Tobramycin Inhalation

Q: Who makes Tobramycin Inhalation?

Tobramycin Inhalation is listed by 1 labeler in the FDA NDC directory, including Prasco, LLC.

Solution · Respiratory (inhalation)

Prescription (Rx) Aminoglycoside Antibacterial

Uses

Tobramycin Inhalation Solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV 1 less than 40% or greater than 80% predicted, or patients colonized with 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 ) less than 40% or greater than 80% predicted, or patients colonized with 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. ( 2.1 ) 2.1 Dosage Tobramycin Inhalation Solution is for oral inhalation only [see Dosage and Administration ( 2.2 )] . The recommended dosage of Tobramycin Inhalation Solution for patients six years of age and older is to administer one single-use ampule (300 mg/4 mL) twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug. The doses should be taken as close to 12 hours apart as possible and not less than 6 hours apart. 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. 2.2 Administration Instructions 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 for subcutaneous, intravenous, or intrathecal administration. 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.

Dosage forms and strengths

Tobramycin Inhalation Solution is supplied as a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous inhalational solution for nebulization in single-use 4 mL ampule containing 300 mg of tobramycin. Inhalation solution: 300 mg tobramycin per 4-mL solution in a single-use ampule. ( 16 )

Contraindications

Tobramycin Inhalation Solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Tobramycin Inhalation Solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. ( 4 )

Warnings and precautions

Caution should be exercised when prescribing Tobramycin Inhalation Solution to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. ( 5.1 , 5.2 , 5.3 and 5.5 ) Aminoglycoside may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. ( 5.3 ) Bronchospasm can occur with inhalation of Tobramycin Inhalation Solution. ( 5.4 ) Audiograms, serum concentration, and renal function should be monitored as appropriate. ( 5.2 and 5.5 ) Fetal harm can occur when aminoglycosides are administered to a pregnant woman. Apprise women of the potential hazard to the fetus. ( 5.6 ) 5.1 Ototoxicity Ototoxicity with use of Tobramycin Inhalation Solution Caution should be exercised when prescribing Tobramycin Inhalation Solution to patients with known or suspected auditory or vestibular dysfunction. Findings related to ototoxicity as measured by audiometric evaluations and auditory adverse event reports were similar between Tobramycin Inhalation Solution and placebo in controlled clinical trials. Hearing loss was reported in two (1.1%) Tobramycin Inhalation Solution-treated patients and in one (0.9%) placebo-treated patient during clinical studies. Additionally, dizziness and vertigo, both of which may be manifestations of vestibular forms Tobramycin Inhalation Solution of ototoxicity, were observed in similar numbers of Tobramycin Inhalation Solution- and placebo-treated patients. Dizziness occurred in two (1.1%) Tobramycin Inhalation Solution-treated patients and one (0.9%) placebo-treated patient and vertigo occurred in two (1.1%) Tobramycin Inhalation Solution-treated patients versus no placebo patients in clinical studies. None of the Tobramycin Inhalation Solution patients discontinued their therapy due to hearing loss, dizziness or vertigo. Tinnitus may be a sentinel symptom of ototoxicity. No reports of tinnitus occurred in patients during clinical studies with Tobramycin Inhalation Solution, but because it has been observed with inhaled tobramycin solutions [see Adverse Reactions ( 6.2 )] , onset of this symptom warrants caution. Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness. Patients with known or suspected auditory or vestibular dysfunction should be closely monitored when taking Tobramycin Inhalation Solution. Monitoring may include obtaining audiometric evaluations and serum tobramycin levels. If ototoxicity is noted, the patient should be managed as medically appropriate, including potentially discontinuing Tobramycin Inhalation Solution. Risk of Ototoxicity Due to Mitochondrial DNA Variants Cases of ototoxicity with aminoglycosides have been observed in patients with certain variants in the mitochondrially encoded 12S rRNA gene (MT-RNR1) , particularly the m.1555A>G variant. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. Mitochondrial DNA variants are present in less than 1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as the severity of ototoxicity is unknown. In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies. 5.2 Nephrotoxicity Caution should be exercised when prescribing Tobramycin Inhalation Solution to patients with known or suspected renal dysfunction. Nephrotoxicity was not seen during Tobramycin Inhalation Solution clinical studies but has been associated with aminoglycosides as a class. Patients with known or suspected renal dysfunction or taking concomitant nephrotoxic drugs along with Tobramycin Inhalation Solution should have serum concentrations of tobramycin and laboratory measurements of renal function obtained at the discretion of the treating physician. If nephrotoxicity develops, the patient should be managed as medically appropriate, including potentially discontinuing Tobramycin Inhalation Solution until serum concentrations fall below 2 mcg/mL. Twenty-six (14%) Tobramycin Inhalation Solution patients and 15 (13%) placebo patients had increases in serum creatinine of at least 50% over baseline. Follow-up values were obtained for 17 of the 26 Tobramycin Inhalation Solution patients, all of which decreased to serum creatinine values that were within normal laboratory ranges. Patients who experience an increase in serum creatinine during treatment with Tobramycin Inhalation Solution should have their renal function closely monitored. 5.3 Neuromuscular Disorders Tobramycin Inhalation Solution should be used cautiously in patients with muscular disorders. Aminoglycosides, including tobramycin, may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. Neuromuscular blockade, respiratory failure, and prolonged respiratory paralysis may occur more commonly in patients with underlying neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease. Prolonged respiratory paralysis may also occur in patients receiving concomitant neuromuscular blocking agents. If neuromuscular blockade occurs, it may be reversed by the administration of calcium salts but mechanical assistance may be necessary. 5.4 Bronchospasm Bronchospasm has been reported with inhalation of tobramycin. In clinical studies with Tobramycin Inhalation Solution, bronchospasm was observed in one (0.5%) Tobramycin Inhalation Solution-treated patient and in no placebo-treated patients. Wheezing occurred in ten (5%) Tobramycin Inhalation Solution-treated patients and four (4%) placebo-treated patients.

Side effects

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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 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 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. 52.5% of patients were 6 to 12 years of age while 30.5% of patients were 13-17 years old. Only 16.5% of patients were adults (> 17 years old). Eighty percent (80%) of patients were chronically colonized with Pseudomonas aeruginosa while 20.3% of patients were initially or intermittently colonized with Pseudomonas aeruginosa during the study. 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 6-12 years old while 29% of patients were 13-17 years old. Only 30% were adults (>17 years). Eighty-seven percent (87%) of patients were chronically colonized with P. aeruginosa . Only 13% were either initially or intermittently colonized with P. aeruginosa during the study. 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 6.2 Postmarketing Experience 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, Tinnitus [see Warnings and Precautions ( 5.1 )] Skin and subcutaneous tissue disorders : Hypersensitivity, pruritus, urticaria, rash Nervous system disorders : Aphonia, dysgeusia Respiratory, thoracic, and mediastinal disorders: Bronchospasm [see Warnings and Precautions ( 5.4 )] , oropharyngeal pain Metabolism and Nutrition Disorders: Decreased appetite

Drug interactions

Concurrent and/or sequential use of Tobramycin Inhalation Solution with other drugs with neurotoxic, nephrotoxic or ototoxic potential should be avoided. ( 7.1 ) Tobramycin Inhalation Solution should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. ( 7.2 ) 7.1 Drugs with Neurotoxic, Nephrotoxic, or Ototoxic Potential Concurrent and/or sequential use of Tobramycin Inhalation Solution with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. 7.2 Diuretics 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.

Use in specific populations

Aminoglycosides can cause fetal harm when administered to a pregnant woman. ( 8.1 ) Nursing mothers: discontinue drug or nursing, taking into consideration the importance of the drug to a mother. ( 8.2 ) 8.1 Pregnancy 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 ( 5.6 )] . Although there are no available data on use of Tobramycin Inhalation Solution in pregnant women to be able to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology ( 12.3 )] . There are risks to the mother associated with cystic fibrosis in pregnancy (see Clinical Considerations) . In animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis there were no adverse developmental outcomes; however, ototoxicity was not evaluated in the offspring from these studies (see Data ) . Advise pregnant women of the potential risk to a fetus. 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. In the U.S. 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. 8.2 Lactation 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 )] . Tobramycin may cause alteration in the intestinal flora of the breastfeeding infant (see Clinical Considerations) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tobramycin Inhalation Solution and any potential adverse effects on the breastfed child from Tobramycin Inhalation Solution or from the underlying maternal condition. 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). 8.4 Pediatric Use The safety and efficacy of Tobramycin Inhalation Solution have not been studied in pediatric cystic fibrosis patients under six years of age. 8.5 Geriatric Use 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 ( 5.2 , 5.5 )] . 8.6 Renal Impairment 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 ( 5.2 , 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.

Pregnancy

8.1 Pregnancy 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 ( 5.6 )] . Although there are no available data on use of Tobramycin Inhalation Solution in pregnant women to be able to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology ( 12.3 )] . There are risks to the mother associated with cystic fibrosis in pregnancy (see Clinical Considerations) . In animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis there were no adverse developmental outcomes; however, ototoxicity was not evaluated in the offspring from these studies (see Data ) . Advise pregnant women of the potential risk to a fetus. 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. In the U.S. 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.

Pediatric use

8.4 Pediatric Use The safety and efficacy of Tobramycin Inhalation Solution have not been studied in pediatric cystic fibrosis patients under six years of age.

Geriatric use

8.5 Geriatric Use 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 ( 5.2 , 5.5 )] .

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.

Description

Tobramycin Inhalation Solution is a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. Tobramycin Inhalation Solution is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C 18 H 37 N 5 O 9 and the molecular weight is 467.52. Tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino- 2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L‑streptamine. The structural formula for tobramycin is: Each single-use 4 mL ampule of Tobramycin Inhalation Solution contains one 300 mg dose of tobramycin, with sodium chloride and sulfuric acid in water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0. Nitrogen is used for sparging, filling and pouching. The formulation contains no preservatives. Tobramycin structural formula

Mechanism of action

12.1 Mechanism of Action Tobramycin Inhalation Solution is an aminoglycoside antibacterial [see Clinical Pharmacology ( 12.4 )] .

How supplied

16.1 How Supplied Tobramycin Inhalation Solution 300 mg/4 mL is supplied as a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution and is available as follows: NDC 66993-195-94: 4 mL single-use ampule (carton of 14 foil pouches each containing four ampules) 16.2 Storage and Handling Tobramycin Inhalation Solution should be stored under refrigeration at 2°C ‑ 8°C (36°F ‑ 46°F). Upon removal from the refrigerator, or if refrigeration is unavailable, Tobramycin Inhalation Solution pouches (opened or unopened) may be stored at room temperature [up to 25°C (77°F)] for up to 28 days. Tobramycin Inhalation Solution should not be used beyond the expiration date stamped on the ampule when stored under refrigeration 2°C ‑ 8°C (36°F ‑ 46°F) or beyond 28 days when stored at room temperature [up to 25°C (77°F)]. Tobramycin Inhalation Solution ampules should not be exposed to intense light. Tobramycin Inhalation Solution is light sensitive; unopened ampules should be returned to the foil pouch. The solution in the ampule is colorless to pale yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions. 16.1 How Supplied Tobramycin Inhalation Solution 300 mg/4 mL is supplied as a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution and is available as follows: NDC 66993-195-94: 4 mL single-use ampule (carton of 14 foil pouches each containing four ampules)

Storage

16.2 Storage and Handling Tobramycin Inhalation Solution should be stored under refrigeration at 2°C ‑ 8°C (36°F ‑ 46°F). Upon removal from the refrigerator, or if refrigeration is unavailable, Tobramycin Inhalation Solution pouches (opened or unopened) may be stored at room temperature [up to 25°C (77°F)] for up to 28 days. Tobramycin Inhalation Solution should not be used beyond the expiration date stamped on the ampule when stored under refrigeration 2°C ‑ 8°C (36°F ‑ 46°F) or beyond 28 days when stored at room temperature [up to 25°C (77°F)]. Tobramycin Inhalation Solution ampules should not be exposed to intense light. Tobramycin Inhalation Solution is light sensitive; unopened ampules should be returned to the foil pouch. The solution in the ampule is colorless to pale yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.

Patient information

Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Information for Patients Information on the long term efficacy and safety of Tobramycin Inhalation Solution is limited. There is no information in patients with severe cystic fibrosis (FEV 1 < 40% predicted). Patients should be advised to complete a full 28-day course of Tobramycin Inhalation Solution, even if they are feeling better. After 28 days of therapy, patients should stop Tobramycin Inhalation Solution therapy for the next 28 days, and then resume therapy for the next 28 day on and 28 day off cycle. For patients taking several different inhaled medications and/or performing chest physiotherapy, advise the patient regarding the order they should take the therapies. It is recommended that Tobramycin Inhalation Solution be taken last. Tobramycin Inhalation Solution is to be used with the PARI LC PLUS reusable nebulizer and the PARI VIOS air compressor. Refer to the manufacturer’s instructions for care and use of the nebulizer and compressor. 17.1 Ototoxicity Inform patients that ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients treated with tobramycin. Physicians should consider an audiogram at baseline, particularly for patients at increased risk of auditory dysfunction. If a patient reports tinnitus or hearing loss during Tobramycin Inhalation Solution therapy, the physician should refer that patient for audiological assessment. Patients should be reminded that vestibular toxicity may manifest as vertigo, ataxia, or dizzines. 17.2 Bronchospasm Inform patients that bronchospasm can occur with inhalation of tobramycin. 17.3 Risks Associated with Aminoglycosides Inform patients of adverse reactions associated with aminoglycosides such as nephrotoxicity and neuromuscular disorders. 17.4 Laboratory Tests Inform patients of the need to monitor hearing, serum concentrations of tobramycin, or renal function as necessary during treatment with Tobramycin Inhalation Solution. 17.5 Embryo-Fetal Toxicity Inform patients that aminoglycosides can cause fetal harm when administered to a pregnant woman. Advise them to inform their doctor if they are pregnant, become pregnant, or plan to become pregnant. 17.6 Administration Patients should be informed about what to do in the event they miss a dose of Tobramycin Inhalation Solution: In case a dose of Tobramycin Inhalation Solution is missed and there are at least 6 hours until the next dose, patients should be instructed to take the prescribed dose of Tobramycin Inhalation Solution as soon as possible. Otherwise, the missed dose should not be taken and the patient should resume the usual dosing schedule. Patients should be advised to contact their healthcare provider if they have questions. 17.7 Storage Instructions You should store Tobramycin Inhalation Solution ampules in a refrigerator (36-46 °F or 2-8 °C). However, when you don’t have a refrigerator available (e.g., transporting your Tobramycin Inhalation Solution), you may store the foil pouches (opened or unopened) at room temperature (up to 77 °F/25 °C) for up to 28 days. Tobramycin Inhalation Solution is light sensitive; unopened ampules should be returned to the foil pouch. Avoid exposing Tobramycin Inhalation Solution ampules to intense light. Unrefrigerated Tobramycin Inhalation Solution, which is normally colorless to pale yellow, may darken with age; however, the color change does not indicate any change in the quality of the product. You should not use Tobramycin Inhalation Solution 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. You should not use Tobramycin Inhalation Solution beyond the expiration date stamped on the ampule. Nebulizers and Compressors: 1-800-327-8632 Tobramycin Inhalation Solution: 1-866-525-0688 U.S. Patent 6,987,094. Manufactured for Prasco Laboratories Mason, Ohio 45040 USA by Woodstock Sterile Solutions, Inc. Woodstock, Illinois 60098 Printed in USA CTB-013-1022-02-SPL FDA-Approved Patient Labeling Patient Information Tobramycin Inhalation Solution (toh-bruh- mahy -sin) 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 . Tobramycin Inhalation Solution contains an antibacterial medicine called tobramycin (an aminoglycoside). 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 ) less than 40% or greater than 80% predicted in people who are colonized with a bacterium called Burkholderia cepacian Do not take Tobramycin Inhalation Solution if you are allergic to tobramycin, any of the ingredients in Tobramycin Inhalation Solution, or to any other aminoglycoside antibacterial. 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.

Label text from the FDA structured product label by Prasco, LLC (revised Feb 24, 2023). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Tobramycin in 1 product

Tobramycin Inhalation NDC products (1)

NDC	Strength & form	Labeler	Type
66993-195	Tobramycin 300 mg/4mL Solution	Prasco, LLC	NDA AUTHORIZED GENERIC

Frequently asked questions

What is Tobramycin Inhalation used for?

What are the side effects of Tobramycin Inhalation?

Who makes Tobramycin Inhalation?

Tobramycin Inhalation is listed by 1 labeler in the FDA NDC directory, including Prasco, LLC.