Gentamicin Sulfate
3 mg/mL · Solution
- Prescription only
- Aminoglycoside Antibacterial
- Active substance
- Gentamicin Sulfate
- Made by
- Sandoz Inc
- 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 · 2024-01-02
Aminoglycoside Antibacterial
- Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria…
Gentamicin Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the 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 · 2024-01-02 · DailyMed
How it works
From this product’s own US prescribing label.
Microbiology: Gentamicin sulfate is active in vitro against 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 · 2024-01-02
Do not take it if
Gentamicin Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the 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 once 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 non-susceptible 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
- 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.
- Pediatric Use Safety and effectiveness in neonates have not been established.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- 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 “OTC — Pregnancy or Breast Feeding”.
Use in children
Safety and effectiveness in neonates have not been established.
Quoted from the official label, section “Pediatric Use”.
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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
To avoid contamination, do not touch tip of container to the eye, eyelid, or any surface.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
- Gentamicin Sulfate Ophthalmic Solution is supplied sterile, in a natural LDPE plastic bottle with a natural LDPE dropper tip and a white polypropylene cap as follows:
- NDC 61314-633-05 - 5mL filled in 8mL bottle.
- STORAGE Store at controlled room temperature 15° to 25°C (59° to 77°F).
- Protect from light and store away from heat.
Quoted from the official label, section “How Supplied”.
What is in it
- Gentamicin Sulfate is a water-soluble antibiotic of the aminoglycoside group.
- Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered to approximately pH 7 for ophthalmic use.
- Gentamicin is obtained from cultures of Micromonospora purpurea .
- It is a mixture of the sulfate salts of gentamicin C 1 , C 2 , and C 1A .
- All three components appear to have similar antimicrobial activities.
- Gentamicin sulfate occurs as white powder and is soluble in water and insoluble in alcohol.
- The structure is as follows:
- Established name:
- Gentamicin Sulfate Chemical name:
- 0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine.
- Ingredients:
- Each mL contains:
- Active:
- Gentamicin Sulfate USP (equivalent to 3 mg gentamicin).
- Preservative: Benzalkonium Chloride 0.1 mg (0.01%).
- Inactives:
- Dibasic Sodium Phosphate Anhydrous, Sodium Chloride, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH), Tyloxapol and Purified Water. chemicalstructure
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 SulfateThis onePrescription onlySandoz IncNo 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 Sulfate Opth SolutionPrescription 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
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 | Sandoz Inc |
|---|---|
| Active substance | Gentamicin Sulfate |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 3 mg/mL |
| Form | Solution |
| Route | Ophthalmic |
| Packs | 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER |
| NDC | 61314-633 |
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
22 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Solution/ Drops8 products
- Injection, Solution5 products
- Solution4 products
3 mg/mL4
3 mg/mL · 4 companies
- Asclemed USA, Inc.
- NuCare Pharmaceuticals,Inc.
- Proficient Rx LP
- Sandoz Inc · this page
- Ointment3 products
1 mg/g3
1 mg/g · 3 companies
Show all forms · 5 forms
- Cream2 products
1 mg/g2
1 mg/g · 2 companies
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.