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CORTISPORIN® OINTMENT Adverse Reactions (neomycin and polymyxin B sulfates, bacitracin zinc, hydrocortisone)

ADVERSE REACTIONS

Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported. (See WARNINGS.) Adverse reactions have occurred with topical use of antibiotic combinations including neomycin, bacitracin, and polymyxin B. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general population.1 In another study, the incidence was found to be approximately 1%.2

The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

When steroid preparations are used for long periods of time in intertriginous areas or over extensive body areas, with or without occlusive non-permeable dressings, striae may occur; also there exists the possibility of systemic side effects when steroid preparations are used over large areas or for a long period of time.

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