Garamycin Eye Drops

Generic Name: gentamicin sulfate
Dosage Form: ophthalmic solution

Garamycin® gentamicin sulfate ophthalmic solution USP, 0.3%

STERILE

Rx Only

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.

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Gentamicin is obtained from cultures of Micromonosporapurpurea. 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:

CLINICAL PHARMACOLOGY:

Microbiology:

Gentamicin sulfate is active in vitro against many strains of the following microorganisms:

Staphylococcus aureus, Staphylococcus epidermidis, Streptoccuspyogenes, Streptococcus pneumonia, Enterobacteraerogenes, Escherichia coli, Haemophilus influenza, Klebsiella pneumonia, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratiamarcescens.

INDICATIONS AND USAGE:

Garamycin® 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, Enterobacteraerogenes, Escherichia coli, Haemophilus influenza, Klebsiella pneumonia, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratiamarcescens.

CONTRAINDICATIONS:

Garamycin® 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 have 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.

To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 per hour.

HOW SUPPLIED:

Garamycin® Ophthalmic Solution, 0.3% is a sterile solution supplied in a plastic dropper bottle, box of one.

NDC 0574-4072-05 5 mL Bottle

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Garamycin® is a Registered Trademark of Perrigo Company.

Manufactured For

Perrigo®

Minneapolis, MN

55427

1X400 RC J1

Rev 10-13 A

R1013

Ini 1013

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - Carton

Rx Only

NDC 0574-4072-05

STERILE

Garamycin®

gentamicin sulfate ophthalmic solution USP, 0.3%

(equivalent to 3 mg gentamicin base per mL)

FOR OPHTHALMIC USE ONLY

5 mL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - Label

Rx Only

NDC 0574-4072-05

Garamycin®

gentamicin sulfate ophthalmic solution USP, 0.3%

(equivalent to 3 mg gentamicin base per mL)

FOR OPHTHALMIC USE ONLY

5 mL

STERILE

GARAMYCIN GENTAMICIN SULFATE 
gentamicin sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0574-4072
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN SULFATE (GENTAMICIN) GENTAMICIN 3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE  
BENZALKONIUM CHLORIDE  
WATER  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
Packaging
# Item Code Package Description
1 NDC:0574-4072-05 1 BOTTLE, DROPPER in 1 CARTON
1 5 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065121 06/05/2014
Labeler - Paddock Laboratories, LLC (967694121)
Revised: 07/2014
 
Paddock Laboratories, LLC



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