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Tobramycin

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This product has been discontinued

Active ingredient
Tobramycin 3 mg/1 mL
Other brand names
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 13, 2012
FDA Insert
Prescribing information, PDF file
Active ingredient
Tobramycin 3 mg/1 mL
Other brand names
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 13, 2012
Manufacturer
H. J. Harkins Company, Inc.
Registration number
ANDA064052
NDC root
52959-108
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Drug Overview

Tobramycin ophthalmic solution 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 that can affect the eyes.

This medication is typically used to help clear up infections and promote healing. It is important to monitor the response to treatment to ensure the infection is effectively managed. Tobramycin ophthalmic solution has been shown to be safe and effective for use in children as well.

Uses

Tobramycin Ophthalmic Solution is a topical antibiotic that you can use to treat external infections of the eye and the surrounding areas caused by certain bacteria. It's important to monitor how well the bacteria respond to this treatment to ensure its effectiveness.

Clinical studies have demonstrated that tobramycin is both safe and effective for use in children, making it a reliable option for treating eye infections in younger patients.

Dosage and Administration

If you have mild to moderate eye disease, you should instill one or two drops of the medication into the affected eye(s) every four hours. This helps manage your symptoms effectively throughout the day.

For more severe infections, you will need to instill two drops into the eye(s) every hour until you notice an improvement. Once your condition starts to get better, it's important to gradually reduce the frequency of the drops before stopping the treatment altogether. Remember, this medication is for ophthalmic (eye) use only, so be sure to follow these instructions carefully for the best results.

What to Avoid

You should avoid using Tobramycin Ophthalmic Solution if you are known to be hypersensitive (allergic) to any of its components. It's important to be aware of this to prevent any adverse reactions. Always consult with your healthcare provider if you have any concerns or questions about your allergies or the use of this medication.

Side Effects

You may experience some side effects when using tobramycin ophthalmic solution. The most common reactions include localized eye irritation, such as itching and swelling of the eyelids, and redness of the conjunctiva (the membrane covering the eye). These effects occur in fewer than 3 out of 100 patients. If you notice any sensitivity reactions, it's important to stop using the solution.

Be aware that using tobramycin for an extended period can lead to an overgrowth of non-susceptible organisms, including fungi. If you develop a secondary infection, you should seek appropriate treatment. Additionally, signs of an overdose, such as increased tearing, redness, and eyelid swelling, can resemble these side effects. Always remember that this medication is not meant for injection into the eye.

Warnings and Precautions

You should be aware that this medication is not meant for injection into the eye. Some people may experience sensitivity to Tobramycin Ophthalmic Solution. If you notice any signs of a sensitivity reaction, it’s important to stop using the product immediately and consult your doctor.

Additionally, using this antibiotic for an extended period can lead to the growth of other organisms that are not affected by the medication, including fungi. If you develop a superinfection (an infection caused by organisms that are resistant to the antibiotic), you should seek appropriate treatment from your healthcare provider. Always prioritize your health and reach out to your doctor if you have any concerns.

Overdose

If you suspect an overdose of tobramycin ophthalmic solution, it's important to be aware of the signs and symptoms. You may notice symptoms such as punctate keratitis (small, pinpoint damage to the cornea), redness of the eye (erythema), increased tearing (lacrimation), swelling (edema), and itching of the eyelids. These symptoms can resemble side effects that some patients experience, so it's crucial to pay attention to any changes in your eyes.

If you experience any of these symptoms, you should seek medical advice promptly. It's always better to err on the side of caution when it comes to your health. If you feel that you or someone else may have taken too much of this medication, contact your healthcare provider or local poison control center for guidance on what to do next.

Pregnancy Use

This medication is classified as Pregnancy Category B, which means that studies in animals have not shown any harm to fertility or the developing fetus when given at doses much higher than what humans typically receive. However, it’s important to note that there are no well-controlled studies in pregnant women.

Because animal studies do not always predict how humans will respond, you should only use this medication during pregnancy if it is clearly necessary. Always consult with your healthcare provider to weigh the benefits and risks before taking any medication while pregnant.

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. Consider the importance of the medication for your health when making this decision. Always prioritize both your well-being and that of your baby.

Pediatric Use

Clinical studies have demonstrated that tobramycin is both safe and effective for children. If you are considering this medication for your child, you can feel reassured by the research supporting its use in the pediatric population (children and adolescents). Always consult with your child's healthcare provider to ensure the appropriate dosage and to discuss any specific concerns you may have regarding their treatment.

Geriatric Use

When using Tobramycin Ophthalmic Solution, it's important to be aware that there hasn't been specific research on its use in older adults. As you age, your body may respond differently to medications, and you might be more sensitive to the effects of aminoglycosides like tobramycin.

If you or a loved one is an older adult, your doctor may need to adjust the dosage of this medication, especially if there are concerns about kidney function, which can decline with age. Always discuss your overall health and any potential side effects with your healthcare provider to ensure safe and effective treatment.

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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how to manage your health while considering your liver condition.

Drug Interactions

It's important to be cautious when using tobramycin ophthalmic solution, especially if you are also taking systemic aminoglycoside antibiotics (a type of antibiotic that works throughout the body). When these medications are used together, your healthcare provider should monitor the total serum concentration, which means they will check the levels of the drug in your blood to ensure safety and effectiveness.

Always discuss any medications you are taking with your healthcare provider, including over-the-counter drugs and supplements. This helps prevent potential interactions and ensures that your treatment is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 2°-30°C (36°-86°F). It's important to avoid exposing it to excessive heat, as this can compromise its quality.

Always keep the product out of reach of children to prevent any accidental misuse. By following these simple storage and handling guidelines, you can help maintain the product's integrity and ensure safe usage.

Additional Information

It's important to handle the dropper tip of Tobramycin Ophthalmic Solution carefully. Avoid touching it to any surface to prevent contamination. If you are nursing and using this medication, you should consider whether to continue breastfeeding or to stop using the drug, weighing the importance of the medication for your health against the potential risks to your infant.

FAQ

What is Tobramycin Ophthalmic Solution used for?

Tobramycin Ophthalmic Solution is a topical antibiotic indicated for the treatment of external infections of the eye and its adnexa caused by susceptible bacteria.

How should I use Tobramycin Ophthalmic Solution?

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

Are there any contraindications for using Tobramycin Ophthalmic Solution?

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

What are the common side effects of Tobramycin Ophthalmic Solution?

The most frequent adverse reactions include localized ocular toxicity and hypersensitivity, such as lid itching and swelling, and conjunctival erythema.

Is Tobramycin Ophthalmic Solution safe for use in children?

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

What should I do if I experience a sensitivity reaction?

If a sensitivity reaction occurs, you should discontinue the use of Tobramycin Ophthalmic Solution.

Can I use Tobramycin Ophthalmic Solution while pregnant?

Tobramycin is classified as Pregnancy Category B, indicating no evidence of harm in animal studies, but it should be used during pregnancy only if clearly needed.

What precautions should I take if I am nursing?

You should decide whether to discontinue nursing or the drug, considering the importance of the medication to your health.

How should I store Tobramycin Ophthalmic Solution?

Store it at 2°-30°C (36°-86°F) and avoid excessive heat. Keep it out of reach of children.

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 is a sterile topical ophthalmic antibiotic formulation designed for the treatment of external infections. Each milliliter contains 3 mg (0.3%) of the active ingredient tobramycin, along with inactive components including boric acid, sodium sulfate, sodium chloride, tyloxapol, and purified water. The pH of the solution is adjusted to a range of 7.0 to 8.0 using sodium hydroxide and/or sulfuric acid as necessary. Additionally, the formulation includes 0.1 mg (0.01%) of benzalkonium chloride as a preservative.

The structural formula of tobramycin is represented by the molecular formula C18H37N5O9, with a molecular weight of 467.52. The chemical name is O-3-amino-3-deoxy—α-D-gluco-pyranosyl-(1 → 4)-O-2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1 → 6)-2-deoxystreptamine. Tobramycin is classified as a water-soluble aminoglycoside antibiotic, exhibiting activity against a broad spectrum of gram-negative and gram-positive ophthalmic pathogens.

Uses and Indications

Tobramycin Ophthalmic Solution 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 has been demonstrated to be safe and effective for use in pediatric patients.

Appropriate monitoring of the bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution to ensure optimal therapeutic outcomes.

There are no teratogenic or nonteratogenic effects associated with the use of this medication.

Dosage and Administration

In cases of mild to moderate disease, the recommended dosage is to instill one or two drops into the affected eye(s) every four hours. For severe infections, the dosage is increased to instilling two drops 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 ophthalmic use only.

Contraindications

Tobramycin Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components. Use in these patients may lead to severe allergic reactions.

Warnings and Precautions

The use of Tobramycin Ophthalmic Solution is contraindicated for injection into the eye. Healthcare professionals should be aware that some patients may exhibit sensitivity to topically applied aminoglycosides. In the event of a sensitivity reaction, it is imperative to discontinue the use of the solution immediately.

Additionally, similar to other antibiotic preparations, prolonged use of Tobramycin Ophthalmic Solution may lead to the overgrowth of nonsusceptible organisms, including fungi. Should a superinfection occur, it is essential to initiate appropriate therapy to address the condition effectively. Regular monitoring for signs of superinfection is recommended to ensure timely intervention.

Side Effects

The most frequent adverse reactions associated with tobramycin ophthalmic solution include localized ocular toxicity and hypersensitivity reactions, such as lid itching and swelling, as well as conjunctival erythema. These reactions have been observed in less than three out of 100 patients treated with tobramycin. Similar reactions may also occur with the topical use of other aminoglycoside antibiotics.

In clinical practice, it is important to note that sensitivity to topically applied aminoglycosides may develop in some patients. Should a sensitivity reaction to tobramycin ophthalmic solution occur, discontinuation of the treatment is recommended.

Clinically apparent signs and symptoms of an overdose of tobramycin ophthalmic solution may include punctate keratitis, erythema, increased lacrimation, edema, and lid itching, which can resemble the adverse reactions experienced by some patients during normal use.

Additionally, as with other antibiotic preparations, prolonged use of tobramycin may lead to the overgrowth of nonsusceptible organisms, including fungi. In the event of a superinfection, appropriate therapeutic measures should be initiated.

It is also crucial to avoid injecting tobramycin ophthalmic solution into the eye. If tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, careful monitoring of the total serum concentration is advised, as other adverse reactions have not been reported from tobramycin therapy.

Drug Interactions

Concomitant use of tobramycin ophthalmic solution with systemic aminoglycoside antibiotics requires caution. It is essential to monitor the total serum concentration of aminoglycosides to avoid potential toxicity. Adjustments to the dosage of systemic aminoglycosides may be necessary based on serum concentration levels and clinical response.

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

Clinical studies have demonstrated that tobramycin is safe and effective for use in pediatric patients. The data support its application in children, indicating favorable outcomes in terms of both efficacy and safety. Healthcare professionals should consider these findings when prescribing tobramycin for pediatric use.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the effects of aminoglycosides, including tobramycin. While geriatric use has not been specifically studied in clinical trials for Tobramycin Ophthalmic Solution, it is important to consider that dosage adjustments may be necessary for this population due to potential reduced kidney function.

Caution should be exercised when administering tobramycin to elderly patients, taking into account their overall health status and the potential for increased sensitivity to side effects. Healthcare providers are advised to closely monitor these patients for any adverse reactions and to adjust dosages as needed to ensure safety and efficacy.

Pregnancy

Pregnancy Category B. Reproduction studies conducted in three types of animals at doses up to thirty-three times the normal human systemic dose have shown no evidence of impaired fertility or harm to the fetus associated with tobramycin. However, there are no adequate and well-controlled studies in pregnant women. Due to the limitations of animal studies in predicting 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 medication 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

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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment, as individual responses may vary.

Overdosage

Clinically apparent signs and symptoms of an overdose of tobramycin ophthalmic solution may include punctate keratitis, erythema, increased lacrimation, edema, and lid itching. These manifestations can resemble adverse reaction effects observed in some patients, making it essential for healthcare professionals to differentiate between overdose symptoms and typical side effects.

In the event of an overdose, it is recommended that healthcare providers assess the patient for the aforementioned symptoms. Management should focus on symptomatic relief and supportive care. If necessary, discontinuation of the medication may be warranted to prevent further complications. Continuous monitoring of the patient's condition is advised to ensure appropriate intervention and recovery.

Nonclinical Toxicology

Reproduction studies conducted in three animal species at doses up to thirty-three 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

The most frequently reported adverse reactions associated with tobramycin ophthalmic solution include localized ocular toxicity and hypersensitivity reactions, such as lid itching, swelling, and conjunctival erythema. These reactions have been observed in less than three out of 100 patients treated with tobramycin.

Similar localized reactions may also occur with the topical application of other aminoglycoside antibiotics. While no additional adverse reactions have been reported specifically from tobramycin therapy, it is advised that when tobramycin is used concurrently with systemic aminoglycoside antibiotics, careful monitoring of the total serum concentration is warranted.

In cases of overdose with tobramycin ophthalmic solution, clinically apparent signs and symptoms may include punctate keratitis, erythema, increased lacrimation, edema, and lid itching, which can resemble the adverse reactions experienced by some patients.

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 discuss the potential risks associated with Tobramycin Ophthalmic Solution, particularly for nursing mothers. Providers should inform patients that due to the possibility of adverse reactions in nursing infants, a decision must be made regarding whether to discontinue breastfeeding or the medication, weighing the importance of the drug to the mother.

Patients should be made aware that Tobramycin Ophthalmic Solution is classified as Pregnancy Category B. However, they should be informed that there are no adequate and well-controlled studies in pregnant women. Therefore, this medication should only be used during pregnancy if it is clearly necessary.

In the event of a sensitivity reaction to Tobramycin Ophthalmic Solution, patients should be instructed to discontinue use immediately. Additionally, healthcare providers should emphasize the importance of appropriate monitoring of bacterial response to topical antibiotic therapy while using this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 2° to 30°C (36° to 86°F). Care should be taken to avoid exposure to excessive heat. Additionally, it is imperative to keep the product out of reach of children to ensure safety.

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 H. J. Harkins Company, Inc.. 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

Last AI update:

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.