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All about: Gentamicin ophthalmic solution

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Generic Name: Gentamicin Sulfate
Dosage Form: Ophthalmic solution

Rx only

Gentamicin Description

Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered with dibasic sodium phosphate and monobasic sodium phosphate to approximately pH 7 (pH range 6.5 - 7.5) for ophthalmic use. Each mL contains Gentamicin sulfate, USP (equivalent to 3 mg Gentamicin base), sodium chloride; and benzalkonium chloride (0.1 mg) as a preservative.

Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of Gentamicin C1, C2, and C1A. 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 structure is as follows:

Gentamicin - 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.

Indications and Usage for Gentamicin

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.

Contraindications

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

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 non-susceptible 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 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.

Pediatric Use

Safety and effectiveness in neonates has not been established.

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.

Gentamicin 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 once every hour.

How is Gentamicin Supplied

Gentamicin Ophthalmic Solution, USP 0.3% is a sterile solution in a plastic dropper bottle, box of one.

 
NDC 0168 - 0178 - 03                  5 mL Bottle

STORAGE: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
[see USP Controlled Room Temperature].

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747

I2178
R2/04
#185


Gentamicin Sulfate (Gentamicin Sulfate)
PRODUCT INFO
Product Code 0168-0178 Dosage Form SOLUTION
Route Of Administration OPHTHALMIC DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Gentamicin sulfate (Gentamicin) Active 3 MILLIGRAM  In 1 MILLILITER
sodium chloride Inactive  
benzalkonium chloride Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0168-0178-03 5 MILLILITER In 1 BOTTLE, DROPPER None

Revised: 04/2007

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