Gentamicin Sulfate Opth Solution
3 mg/mL · Solution/ Drops
- Prescription only
- Aminoglycoside Antibacterial
- Active substance
- Gentamicin Sulfate Opth Solution
- Made by
- Direct_Rx
- 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 · 2026-03-17
Aminoglycoside Antibacterial
- Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli;
Gentamicin sulfate ophthalmic solution 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
Gentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms:
- Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli;
- Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
From the official label · 2026-03-17 · DailyMed
How it works
From this product’s own US prescribing label.
Microbiology Gentamicin sulfate is active in vitroagainst many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes Escherichia coli; Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-03-17
Do not take it if
Gentamicin sulfate ophthalmic solution 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.
Instill one or two drops into the affected eye(s) every four hours. In severe infections dosage may be increased to as much as two drops every hour.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- NOT FOR INJECTION INTO THE EYE Gentamicin sulfate ophthalmic solution is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.
- General Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms including fungi.
- Bacterial resistance to gentamicin may also develop.
- If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
- If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted.
- Information for Patients To
- avoid contamination, do not touch tip of container to the eye, eyelid or any surface.
- Carcinogenesis, Mutagenesis, Impairment of Fertility There are no published carcinogenicity or impairment of fertility studies on gentamicin.
- Aminoglycoside antibiotics have been found to be non-mutagenic.
- Pregnancy Gentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose.
- There are no adequate and well-controlled studies in pregnant women.
- Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Quoted from the official label, section “Warnings”.
Side effects
- Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.
- The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.
- Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.
- To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Gentamicin Sulfate Ophthalmic Solution, USP 0.3% is supplied in a plastic bottle with a controlled drop tip and a white polypropylene cap in the following sizes:
- NDC 24208-580-60 - 5 mL NOT FOR INJECTION INTO THE EYE FOR OPHTHALMIC USE ONLY
- DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.
Quoted from the official label, section “How Supplied”.
How to store it
- Store between 2°-25°C (36°-77°F).
- Avoid exposure to excessive heat.
- Keep out of reach of children.
- Distributed by:
- Bausch + Lomb, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by:
- Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2020 Bausch & Lomb Incorporated or its affiliates Revised:
- February 2020 9116005 (Folded) 9116105 (Flat)
Quoted from the official label, section “Storage and Handling”.
What is in it
- Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered to approximately pH 7.0 and formulated for ophthalmic use.
- Each mL contains Active: Gentamicin Sulfate (equivalent to 3 mg gentamicin).
- Inactives:
- Dibasic Sodium Phosphate, Sodium Chloride, Monobasic Sodium Phosphate, Purified Water.
- Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.5 - 7.5).
- Preservative Added: Benzalkonium Chloride 0.01%.
- Gentamicin is an aminoglycoside antibiotic obtained from cultures of Micromonospora purpurea.
- It is a mixture of the sulfate salts of Gentamicin C1, C2, C1a and C2a.
- All three components appear to have similar antimicrobial activity.
- Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol.
- The structural formula is as follows: [Gentamicin Sulfate (structural formula)]
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 (13)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 13 of 13
- Gentamicin Sulfate Opth SolutionThis onePrescription onlyDirect_RxNo ingredient list on the stored label
- Gentamicin SulfatePrescription onlyA-S Medication SolutionsNo ingredient list on the stored label
- Gentamicin SulfatePrescription onlyAsclemed USA, Inc.No ingredient list on the stored label
- Gentamicin SulfatePrescription onlyAsclemed USA, Inc.No ingredient list on the stored label
- Gentamicin SulfatePrescription onlyBausch & Lomb IncorporatedNo ingredient list on the stored label
- Gentamicin SulfatePrescription onlyDIRECT RXNo ingredient list on the stored label
- Gentamicin SulfatePrescription onlyNuCare Pharmaceuticals, Inc.No ingredient list on the stored label
- Gentamicin SulfatePrescription onlyNuCare Pharmaceuticals,Inc.No ingredient list on the stored label
- Gentamicin SulfatePrescription onlyNuCare Pharmaceuticals,Inc.No ingredient list on the stored label
- Gentamicin SulfatePrescription onlyPreferred Pharmaceuticals Inc.No ingredient list on the stored label
- Gentamicin SulfatePrescription onlyProficient Rx LPNo ingredient list on the stored label
- Gentamicin SulfatePrescription onlyProficient Rx LPNo ingredient list on the stored label
- Gentamicin SulfatePrescription onlySandoz IncNo 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
CanadaNo exact match for this strength and form
Details
| Made by | Direct_Rx |
|---|---|
| Active substance | Gentamicin Sulfate Opth Solution |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 3 mg/mL |
| Form | Solution/ Drops |
| Route | Ophthalmic |
| Packs | 5 mL in 1 BOTTLE, DROPPER |
| NDC | 72189-359 |
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).