GENOPTIC® is a sterile, topical anti-infective agent for ophthalmic use. Gentamicin sulfate is a water-soluble antibiotic of the aminoglycoside group.
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 a white to buff powder and is soluble in water and insoluble in alcohol.
Contains: Each mL contains--Active: gentamicin sulfate equivalent to 3 mg (0.3%) gentamicin base. Preservative: benzalkonium chloride. Inactives: Liquifilm® (polyvinyl alcohol) 14 mg (1.4%); edetate disodium; sodium phosphate, dibasic; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH; and purified water. The solution is an aqueous, buffered solution with a pH of 7.2-7.5.
Contains: Each gram contains gentamicin sulfate, USP (equivalent to 3.0 mg gentamicin) in a base of white petrolatum, with methylparaben (0.5 mg) and propylparaben (0.1 mg) as preservatives.
Clinical Pharmacology: 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.
and Usage: GENOPTIC® Ointment and Solution are 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.
Contraindications: GENOPTIC® is contraindicated in patients with known hypersensitivity to any of the components.
NOT FOR INJECTION INTO THE EYE.
Gentamicin sulfate ophthalmic ointment and solution are not for injection. They should never be injected subconjunctivally, nor should they 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.
Ophthalmic ointments may retard corneal healing.
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: Pregnancy Category C. 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.
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.
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.
How Supplied: GENOPTIC® (gentamicin sulfate ophthalmic solution, USP) 0.3% is supplied sterile in plastic dropper bottles in the following sizes:
1 mL--NDC 11980-117-01
5 mL--NDC 11980-117-05
Note: Store at or below 25°C (77°F). Avoid exposure to excessive heat (104°F/40°C or above).
Dosage and Administration: Apply a small amount (about 1 / 2 inch) to the affected eye two to three times a day.
How Supplied: GENOPTIC® (gentamicin sulfate ophthalmic ointment, USP) 0.3% is supplied sterile in a 3.5 gram tube (NDC 0023-0320-04).
Note: Store between 2° and 30°C (36° and 86°F).