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CORTISPORIN® OTIC SOLUTION (neomycin and polymyxin B sulfates, hydrocortisone) Description

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. The structural formulae are:

Chemical Structure

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. The structural formulae are:

Chemical Structure

Hydrocortisone, 11β,17,21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is:

Chemical Structure

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