Gentamicin Sulfate Opth Solution 3 mg/mL
Gentamicin Sulfate Opth Solution · SOLUTION/ DROPS · Direct_Rx
Gentamicin Sulfate Opth Solution is a solution/ drops containing gentamicin sulfate opth solution at 3 mg/mL, taken ophthalmic. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Gentamicin Sulfate Opth Solution
- Generic Name
- Gentamicin Sulfate Opth Solution
- NDC Code (Product)
72189-359- Manufacturer
- Direct_Rx
- Strength
- 3 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA064048
- Marketing Start
- 06/17/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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.
Dosage & Administration
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.
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.
Contraindications
Gentamicin sulfate ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.
Adverse Reactions
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.
Frequently Asked Questions
What is Gentamicin Sulfate Opth Solution used for?
Gentamicin Sulfate Opth Solution contains Gentamicin Sulfate Opth Solution. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Gentamicin Sulfate Opth Solution a controlled substance?
Gentamicin Sulfate Opth Solution is not classified as a controlled substance by the DEA.
What is the generic name for Gentamicin Sulfate Opth Solution?
The generic name for Gentamicin Sulfate Opth Solution is Gentamicin Sulfate Opth Solution. There are no other listed brand versions of Gentamicin Sulfate Opth Solution.
What is the NDC code for Gentamicin Sulfate Opth Solution 3 mg/mL?
The NDC (National Drug Code) for Gentamicin Sulfate Opth Solution 3 mg/mL is 72189-359, listed by Direct_Rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)