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:

Physicians Total Care, 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    NDC 54868-6225-0 Store at controlled room temperature 20°-25°C (68°-77°F) [see USP]. Shake well before using. Keep tightly closed. E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747 I2382A R11/07 #280 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK       74146

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

SULFACETAMIDE SODIUM - SULFACETAMIDE SODIUM SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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SULFACETAMIDE SODIUM
TOPICAL SUSPENSION USP, 10%
Rx 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.
INDICATIONS AND USAGE
Sulfacetamide Sodium Topical Suspension USP, 10% is indicated in the
topical treatment of _acne_
_vulgaris_.
CONTRAINDICATIONS
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).
WARNINGS
Fatalities have occurred, although rarely, due to severe reactions to
sulfonamides including Stevens-
Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic
necrosis, agranulocytosis, aplastic
anemia, and other blood dyscrasias. Hypersensitivity reactions may
occur when a sulfonamide is
readministered, irrespective of the route of admi