Tobramycin
3 mg/mL · Solution/ Drops
- Prescription only
- Aminoglycoside Antibacterial
- Active substance
- Tobramycin
- Made by
- A-S Medication Solutions
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2024-01-05
Aminoglycoside Antibacterial
- Tobramycin ophthalmic solution 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria.
Tobramycin ophthalmic solution 0.3% is contraindicated in patients with known hypersensitivity to any of its components.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Tobramycin ophthalmic solution 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria.
- Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution 0.3%.
- Clinical studies have shown tobramycin to be safe and effective for use in children.
From the official label · 2024-01-05 · DailyMed
How it works
From this product’s own US prescribing label.
In Vitro Data: In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-01-05
Do not take it if
Tobramycin ophthalmic solution 0.3% is contraindicated in patients with known hypersensitivity to any of its components.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
In mild to moderate disease, instill 1 or 2 drops into the affected eye(s) every 4 hours. In severe infections, instill 2 drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- FOR TOPICAL OPHTHALMIC USE.
- NOT FOR INJECTION INTO THE EYE.
- Sensitivity to topically applied aminoglycosides may occur in some patients.
- Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions.
- If a sensitivity reaction to tobramycin ophthalmic solution 0.3% occurs, discontinue use.
- General:
- As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.
- If superinfection occurs, appropriate therapy should be initiated.
- Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.
- Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.
- Information for Patients:
- Do not touch dropper tip to any surface, as this may contaminate the solution.
- Pregnancy:
- Reproduction studies in 3 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.
- There are, however, no adequate and well-controlled studies in pregnant women.
- Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
- Nursing Mothers:
- Because of the potential for adverse reactions in nursing infants from tobramycin ophthalmic solution 0.3%, 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.
- Pediatric Use:
- Safety and effectiveness in pediatric patients below the age of 2 months has not been established.
- Geriatric Use:
- No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Quoted from the official label, section “Warnings”.
Side effects
- The most frequent adverse reactions to tobramycin ophthalmic solution 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema.
- These reactions occur in less than three of 100 patients treated with tobramycin ophthalmic solution 0.3%.
- Postmarketing Experience:
- Additional adverse reactions identified from post-marketing use include anaphylactic reaction, Stevens-Johnson syndrome, and erythema multiforme.
- The following additional adverse reactions have been reported with systemic aminoglycosides:
- Neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy.
- Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson's disease, because of their potential effect on neuromuscular function.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
Product: 50090-4190 NDC: 50090-4190-0 5 mL in a BOTTLE / 1 in a CARTON
Quoted from the official label, section “How Supplied”.
How to store it
- Storage:
- Store at 2° - 25°C (36° - 77°F). Manufactured by:
- Wintac Limited Bangalore 562123 India.
Quoted from the official label, section “Storage and Handling”.
What is in it
- Tobramycin ophthalmic solution 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.
- Each mL of Tobramycin ophthalmic solution USP, 0.3% contains:
- Active:
- tobramycin 0.3% (3 mg).
- Preservative: benzalkonium chloride 0.01% (0.1 mg).
- Inactives:
- boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection.
- Tobramycin ophthalmic solution 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg.
- Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram- negative and gram-positive ophthalmic pathogens.
- The chemical structure of tobramycin is: Molecular Weight =
- 467.52 Molecular Formula:
- C 18 H 37 N 5 O 9 Chemical Name:
- 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl (1→4) }-0-{2,6-diamino-2,3,6-trideoxy α-D-ribohexo-pyranosyl-(1→6) }-2 deoxystreptamine.
- Image
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (22)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 22 of 22
- TobramycinThis onePrescription onlyA-S Medication SolutionsNo ingredient list on the stored label
- TobramycinPrescription onlyA-S Medication SolutionsNo ingredient list on the stored label
- TobramycinPrescription onlyAdvanced Rx Pharmacy of Tennessee, LLCNo ingredient list on the stored label
- TobramycinPrescription onlyAsclemed USA, Inc.No ingredient list on the stored label
- TobramycinPrescription onlyAsclemed USA, Inc.No ingredient list on the stored label
- TobramycinPrescription onlyBausch & Lomb IncorporatedNo ingredient list on the stored label
- TobramycinPrescription onlyBelcher Pharmaceuticals, LLCNo ingredient list on the stored label
- TobramycinPrescription onlyDirectRXNo ingredient list on the stored label
- TobramycinPrescription onlyGland Pharma LimitedNo ingredient list on the stored label
- TobramycinPrescription onlyJVET PHARMACEUTICALS LLCNo ingredient list on the stored label
- TobramycinPrescription onlyNuCare Pharmaceuticals,Inc.No ingredient list on the stored label
- TobramycinPrescription onlyNuCare Pharmaceuticals,Inc.No ingredient list on the stored label
- TobramycinPrescription onlyPreferred Pharmaceuticals Inc.No ingredient list on the stored label
- TobramycinPrescription onlyPreferred Pharmaceuticals Inc.No ingredient list on the stored label
- TobramycinPrescription onlyProficient Rx LPNo ingredient list on the stored label
- TobramycinPrescription onlyProficient Rx LPNo ingredient list on the stored label
- TobramycinPrescription onlyREMEDYREPACK INC.No ingredient list on the stored label
- TobramycinPrescription onlySandoz IncNo ingredient list on the stored label
- TobramycinPrescription onlySomerset Therapeutics, LLCNo ingredient list on the stored label
- TobramycinPrescription onlySportpharm LLCNo ingredient list on the stored label
- TobramycinPrescription onlySportpharm LLCNo ingredient list on the stored label
- TobramycinPrescription onlySt. Mary's Medical Park PharmacyNo ingredient list on the stored label
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | A-S Medication Solutions |
|---|---|
| Active substance | Tobramycin |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 3 mg/mL |
| Form | Solution/ Drops |
| Route | Ophthalmic |
| Packs | 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE |
| NDC | 50090-4190 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
50 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Solution21 products
300 mg/4mL2
300 mg/4mL · 2 companies
- Solution/ Drops13 products
3 mg/mL13
3 mg/mL · 13 companies
- A-S Medication Solutions · this page
- Asclemed USA, Inc.
- Belcher Pharmaceuticals, LLC
- DirectRX
- Gland Pharma Limited
- JVET PHARMACEUTICALS LLC
- NuCare Pharmaceuticals,Inc.
- Preferred Pharmaceuticals Inc.
- Injection, Powder, Lyophilized, for Solution6 products
1.2 g/30mL6
- Injection4 products
- 10 mg/mL
40 mg/mL3
40 mg/mL · 3 companies
Show all forms · 7 forms
- Injection, Solution3 products
- 10 mg/mL
40 mg/mL2
40 mg/mL · 2 companies
- Injection, Powder, for Solution2 products
1200 mg/30mL2
1200 mg/30mL · 2 companies
- Inhalant1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.