Tobramycin Ophthalmic Solution
3 mg/mL · Solution/ Drops
- Prescription only
- Aminoglycoside Antibacterial
- Active substance
- Tobramycin Ophthalmic Solution
- Made by
- Alembic Pharmaceuticals Limited
- 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 · 2024-06-14
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.
- Clinical studies have shown tobramycin to be safe and effective for use in children.
From the official label · 2024-06-14 · 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. a ureus 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 · 2024-06-14
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.
- Nursing Mothers 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.
- 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.
- 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.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- 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.
- 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.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
Safety and effectiveness in pediatric patients below the age of 2 months has not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Quoted from the official label, section “Geriatric Use”.
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.
- 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 to discuss with your doctor
Do not touch dropper tip to any surface, as this may contaminate the solution.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
- Tobramycin ophthalmic solution USP, 0.3% is supplied in opaque white low density polyethylene bottle which is closed with natural low density polyethylene nozzle and then with tan colored high density polyethylene cap containing tobramycin 0.3% (3 mg/mL). 5 mL in a 5 mL bottle (NDC 46708-518-05) Storage :
- Store at 2°C to 25°C (36°F to 77°F).
- After opening, Tobramycin ophthalmic solution USP, 0.3% can be used until the expiration date on the bottle.
- Manufactured by: Alembic Pharmaceuticals Limited Karakhadi - 391 450, Gujarat, India.
- Revised: 04/2024
Quoted from the official label, section “How Supplied”.
What is in it
- Tobramycin ophthalmic solution USP, 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 contains: Active : tobramycin 0.3% (3 mg).
- Preservative : benzalkonium chloride 0.01% (0.1 mg).
- Inactives :
- boric acid, sodium sulfate decahydrate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection.
- Tobramycin ophthalmic solution USP, 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260 to 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. tobra-struc
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 (2)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 2 of 2
Details
| Made by | Alembic Pharmaceuticals Limited |
|---|---|
| Active substance | Tobramycin Ophthalmic Solution |
| 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 | 46708-518 |
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
2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Solution/ Drops2 products
3 mg/mL2
3 mg/mL · 2 companies
- Alembic Pharmaceuticals Inc.
- Alembic Pharmaceuticals Limited · this page
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.