Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)
Bausch & Lomb Incorporated
SULFACETAMIDE SODIUM
SULFACETAMIDE SODIUM 100 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Sulfacetamide sodium ophthalmic solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: 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. Sulfacetamide sodium ophthalmic solution USP, 10% is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.
Sulfacetamide sodium ophthalmic solution USP, 10% is supplied in a plastic squeeze bottle with a controlled drop tip in the following size: NDC 24208-670-04 15 mL bottle Sulfonamide solutions, on long standing, will darken in color and should be discarded. Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: August 2023 9113204 (Folded) 9113304 (Flat)
Abbreviated New Drug Application
SULFACETAMIDE SODIUM- SULFACETAMIDE SODIUM SOLUTION/ DROPS BAUSCH & LOMB INCORPORATED ---------- SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION, USP 10% (STERILE) RX ONLY FOR TOPICAL EYE USE ONLY DESCRIPTION Sulfacetamide sodium ophthalmic solution USP, 10% is a sterile, topical antibacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula: CHEMICAL NAME: _N_-Sulfanilylacetamide monosodium salt monohydrate. EACH ML CONTAINS: Active: sulfacetamide sodium, 100 mg/mL (10%); Inactives: methylcellulose, purified water, sodium thiosulfate. Sodium phosphate monobasic may be added to adjust pH (6.8-8.0). Preservatives: methylparaben 0.05% and propylparaben 0.01%. The osmolality range is 700-1300 mOsm/kg. 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. INDICATIONS AND USAGE Sulfacetamide sodium ophthalmic solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: _Es read_full_document