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:
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 | ||||||||||||||||||||
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| 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) |
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