SODIUM SULFACETAMIDE, SULFUR- sulfacetamide sodium cream

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

BioComp Pharma, Inc.

INN (Међународно име):

SULFACETAMIDE SODIUM

Састав:

SULFACETAMIDE SODIUM 100 mg in 1 g

Пут администрације:

TOPICAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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.

Резиме производа:

This product is supplied in the following size(s): 2 oz. (57 g) bottles, NDC 44523-542-02 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 L64202R0222

Статус ауторизације:

unapproved drug other

Карактеристике производа

SODIUM SULFACETAMIDE, SULFUR- SULFACETAMIDE SODIUM 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% 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, 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:
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 this product
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: Streptococ