SODIUM SULFACETAMIDE gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)

Tilgængelig fra:

Acella Pharmaceuticals, LLC

INN (International Name):

SULFACETAMIDE SODIUM

Sammensætning:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

SODIUM SULFACETAMIDE 10% CLEANSING GEL is available in a 12 fl. oz. (355 mL) bottle, NDC 42192-146-12.

Autorisation status:

unapproved drug other

Produktets egenskaber

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._
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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,