SUMMARY
Neomycin and Polymyxin B Sulfates
and Hydrocortisone Ophthalmic
Suspension, USP
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%).
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).
Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetacae).
Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20 dione, is an anti-inflammatory hormone.
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (See CLINICAL PHARMACOLOGY: Microbiology).
The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens:
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.
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