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Tobramycin

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Active ingredient
Tobramycin 3 mg/1 mL
Other brand names
Drug class
Aminoglycoside Antibacterial
Dosage form
Solution
Route
Ophthalmic
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1993
Label revision date
February 5, 2026
FDA Insert
Prescribing information, PDF file
Active ingredient
Tobramycin 3 mg/1 mL
Other brand names
Drug class
Aminoglycoside Antibacterial
Dosage form
Solution
Route
Ophthalmic
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 1993
Label revision date
February 5, 2026
Manufacturer
Sportpharm LLC
Registration number
ANDA064052
NDC root
85766-025
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 ophthalmic solution USP, 0.3% is a sterile antibiotic eye drop specifically designed to treat external infections of the eye and its surrounding areas caused by certain bacteria. It contains tobramycin, a water-soluble aminoglycoside antibiotic that is effective against a wide range of both gram-negative and gram-positive bacteria.

This medication is typically used to help clear up infections and is safe for use in children, as demonstrated in clinical studies. When using tobramycin ophthalmic solution, it's important to monitor how well the infection responds to the treatment.

Uses

Tobramycin ophthalmic solution, 0.3%, is a topical antibiotic that you can use to treat external infections of the eye and the surrounding areas caused by certain bacteria that are sensitive to this medication. It's important to have your bacterial response monitored while using this treatment to ensure it's working effectively.

Clinical studies have demonstrated that tobramycin is both safe and effective for children, making it a suitable option for younger patients who may need treatment for eye infections. Always consult with your healthcare provider for guidance tailored to your specific situation.

Dosage and Administration

If you have mild to moderate eye disease, you should put 1 or 2 drops of the medication into the affected eye(s) every 4 hours. This helps to manage your symptoms effectively.

For more severe infections, you will need to use 2 drops in the eye(s) every hour until you notice improvement. Once your condition starts to get better, you should gradually reduce the frequency of the drops before stopping the treatment altogether. Remember, this medication is meant for topical ophthalmic (related to the eyes) use only, so make sure to follow these instructions carefully for the best results.

What to Avoid

If you are considering using Tobramycin ophthalmic solution, it's important to be aware of certain precautions. First, do not use this medication if you have a known allergy to any of its ingredients, as this could lead to serious reactions. Additionally, if you are experiencing signs of a bacterial eye infection, you should avoid wearing contact lenses until the infection has resolved.

Always prioritize your eye health and consult with your healthcare provider if you have any concerns or questions about using this medication.

Side Effects

You may experience some side effects when using tobramycin ophthalmic solution. The most common reactions include hypersensitivity, which can manifest as localized eye irritation such as itching, swelling, or redness. These effects occur in fewer than 3 out of 100 patients. In rare cases, more serious reactions like anaphylaxis (a severe allergic reaction), Stevens-Johnson syndrome, and erythema multiforme (a skin condition) have been reported.

Additionally, if you have certain neuromuscular disorders, using this medication may worsen muscle weakness. Other potential side effects associated with systemic aminoglycosides include neurotoxicity (nerve damage), ototoxicity (hearing damage), and nephrotoxicity (kidney damage). If you notice any signs of hypersensitivity, such as rash, itching, or swelling, it’s important to stop using the medication and consult your healthcare provider.

Warnings and Precautions

This medication is intended for use in your eyes only and should never be injected directly into the eye. Some people may experience sensitivity to this treatment, which can range from mild reactions like redness and itching to more severe issues such as skin rashes or even life-threatening reactions. If you notice any signs of a sensitivity reaction, stop using the medication immediately and contact your doctor.

Using this antibiotic for a long time can lead to an overgrowth of other organisms, including fungi. If you develop a secondary infection, it's important to seek appropriate treatment. Additionally, if you have had allergic reactions to other aminoglycoside antibiotics, you may be at risk for similar reactions with this medication, so discontinue use and consult your healthcare provider if that happens. Lastly, avoid wearing contact lenses if you have any signs of a bacterial eye infection.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or details on hand can help healthcare professionals provide the best care. Always remember, when in doubt, it’s better to be safe and get help.

Pregnancy Use

Reproduction studies in animals have shown that tobramycin, even at doses much higher than what humans typically receive, does not appear to harm fertility or the developing fetus. However, it’s important to note that there are no well-controlled studies in pregnant women to confirm these findings. Since animal studies may not always reflect how humans will respond, you should only use this medication during pregnancy if it is clearly necessary and prescribed by your healthcare provider. Always discuss any concerns or questions with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding and considering the use of tobramycin ophthalmic solution, it's important to weigh the potential risks to your nursing infant. This medication may cause adverse reactions in infants, so you should discuss with your healthcare provider whether to continue breastfeeding or to stop using the drug. Your decision should take into account how essential the medication is for your health. Always prioritize both your well-being and that of your baby when making this choice.

Pediatric Use

When considering this medication for your child, it's important to note that its safety and effectiveness have not been established for children younger than 2 months old. If your child falls into this age group, you should consult with your healthcare provider for guidance and alternative options. Always prioritize your child's health and well-being by discussing any concerns with a medical professional.

Geriatric Use

As an older adult or caregiver, it's reassuring to know that there are no significant differences in safety or effectiveness when using this medication compared to younger patients. This means that you can expect similar results and side effects, regardless of age.

However, it's always important to consult with your healthcare provider about any specific concerns or conditions you may have, as individual health needs can vary. Your doctor can help ensure that the medication is appropriate for you and monitor any potential effects.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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, and there are no special monitoring or precautions outlined for patients like you.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your full list of medications and any health concerns to receive the best care possible.

Storage and Handling

To ensure the best results with your tobramycin ophthalmic solution USP, 0.3%, store it in a cool, dry place at a temperature between 2°C to 25°C (36°F to 77°F). It's important to avoid exposing the solution to excessive heat, as this can affect its effectiveness.

Once you open the bottle, you can continue to use the solution until the expiration date printed on the label. Always handle the bottle with care to maintain its sterility (cleanliness) and effectiveness. If you have any questions about disposal or further handling, please consult your healthcare provider.

Additional Information

No further information is available.

FAQ

What is Tobramycin ophthalmic solution USP, 0.3%?

Tobramycin ophthalmic solution USP, 0.3% is a sterile topical antibiotic formulation used for treating external infections of the eye and its surrounding areas caused by susceptible bacteria.

How should I use Tobramycin ophthalmic solution?

In mild to moderate infections, instill 1 or 2 drops into the affected eye(s) every 4 hours. For severe infections, instill 2 drops hourly until improvement, then reduce the frequency before discontinuation.

What are the common side effects of Tobramycin ophthalmic solution?

Common side effects include hypersensitivity, lid itching, swelling, and conjunctival erythema, occurring in less than three of 100 patients treated.

Are there any contraindications for using Tobramycin ophthalmic solution?

Yes, it is contraindicated in patients with known hypersensitivity to any of its components.

Can I wear contact lenses while using Tobramycin ophthalmic solution?

No, you should not wear contact lenses if you have signs and symptoms of a bacterial ocular infection.

Is Tobramycin ophthalmic solution safe for children?

Clinical studies have shown that Tobramycin is safe and effective for use in children.

What should I do if I experience a hypersensitivity reaction?

If you experience a hypersensitivity reaction, such as itching or rash, discontinue use immediately and consult your healthcare provider.

What precautions should I take if I am pregnant or nursing?

Tobramycin should be used during pregnancy only if clearly needed, and nursing mothers should decide whether to discontinue nursing or the drug, considering its importance.

How should I store Tobramycin ophthalmic solution?

Store the solution at 2°C to 25°C (36°F to 77°F) and avoid excessive heat. After opening, use it until the expiration date on the bottle.

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 ophthalmic solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation designed for the treatment of external ophthalmic infections. Each mL of the solution contains tobramycin 3 mg (0.3%). Inactive ingredients include boric acid, sodium sulfate, sodium chloride, tyloxapol, and purified water, with sodium hydroxide and/or sulfuric acid used to adjust the pH. The pH of the solution ranges from 7.0 to 8.0. The formulation also contains benzalkonium chloride as a preservative at a concentration of 0.1 mg (0.01%). Tobramycin is classified as a water-soluble aminoglycoside antibiotic, effective against a broad spectrum of gram-negative and gram-positive ophthalmic pathogens. The chemical name of tobramycin is (2S,3R,4S,5S,6R)-4-amino-2-[(1S,2S,3R,4S,6R)-4,6-diamino-3-(2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxyoxan-2-yloxy-2-hydroxycyclohexyl]oxy-6-(hydroxymethyl)oxane-3,5-diol.

Uses and Indications

Tobramycin ophthalmic solution, 0.3%, is indicated for the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. This topical antibiotic is effective in managing bacterial infections and is supported by clinical studies demonstrating its safety and efficacy in pediatric populations.

Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution to ensure optimal therapeutic outcomes.

Dosage and Administration

In cases of mild to moderate disease, the recommended dosage is to instill 1 or 2 drops into the affected eye(s) every 4 hours. For severe infections, the dosage is increased to 2 drops instilled into the eye(s) hourly until clinical improvement is observed. Following improvement, the frequency of administration should be gradually reduced before discontinuation of treatment.

This medication is intended for topical ophthalmic use only.

Contraindications

Tobramycin ophthalmic solution, 0.3% is contraindicated in patients with known hypersensitivity to any of its components. Additionally, patients should be advised against wearing contact lenses if they exhibit signs and symptoms of bacterial ocular infection, as this may exacerbate the condition.

Warnings and Precautions

Topical ophthalmic use is the sole intended application for this product; it is strictly contraindicated for injection into the eye.

Patients may experience sensitivity to topically applied aminoglycosides, which can manifest in varying degrees of hypersensitivity reactions. These reactions may range from localized effects to more severe systemic responses, including erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. In the event of a sensitivity reaction to tobramycin ophthalmic solution, 0.3%, it is imperative to discontinue use immediately.

Prolonged use of this antibiotic preparation may lead to the overgrowth of nonsusceptible organisms, including fungi. Should a superinfection occur, it is essential to initiate appropriate therapy without delay.

Cross-sensitivity to other aminoglycoside antibiotics is a possibility. If hypersensitivity develops while using this product, it is crucial to discontinue use and implement suitable therapeutic measures.

Patients should be counseled against wearing contact lenses if they exhibit signs and symptoms of a bacterial ocular infection to prevent exacerbation of the condition.

Side Effects

Patients receiving tobramycin ophthalmic solution may experience adverse reactions, which can be categorized by frequency and seriousness.

The most frequent adverse reactions observed include hypersensitivity and localized ocular toxicity. Localized ocular toxicity may manifest as lid itching, swelling, and conjunctival erythema, occurring in less than three out of 100 patients treated with the solution. Hypersensitivity reactions can range from local effects to more generalized responses, including erythema, itching, urticaria, skin rash, and in severe cases, anaphylaxis or anaphylactoid reactions. It is recommended that treatment be discontinued if any sensitivity reaction occurs.

In addition to the common adverse reactions, postmarketing experience has reported more serious events such as anaphylactic reactions, Stevens-Johnson syndrome, and erythema multiforme.

Furthermore, patients should be aware of additional adverse reactions associated with systemic aminoglycosides, which may include neurotoxicity, ototoxicity, and nephrotoxicity. There is also a risk of aggravation of muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, due to potential effects on neuromuscular function.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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

Safety and effectiveness in pediatric patients below the age of 2 months have not been established. Therefore, caution is advised when considering treatment in this age group.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, have not demonstrated any overall differences in safety or effectiveness compared to younger patients. Therefore, no specific dosage adjustments are necessary for this population. However, healthcare providers should remain vigilant in monitoring geriatric patients for any potential age-related changes that may influence individual responses to treatment. Regular assessment and consideration of comorbidities are recommended to ensure optimal therapeutic outcomes in this demographic.

Pregnancy

Reproduction studies in three types of animals at doses up to 33 times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. However, there are no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, tobramycin should be used during pregnancy only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against the risks when considering the use of this drug in pregnant patients.

Lactation

Because of the potential for adverse reactions in nursing infants from tobramycin ophthalmic solution, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

Nonclinical Toxicology

Reproduction studies conducted in three animal species at doses up to 33 times the normal human systemic dose have demonstrated no evidence of impaired fertility or teratogenic effects associated with tobramycin. However, it is important to note that there are no adequate and well-controlled studies in pregnant women. Given that animal studies may not always accurately predict human responses, the use of this drug during pregnancy should be considered only when clearly necessary.

Postmarketing Experience

Postmarketing experience has identified additional adverse reactions associated with the use of the product. Reports include anaphylactic reactions, Stevens-Johnson syndrome, and erythema multiforme.

Furthermore, systemic aminoglycosides have been associated with neurotoxicity, ototoxicity, and nephrotoxicity in patients undergoing treatment. It has also been noted that aminoglycosides may exacerbate muscle weakness in individuals with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, due to their potential impact on neuromuscular function.

Patient Counseling

Healthcare providers should advise patients to avoid touching the dropper tip to any surface, as this may lead to contamination of the solution. It is important to inform patients that they should not wear contact lenses if they exhibit signs and symptoms of a bacterial ocular infection.

Providers should discuss the potential risks associated with tobramycin ophthalmic solution in nursing mothers. A careful decision should be made regarding whether to discontinue nursing or to discontinue the medication, considering the importance of the drug to the mother’s health.

Additionally, healthcare providers should communicate that the safety and effectiveness of this medication have not been established in pediatric patients under the age of 2 months.

Storage and Handling

Tobramycin ophthalmic solution USP, 0.3% is supplied in a suitable container that ensures the integrity of the product. It should be stored at a temperature range of 2°C to 25°C (36°F to 77°F) and must be protected from excessive heat to maintain its efficacy.

Once opened, the solution can be used until the expiration date indicated on the bottle. It is essential to adhere to these storage conditions to ensure the product remains safe and effective for use.

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 Sportpharm 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 (ANDA064052) 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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Primary FDA sources:

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.