Product Elements:
Sodium sulfacetamide 10% and sulfur 5% emollient cream sodium sulfacetamide 10% and sulfur 5% emollient cream triacetin butylated hydroxytoluene cetyl alcohol edetate disodium glyceryl stearate se peg-100 stearate mineral oil citric acid monohydrate phenoxyethanol propylene glycol water sodium thiosulfate stearyl alcohol xanthan gum sulfacetamide sodium sulfacetamide sulfur sulfur
Drug Interactions:
Drug interactions: this product is incompatible with silver preparations.
Indications and Usage:
Indications: this product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
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. for external use only. not for ophthalmic use. 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.
Read more...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. the object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. these side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. 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.
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 circumstan
Read more...ces, 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. the object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. these side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.
Dosage and Administration:
Dosage and administration: cleanse affected areas. apply a thin layer to the affected areas with light massaging, 1 to 3 times daily or as directed by a physician.
Contraindications:
Contraindications: 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.
Adverse Reactions:
Adverse reactions: reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. the following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of stevens-johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see warnings).
Drug Interactions:
Drug interactions: this product is incompatible with silver preparations.
Use in Pregnancy:
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.
Pediatric Use:
Pediatric use: safety and effectiveness in children under the age of 12 years have not been 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 or your doctor.
Description:
Description: each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: butylated hydroxytoluene, cetyl alcohol, citric acid, disodium edta, glyceryl stearate se, mineral oil, peg-100 stearate, phenoxyethanol, propylene glycol, purified water, sodium thiosulfate, stearyl alcohol, triacetin, xanthan gum. sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. sodium sulfacetamide is c 8 h 9 n 2 nao 3 s·h 2 o with molecular weight of 254.24. chemically, sodium sulfacetamid 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. structure
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 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 pneumoniae, pseudomonas pyocyanea, salmonella species, proteus vulgaris, nocardia and actinomyces. the exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of pro
Read more...pionibacterium acnes and the formation of free fatty acids.
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 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.
How Supplied:
How supplied: this product is supplied in the following sizes: 1 oz. (28 g) bottles, ndc 58657-468-01 2 oz. (57 g) bottles, ndc 58657-468-02 to report a serious adverse event or obtain product information, call (877) 250-3427. manufactured in the u.s.a. for method pharmaceuticals, llc southlake, texas 76092
Information for Patients:
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.
Package Label Principal Display Panel:
1 oz. (28 g) bottles, ndc 58657-468-01 2 oz. (57 g) bottles, ndc 58657-468-02 28g 57g