Garamycin (Gentamicin Sulfate)

GARAMYCIN® Topical Preparations

Schering

Gentamicin Sulfate

Topical Antibiotic

Indications And Clinical Uses: For use in the treatment of primary and secondary infections caused by sensitive strains of streptococci (Group A beta-hemolytic, alpha-hemolytic), S. aureus (coagulase positive, coagulase-negative, and some penicillinase producing strains), and the gram-negative bacteria P. aeruginosa, A. aerogenes, E. coli, P. vulgaris, and K. pneumoniae. Primary skin infections that may be expected to respond to treatment with gentamicin include: impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum; also such secondary skin infections as infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial superinfections of fungal or viral origin infected burns, insect bites or stings, infected cuts, scrapes and wounds following surgical procedures. Gentamicin has been used successfully in infants over 1 year of age as well as in adults and children.

Contra-Indications: Sensitivity to any of the components of the preparation.

Precautions: Treatment of severe or refractory skin lesions should be supplemented with the administration of a systemic antibacterial agent. Use of topical antibiotics occasionally allows overgrowth of nonsusceptible organisms such as fungi. If this occurs, or if irritation, sensitization or superinfection develop, treatment with gentamicin should be discontinued and appropriate therapy instituted. Patients sensitive to neomycin can be treated with gentamicin, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Pregnancy: The safety of gentamicin for use during pregnancy has not been established.

Adverse Reactions: In patients with dermatoses treated with gentamicin, mild irritation (erythema and pruritus) that did not usually require discontinuance of treatment, has been reported in a small percentage of cases. There was no evidence of irritation or sensitization, however, in any of these patients patch tested subsequently with gentamicin on normal skin. Possible photosensitization has been reported in several patients but could not be elicited in these patients by reapplication of gentamicin followed by exposure to ultraviolet radiation.

Symptoms And Treatment Of Overdose: Symptoms: A single overdose of gentamicin would not be expected to produce symptoms. Excessive prolonged use of topical gentamicin may lead to overgrowth of lesions by fungi or nonsusceptible bacteria.

Treatment: Appropriate antifungal or antibacterial therapy is indicated if overgrowth occurs.

Dosage: A small amount of cream or ointment should be applied gently to the lesions 3 or 4 times daily until favorable results are achieved. The area treated can be covered with a gauze dressing if desired. In impetigo contagiosa, the crusts should be removed before application to permit maximum contact between the antibiotic and the infection. Care should be exercised to avoid further contamination of the infected skin. Infected stasis ulcers have responded well to gentamicin under gelatin packing. Concomitant treatment of the skin around the ulcer with a topical corticosteroid helps control inflammation. Treatment of infected skin cysts and certain other skin abscesses must be preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria.

Availability And Storage: Cream: Each g contains: gentamicin 1 mg (as sulfate USP). The cream is recommended for wet and oozing primary or secondary infections. Nonmedicinal ingredients: cetostearyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, polyethylene glycol 1 000 monocetyl ether, water and white petrolatum. Tubes of 15 g and jars of 450 g.

Ointment: Each g contains: gentamicin 1 mg (as sulfate USP). The ointment helps retain moisture and has been useful in infections on dry eczematous or psoriatic skin. Nonmedicinal ingredients: methylparaben, propylparaben and white petrolatum. Tubes of 15 g and jars of 450 g.

Store below 30°C.

GARAMYCIN® Topical Preparations Schering Gentamicin Sulfate Topical Antibiotic

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