KLARON- sulfacetamide sodium lotion

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5)

Fáanlegur frá:

Physicians Total Care, Inc.

INN (Alþjóðlegt nafn):

sulfacetamide sodium

Samsetning:

sulfacetamide sodium 10 mg in 1 mL

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Klaron Lotion is indicated in the topical treatment of acne vulgaris . Klaron Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).

Vörulýsing:

4 FL OZ (118mL) bottles (NDC 54868-5401-0). Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. Shake well before using. Keep tightly closed.

Leyfisstaða:

New Drug Application

Vara einkenni

KLARON - SULFACETAMIDE SODIUM LOTION
PHYSICIANS TOTAL CARE, INC.
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KLARON® (SODIUM SULFACETAMIDE LOTION) LOTION, 10%
DESCRIPTION
Each mL of KLARON (sodium sulfacetamide lotion) LOTION, 10% contains
100 mg of sodium
sulfacetamide 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.
Sodium sulfacetamide is a sulfonamide with antibacterial activity.
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, 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%.
Sodium sulfacetamide 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
sulfaniliamide in KLARON LOTION was
evaluated in adult subjects (N=14) with acne vulgaris. The subjects
applied KLARON LOTION to their face,
back, chest and shoulders every 12 hours for 28 days. The percentage
of the applied dose of KLARON
LOTION excreted in the urine as sulfacetamide plus sulfanilamide,
ranged from 0.08 to 0.33%.
INDICATIONS
KLARON LOTION is indicated in the topical treatment of _acne
vulgaris_.
CONTRAINDICATIONS
KLARON LOTION is contraindicated for use by patients having known
hypersensitivity to sulfonamides or
any other component of this preparation (see WARNINGS section).
WARNINGS
Fatalities have occurred, although rarely, due to severe r