SULFACETAMIDE SODIUM- sulfacetamide sodium suspension

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International ime):

SULFACETAMIDE SODIUM

Sastav:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Sulfacetamide Sodium Topical Suspension USP, 10% is indicated in the topical treatment of acne vulgaris . Sulfacetamide Sodium Topical Suspension USP, 10% is contraindicated for use by patients having a known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).

Proizvod sažetak:

Sulfacetamide Sodium Topical Suspension USP, 10%, is supplied in 118 mL bottles (4 fl oz) NDC 0168-0382-04 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Shake well before using. Keep tightly closed. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2382C/IF2382C R07/13 #280

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

SULFACETAMIDE SODIUM- SULFACETAMIDE SODIUM SUSPENSION
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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SULFACETAMIDE SODIUM
TOPICAL SUSPENSION USP, 10%
Rx only
FOR TOPICAL USE ONLY.
DESCRIPTION:
Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% contains
100 mg of sulfacetamide
sodium in a vehicle consisting of purified water, propylene glycol,
lauramide DEA (and)
diethanolamine, polyethylene glycol 400 monolaurate, hydroxyethyl
cellulose, sodium chloride,
sodium metabisulfite, methylparaben, xanthan gum, EDTA and
simethicone. Sulfacetamide sodium is a
sulfonamide with antibacterial activity. Chemically sulfacetamide
sodium 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, based on
sulfonamides acting as a competitive inhibitor of para-aminobenzoic
acid (PABA) utilization, an
essential component for bacterial growth. While absorption through
intact skin in humans has not been
determined, _in vitro_ studies with human cadaver skin indicated a
percutaneous absorption of about 4%.
Sulfacetamide sodium is readily absorbed from the gastrointestinal
tract when taken orally and excreted
in the urine largely unchanged. The biological half-life has been
reported to be between 7 to 13 hours.
The pharmacokinetics of sulfacetamide and its major metabolite
sulfanilamide in Sulfacetamide Sodium
Topical Suspension USP, 10% was evaluated in adult subjects (N=14)
with acne vulgaris. The subjects
applied Sulfacetamide Sodium Topical Suspension USP, 10% to their
face, back, chest and shoulders
every 12 hours for 28 days. The percentage of the applied dose of
Sulfacetamide Sodium Topical
Suspension USP, 10% excreted in the urine as sulfacetamide plus
sulfanilamide, ranged from 0.08 to
0.33%.
INDICATIONS:
Sulfacetamide Sodium Topical Suspension USP, 10% is indicated in the
topical treatment of _acne_
_vulgaris_.
CONTRAINDICATIONS:
Sulfacetamid