البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)
STAT RX USA LLC
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 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 sterile in plastic bottles in the following sizes: 15 mL: NDC 61314-701-01 Note: Store between 8°-25°C (46°-77°F). Protect from light. Sulfonamide solutions, on long standing, will darken in color and should be discarded. Rx Only Dist. by: FALCON Pharmaceuticals, Ltd Fort Worth, Texas 76134 Mfd. by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 Printed in USA
Abbreviated New Drug Application
SULFACETAMIDE SODIUM - SULFACETAMIDE SODIUM SOLUTION/ DROPS STAT RX USA LLC ---------- DESCRIPTION Sulfacetamide Sodium Ophthalmic Solution 10% is a sterile topical antibacterial agents for ophthalmic use. The active ingredient is represented by the following structural formula: CHEMICAL NAME: N-Sulfanilylacetamide monosodium salt monohydrate. C H N Na0 S·H O MW = 254.24 CONTAINS : ACTIVE: sulfacetamide sodium 10% (100 mg/mL). PRESERVATIVE: methylparaben and propylparaben INACTIVES: sodium thiosulfate, methylcellulose, and monobasic sodium phosphate 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: _Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus_ (viridans group), _Haemophilus influenzae, Klebsiella_ species, and _Enterobacter_ species. 8 9 2 3 2 Topically app اقرأ الوثيقة كاملة