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Tobramycin

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Active ingredient
Tobramycin 300 mg/5 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 2021
Label revision date
May 18, 2023
FDA Insert
Prescribing information, PDF file
Active ingredient
Tobramycin 300 mg/5 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 2021
Label revision date
May 18, 2023
Manufacturer
Aurobindo Pharma Limited
Registration number
ANDA210871
NDC root
59651-129
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, and slightly yellow liquid used primarily to help manage cystic fibrosis in adults and children aged 6 years and older who are infected with Pseudomonas aeruginosa (a type of bacteria that can cause lung infections). This medication contains tobramycin, which is an aminoglycoside antibacterial that works by targeting and killing bacteria in the airways.

When you inhale tobramycin, it is delivered directly to your lungs, where it can effectively concentrate and combat the infection. This solution is designed for use with a nebulizer, a device that turns the liquid medication into a mist for easy inhalation. It is important to note that the safety and effectiveness of tobramycin inhalation solution have not been established for children under 6 years of age or for certain patients with specific lung function conditions.

Uses

Tobramycin inhalation solution is used to help manage cystic fibrosis in adults and children aged 6 years and older who have an infection caused by a bacteria called Pseudomonas aeruginosa. This treatment is specifically designed for those who are dealing with this particular type of infection, which can complicate cystic fibrosis.

It's important to note that the safety and effectiveness of this medication have not been established for children younger than 6 years, or for patients whose lung function is significantly impaired (with a forced expiratory volume in 1 second, or FEV1, below 25% or above 75% of what is expected). Additionally, it is not recommended for patients who are colonized with another type of bacteria known as Burkholderia cepacia.

Dosage and Administration

You will use this medication only for oral inhalation, which means you will breathe it in through your mouth. If you are an adult or a child aged 6 years and older, the recommended dosage is one single-dose ampule containing 300 mg, taken twice a day. You should alternate between taking the medication for 28 days and then taking a break for 28 days.

It's important to take your doses as close to 12 hours apart as possible, but make sure they are at least 6 hours apart. To use the medication, you will need a hand-held PARI LC PLUS Reusable Nebulizer along with a DeVilbiss Pulmo-Aide compressor to help you inhale the dose effectively. Remember, the dosage does not change based on your weight, so everyone follows the same guidelines.

What to Avoid

It's important to be aware of certain situations where you should not use this medication. If you have a known hypersensitivity (allergic reaction) to any aminoglycoside, you should avoid taking this drug.

Additionally, this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Be cautious and follow your healthcare provider's instructions closely to prevent any issues related to dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and consult with your doctor if you have any concerns.

Side Effects

You may experience some common side effects when using tobramycin inhalation solution, including an increased cough, sore throat (pharyngitis), more sputum production, shortness of breath (dyspnea), coughing up blood (hemoptysis), decreased lung function, changes in your voice, altered taste, and skin rash.

There are also serious side effects to be aware of. Bronchospasm (tightening of the airways) can occur, and if it does, seek medical help. Ototoxicity, which includes symptoms like ringing in the ears (tinnitus) and hearing loss, has been reported, and you may need to stop using the medication if these occur. Additionally, nephrotoxicity (kidney damage) and worsening muscle weakness due to neuromuscular disorders can happen. If you are pregnant or planning to become pregnant, be aware that this medication can harm a developing fetus. If you suspect an overdose, seek immediate medical attention, as symptoms can include dizziness, hearing issues, and respiratory problems.

Warnings and Precautions

Using tobramycin inhalation solution may come with some important risks. You should be aware that it can cause bronchospasm (a tightening of the airways), which should be treated appropriately if it occurs. Additionally, some patients have reported tinnitus (ringing in the ears) and hearing loss, which may require you to stop using the medication and consult your doctor. There is also a risk of nephrotoxicity (kidney damage) associated with this medication, so if you experience any signs of kidney issues, it's crucial to seek medical advice and possibly discontinue use.

If you have any neuromuscular disorders, be cautious, as this medication may worsen muscle weakness. In such cases, medical assistance may be necessary. Lastly, if you are pregnant or planning to become pregnant, be aware that tobramycin can potentially harm a developing fetus. Always consult your healthcare provider for guidance tailored to your specific situation.

Overdose

If you suspect an overdose of intravenous (IV) tobramycin, it's important to be aware of potential signs and symptoms. These may include dizziness, ringing in the ears (tinnitus), a spinning sensation (vertigo), loss of high-frequency hearing, difficulty breathing (respiratory failure), muscle weakness (neuromuscular blockade), and kidney problems (renal impairment). If you experience any of these symptoms, seek immediate medical attention.

In the event of an overdose, you should stop using the tobramycin inhalation solution right away and have your kidney function tested. It's also crucial to contact your doctor or the Regional Poison Control Center for guidance on the best course of action. They may recommend monitoring your tobramycin levels in the blood and considering treatments like hemodialysis, which can help remove the drug from your system. Always keep in mind that drug interactions can affect how your body processes medications, so inform your healthcare provider about any other drugs you are taking.

Pregnancy Use

Aminoglycosides, such as streptomycin, can potentially harm a developing fetus, with reports indicating that it may cause total, irreversible, bilateral congenital deafness 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 an increased risk of preterm delivery.

If you are pregnant or planning to become pregnant, it is crucial to discuss any medications with your healthcare provider. They can help you understand the potential risks to your fetus and the background risk of major birth defects and miscarriage, which is estimated to be between 2% to 4% and 15% to 20%, respectively, in the general U.S. population. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is currently no data on the use of tobramycin inhalation solution in pregnant women. This means we can't determine if it poses risks for major birth defects, miscarriage, or other negative outcomes for mothers or their babies. However, when tobramycin is inhaled, it is expected that only a small amount will enter the bloodstream.

If you are pregnant, it's advisable to discuss the potential risks to your fetus with your healthcare provider. Always prioritize open communication about any medications you are considering while breastfeeding or during pregnancy.

Pediatric Use

When considering tobramycin inhalation solution for your child, it's important to note that its safety and effectiveness have not been established for children under 6 years old. Therefore, this medication is not recommended for use in children younger than this age. Always consult with your child's healthcare provider for guidance on appropriate treatments and alternatives.

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.

As you age, your kidney function may decline, so it’s advisable to have your renal function (how well your kidneys are working) monitored while using this medication. This precaution can help ensure your safety and the effectiveness of the treatment. Always consult with your healthcare provider to discuss any concerns and to determine the best approach for your health needs.

Renal Impairment

If you have kidney problems, it's important to be aware that tobramycin inhalation solution, like other medications in the aminoglycoside class, can potentially harm your kidneys (a condition known as nephrotoxicity). If you experience any signs of kidney issues while using this medication, your healthcare provider may need to adjust your treatment or possibly stop the medication altogether. Always communicate openly with your doctor about any changes in your health, especially related to your kidneys, to ensure you receive the best care possible.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to be cautious when using tobramycin inhalation solution alongside other medications. You should avoid taking it with drugs that can harm your nerves, kidneys, or hearing, as this combination can increase the risk of serious side effects. Specifically, medications like ethacrynic acid, furosemide, urea, or intravenous mannitol should not be used together with tobramycin, as they may heighten the risk of toxicity.

Always discuss your current medications and any planned tests with your healthcare provider. They can help ensure that your treatment is safe and effective, minimizing the risk of harmful interactions. Your health and safety are the top priority, so open communication with your provider is essential.

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 2º to 8ºC (36º to 46ºF). If you need to take it out of the refrigerator, you can store the pouches—whether opened or unopened—at room temperature (up to 25ºC/77ºF) 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, as this can affect the solution. You may notice that the solution appears slightly yellow, and it may 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 dispose of any expired or unused solution safely, following local guidelines.

Additional Information

No further information is available.

FAQ

What is Tobramycin inhalation solution?

Tobramycin inhalation solution is a sterile, clear, slightly yellow, non-pyrogenic aqueous solution used for the management of cystic fibrosis in patients 6 years and older with Pseudomonas aeruginosa.

What is the recommended dosage for Tobramycin inhalation solution?

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, alternating between 28 days on and 28 days off.

How should I prepare Tobramycin inhalation solution for use?

Wash your hands, open the foil pouch, separate one ampule, check the expiration date, ensure the solution is clear, and then prepare the nebulizer according to the instructions provided.

What are the common side effects of Tobramycin inhalation solution?

Common side effects include increased cough, pharyngitis, increased sputum, dyspnea, and voice alteration.

What serious adverse reactions should I be aware of?

Serious adverse reactions may include bronchospasm, ototoxicity (hearing loss), nephrotoxicity (kidney damage), and neuromuscular disorders.

Can Tobramycin inhalation solution be used during pregnancy?

There are no available data on the use of Tobramycin inhalation solution in pregnant women, but aminoglycosides can cause fetal harm. Advise pregnant women of the potential risks.

How should I store Tobramycin inhalation solution?

Store Tobramycin inhalation solution under refrigeration at 2º to 8ºC (36º to 46ºF) and do not use beyond the expiration date or 28 days after removal from refrigeration.

What should I do if I experience ototoxicity while using Tobramycin?

If you notice signs of ototoxicity, such as tinnitus or hearing loss, contact your doctor immediately, as you may need to discontinue the medication.

Is Tobramycin inhalation solution safe for children under 6 years of age?

The safety and efficacy of Tobramycin inhalation solution have not been established in children under 6 years of age.

What precautions should I take when using Tobramycin inhalation solution?

Avoid concurrent use with other drugs that have neurotoxic, nephrotoxic, or ototoxic potential, and monitor renal function, especially in elderly patients.

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, slightly yellow, non-pyrogenic aqueous solution specifically formulated for administration via a compressed air-driven reusable nebulizer. The solution has a pH adjusted to 6.0 and is isotonic, with salinity tailored for respiratory use.

The active ingredient, tobramycin, is a white or almost white powder with the chemical formula C18H37N5O9 and a molecular weight of 467.52 g/mol. Its structural designation 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.

Each single-dose 5 mL ampule contains 300 mg of tobramycin USP and 11.25 mg of sodium chloride, dissolved in water for injection. The formulation is adjusted with sulfuric acid and sodium hydroxide to achieve the desired pH, and nitrogen is utilized for sparging. All components comply with USP standards, and the formulation is free from preservatives.

Uses and Indications

Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients aged 6 years and older 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 6 years, in patients with forced expiratory volume in 1 second (FEV1) less than 25% or greater than 75% of predicted values, or in patients colonized with Burkholderia cepacia.

Dosage and Administration

The medication is intended for oral inhalation only. The recommended dosage for adults and pediatric patients aged 6 years and older is one single-dose ampule (300 mg) administered twice daily via oral inhalation. This regimen should be followed in alternating cycles of 28 days on the medication, followed by 28 days off.

Dosage adjustments based on body weight are not necessary. It is advised that doses be taken as close to 12 hours apart as possible, with a minimum interval of 6 hours between doses. Each 300 mg dose should be administered using a hand-held PARI LC PLUS Reusable Nebulizer in conjunction with a DeVilbiss Pulmo-Aide compressor to ensure proper delivery of the medication.

Contraindications

Use of this product is contraindicated in patients with a known hypersensitivity to any aminoglycoside. This contraindication is based on the potential for severe allergic reactions in individuals with a history of such hypersensitivity.

Warnings and Precautions

Bronchospasm may occur following the inhalation of tobramycin inhalation solution. In the event of bronchospasm, it is imperative to treat the patient using appropriate medical interventions.

Ototoxicity is a significant concern associated with the use of tobramycin inhalation solution, with reports of tinnitus and hearing loss in patients. Should these symptoms arise, it is essential to manage the situation appropriately, which may include the discontinuation of the medication.

Nephrotoxicity is another potential risk linked to aminoglycosides, including tobramycin. If signs of nephrotoxicity develop, healthcare professionals should manage the patient accordingly, which may involve discontinuing the use of tobramycin inhalation solution.

Patients with neuromuscular disorders may experience exacerbated muscle weakness due to the curare-like effects of aminoglycosides on neuromuscular function. In cases of neuromuscular blockade, administration of calcium salts may reverse the effects; however, mechanical assistance may be required.

It is crucial to note that aminoglycosides, including tobramycin, can cause embryo-fetal toxicity, potentially leading to fetal harm. Therefore, careful consideration should be given when prescribing to pregnant individuals.

In summary, healthcare professionals should remain vigilant for signs of bronchospasm, ototoxicity, nephrotoxicity, and neuromuscular effects in patients receiving tobramycin inhalation solution, and take appropriate actions as necessary.

Side Effects

Patients receiving tobramycin inhalation solution may experience a range of adverse reactions. The most common adverse reactions observed include increased cough, pharyngitis, increased sputum production, dyspnea, hemoptysis, decreased lung function, voice alteration, taste perversion, and rash.

Serious adverse reactions have also been reported. Bronchospasm may occur with the inhalation of tobramycin inhalation solution and should be treated as medically appropriate if it arises. Ototoxicity, characterized by tinnitus and hearing loss, has been noted in patients receiving this treatment; management may require discontinuation of the medication. Nephrotoxicity, a known risk associated with aminoglycosides, necessitates appropriate management if it develops, which may include discontinuation of tobramycin inhalation solution. Additionally, patients with neuromuscular disorders may experience exacerbated muscle weakness due to a potential curare-like effect on neuromuscular function. In cases of neuromuscular blockade, administration of calcium salts may reverse the effects, although mechanical assistance may be required.

It is important to note that aminoglycosides, including tobramycin, can cause embryo-fetal toxicity, posing a risk of fetal harm.

Further, signs and symptoms of acute toxicity from intravenous tobramycin overdosage may include dizziness, tinnitus, vertigo, loss of high-tone hearing acuity, respiratory failure, neuromuscular blockade, and renal impairment. Immediate withdrawal of tobramycin inhalation solution is essential in cases of acute toxicity, and baseline renal function tests should be conducted. Physicians should contact the Regional Poison Control Center for guidance on effective treatment in suspected overdosage cases, and hemodialysis may be beneficial in removing tobramycin from the body.

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 toxic effects.

In particular, the concomitant administration of tobramycin inhalation solution with ethacrynic acid, furosemide, urea, or intravenous mannitol is not recommended. The combination of these medications may enhance the toxicity associated with aminoglycosides, necessitating careful consideration of alternative therapeutic options. Monitoring for signs of toxicity is advised if such combinations are deemed necessary.

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 under 6 years of age. Consequently, the use of tobramycin inhalation solution is not indicated for children younger than 6 years.

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 substantially 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 result in total, irreversible, bilateral congenital deafness. While there are no available data specifically regarding the use of tobramycin inhalation solution in pregnant women to assess the 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 informed of the potential risks to the fetus associated with aminoglycoside use. Additionally, cystic fibrosis in pregnancy poses risks to the mother, including an increased likelihood of preterm delivery. The estimated background risk of major birth defects and miscarriage for the general population is not well defined for the indicated populations; however, 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.

In animal reproduction studies involving subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis, no adverse developmental outcomes were observed. However, it is important to note that ototoxicity was not evaluated in the offspring from these studies. Therefore, healthcare professionals should exercise caution and consider the potential risks when prescribing tobramycin to pregnant patients.

Lactation

There are no available data on tobramycin inhalation solution use in lactating mothers to inform a drug-associated risk of adverse effects in breastfed infants. Systemic absorption of tobramycin following inhaled administration is expected to be minimal, suggesting a low likelihood of significant excretion into breast milk. However, due to the lack of specific studies, caution is advised when administering this medication to lactating mothers. Healthcare professionals should consider the potential risks and benefits before prescribing tobramycin inhalation solution to nursing mothers.

Renal Impairment

Patients with renal impairment may experience nephrotoxicity associated with aminoglycosides, including tobramycin inhalation solution. In cases where nephrotoxicity develops, it is essential to manage the patient appropriately, which may include the discontinuation of the medication. Monitoring renal function is recommended to ensure patient safety and to adjust treatment as necessary.

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

Acute toxicity resulting from an overdosage of intravenous (IV) tobramycin can manifest through a variety of signs and symptoms. Healthcare professionals should be vigilant for indications such as dizziness, tinnitus, vertigo, loss of high-tone hearing acuity, respiratory failure, neuromuscular blockade, and renal impairment.

When tobramycin is administered via inhalation, it is important to note that it exhibits low systemic bioavailability. Additionally, tobramycin is not significantly absorbed when taken orally, which may influence the clinical management of overdosage cases.

Monitoring tobramycin serum concentrations can be beneficial in assessing the extent of overdosage. In instances of suspected acute toxicity, immediate withdrawal of the tobramycin inhalation solution is essential. Furthermore, baseline tests of renal function should be conducted to evaluate any potential renal impairment.

In all cases of suspected overdosage, it is imperative for physicians to contact the Regional Poison Control Center for guidance on effective treatment strategies. It is also crucial to consider the possibility of drug interactions that may alter drug disposition, which could complicate the clinical scenario.

For patients experiencing severe overdosage, hemodialysis may be a useful intervention to facilitate the removal of tobramycin from the body, thereby mitigating the effects of toxicity.

Nonclinical Toxicology

A two-year inhalation toxicology study in rats was conducted to evaluate the carcinogenic potential of tobramycin inhalation solution. In this study, rats were exposed to the clinical formulation of tobramycin inhalation solution for up to 1.5 hours per day over a period of 95 weeks. Serum levels of tobramycin reached up to 35 mcg/mL in the rats, which is significantly higher than the average serum 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 type of tumor.

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, regardless of metabolic activation. Additionally, 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.

Furthermore, 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

Postmarketing experience with tobramycin inhalation solution includes reports of hearing loss associated with its use. Additionally, there have been observations of airway narrowing in patients receiving this treatment. It is important to note that tobramycin inhalation solution belongs to a class of drugs known to potentially cause kidney damage. Furthermore, the use of aminoglycosides during pregnancy has been linked to the risk of irreversible congenital deafness.

Patient Counseling

Patients should be advised to read the FDA-approved patient labeling, which includes the Patient Information and Instructions for Use, to ensure they understand the proper use and potential risks associated with tobramycin inhalation solution.

Patients must be informed to report any instances of shortness of breath or wheezing following the administration of tobramycin inhalation solution, as it may lead to airway narrowing. Additionally, they should be counseled to notify their physician if they experience ringing in the ears, dizziness, or any changes in hearing, given that tobramycin inhalation solution has been linked to hearing loss.

It is important for patients to disclose any history of kidney problems to their physician, as tobramycin inhalation solution belongs to a class of drugs known to potentially cause kidney damage.

Pregnant women should be specifically advised that aminoglycosides, including tobramycin, can result in irreversible congenital deafness if administered during pregnancy.

Storage and Handling

Tobramycin inhalation solution, USP is supplied in ampules and should be stored under refrigeration at a temperature range of 2º to 8ºC (36º to 46ºF). If refrigeration is unavailable, the solution may be stored at room temperature, not exceeding 25ºC (77ºF), for a maximum of 28 days after removal from the refrigerator, whether the pouches are opened or unopened.

It is imperative that tobramycin inhalation solution, USP is not used beyond the expiration date indicated on the ampule when stored under refrigeration or beyond 28 days when kept at room temperature. Additionally, the ampules should be protected from intense light exposure. The solution may appear slightly yellow, and while it may darken with age if not refrigerated, this color change does not affect the product's quality as long as it is stored according to the recommended conditions.

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 Aurobindo Pharma Limited. 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 (ANDA210871) 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.

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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.