Gentamicin Sulfate

ADVERSE REACTIONS In patients with dermatoses treated with Gentamicin Sulfate, 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.

CONTRAINDICATIONS Gentamicin Sulfate Ointment USP, 0.1% is contraindicated in individuals with a history of sensitivity reactions to any of its components.

DESCRIPTION Gentamicin Sulfate Ointment USP, 0.1% is a wide spectrum antibiotic preparation for topical administration. Each gram of Gentamicin Sulfate Ointment USP, 0.1% contains Gentamicin Sulfate USP equivalent to 1 mg of gentamicin base in a base of light mineral oil and white petrolatum, with 0.5 mg methylparaben and 0.1 mg propylparaben as preservatives.

DOSAGE AND ADMINISTRATION A small amount of Gentamicin Sulfate Ointment USP, 0.1% should be applied gently to lesions three to four times a day. The area treated may be covered with a gauze dressing, if desired. In impetigo contagiosa, the crusts should be removed before application of Gentamicin Sulfate Ointment USP, 0.1% 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 Sulfate under gelatin packing.

CLINICAL PHARMACOLOGY Gentamicin Sulfate is a wide spectrum antibiotic that provides highly effective topical treatment in primary and secondary bacterial infections of the skin. This product may clear infections that have not responded to other topical antibiotic agents. In impetigo contagiosa and other primary skin infections, treatment with a small amount of Gentamicin Sulfate Ointment three to four times daily usually clears the lesions promptly. In secondary skin infections, the product facilitates the treatment of the underlying dermatosis by controlling the infection. Bacteria susceptible to the action of Gentamicin Sulfate include sensitive strains of Streptococci (group A beta-hemolytic, alpha-hemolytic), Staphylococcus aureus (coagulase positive, coagulase negative, and some penicillinase-producing strains), and the gram-negative bacteria, Pseudomonas aeruginosa, Aerobacter aerogens, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.

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Gentamicin Sulfate Gentamicin Sulfate GENTAMICIN SULFATE GENTAMICIN LIGHT MINERAL OIL PETROLATUM METHYLPARABEN PROPYLPARABEN

ANDA062351

Gentamicin Sulfate

Gentamicin Sulfate

45802-046

HUMAN PRESCRIPTION DRUG

TOPICAL

Principal Display Panel - Carton NDC 45802-046-35 Rx Only Gentamicin Sulfate Ointment USP, 0.1% NET WT 15 g The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. A white and blue Gentamycin Sulfate Ointment, USP 0.1% package serialization-template.jpg

For Dermatologic Use Only Not For Ophthalmic Use Rx Only

HOW SUPPLIED Gentamicin Sulfate Ointment USP, 0.1% is available as follows: 15 g tube (NDC 45802- 046 -35) 30 g tube (NDC 45802- 046 -11)

STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

PRECAUTIONS Use of topical antibiotics occasionally allows overgrowth of nonsusceptible organisms, including fungi. If this occurs, or if irritation, sensitization, or superinfection develops, treatment with Gentamicin Sulfate Ointment USP, 0.1% should be discontinued and appropriate therapy instituted.