PEDIOTIC® Suspension (neomycin and polymyxin B sulfates and hydrocortisone
otic suspension) 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 0.001% (added as a preservative)
and the inactive ingredients cetyl alcohol, glyceryl monostearate, mineral oil,
polyoxyl 40 stearate, propylene glycol, and Water for Injection. Sulfuric acid
may be added to adjust pH. PEDIOTIC (neomycin, polymyxin b and hydrocortisone) ® Suspension has a minimum pH of 4.1,
which is less acidic than the minimum pH of 3.0 for CORTISPORIN® Otic Suspension.
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, 11β, 17, 21-trihydroxypregn-4-ene-3,20-dione, is an anti-inflammatory
hormone. Its structural formula is:
Last reviewed on RxList: 2/23/2009
This monograph has been modified to include the generic and brand name in many instances.