SODIUM SULFACETAMIDE liquid

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Exact-Rx, Inc.

INN (mednarodno ime):

SULFACETAMIDE SODIUM

Sestava:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Pot uporabe:

TOPICAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

INDICATIONS AND USAGE: Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dematoses: seborrheic dermatitis and sebonthea 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% Wash 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 have not been established.

Povzetek izdelek:

HOW SUPPLIED: Sodium Sulfacetamide Wash 10% is available in a 6 oz. (177 mL) bottle, NDC 42808-0100-06, and in a 12 oz. (354.8 mL) bottle, NDC 42808-0100-12.

Status dovoljenje:

unapproved drug other

Lastnosti izdelka

SODIUM SULFACETAMIDE - SODIUM SULFACETAMIDE LIQUID
EXACT-RX, 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% WASH
(SODIUM SULFACETAMIDE 10%)
RX ONLY
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION: Each gram contains 100 mg of sodium sulfacetamide USP in
a vehicle consisting of:
cocamidopropyl betaine, disodium EDTA, methyl paraben, PEG-60 almond
triglyceride, PEG-6
caprylic/capric glycerides, PEG-150 pentaerythrityl tetrastearate,
purified water, sodium laureth
sulfate, and sodium thiosulfate.
Chemically, it is Acetamide N-[4-aminophenyl)sulfonyl]-, monosodium
salt, monohydrate, with the
following structural formula:
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 are no clinical data
available on the degree and rate of systemic competition with
para-aminobenzoic acid absorption of
Sodium Sulfacetamide 10% Wash when applied to the skin or scalp.
However, significant absorption of
sodium sulfacetamide through the skin has been reported. The following
in vitro data are available but
their clinical significance is unknown. Organisms which show
susceptibility to sodium sulfacetamide
are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae,
Pseudomonas pyocyanea, Salmonella
species, Proteus vulgaris, Nocardia and Actinomyces.
INDICATIONS AND USAGE: Sodium Sulfacetamide 10% Wash is intended for
topical application