SODIUM SULFACETAMIDE AND SULFUR WASH- sodium sulfacetamide and sulfur liquid

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Acella Pharmaceuticals, LLC

SNN (starptautisko nepatentēto nosaukumu):

SULFACETAMIDE SODIUM

Kompozīcija:

SULFACETAMIDE SODIUM 100 mg in 1 g

Ievadīšanas:

TOPICAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

INDICATIONS AND USAGE: BP 10-1 Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. CONTRAINDICATIONS: BP 10-1 Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. BP 10-1 Wash is not to be used by patients with kidney disease. Pediatric Use - Safety and effectiveness in children under the age of 12 have not been established.

Produktu pārskats:

HOW SUPPLIED: BP 10-1 Wash is available in 170.1 g (6.0 oz) tubes, NDC 42192-104-06. Store at controlled room temperature, 15°-30°C (59°-86°F).

Autorizācija statuss:

unapproved drug other

Produkta apraksts

SODIUM SULFACETAMIDE AND SULFUR WASH- SODIUM SULFACETAMIDE AND
SULFUR LIQUID
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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BP10-1
(SODIUM SULFACETAMIDE 10% AND SULFUR 1 %)
WASH
R
ONLY
DESCRIPTION:Each gram of BP 10-1 Wash contains 100 mg of sodium
sulfacetamide
and 10 mg of sulfur in a wash containing butylated hydroxytoluene,
cetyl alcohol,
edetate disodium, glyceryl stearate and PEG-100 stearate, lactic acid,
magnesium
aluminum silicate, methylparaben, propylparaben, purified water,
sodium C14-16 olefin
sulfonate, sodium hydroxide, sodium thiosulfate, stearyl alcohol,
white petrolatum, and
xanthan gum.
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:
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
unknown, but it has been
reported that it inhibits the growth of Propionibacterium acnes and
the formation of free
fatty acids.
INDICATIONS AND USAGE:BP 10-1 Wash is indicated in the topical control
of acne
vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS:BP 10-1 Wash is contraindicated for use by patients
having
known hypersensitivity to sulfonamides, sulfur or any other component
of this
pre