Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
Sulfacetamide Sodium (UNII: 4NRT660KJQ) (Sulfacetamide - UNII:4965G3J0F5)
Akorn
OPHTHALMIC
PRESCRIPTION DRUG
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. Hypersensitivity to sulfonamides or to any ingredient of the preparation.
Sulfacetamide Sodium Ophthalmic Solution, USP 30% NDC 17478-242-12 15 mL dropper bottle, box of one. Sulfacetamide Sodium Ophthalmic Solution, USP 10% NDC 17478-221-12 15 mL dropper bottle, box of one. STORAGE: Store between 2° and 30°C (36° to 86°F). Store away from heat. Sulfonamide solution, on long standing will darken in color and should be discarded. AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045 SU00N Rev. 02/14
Abbreviated New Drug Application
SULFACETAMIDE SODIUM- SULFACETAMIDE SODIUM SOLUTION/ DROPS AKORN ---------- SULFACETAMIDE SODIUM Ophthalmic Solution USP, 30% Ophthalmic Solution USP, 10% RX ONLY DESCRIPTION Sulfacetamide Sodium Ophthalmic Solution USP 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. OPHTHALMIC SOLUTION 30%, EACH ML CONTAINS: ACTIVE: Sulfacetamide Sodium 300 mg. INACTIVES: Sodium Thiosulfate 1.5 mg and Monobasic Sodium Phosphate as buffer. PRESERVATIVES: Methylparaben 0.5 mg and Propylparaben 0.1 mg. OPHTHALMIC SOLUTION 10%, EACH ML CONTAINS: ACTIVE: Sulfacetamide Sodium 100 mg. INACTIVES: Hydroxypropyl Methylcellulose 5 mg, Sodium Thiosulfate 3.1 mg and Monobasic Sodium Phosphate as buffer. PRESERVATIVES: Methylparaben 0.5 mg and Propylparaben 0.1 mg. 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 For the treatment of conjunctivitis and other superficial ocular infections due to suscepti Прочитајте комплетан документ