Garamycin Ophthalmic (Gentamicin Sulfate)

GARAMYCIN® Ophthalmic/Otic Preparations

Schering

Gentamicin Sulfate

Topical Antibiotic

Action And Clinical Pharmacology: Gentamicin, an aminoglycoside antibiotic, is active against the gram-positive bacteria commonly found in eye-ear infections: coagulase-positive and coagulase-negative Staphylococci; Group A beta-hemolytic and non-hemolytic Streptococci; and Diplococcus pneumoniae. Garamicin is also active against gram-negative bacteria including P. aeruginosa, indole-positive and indole-negative Proteus species, E. coli, species of the Klebsiella-Enterobacter-Serratia group, Citrobacter species, Salmonella and Shigella, Moraxella species, Providencia species, H. vaginicoli and Neisseria species, especially the gonococcus.

Indications And Clinical Uses: Ophthalmic: The treatment of superficial bacterial infections of the conjunctiva, cornea, eyelids, tear ducts, and skin adjacent to the eye. Such infections include conjunctivitis, blepharitis, blepharoconjunctivitis, keratitis, keratoconjunctivitis, episcleritis, dacryocystitis, corneal ulcers, and infected eye sockets. Also for the prevention of ocular infection if injury makes the eye or adjacent area vulnerable to infections: after removal of foreign bodies; after burns or laceration of the lids or conjunctivae; or after damage from chemical or physical agents; and before and after eye surgery.

Otic: May be used for the topical treatment of otitis externa caused by susceptible bacteria.

Contra-Indications: Sensitivity to any of the components in the preparations. As with all ophthalmic preparations containing benzalkonium chloride, patients are advised not to wear soft contact lenses during treatment with gentamicin ophthalmic preparations. Contraindicated in patients with absent or perforated tympanic membranes.

Precautions: Use of topical antibiotics occasionally allows overgrowth of nonsusceptible microorganisms such as fungi. If this occurs, or if irritation or sensitization to any of the components of this preparation develops, treatment with it should be discontinued and appropriate therapy initiated. To avoid possible contamination of the drops or ointment, do not touch the dropper tip or the ointment tube tip to any surface.

Clinical studies have shown that organisms previously sensitive to gentamicin have become resistant during therapy. Although this has occurred infrequently, the possibility should nevertheless be considered. There is evidence that cross-resistance between gentamicin and the aminoglycoside antibiotics may occur since bacteria made resistant to aminoglycoside antibiotics artificially in the laboratory are also resistant to gentamicin; however, gentamicin may be active against clinical isolates of bacteria resistant to other aminoglycosides. Conversely, organisms resistant to gentamicin may be sensitive to other aminoglycoside antibiotics.

Pregnancy and Lactation: The safety during pregnancy has not been established. Since it is not known whether components of gentamicin ophthalmic/otic solution are excreted in human milk, caution should be exercised when administered to a nursing woman.

Children: Safety and effectiveness in children below the age of 6 years have not been established.

Adverse Reactions: Eye and ear medications may sting briefly on application, and gentamicin ophthalmic and otic preparations are no exception.

After application of gentamicin ophthalmic or otic drops no sensitization or allergy has been reported to date. The most frequently reported adverse reactions at least possibly related to gentamicin are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.

The possibility of ototoxicity following otic application should be kept in mind, and the patient monitored accordingly.

Symptoms And Treatment Of Overdose: Symptoms: A single overdose of gentamicin would not be expected to produce symptoms.

Treatment: Although a single overdose is not expected to require treatment, gentamicin can be removed from the blood by hemodialysis or peritoneal dialysis.

Dosage And Administration: Ophthalmic: Drops: Instill 2 drops into the conjunctival sac of the affected eye 3 or 4 times daily. Dosage may be increased in severe infections and reduced at the end of treatment. In the infections that may develop intermittently in the immature tear ducts of children (dacryocystitis), hot compresses and massage of the area over the tear duct may be useful as adjuncts to the solution.

In the treatment of acute pseudomonal corneal ulcer, 1 or 2 drops every 15 minutes in the daytime hours can be supplemented with the ophthalmic ointment at bedtime. For prophylaxis, such as after removal of a foreign body or following physical or chemical trauma, instill 1 to 2 drops 3 to 4 times daily until signs of inflammation have subsided. For prophylaxis before intraocular surgery, 1 to 2 drops should be instilled 4 to 5 times, preferably within 8 hours prior to surgery. Gentamicin ophthalmic/otic solution may be administered as part of the routine post-operative daily dressing of the eye, until recovery from post-surgical inflammation is evident.

Ointment: Apply ophthalmic ointment to the affected areas in or near the eye 3 or 4 times a day. If the eye/ear drops are used during the day, the ointment can be used at bedtime to continue treatment during the night.

Otic: Drops: Thoroughly clean the ear canal of cerumen or debris. Instill 3 or 4 drops in the infected ear 3 times daily. The patient should lie with the affected ear upward; instill the solution and let the patient remain in this position for several minutes to insure penetration of the medication into the ear canal.

Availability And Storage: Ophthalmic: Drops: Each mL of sterile aqueous solution buffered to approximately pH 7 contains: gentamicin 3 mg (as sulfate USP). Nonmedicinal ingredients: benzalkonium chloride, sodium chloride, sodium phosphate dibasic and sodium phosphate monobasic. Plastic dropper bottles of 5 mL.

Ointment: Each g of sterile ointment contains: gentamicin 3 mg (as sulfate USP). Nonmedicinal ingredients: methylparaben, propylparaben and white petrolatum. Tubes of 3.5 g with applicator tip.

Otic: Drops: Each mL of sterile aqueous solution buffered to approximately pH 7 contains: gentamicin 3 mg (as sulfate USP). Nonmedicinal ingredients: benzalkonium chloride, sodium chloride, sodium phosphate dibasic and sodium phosphate monobasic. Plastic dropper bottles of 7.5 mL.

Store in a cool place away from heat (2 to 30°C).

GARAMYCIN® Ophthalmic/Otic Preparations Schering Gentamicin Sulfate Topical Antibiotic

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