SODIUM SULFACETAMIDE AND SULFUR solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Acella Pharmaceuticals, LLC

INN (International Name):

SULFACETAMIDE SODIUM

Composition:

SULFACETAMIDE SODIUM 80 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is not to be used by patients with kidney disease. Safety and effectiveness in children under the age of 12 have not been established.

Product summary:

Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is available in 16 fl oz (473 mL) bottles, NDC 42192-133-16.

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM SULFACETAMIDE AND SULFUR- SODIUM SULFACETAMIDE AND
SULFUR SOLUTION
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 8% - SULFUR 4% TOPICAL SUSPENSION
IN A VEHICLE CONTAINING GREEN TEA AND ALOE
RX ONLY
DESCRIPTION:
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:
Each mL of Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension
contains 80 mg of
Sodium Sulfacetamide and 40 mg of Sulfur in a formulation containing
purified water,
sodium cocoyl isethionate, disodium oleamido MEA sulfosuccinate, green
tea extract,
cetyl alcohol, stearyl alcohol, glycerol stearate and PEG 100
stearate, methyl paraben,
propyl paraben, butylated hydroxytoluene, aloe vera gel, sodium
thiosulfate, disodium
EDTA, magnesium aluminum silicate, xanthan gum, sodium methyl cocoyl
taurate and
white petrolatum.
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
not known, but it
has been reported that it inhibits the growth of Propionibacterium
acnes and the
formation of free fatty acids.
INDICATIONS:
Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is indicated in
the topical
control of acne vulgaris, acne ro