OVACE PLUS- sodium sulfacetamide aerosol, foam

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Mission Pharmacal Company

INN (Isem Internazzjonali):

SULFACETAMIDE SODIUM

Kompożizzjoni:

SULFACETAMIDE SODIUM 98 mg in 1 g

Rotta amministrattiva:

TOPICAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 thera

Sommarju tal-prodott:

This product is supplied in the following size(s): 3.5 oz. (100 g) can, NDC 0178-0696-01 To report a serious adverse event or obtain product information, call 1-800-298-1087. Manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355 826528

L-istatus ta 'awtorizzazzjoni:

unapproved drug other

Karatteristiċi tal-prodott

OVACE PLUS- SODIUM SULFACETAMIDE AEROSOL, FOAM
MISSION PHARMACAL COMPANY
_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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OVACE PLUS (SODIUM SULFACETAMIDE 9.8%) FOAM
RX ONLY
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram contains 98 mg of sodium sulfacetamide in a vehicle
consisting of: benzyl alcohol, cetyl
alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate,
magnesium aluminum silicate,
phenoxyethanol, propylene glycol, purified water, sodium lauryl
sulfate, sodium magnesium silicate,
sodium thiosulfate, stearyl alcohol, and xanthan gum. This product
also contains tetrafluoroethane
(propellant). Sodium sulfacetamide is a sulfonamide with antibacterial
activity while sulfur acts as a
keratolytic agent. 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, S