SODIUM SULFACETAMIDE, SULFUR- sulfacetamide sodium and sulfur liquid

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Westminster Pharmaceuticals, LLC

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is not to be used by patients with kidney disease.

Dettagli prodotto:

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is available in 6 oz. (170.3 g) bottles, NDC 69367-247-06 and 12 oz. (340.2 g) bottles, NDC 69367-247-12. Store at 15°C to 30°C (59°F to 86°F). Protect from freezing.

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

SODIUM SULFACETAMIDE, SULFUR- SULFACETAMIDE SODIUM AND SULFUR LIQUID
WESTMINSTER 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% AND SULFUR 5% CLEANSER
RX ONLY
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser contains
100 mg of sodium
sulfacetamide and 50 mg of sulfur in a formulation containing ammonium
lauryl sulfate, butylated
hydroxytoluene, cetyl alcohol, cocamidopropyl betaine, disodium EDTA,
glycerin, glyceryl stearate
SE, guar gum, methylparaben, PEG-100 stearate, propylene glycol,
propylparaben, puried water,
sodium thiosulfate, stearyl alcohol, triacetin.
Sodium sulfacetamide is a sulfonamide with antibacterial activity
while sulfur acts as a keratolytic
agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl)
sulfonyl]-acetamide, monosodium salt,
monohydrate. The structural formula is:
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 known,
but it has been reported that it
inhibits the growth of Propionibacterium acnes and the formation of
free fatty acids.
INDICATIONS
Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is indicated in the
topical control of acne vulgaris,
acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS
Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is contraindicated f