SULFACETAMIDE SODIUM lotion

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Padagis Israel Pharmaceuticals Ltd

INN (nume internaţional):

SULFACETAMIDE SODIUM

Compoziție:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is available as follows: 4 FL OZ (118 mL) bottles (NDC 45802-896 -26)

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

SULFACETAMIDE SODIUM- SULFACETAMIDE SODIUM LOTION
PADAGIS ISRAEL PHARMACEUTICALS LTD
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SULFACETAMIDE SODIUM TOPICAL SUSPENSION USP, 10% (LOTION)
RX ONLY
DESCRIPTION
Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)
contains 100
mg of sulfacetamide sodium in a vehicle consisting of diethanolamine;
EDTA;
hydroxyethyl cellulose; lauramide DEA; methylparaben; polyethylene
glycol 400,
monolaurate; propylene glycol; purified water; simethicone; sodium
chloride; sodium
metabisulfite and xanthan gum.
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
paraminobenzoic 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 lotion was evaluated in adult subjects (N=14)
with acne vulgaris.
The subjects applied sulfacetamide sodium lotion to their face, back,
chest and
shoulders every 12 hours for 28 days. The percentage of the applied
dose of
sulfacetamide sodium lotion excreted in the urine as sulfacetamide
plus sulfanilamide
ranged from 0.08 to 0.33%.
INDICATIONS
Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is indicated
in the topical
treatment of _acne vulgaris_.
CONTRAINDICATIONS
Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is
contraindicated for use
by patients having known h