Gentamicin Sulfate

INDICATIONS AND USAGE Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: 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 infections. NOTE: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. It is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions and wounds from minor surgery. Patients sensitive to neomycin can be treated with Gentamicin Sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin sulfate cream is recommended for wet, oozing primary infections, and greasy, secondary infections, such as postular acne or infected seborrheic dermatitis. Gentamicin Sulfate Ointment USP, 0.1% helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment USP, 0.1% has been used successfully in infants over one year of age as well as in adults and children.

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.

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

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. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

HOW SUPPLIED Gentamicin Sulfate Ointment, USP 0.1% is available as follows: 15 g tube (NDC 71205- 560 -15) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Iss. 08/2019 8-0682CP1