Drug Detail:Gentamicin ophthalmic (Gentamicin ophthalmic [ jen-ta-mye-sin-off-thal-mik ])
Drug Class: Ophthalmic anti-infectives
Garamycin Eye Drops 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 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:
Garamycin Eye Drops - 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 for Garamycin Eye Drops
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
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.
Adverse Reactions/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, 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.
Garamycin Eye Drops 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 is Garamycin Eye Drops 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
| GARAMYCIN GENTAMICIN SULFATE
gentamicin sulfate solution |
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| Labeler - Paddock Laboratories, LLC (967694121) |
