SODIUM SULFACETAMIDE liquid

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

BioComp Pharma, Inc.

INN (International ime):

SULFACETAMIDE SODIUM

Sastav:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease. General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. The use of this product also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop. Avoid contact with eyes, lips and mucous membranes. Drug Interactions: This product is incompatible with silver preparations. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction has been reported in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown. Pregnancy: Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established.

Proizvod sažetak:

This product is supplied in the following size(s): 12 fl. oz. (355 mL) bottles, NDC 44523-606-12 16 fl. oz. (480 mL) bottles, NDC 44523-606-16 To report a serious adverse event or obtain product information, call 1-866-762-2365. Manufactured for: BIOCOMP PHARMA ® , INC. San Antonio, TX 78230 1355 826177 I826177R0415

Status autorizacije:

unapproved drug other

Svojstava lijeka

SODIUM SULFACETAMIDE- SODIUM SULFACETAMIDE LIQUID
BIOCOMP PHARMA, INC.
_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
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram contains 100 mg of sodium sulfacetamide in a vehicle
consisting of: citric
acid, disodium EDTA, fragrance, methylparaben, PEG-150 pentaerythrityl
tetrastearate
(and) aqua (and) PEG-6 caprylic/capric glycerides, PEG-60 almond
triglycerides,
propylene glycol, propylparaben, purified water, sodium chloride, and
sodium laureth
sulfate (and) cocamide DEA (and) cocamidopropyl betaine (and) glycol
stearate.
Sodium sulfacetamide is a sulfonamide with antibacterial activity.
Sodium sulfacetamide is
C
H
N
NaO
S·H
O with molecular weight of 254.24. Chemically, sodium
sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium
salt,
monohydrate. The structural formula is:
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 this product
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 unknown. Organisms
that show susceptibility to sodium sulfacetamide are: Streptococci,
Staphylococci, E.
coli, Klebsiella pneumo