OVACE- sulfacetamide sodium liquid

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Mission Pharmacal Company

SNN (starptautisko nepatentēto nosaukumu):

SULFACETAMIDE SODIUM

Kompozīcija:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Ievadīšanas:

TOPICAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

This product is supplied in the following size(s): 6 fl. oz. (180 mL) bottles, NDC 0178-0499-06 To report a serious adverse event or obtain product information, call 1-800-298-1087. Manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355 L669906R0222

Autorizācija statuss:

unapproved drug other

Produkta apraksts

OVACE- SULFACETAMIDE SODIUM LIQUID
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® WASH (SODIUM SULFACETAMIDE 10%)
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 pneumonia