SODIUM SULFACETAMIDE liquid

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Acella Pharmaceuticals, LLC

INN (Tarptautinis Pavadinimas):

SULFACETAMIDE SODIUM

Sudėtis:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides. Sodium Sulfacetamide 10% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this product. Safety and effectiveness in children under the age of 12 have not been established.

Produkto santrauka:

Sodium Sulfacetamide 10% Wash is available in 16 fluid ounce bottles, NDC 42192-129-16.

Autorizacija statusas:

unapproved drug other

Prekės savybės

SODIUM SULFACETAMIDE- SODIUM SULFACETAMIDE 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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SODIUM SULFACETAMIDE 10% WASH
RX ONLY
DESCRIPTION:
Sodium sulfacetamide is C
H
N
NaO
S·H
O with molecular weight of 254.24.
Chemically, it is Acetamide N-[(4-aminophenyl) sulfonyl]-acetamide,
monosodium salt,
monohydrate. The structural formula is:
Each gram of Sodium Sulfacetamide 10% Wash contains 100 mg of Sodium
Sulfacetamide, USP in a formulation containing cocamidopropyl betaine,
disodium
EDTA,PEG-150 pentaerythrityl tetrastearate and PEG 6 caprylic/capric
glycerides,
glyceryl monostearate, methyl paraben, PEG-60 almond triglyceride,
polysorbate 60,
purified water, sodium lauryl sulfate and sodium thiosulfate.
Sodium Sulfacetamide is an odorless, white, crystalline powder with a
bitter taste. It is
freely soluble in water, sparingly soluble in alcohol, while
practically insoluble in benzene,
in chloroform and in ether.
CLINICAL PHARMACOLOGY:
Sodium sulfacetamide exerts a bacteriostatic effect against
sulfonamide sensitive Gram-
positive and Gram-negative microorganisms commonly isolated from
secondary
cutaneous pyogenic infections. It acts by restricting the synthesis of
folic acid required
by bacteria for growth, by its competition with para-aminobenzoic
acid. There is no
clinical data available on the degree and rate of systemic absorption
of Sodium
Sulfacetamide 10% Wash when applied to the skin or scalp. However,
significant
absorption of sodium sulfacetamide through the skin has been reported.
The following in vitro data is available but the clinical significance
is not known.
Organisms which show susceptibility to sodium sulfacetamide are:
_Streptococci,_
_Staphylococci, E. coli, Klebsiella pneumonia, Pseudomonas pyocyanea,
Salmonella_
_species, Proteus vulgaris, Nocardia and Actinomyces_ .
8
9
2
3
2
INDICATIONS:
Sodium Sulfacet