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Bleph-10 (Sulfacetamide Sodium Ophthalmic) - Description and Clinical Pharmacology

 



BLEPH®-10
(sulfacetamide sodium ophthalmic solution, USP) 10%

DESCRIPTION

BLEPH®-10 (sulfacetamide sodium ophthalmic solution, USP) 10% is a sterile, topical anti-bacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula:

Chemical Name:

N-Sulfanilylacetamide monosodium salt monohydrate.

Contains: Active: sulfacetamide sodium 10% (100 mg/mL). Preservative: benzalkonium chloride 0.005%. lnactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium phosphate dibasic; sodium phosphate monobasic; sodium thiosulfate; hydrochloric acid and/or sodium hydroxide to adjust the pH (6.8 to 7.5).

CLINICAL PHARMACOLOGY

Microbiology: The sulfonamides are bacteriostatic agents and the spectrum of activity is similar for all. Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase. Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of aminobenzoic acid.

Topically applied sulfonamides are considered active against susceptible strains of the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

Page last updated: 2006-09-19

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