Garamycin Eye Drops

Generic Name: gentamicin sulfate
Dosage Form: ophthalmic solution

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:



CLINICAL PHARMACOLOGY:

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

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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:

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, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

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 and 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 Fera Pharmaceuticals, LLC at (414) 434-6604, Monday-Friday 9am-5pm EST, 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 plactic dropper bottle, box of one.

NDC 48102-022-05                  5mL Bottle

Store at 20o-25oC (68o-77oF) [See USP Controlled room temperature].

GARAMYCIN® is a Registered Trademark of Fera Pharmaceuticals, LLC.

FERA

Mfd. for:

Fera Pharmaceuticals, LLC

Locust Valley, NY  11560

PF022A

R0411

PRINCIPAL DISPLAY PANEL - CARTON








FERA

NDC 48102-022-05

STERILE      Rx only

Garamycin®

gentamicin sulfate

Ophthalmic

Solution, USP, 0.3%


(equivalent to 3 mg

gentamicin base per mL)


FOR OPHTHALMIC USE ONLY

5mL

CF02202A
R0311

PRINCIPAL DISPLAY PANEL - BOTTLE



FERA

NDC 48102-022-05

Garamycin®

gentamicin sulfate

Opthalmic Solution USP, 0.3%

(equivalent to 3 mg gentamicin base per mL)

FOR OPHTHALMIC USE ONLY

Sterile   5mL   Rx only
GARAMYCIN 
gentamicin sulfate solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:48102-022
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
BENZALKONIUM CHLORIDE  
SODIUM CHLORIDE  
SODIUM PHOSPHATE, DIBASIC  
SODIUM PHOSPHATE, MONOBASIC  
Packaging
# Item Code Package Description
1 NDC:48102-022-05 1 BOTTLE, DROPPER (BOTTLE) in 1 BOX
1 5 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065121 05/15/2011
Labeler - Fera Pharmaceuticals, LLC (831023713)
Registrant - Fera Pharmaceuticals, LLC (831023713)
Revised: 04/2011
 
Fera Pharmaceuticals, LLC



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