Gentamicin Sulfate Ophthalmic Solution USP, 0.3%

Sterile

Rx only

Gentamicin sulfate is a water-soluble antibiotic of the aminoglycoside group.

Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution for ophthalmic use.

1. Each mL contains:
   Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin base)
   Preservative: Benzalkonium Chloride
   Inactives: Disodium Phosphate, Monosodium Phosphate, and Sodium Chloride. The pH range is from 6.8 to 7.3.

Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C₁, C₂, and C_1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:

Gentamicin Sulfate Sterile 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.

Gentamicin Sulfate Sterile Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.

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.

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.

Gentamicin Sulfate sterile ophthalmic solution; 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.

Gentamicin Sulfate ophthalmic solution - Sterile, 5-mL plastic dropper bottle, box of one. (NDC 68788-6342-5)

Akorn

Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

GK00N

Rev. 06/16

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel Text for Container Label:

NDC 68788-6342-5

Gentamicin

Sulfate Ophthalmic

Solution, USP

0.3%

(equivalent to 3 mg

gentamicin per mL)

Sterile

Rx only 5 mL