Medicine guide

Tobramycin

300 mg/5mL · Solution

Prescription only
Aminoglycoside Antibacterial

Active substance: Tobramycin
Used in: Antibiotics, antivirals and antifungals taken into the body
Made by: Teva Pharmaceuticals USA, Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2023-10-31

What it is

Aminoglycoside Antibacterial

Used for

Tobramycin inhalation solution is indicated for the management of cystic fibrosis in

The label’s usual adult dose

Adults and pediatric patients 6 years of age and older is one single-dose ampule (300 mg) twice daily by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug.

Full directions ↓

Do not take it if

Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Known hypersensitivity to any aminoglycoside ( 4 )

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

51other products contain Tobramycin — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Tobramycin inhalation solution is indicated for the management of cystic fibrosis in
adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa .
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies ( 14 )].
Tobramycin inhalation solution is an aminoglycoside antibacterial indicated for the management of cystic fibrosis in
adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa .
( 1 ) Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
( 1 )

From the official label · 2023-10-31 · DailyMed

How it works

From this product’s own US prescribing label.

Tobramycin is an aminoglycoside antibacterial [see Microbiology ( 12.4 )].

Half-life2–3 h

Mostly cleared after≈ 12.5 hfive half-lives — our arithmetic

How the body breaks it down

Tobramycin is not metabolized.

How it leaves the body

Systemically absorbed tobramycin is primarily excreted unchanged in the urine principally by glomerular filtration.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-10-31

Do not take it if

Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Known hypersensitivity to any aminoglycoside ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

For oral inhalation only.
( 2.1 ) The recommended dosage for
adults and pediatric patients 6 years of age and older is one single-dose ampule (300 mg) twice daily by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug.
( 2.1 ) Dosage is not adjusted by weight.
( 2.1 ) Take doses as close to 12 hours apart as possible; but not less than 6 hours apart.
( 2.1 ) Administer each 300 mg dose by inhalation using a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor.
( 2.2 )
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 both
adults and pediatric patients 6 years of age and older is one single-dose ampule (300 mg) administered twice daily for 28 days.
Dosage is not adjusted by weight.
All patients should be administered 300 mg twice daily.
Tobramycin inhalation solution is administered twice daily in alternating periods of 28 days.
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/28 day off cycle.
The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.
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 over an approximately 15-minute period, using a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor.
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.
Prior to administration of tobramycin inhalation solution, read the Patient Information/Instructions for Use for tobramycin inhalation solution for detailed information on how to use tobramycin inhalation solution and follow the manufacturer’s instructions for use and care of the PARI LC PLUS Reusable Nebulizer and DeVilbiss Pulmo-Aide air compressor.
Tobramycin inhalation solution is inhaled while the patient is sitting or standing upright and breathing normally through the mouthpiece of the nebulizer.
Nose clips may help the patient breathe through the mouth.
Instruct patients on multiple therapies to take their medications, prior to inhaling tobramycin inhalation solution or as directed by their physician.
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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

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.
If nephrotoxicity develops, manage the patient as medically appropriate, including potentially discontinuing tobramycin inhalation solution.
( 5.3 ) Neuromuscular Disorders:
Aminoglycosides may aggravate muscle weakness because of a potential curare‐like effect on neuromuscular function.
If neuromuscular blockade occurs, it may be reversed by the administration of calcium salts but mechanical assistance may be necessary.
( 5.4 ) Embryo-fetal Toxicity: Aminoglycosides can cause fetal harm ( 5.5 , 8.1 )
5.1 Bronchospasm Bronchospasm can occur with inhalation of tobramycin inhalation solution.
In clinical studies with tobramycin inhalation solution, changes in FEV 1 measured after the inhaled dose were similar in tobramycin inhalation solution and placebo groups.
Bronchospasm that occurs during the use of tobramycin inhalation solution should be treated as medically appropriate.
5.2 Ototoxicity Ototoxicity with use of tobramycin inhalation solution Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides.
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 further clinical investigation.
Ototoxicity, as measured by complaints of hearing loss or by audiometric evaluations, did not occur with tobramycin inhalation solution therapy during clinical studies, however in postmarketing experience, patients receiving tobramycin inhalation solution have reported hearing loss.
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 might 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.
5.3 Nephrotoxicity Nephrotoxicity was not seen during clinical studies with tobramycin inhalation solution 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.
5.4 Neuromuscular 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.
5.5 Embryo-fetal Toxicity 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 [see Use in Specific Populations ( 8.1 )].
5.6 Concomitant Use of Systemic Aminoglycosides Patients receiving concomitant tobramycin inhalation solution and parenteral aminoglycoside therapy should be monitored as clinically appropriate for toxicities associated with aminoglycosides as a class.
Serum tobramycin levels should be monitored.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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 [see Warnings and Precautions ( 5.5 )].
Although there are no available data on tobramycin inhalation solution use in pregnant women 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 (se e 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 reproductive toxicity studies have been conducted with tobramycin inhalation solution (tobramycin administered by inhalation).
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.
Doses of tobramycin ≥40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes.
Ototoxicity was not evaluated in offspring during non-clinical reproductive toxicity studies with tobramycin.
IN SPECIFIC POPULATIONS
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 [see Warnings and Precautions ( 5.5 )].
Although there are no available data on tobramycin inhalation solution use in pregnant women 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 (se e 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 reproductive toxicity studies have been conducted with tobramycin inhalation solution (tobramycin administered by inhalation).
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.
Doses of tobramycin ≥40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes.
Ototoxicity was not evaluated in offspring during non-clinical reproductive toxicity studies with tobramycin.
8.2 Lactation Risk Summary There are no data on the presence of tobramycin inhalation solution in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.
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 infant 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 in pediatric patients under 6 years of age has not been established.
The use of tobramycin inhalation solution is not indicated in children <6 years of age [see Indications and Usage ( 1 ) and Dosage and Administration ( 2 )].
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 ( 5.3 )].

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Concurrent and/or sequential use of tobramycin inhalation solution with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided.
( 7.1 ) Concomitant administration with ethacrynic acid, furosemide, urea, or intravenous mannitol is not recommended due to possible enhancement of aminoglycoside toxicity.
( 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 aminoglycoside concentrations in serum and tissue.
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.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Signs and symptoms of acute toxicity from overdosage of intravenous (IV) 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.
Acute toxicity should be treated with immediate withdrawal of tobramycin inhalation solution, and baseline tests of renal function should be undertaken.
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.
Hemodialysis may be helpful in removing tobramycin from the body.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and efficacy of tobramycin inhalation solution in pediatric patients under 6 years of age has not been established.
The use of tobramycin inhalation solution is not indicated in children <6 years of age [see Indications and Usage ( 1 ) and Dosage and Administration ( 2 )].

Quoted from the official label, section “Pediatric Use”.

Use in older people

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 ( 5.3 )].

Quoted from the official label, section “Geriatric Use”.

Side effects

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 [s ee 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 Teva at 1-888-838-2872 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 T o bramyci n Inhalation Solution (n=258) % Placebo (n=2 6 2 ) % 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.
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.
Changes in Serum Creatinine 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.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval 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:
Some of these reports occurred in patients with previous or concomitant treatment with systemic aminoglycosides.
Patients with hearing loss frequently reported tinnitus. [ see Warnings and Precautions ( 5.2 )] Skin and Subcutaneous Tissue Disorders Hypersensitivity, pruritus, urticaria, rash Nervous System Disorders Aphonia, dysgeusia Respiratory, Thoracic, and Mediastinal Disorders Bronchospasm [see Warnings and Precautions ( 5.1 )] oropharyngeal pain Metabolism and Nutrition Disorders Decreased appetite

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Difficulty Breathing :
Advise patients to inform their physicians if they experience shortness of breath or wheezing after administration of tobramycin inhalation solution.
Tobramycin inhalation solution can cause a narrowing of the airway [ s ee Warnings and Precautions ( 5.1 )].
Hearing Loss :
Advise patients to inform their physician if they experience ringing in the ears, dizziness, or any changes in hearing because tobramycin inhalation solution has been associated with hearing loss [ see Warnings and Precautions ( 5.2 )].
Kidney Damage:
Advise patients to inform their physician if they have any history of kidney problems because tobramycin inhalation solution is in a class of drugs that have caused kidney damage [see Warnings and Precautions ( 5.3 )] .
Embryofetal Toxicity:
Advise pregnant women that aminoglycosides can cause irreversible congenital deafness when administered to a pregnant woman [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.1 )].
Lactation:
Advise a woman to monitor their breastfed infants for diarrhea and/or bloody stools [see Use in Specific Populations ( 8.2 )] .
Manufactured In England By:
Norton Healthcare Limited T/A Ivax Pharmaceuticals UK Runcorn, Cheshire WA7 3FA England Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454 Rev.
I 10/2023

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Tobramycin Inhalation Solution, USP is supplied as a sterile inhalational solution for nebulization in single-dose 5 mL ampules.
Each 5 mL ampule contains 300 mg of tobramycin.
Inhalation Solution: 300 mg per 5 mL solution in a single-dose ampule ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

16.1 How Supplied Tobramycin Inhalation Solution, USP is supplied as a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution packaged in a 5 mL single-dose ampule (300 mg tobramycin) for nebulization.
Tobramycin Inhalation Solution USP 300 mg is available as follows:
NDC 0093-4085-63 5 mL single-dose ampule packed in cartons of 56 ampules (14 pouches, each containing 4 ampules).
16.2 Storage and Handling Tobramycin Inhalation Solution, USP should be stored under refrigeration at 2º to 8ºC/36º to 46ºF.
Upon removal from the refrigerator, or if refrigeration is unavailable, Tobramycin Inhalation Solution, USP pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days.
Tobramycin Inhalation Solution, USP should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2º to 8ºC/36º to 46ºF) or beyond 28 days when stored at room temperature (25ºC/77ºF).
Tobramycin Inhalation Solution, USP ampules should not be exposed to intense light.
The solution in the ampule is slightly 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.

Quoted from the official label, section “How Supplied”.

What is in it

Tobramycin Inhalation Solution, USP is a tobramycin solution for inhalation.
It is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer.
The chemical formula for tobramycin, USP is C 18 H 37 N 5 O 9 and the molecular weight is 467.52 g/mol.
Tobramycin, USP 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, USP is:
Each single-dose 5 mL ampule contains 300 mg tobramycin, USP and 11.25 mg sodium chloride in sterile water for injection.
Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0.
Nitrogen is used for sparging.
All ingredients meet USP requirements.
The formulation contains no preservatives.
Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (13)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

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Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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European UnionNo exact match for this strength and form

Every strength and form (3)

CanadaNo exact match for this strength and form

Every strength and form (5)

Details

Made by	Teva Pharmaceuticals USA, Inc.
Active substance	Tobramycin
Used in	Antibiotics, antivirals and antifungals taken into the body
Strength	300 mg/5mL
Form	Solution
Route	Respiratory (inhalation)
Packs	56 AMPULE in 1 CARTON / 5 mL in 1 AMPULE
NDC	0093-4085

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

50 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Solution21 products
- 3 mg/mL9
  3 mg/mL · 9 companies
  +1 more
- 300 mg/5mL10
  300 mg/5mL · 10 companies
  +2 more
- 300 mg/4mL2
  300 mg/4mL · 2 companies
  - Lifestar Pharma LLC
  - NorthStar RxLLC
Solution/ Drops13 products
- 3 mg/mL13
  3 mg/mL · 13 companies
  +5 more
Injection, Powder, Lyophilized, for Solution6 products
- 1.2 g/30mL6
  1.2 g/30mL · 6 companies
Injection4 products
- 10 mg/mL
- 40 mg/mL3
  40 mg/mL · 3 companies

Show all forms · 7 forms

Injection, Solution3 products
- 10 mg/mL
- 40 mg/mL2
  40 mg/mL · 2 companies
  - Fresenius Kabi USA, LLC
  - Hospira, Inc.
Injection, Powder, for Solution2 products
- 1200 mg/30mL2
  1200 mg/30mL · 2 companies
  - Fresenius Kabi USA, LLC
  - Slate Run Pharmaceuticals, LLC
Inhalant1 products
- 300 mg/5mL

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Bethkis300 mg/4mLPrescription onlySolution Chiesi USA, Inc. · Tobramycin Kitabis Pak300 mg/5mLPrescription onlySolution Pari Respiratory Equipment, Inc. · Tobramycin Tobi300 mg/5mLPrescription onlySolution Viatris Specialty LLC · Tobramycin Tobi Podhaler28 mgPrescription onlyCapsule Viatris Specialty LLC · Tobramycin Tobramycin40 mg/mLPrescription onlyInjection, Solution Hospira, Inc. · Tobramycin Tobramycin3 mg/mLPrescription onlySolution Bausch & Lomb Incorporated · Tobramycin

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