Gentamicin Sulfate Opth Solution
FDA Drug Information • Also known as: Gentamicin Sulfate Opth Solution
- Brand Names
- Gentamicin Sulfate Opth Solution
- Route
- OPHTHALMIC
- Dosage Form
- SOLUTION/ DROPS
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
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)]
What Is Gentamicin Sulfate Opth Solution Used 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.
Dosage and 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.
Side Effects (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.
Warnings and Precautions
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.
How Supplied
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.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.