inhaled while you are sitting or standing upright and breathing normally through the mouthpiece of the nebulizer. Nose clips may help you to breathe through your mouth. If you forget to take tobramycin inhalation solution and there are at least 6 hours to your next dose, take your dose as soon as you can. Otherwise, wait for your next dose. Do not double the dose to make up for the missed dose. After taking tobramycin inhalation solution for 28 days, you should stop taking it and wait 28 days. After you have stopped taking tobramycin inhalation solution for 28 days, you should start taking tobramycin inhalation solution again for 28 days. Complete the full 28-day course even if you are feeling better. It is important that you keep to the 28-day on, 28-day off cycle. If you are taking several other medicines or treatments to treat your cystic fibrosis, you should take your medicines or other treatments before inhaling tobramycin inhalation solution or as directed by your healthcare provider. Taking tobramycin inhalation solution with certain other medicines can cause serious side effects. If you are taking tobramycin inhalation solution, you should discuss with your healthcare provider if you should take: other medicines that may harm your nervous system, kidneys, or hearing “water pills” (diuretics) such as ethacrynic acid, furosemide, or intravenous mannitol Urea Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. If you take too much tobramycin inhalation solution, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of tobramycin inhalation solution? Tobramycin inhalation solution can cause serious side effects, including: hearing loss or ringing in the ears (ototoxicity). worsening kidney problems (nephrotoxicity). worsening muscle weakness (neuromuscular disorder). severe breathing problems (bronchospasm). shortness of breath with wheezing coughing and chest tightness The most common side effects of tobramycin inhalation solution include: worsening of lung problems or cystic fibrosis noisy breathing (rales) abnormal red blood cell activity changes in your voice (hoarseness) These are not all of the possible side effects of tobramycin inhalation solution. General information about the safe and effective use of tobramycin inhalation solution. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use tobramycin inhalation solution for a condition for which it was not prescribed. Do not give tobramycin inhalation solution to other people, even if they have the same symptoms that you have. It may harm them. What are the ingredients in tobramycin inhalation solution? Active ingredient: Inactive ingredients: What is Pseudomonas aeruginosa? It is a very common bacterium that infects the lungs of nearly everyone with cystic fibrosis at some time during their lives. Some people do not get this infection until later in their lives, while others get it very young. It is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly managed, it will continue to damage your lungs causing further problems to your breathing. Brands listed are the trademark of their respective owners. Manufactured In England By: Norton Healthcare Limited T/A IVAX Pharmaceuticals UK, Teva Pharmaceuticals USA, Inc., For more information call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872. This Patient Information has been approved by the U.S. Food and Drug Administration. Rev. A 10/2023

Teva Pharmaceuticals USA, Inc.

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