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Tobramycin

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Active ingredient
Tobramycin 300 mg/4 mL
Other brand names
Drug class
Aminoglycoside Antibacterial
Dosage form
Solution
Route
Respiratory (inhalation)
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
March 10, 2023
FDA Insert
Prescribing information, PDF file
Active ingredient
Tobramycin 300 mg/4 mL
Other brand names
Drug class
Aminoglycoside Antibacterial
Dosage form
Solution
Route
Respiratory (inhalation)
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
March 10, 2023
Manufacturer
Lifestar Pharma LLC
Registration number
ANDA216725
NDC root
70756-617
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Tobramycin inhalation solution is a sterile, clear liquid medication that is primarily used to treat lung infections in patients with cystic fibrosis caused by a bacteria called Pseudomonas aeruginosa. It belongs to a class of antibiotics known as aminoglycosides, which work by targeting and killing bacteria to help manage infections.

This medication is delivered through a nebulizer, a device that turns the liquid into a mist for easy inhalation. Each dose contains 300 mg of tobramycin, and it is designed to remain concentrated in the airways, where it can effectively combat the infection. Tobramycin is not absorbed into the bloodstream in significant amounts, which helps minimize systemic side effects.

Uses

Tobramycin inhalation solution is used to help manage cystic fibrosis in patients who have an infection caused by a specific bacteria called Pseudomonas aeruginosa. This treatment is specifically designed for individuals with this condition to improve their respiratory health.

It's important to note that the safety and effectiveness of this medication have not been established for children under six years old, or for patients whose lung function, measured by forced expiratory volume in one second (FEV1), is either below 40% or above 80% of what is expected. Additionally, it is not recommended for those who are colonized with another type of bacteria known as Burkholderia cepacia.

Dosage and Administration

You will use this medication by inhaling it directly into your lungs. It comes in small containers called ampules, and you should use one ampule each time. You need to take the entire contents of one ampule two times a day.

This treatment is designed to be used in cycles: you will take the medication for 28 days, followed by a break of 28 days where you do not take the drug. This cycle helps manage your treatment effectively while giving your body a rest.

What to Avoid

If you are considering using Tobramycin inhalation solution, it’s important to know that you should not use it if you have a known allergy to any aminoglycoside, which is a class of antibiotics. This is to ensure your safety and avoid any serious allergic reactions.

Additionally, be aware that Tobramycin is a controlled substance, meaning it has the potential for abuse or misuse. This can lead to dependence (a condition where your body becomes reliant on a substance). Always follow your healthcare provider's instructions and discuss any concerns you may have about its use.

Side Effects

You may experience some common side effects when using tobramycin inhalation solution, including a decrease in forced expiratory volume (how much air you can forcefully exhale), rales (abnormal lung sounds), an increased red blood cell sedimentation rate (a test that can indicate inflammation), and dysphonia (difficulty speaking).

It's important to be cautious if you have any known issues with hearing, balance, kidney function, or muscle strength, as this medication can worsen these conditions. Additionally, bronchospasm (tightening of the muscles around the airways) may occur, and there is a risk of harm to a fetus if used during pregnancy. If you have a known allergy to aminoglycosides, you should not use this medication. In cases of overdose, symptoms may include dizziness, ringing in the ears, balance issues, respiratory failure, muscle weakness, and kidney problems.

Warnings and Precautions

You should be cautious if you have any known or suspected issues with your hearing, balance, kidneys, or muscle function before using tobramycin inhalation solution. This medication can potentially worsen muscle weakness due to its effects on neuromuscular function. Additionally, be aware that inhaling this solution may cause bronchospasm (a tightening of the muscles around the airways), which can make breathing difficult.

It's important to have regular check-ups that include audiograms (hearing tests), serum concentration tests (to measure the level of the drug in your blood), and assessments of your kidney function while using this medication. If you are pregnant or planning to become pregnant, talk to your doctor, as aminoglycosides like tobramycin can harm the developing fetus.

If you experience any severe side effects, such as difficulty breathing or significant muscle weakness, seek emergency help immediately. You should also stop using the medication and contact your doctor if you notice any unusual symptoms or if your condition worsens.

Overdose

While there have been no reported overdoses with tobramycin inhalation solution in clinical trials, it's important to be aware of the signs and symptoms that may indicate an overdose from intravenous tobramycin. These can include dizziness, ringing in the ears (tinnitus), spinning sensation (vertigo), loss of high-frequency hearing, difficulty breathing (respiratory failure), muscle weakness (neuromuscular blockade), and kidney problems (renal impairment).

If you suspect an overdose, it's crucial to seek immediate medical attention. You should contact your healthcare provider or the Regional Poison Control Center for guidance on effective treatment. Additionally, monitoring tobramycin serum concentrations can be helpful in assessing an overdose situation. Always consider the potential for drug interactions that may affect how the medication works in your body.

Pregnancy Use

Aminoglycosides, such as streptomycin, can potentially harm a developing fetus, with reports indicating that it may cause irreversible hearing loss if used during pregnancy. While there is limited information on the use of tobramycin inhalation solution in pregnant women, it is believed that the amount absorbed into the bloodstream is minimal. However, it is important to be aware of the risks associated with cystic fibrosis during pregnancy, which may include complications for both the mother and the baby, such as preterm delivery.

All pregnancies carry a background risk of birth defects and miscarriage, estimated at 2 to 4% and 15 to 20% respectively in the general U.S. population. Although animal studies with tobramycin did not show adverse developmental outcomes, the effects on hearing were not assessed. Therefore, it is crucial to discuss any potential risks with your healthcare provider if you are pregnant or planning to become pregnant.

Lactation Use

When it comes to breastfeeding, it's important to be aware that the provided drug insert does not include specific information or guidelines for nursing mothers. This means that there are no clear recommendations or warnings about how the medication may affect you or your breast milk.

If you are breastfeeding or planning to breastfeed, it's always a good idea to consult with your healthcare provider about any medications you are taking. They can help you understand any potential risks and ensure the safety of both you and your baby.

Pediatric Use

When considering tobramycin inhalation solution for your child, it's important to note that its safety and effectiveness have not been tested in children with cystic fibrosis who are younger than six years old. If your child falls into this age group, you should discuss alternative treatment options with your healthcare provider to ensure their safety and well-being. Always consult with a medical professional before starting any new medication for your child.

Geriatric Use

When considering tobramycin inhalation solution, it's important to note that clinical studies did not include patients aged 65 and older. This means there is limited information on how this medication specifically affects older adults. Since tobramycin is primarily eliminated through the kidneys, older adults may face a higher risk of side effects, especially if they have any kidney issues (renal impairment).

As you age, your kidney function may naturally decline, so it’s advisable to have your kidney function monitored if you are prescribed this medication. This precaution can help ensure your safety and the effectiveness of the treatment. Always discuss any concerns with your healthcare provider to make informed decisions about your medications.

Renal Impairment

If you have kidney problems, it's important to be cautious when using tobramycin inhalation solution. This medication can affect your kidneys, so your healthcare provider will need to monitor your kidney function closely. They may also check your hearing (audiograms) and the levels of the medication in your blood to ensure it's safe for you.

Make sure to discuss your kidney health with your doctor before starting this treatment, as they may need to adjust your dosage or take additional precautions based on your specific condition.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware that using tobramycin inhalation solution alongside certain other medications can lead to serious side effects. Specifically, you should avoid taking it with drugs that can harm your nerves, kidneys, or hearing. This includes medications like ethacrynic acid, furosemide, urea, and intravenous mannitol.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and to prevent harmful interactions. Your provider can help you understand the risks and make informed decisions about your treatment.

Storage and Handling

To ensure the safety and effectiveness of your tobramycin inhalation solution, it's important to store it properly. Keep the solution refrigerated at a temperature between 2°C to 8°C (36°F to 46°F). If you need to take it out of the refrigerator, you can store the pouches—whether opened or unopened—at room temperature (up to 25°C or 77°F) for a maximum of 28 days. Always check the expiration date on the ampule; do not use it beyond this date, whether stored in the fridge or at room temperature.

When handling the ampules, avoid exposing them to intense light. To protect them, return unopened ampules to their foil pouch. You may notice that the solution, which is normally colorless to pale yellow, can darken over time if not refrigerated. However, this color change does not affect the quality of the product as long as it has been stored correctly. Always follow these guidelines to ensure safe use and storage.

Additional Information

No further information is available.

FAQ

What is Tobramycin inhalation solution?

Tobramycin inhalation solution is a sterile, clear, colorless or slight yellow aqueous solution used as an aminoglycoside antibacterial for managing cystic fibrosis patients with Pseudomonas aeruginosa.

How is Tobramycin inhalation solution administered?

It is administered by a compressed air driven reusable nebulizer, with the entire contents of one 4 mL ampule inhaled twice daily in cycles of 28 days on drug followed by 28 days off.

What are the contraindications for using Tobramycin inhalation solution?

It is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

What are the common adverse reactions associated with Tobramycin inhalation solution?

Common adverse reactions include decreased forced expiratory volume, rales, increased red blood cell sedimentation rate, and dysphonia.

What precautions should be taken when using Tobramycin inhalation solution?

Caution should be exercised in patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction, as bronchospasm may occur with inhalation.

Is Tobramycin inhalation solution safe during pregnancy?

While no teratogenic effects have been mentioned, aminoglycosides can cause fetal harm, so pregnant women should be informed of potential risks.

How should Tobramycin inhalation solution be stored?

It should be stored under refrigeration at 2°C to 8°C (36°F to 46°F) and can be kept at room temperature for up to 28 days after removal from refrigeration.

What should be monitored while using Tobramycin inhalation solution?

Audiograms, serum concentration, and renal function should be monitored as appropriate, especially in patients with renal dysfunction.

What is the chemical composition of Tobramycin inhalation solution?

The chemical formula is C₁₈H₃₇N₅O₉, with a molecular weight of 467.52.

Who should not use Tobramycin inhalation solution?

Safety and efficacy have not been demonstrated in patients under six years of age or those with a forced expiratory volume in one second (FEV1) less than 40% or greater than 80% predicted.

Packaging Info

The table below lists all NDC Code configurations of Tobramycin, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tobramycin.
Details

FDA Insert (PDF)

This is the full prescribing document for Tobramycin, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Tobramycin inhalation solution, USP is a sterile, clear, colorless to pale yellow aqueous solution that is non-pyrogenic, with pH and salinity adjusted. The chemical formula for tobramycin is C18H37N5O9, and it has a molecular weight of 467.52. The active ingredient, tobramycin, is characterized as 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. Each single-dose 4 mL ampule contains a 300 mg dose of tobramycin, along with sodium chloride and sulfuric acid in water for injection. Sulfuric acid and sodium hydroxide are utilized as necessary to adjust the pH to 5.0. Nitrogen is employed for sparging, filling, and pouching, and the formulation is free from preservatives. Tobramycin inhalation solution, USP is administered via a compressed air-driven reusable nebulizer.

Uses and Indications

Tobramycin inhalation solution is indicated for the management of patients with cystic fibrosis who are infected with Pseudomonas aeruginosa.

Limitations of Use: The safety and efficacy of tobramycin inhalation solution have not been established in patients under the age of six years, in patients with a forced expiratory volume in one second (FEV1) less than 40% or greater than 80% predicted, or in patients colonized with Burkholderia cepacia.

Dosage and Administration

For oral inhalation only. Healthcare professionals should administer the entire contents of one ampule twice daily by oral inhalation. This regimen should be followed in repeated cycles of 28 days on the drug, succeeded by 28 days off the drug.

Contraindications

Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Use in these patients may lead to severe allergic reactions.

Warnings and Precautions

Caution should be exercised when prescribing tobramycin inhalation solution to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. The use of aminoglycosides, including tobramycin, may exacerbate muscle weakness due to a potential curare-like effect on neuromuscular function, necessitating careful consideration in patients with pre-existing conditions.

Healthcare professionals should be vigilant for the possibility of bronchospasm occurring with the inhalation of tobramycin inhalation solution. Monitoring parameters are essential; therefore, audiograms, serum concentration levels, and renal function should be assessed as appropriate to ensure patient safety and effective management.

It is critical to inform women of childbearing potential about the risks associated with aminoglycoside administration during pregnancy, as fetal harm may occur. Healthcare providers should ensure that patients are adequately apprised of the potential hazards to the fetus when considering treatment options.

Side Effects

Patients receiving tobramycin inhalation solution may experience a range of adverse reactions. Common adverse reactions observed include decreased forced expiratory volume, rales, increased red blood cell sedimentation rate, and dysphonia.

Serious adverse reactions warrant caution, particularly in patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction, as the use of aminoglycosides may exacerbate muscle weakness due to a potential curare-like effect on neuromuscular function. Additionally, bronchospasm has been reported following the inhalation of tobramycin.

It is important to note that the administration of aminoglycosides, including tobramycin, during pregnancy may pose a risk of fetal harm; therefore, women should be informed of this potential hazard.

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

In cases of overdosage, signs and symptoms of acute toxicity from intravenous tobramycin may include dizziness, tinnitus, vertigo, loss of high-tone hearing acuity, respiratory failure, neuromuscular blockade, and renal impairment. These reactions highlight the importance of monitoring patients closely during treatment.

Drug Interactions

Concurrent and/or sequential use of tobramycin inhalation solution with other agents that possess neurotoxic, nephrotoxic, or ototoxic potential is contraindicated. This precaution is essential to mitigate the risk of compounded adverse effects associated with these drug classes.

Specifically, tobramycin inhalation solution should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The combination of these medications may increase the risk of toxicity, necessitating careful consideration of alternative therapeutic options or monitoring strategies when these drugs are indicated.

Packaging & NDC

The table below lists all NDC Code configurations of Tobramycin, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tobramycin.
Details

Pediatric Use

The safety and efficacy of tobramycin inhalation solution have not been established in pediatric patients with cystic fibrosis who are under six years of age. Caution is advised when considering the use of this medication in this age group, as clinical outcomes may differ from those observed in older children and adolescents.

Geriatric Use

Clinical studies of tobramycin inhalation solution did not include elderly patients aged 65 years and over. Therefore, the safety and efficacy of this medication in this age group have not been established.

Tobramycin is primarily excreted by the kidneys, and the risk of adverse reactions may be heightened in patients with impaired renal function. Given that elderly patients are more likely to experience decreased renal function, it is advisable to monitor renal function closely in this population. Dose adjustments may be necessary based on renal status to mitigate the risk of potential adverse effects.

Pregnancy

Aminoglycosides, including tobramycin, have the potential to cause fetal harm. Published literature indicates that the use of streptomycin, an aminoglycoside, during pregnancy can lead to total, irreversible, bilateral congenital deafness. While there are no available data on the use of tobramycin inhalation solution in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, it is anticipated that systemic absorption of tobramycin following inhaled administration is minimal.

Pregnant women should be advised of the potential risks to the fetus associated with the use of tobramycin. The estimated background risk of major birth defects and miscarriage for the indicated populations remains unknown; however, all pregnancies carry a background risk of birth defects, 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 approximately 2 to 4% and 15 to 20%, respectively.

Cystic fibrosis in pregnant women may pose additional risks, including an increased likelihood of preterm delivery. Although animal reproduction studies involving subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis did not reveal adverse developmental outcomes, ototoxicity was not assessed in the offspring from these studies. It is important to note that no reproduction toxicology studies have been conducted with inhaled tobramycin. In the animal studies, subcutaneous doses of tobramycin up to 100 mg/kg/day in rats and 20 mg/kg/day in rabbits did not result in adverse developmental outcomes; however, doses of 40 mg/kg/day or higher were associated with severe maternal toxicity in rabbits, which limited the evaluation of potential adverse developmental effects.

Lactation

There are no specific statements or considerations regarding nursing mothers or lactation in the provided drug insert text. Therefore, the effects of this medication on breastfed infants or its excretion in breast milk remain undetermined. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers.

Renal Impairment

Caution should be exercised when prescribing tobramycin inhalation solution to patients with known or suspected renal dysfunction. It is important to monitor audiograms, serum concentration, and renal function as appropriate to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In clinical trials, no overdoses have been reported with tobramycin inhalation solution. However, healthcare professionals should remain vigilant regarding the potential for acute toxicity associated with intravenous tobramycin overdosage.

Signs and Symptoms of Overdosage Acute toxicity from intravenous tobramycin may manifest through various symptoms, including dizziness, tinnitus, vertigo, loss of high-tone hearing acuity, respiratory failure, neuromuscular blockade, and renal impairment. These symptoms necessitate prompt recognition and management.

Pharmacokinetics Considerations It is important to note that the administration of tobramycin by inhalation results in low systemic bioavailability, and the drug is not significantly absorbed following oral administration. Consequently, monitoring tobramycin serum concentrations may provide valuable information in assessing potential overdosage.

Management Recommendations In all instances of suspected overdosage, it is imperative for physicians to contact the Regional Poison Control Center to obtain guidance on effective treatment strategies. Additionally, healthcare providers should consider the possibility of drug interactions that may alter drug disposition, which could complicate the clinical scenario.

By adhering to these recommendations, healthcare professionals can ensure appropriate management of tobramycin overdosage and mitigate potential adverse effects.

Nonclinical Toxicology

A two-year inhalation toxicology study in rats was conducted to evaluate the carcinogenic potential of an inhaled solution of tobramycin. During the study, rats were exposed to tobramycin for up to 1.5 hours per day over a period of 95 weeks. Serum levels of tobramycin reached up to 35 mcg/mL, which is 35 times higher than the average exposure levels of 1 mcg/mL observed in cystic fibrosis patients during clinical trials. The results indicated no drug-related increase in the incidence of any tumor types.

Tobramycin has also undergone a comprehensive evaluation for genotoxicity through a series of in vitro and in vivo tests. The Ames bacterial reversion test, which utilized five tester strains, did not demonstrate a significant increase in revertants, both with and without metabolic activation across all strains. Furthermore, tobramycin was found to be negative in the mouse lymphoma forward mutation assay, did not induce chromosomal aberrations in Chinese hamster ovary cells, and yielded negative results in the mouse micronucleus test.

In terms of reproductive toxicity, subcutaneous administration of tobramycin at doses of up to 100 mg/kg did not adversely affect mating behavior or result in impairment of fertility in either male or female rats.

Postmarketing Experience

Ototoxicity, characterized by complaints of hearing loss or tinnitus, has been reported in patients treated with tobramycin. It is recommended that physicians consider conducting an audiogram at baseline, especially for patients at increased risk of auditory dysfunction. In cases where patients report tinnitus or hearing loss during therapy with tobramycin inhalation solution, referral for audiological assessment is advised. Additionally, patients should be informed that vestibular toxicity may present as vertigo, ataxia, or dizziness.

Bronchospasm has been noted as a potential adverse reaction associated with the inhalation of tobramycin. Patients are advised to report any symptoms indicative of bronchospasm, such as shortness of breath accompanied by wheezing, coughing, or chest tightness, to their healthcare provider promptly.

Adverse reactions commonly associated with aminoglycosides, including nephrotoxicity and neuromuscular disorders, should be communicated to patients. Worsening kidney function may occur, necessitating blood and urine tests to monitor renal status during treatment with tobramycin inhalation solution. Furthermore, individuals with pre-existing muscle weakness conditions, such as myasthenia gravis or Parkinson's disease, may experience exacerbated muscle weakness.

Patients are encouraged to report any instances of hearing loss or tinnitus, as well as symptoms of vertigo, dizziness, or balance difficulties, to their healthcare provider immediately.

Patient Counseling

Patients should be advised to read the FDA-approved patient labeling, which includes the Patient Information and Instructions for Use. It is important to inform patients that information regarding the long-term efficacy and safety of tobramycin inhalation solution is limited, particularly in patients with severe cystic fibrosis (FEV < 40% predicted).

Patients must be instructed to complete a full 28-day course of tobramycin inhalation solution, even if they begin to feel better. After this 28-day therapy, they should discontinue the use of tobramycin inhalation solution for the next 28 days, followed by a resumption of therapy for another 28 days on and 28 days off cycle.

For patients who are taking multiple inhaled medications or performing chest physiotherapy, it is essential to advise them on the correct order of administration. Tobramycin inhalation solution should be taken last in the sequence of therapies. Additionally, patients should be informed that tobramycin inhalation solution is intended for use with the PARI LC PLUS reusable nebulizer and the PARI VIOS air compressor, and they should refer to the manufacturer's instructions for the care and use of these devices.

Patients should be made aware of the potential for ototoxicity, which may present as hearing loss or tinnitus. Physicians should consider conducting an audiogram at baseline, especially for patients at increased risk of auditory dysfunction. If a patient reports tinnitus or hearing loss during therapy, they should be referred for audiological assessment. Furthermore, patients should be reminded that vestibular toxicity may manifest as vertigo, ataxia, or dizziness.

It is important to inform patients that bronchospasm can occur with the inhalation of tobramycin. They should also be made aware of adverse reactions associated with aminoglycosides, including nephrotoxicity and neuromuscular disorders. Monitoring of hearing, serum concentrations of tobramycin, and renal function may be necessary during treatment.

Patients should be cautioned that aminoglycosides can cause fetal harm when administered to a pregnant woman. They should inform their healthcare provider if they are pregnant, become pregnant, or plan to become pregnant.

In the event that a dose of tobramycin inhalation solution is missed, patients should be instructed to take the missed dose as soon as possible if there are at least 6 hours until the next scheduled dose. If less than 6 hours remain, they should not take the missed dose and should resume their usual dosing schedule.

Patients should be encouraged to contact their healthcare provider if they have any questions regarding their treatment. Additionally, tobramycin inhalation solution ampules should be stored in a refrigerator (36°F to 46°F or 2°C to 8°C). If refrigeration is not available, the foil pouches (opened or unopened) may be stored at room temperature (up to 77°F/25°C) for up to 28 days. It is crucial to keep tobramycin inhalation solution light-sensitive; unopened ampules should be returned to the foil pouch and should not be exposed to intense light.

Patients should not use tobramycin inhalation solution if it appears cloudy, contains particles, or has been stored at room temperature for more than 28 days. They should also refrain from using the solution beyond the expiration date stamped on the ampule.

Storage and Handling

Tobramycin inhalation solution, USP is supplied in ampules that should be stored under refrigeration at a temperature range of 2°C to 8°C (36°F to 46°F). When removed from refrigeration or if refrigeration is not available, the solution may be stored at room temperature, not exceeding 25°C (77°F), for a maximum of 28 days. It is essential that the product is not used beyond the expiration date indicated on the ampule when stored under refrigeration or beyond 28 days when kept at room temperature.

To protect the ampules from intense light, they should remain in their foil pouch until ready for use. The solution is typically colorless to pale yellow; however, it may darken with age if not stored in the recommended refrigeration conditions. This color change does not affect the quality of the product, provided it has been stored according to the specified guidelines.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Tobramycin as submitted by Lifestar Pharma LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Tobramycin, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA216725) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.