CORTISPORIN® Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone
otic suspension, USP) is a sterile antibacterial and anti-inflammatory suspension
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 thimerosal 0.01% (added as a preservative)
and the inactive ingredients cetyl alcohol, propylene glycol, polysorbate 80,
and Water for Injection. 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 mcg of neomycin standard per
mg, calculated on an anhydrous basis. The structural formulae are:
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:
Hydrocortisone, 11b,17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory
hormone. Its structural formula is:
Last reviewed on RxList: 4/29/2008
This monograph has been modified to include the generic and brand name in many instances.