国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)
Acella Pharmaceuticals, LLC
SULFACETAMIDE SODIUM
SULFACETAMIDE SODIUM 100 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
INDICATIONS AND USAGE: SODIUM SULFACETAMIDE 10% CLEANSING GEL is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides. CONTRAINDICATIONS: SODIUM SULFACETAMIDE 10% CLEANSING GEL is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product. Pediatric Use: Safety and effectiveness in children under the age of 12 years has not been established.
SODIUM SULFACETAMIDE 10% CLEANSING GEL is available in a 12 fl. oz. (355 mL) bottle, NDC 42192-146-12.
unapproved drug other
SODIUM SULFACETAMIDE- SODIUM SULFACETAMIDE GEL ACELLA PHARMACEUTICALS, LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- SODIUM SULFACETAMIDE 10% CLEANSING GEL Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION: Each mL of SODIUM SULFACETAMIDE 10% CLEANSING GEL contains 100 mg of sodium sulfacetamide, USP in a formulation containing Citric acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate, Methylparaben, PEG-6 Caprylic/Capric Glycerides, PEG-60 Almond Glycerides, PEG-150 Pentaerythrityl Tetrastearate, Polysorbate 60, Sodium Lauryl Sulfate, Sodium Thiosulfate, Water, Xanthan Gum. Sodium sulfacetamide is C H N NaO S·H O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether. CLINICAL PHARMACOLOGY: Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para- aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of SODIUM SULFACETAMIDE 10% CLEANSING GEL when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported. The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, 阅读完整的文件