CORTISPORIN- neomycin sulfate, polymyxin b sulfate and hydrocortisone acetate cream
Monarch Pharmaceuticals, Inc.
DESCRIPTION
CORTISPORIN Cream (neomycin and polymyxin B sulfates and hydrocortisone acetate cream, USP) is a topical antibacterial cream. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone acetate 5 mg (0.5%). The inactive ingredients are liquid petrolatum, white petrolatum, propylene glycol, polyoxyethylene polyoxypropylene compound, emulsifying wax, purified water, and 0.25% methylparaben added as a preservative. Sodium hydroxide or sulfuric acid may be added to adjust pH.
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 �g of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:
Chem structure 1
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:
chem structure 2
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Hydrocortisone acetate is the acetate ester of hydrocortisone, an anti-inflammatory hormone. Its chemical name is 21-(acetyloxy)- 11?,17-dihydroxypregn-4-ene-3,20-dione. Its structural formula is:
Chem structure 3
The base is a smooth vanishing cream with a pH of approximately 5.0.
CLINICAL PHARMACOLOGY
Corticoids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body�s defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.
The anti-infective components in the combination are included to provide action against specific organisms susceptible to them. Polymyxin B sulfate and neomycin sulfate together are considered active against the following microorganisms: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella- Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae.