Garamycin label

Garamycin

Garamycin Recall

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Side Effects & Adverse Reactions

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.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

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:

Garamycin Ophthalmic Solution Structural Formula

Garamycin Manufacturers

  • Fera Pharmaceuticals, Llc
    Garamycin | Fera Pharmaceuticals, Llc
    No Recall

    Garamycin | Fera Pharmaceuticals, Llc

    Garamycin | Fera Pharmaceuticals, Llc

    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.