Product Elements:
Sodium sulfacetamide sodium sulfacetamide xanthan gum sulfacetamide sodium sulfacetamide butylated hydroxytoluene glyceryl stearate se cocamidopropyl betaine glycerin peg-100 stearate phenoxyethanol sodium laureth sulfate water edetate disodium anhydrous cetyl alcohol sodium thiosulfate stearyl alcohol triacetin citric acid monohydrate
Drug Interactions:
Drug interactions: sodium sulfacetamide 10% wash is incompatible with silver preparations.
Indications and Usage:
Indications and usage: sodium sulfacetamide 10% wash 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.
Warnings:
Warnings: sulfonamides are known to cause stevens-johnson syndrome in hypersensitive individuals. stevens-johnson syndrome also has been reported following the use of sodium sulfacetamide topically. cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. in one of these cases, there was a fatal outcome. keep out of the reach of children.
Dosage and Administration:
Dosage and administration: seborrheic dermatitis including seborrhea sicca - sodium sulfacetamide 10% wash: wash affected areas twice daily (morning and evening), or as directed by your physician. avoid contact with eyes or mucous membranes. wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly/pat dry and repeat after 10-20 seconds. rinsing with plain water will remove any excess medication. repeat application as described for eight to ten days. if skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. regular shampooing following sodium sulfacetamide 10% wash is not necessary, but the hair should be shampooed at least once a week. as the condition subsides, the interval between applications may be lenghtened. applications once or twice weeky or every other week may prevent recurrence. should the condition recur after stopping therapy, the application of sodium sulfacetamid
Read more...e 10% wash should be reinitiated as at the beginning of treament. secondary cutaneous bacterial infections - wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. rinsing with plain water will remove any excess medication. repeat application as described for eight to ten days. if skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.
Contraindications:
Contraindications: sodium sulfacetamide 10% wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.
Adverse Reactions:
Adverse reactions : reports of irritation and hypsersensitivity to sodium sulfacetamide are uncommon. the following advrse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of stevens-johnson syndrome and instanes of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see warnings) call your doctor for medical advice about side effecs. you may report side effects to the fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Drug Interactions:
Drug interactions: sodium sulfacetamide 10% wash is incompatible with silver preparations.
Use in Pregnancy:
Pregnancy: category c: animal reproduction studies have not been conducted with sodium sulfacetamide 10% wash. it also is not known whether sodium sulfacetamide 10% wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfacetamide 10% wash should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
Pediatric Use:
Pediatric use: safety and effectiveness in chlidren under the age of 12 years have not ben established.
Overdosage:
Overdosage : the oral ld 50 of sulfacetamide in mice is 16.5 g/kg. in the event of overdosage, emergency treatment should be started immediately. manifestations: overdosage may cause nausea and vomiting. large oral overdosage may cause hematuria, crystalluria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. for treatment, contact your local poison control center.
Description:
Description: each gram contains 100 mg of sodium sulfacetamide usp in a vehicle consisting of: ammonium lauryl sulfate, butylated hydroxytoluene, ceteareth-25, cetyl alcohol, cocamidopropyl betaine, disodium edta, glycerin, guar gum, methylparaben, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin. chemically it is acetamide n-[4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula: 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. image
Clinical Pharmacology:
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 competition with para-aminobenzoic acid absorption of sodium sulfacetamide 10% wash when applied to the skin or scalp. however, significant absorption of sodium sulfacetamide through the sin has been reported. the following in vitro data are available but their clinical significance is unknown. organisms which show susceptibility to sodium sulfacetamide are: streptococci, staphylococci, e. coli, klebsiella pneumoniae, pseudomonas pyocyanea, solmonella species, proteus vulgaris, nocardia and actinomyces.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis and impairment of fertility: long-term animal studies for carcinogenic potential have not been performed on sodium sulfacetamide 10% wash to date. studies on reprodution and fertility also have not been performed. chromosomal nondisjunction in the yeast, saccharomyces cerevisiae, following application of sodium sulfacetamide has been reported. the significance of this finding to the topical use of sodium sulfacetamide in the human is unknown.
How Supplied:
How supplied: sodium sulfacetamide wash 10% is available in a 6 fl oz (170 ml) bottle, ndc 16477-410-06, and in a 12 oz (354.8 ml) bottle, ndc 16477-410-12.
Information for Patients:
Information for patients : patients should discontinue sodium sulfacetamide 10% wash if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. sodium sulfacetamide 10% wash also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop.
Package Label Principal Display Panel:
Indications: sodium sulfacetamide 10% wash 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. directions for use: wash affected areas twice daily (morning and evening) or as directed by your physician. rinse thoroughly and pat dry. see label booklet for complete product information. for external use only. not for intravaginal or ophthalmic use. (keep away from eyes) keep this and all medication out of the reach of children . in case of accidental ingestion contact a poison control center immediately. keep container tightly closed. contraindications : sodium sulfacetamide 10% wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides. each gram contains 100 mg of sodium sulfacetamide usp in a vehicle consisting of: ammonium lauryl sulfate, butylated hydroxytoluene, ceteareth-25, cetyl alcohol, cocamidopropyl betaine, disodium edta, glycerin, guar gum, methylparaben, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin. store at 25°c (77°f); excursions permitted to 15° to 30°c (59° to 86°f). see usp controlled room. protect from freezing. see bottle for lot number and exiration date. important note: this bottle is not filled to the top but does contain 12 fl oz of product as identified on the front panel of the bottle. ndc 16477-410-12 rx only for external use only sodium sulfacetamide 10% wash laser pharmaceuticals, llc 12 fl oz (354.8 ml) manufactured in the u.s.a. for laser pharmaceuticals, llc alpharetta, ga 30004 6 oz label 12 oz label