SODIUM SULFACETAMIDE, SULFUR- sulfacetamide sodium, sulfur cream

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5), SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)

Dostupno od:

BioComp Pharma, Inc.

INN (International ime):

SULFACETAMIDE SODIUM

Sastav:

SULFACETAMIDE SODIUM 100 mg in 1 g

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

Proizvod sažetak:

This product is supplied in the following size(s): 2 oz. (57 g) bottles, NDC 44523-520-02 To report a serious adverse event or obtain product information, call 1-866-762-2365. Manufactured for: BIOCOMP PHARMA ® , INC. San Antonio, TX 78230 1355 R0222

Status autorizacije:

unapproved drug other

Svojstava lijeka

SODIUM SULFACETAMIDE, SULFUR- SULFACETAMIDE SODIUM, SULFUR CREAM
BIOCOMP PHARMA, INC.
_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% AND SULFUR 5% GREEN EMOLLIENT CREAM
RX ONLY
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram contains 100 mg of sodium sulfacetamide and 50 mg of
colloidal sulfur in a
vehicle consisting of: benzyl alcohol, cetyl alcohol, chromium oxide
green, disodium
EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium
aluminum
silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400,
purified water,
sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan
gum.
Sodium sulfacetamide is a sulfonamide with antibacterial activity
while sulfur acts as a
keratolytic agent. Sodium sulfacetamide is C
H
N
NaO
S·H
O with molecular weight
of 254.24. Chemically, sodium sulfacetamide 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:
The most widely accepted mechanism of action of sulfonamides is the
Woods-Fildes
theory, which is based on the fact that sulfonamides act as
competitive antagonists to
para-aminobenzoic acid (PABA), an essential component for bacterial
growth. While
absorption through intact skin has not been determined, sodium
sulfacetamide is readily
absorbed from the gastrointestinal tract when taken orally and
excreted in the urine,
largely unchanged. The biological half-life has variously been
reported as 7 to 12.8
hours.
The exact mode of action of sulfur in the treatment of acne is
unknown, but it has been
reported that it inhibits the growth of _Propionibacterium acnes_ an