Neomycin and Polymyxin B Sulfates
and Hydrocortisone Ophthalmic
Suspension, USP
DESCRIPTION
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is a sterile antimicrobial and anti-inflammatory suspension for ophthalmic use.
Each mL contains: Actives: neomycin sulfate (equivalent to 3.5 mg neomycin base), polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). Preservative: thimerosal 0.001%. Inactives: cetyl alcohol, glyceryl monostearate, mineral oil, polyoxyl 40 stearate, propylene glycol, sulfuric acid (to adjust pH) and water for injection.
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. Its structural formula are:
Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetacae). It has a potency equivalent to not less than 600 µg of neomycin standard per mg, calculated on an anhydrous basis. Its structural formula are:
Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20 dione, is an anti-inflammatory hormone. Its structural formula is:
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CLINICAL PHARMACOLOGY
Corticosteroids suppress the inflammatory response to a variety of agents, and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, concomitant antimicrobial drugs may be used when this inhibition is considered to be clinically significant in a particular case.
When a decision to administer both a corticosteroid and antimicrobials is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the intended dosage of all drugs is administered. When each type of drug is in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.
The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.
Microbiology
The anti-infective components in Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension are included to provide action against specific organisms susceptible to it. Neomycin sulfate and polymyxin B sulfate are active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterbacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae (see INDICATIONS AND USAGE).
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