Slideshows Images Quizzes

Genoptic

Last reviewed on RxList: 12/28/2004
Drug Description

DESCRIPTION

GENOPTIC (gentamicin sulfate ophthalmic) ® (gentamicin sulfate ophthalmic solution; USP) is a sterile, topical anti-infective agent for ophthalmic use. The active ingredient, 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 but insoluble in alcohol.

GENOPTIC (gentamicin sulfate ophthalmic) ® Solution:

Contains: Each mL contains-- Active: gentamicin sulfate equivalent to 3 mg (0.3%) gentamicin base. Preservative: Benzalkonium chloride. Inactives: edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; and hydrochloric acid and/or sodium hydroxide to adjust the pH. The solution is an aqueous, buffered solution with a pH of 6.5-7.5.

For Consumers

What are the precautions when taking gentamicin sulfate ophthalmic (Genoptic)?

Before using gentamicin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as tobramycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription...

Indications & Dosage

INDICATIONS

Gentamicin 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.

DOSAGE AND ADMINISTRATION

Gentamicin Sterile Ophthalmic Solution: Instill one or two drops into the affected eye every 4 hours. In severe infections, dosage may be increased to as much as two drops once every hour.

HOW SUPPLIED

GENOPTIC® (gentamicin sulfate ophthalmic solution, USP) 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with white high impact polystyrene (HIPS) caps as follows:

1 mL in 5 mL bottle--NDC 11980-117-01

Note: Store at or below 25°C (77°F). Avoid exposure to excessive heat (104°F/40°C or above).

Store Genoptic (gentamicin sulfate ophthalmic) Sterile Ophthalmic Solution between 2° and 30° C (36° and 86° F).

Side Effects & Drug Interactions

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, nonspecific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.

Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura, and hallucinations.

DRUG INTERACTIONS

No information provided.

FDA Logo

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Warnings & Precautions

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.

PRECAUTIONS

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.

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 nonmutagenic.

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.

Pediatric Use

Safety and effectiveness in neonates have not been established.

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

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

Clinical Pharmacology

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.

Medication Guide

PATIENT INFORMATION

To avoid contamination, do not touch tip of container to the eye, eyelid, or any surface.

Health Solutions From Our Sponsors