Product Description.:
Cortisporin Otic Solution (neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP) is a sterile antibacterial and anti-inflammatory solution for otic use. Each mL contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains potassium metabisulfite 0.1% (added as a preservative) and the inactive ingredients cupric sulfate, glycerin, hydrochloric acid, propylene glycol, and Water for Injection.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis.
Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis.
INDICATIONS
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.
SIDE EFFECTS
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 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.2 In another study, the incidence was found to be approximately 1%.3
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. Stinging and burning have been reported when this product has gained access to the middle ear.
