Product Elements:
Sumadan wash sulfacetamide sodium and sulfur sulfacetamide sodium sulfacetamide sulfur sulfur butylated hydroxytoluene alkyl (c12-15) benzoate caprylyl glycol cetyl alcohol cholesterol dimethicone edetate disodium glyceryl monostearate hexylene glycol lemon oil magnesium aluminum silicate magnesium chloride magnesium nitrate methylchloroisothiazolinone methylisothiazolinone niacinamide nonoxynol-20 octoxynol-5 water peg-100 stearate phenoxyethanol propylene glycol sodium methyl cocoyl taurate sodium thiosulfate stearyl alcohol xanthan gum sumadan sulfacetamide sodium and sulfur sumadan wash sulfacetamide sodium and sulfur sulfacetamide sodium sulfacetamide sulfur sulfur butylated hydroxytoluene alkyl (c12-15) benzoate caprylyl glycol cetyl alcohol cholesterol dimethicone disodium oleamido mipa-sulfosuccinate edetate disodium glyceryl monostearate hexylene glycol lemon oil magnesium aluminum silicate magnesium chloride magnesium nitrate methylchloroisothiazolinone methylisothiazolinone niacinamide nonoxynol-20 octoxynol-5 water peg-100 stearate phenoxyethanol propylene glycol sodium methyl cocoyl taurate sodium thiosulfate stearyl alcohol xanthan gum rehyla wash inert water glyceryl monostearate glycerin cetyl alcohol disodium oleamido mipa-sulfosuccinate cholesterol disodium laureth sulfosuccinate helianthus annuus seed wax caprylyl glycol propylene glycol phenoxyethanol sodium cocoyl isethionate cocamidopropyl betaine sodium methyl cocoyl taurate c13-14 isoparaffin sodium chloride niacinamide edetate disodium hexylene glycol laureth-7 chamaemelum nobile flower hyaluronate sodium
Indications and Usage:
Indications sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Warnings:
Warnings 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. 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. for external use only. keep away from eyes. keep out of reach of children. keep container tightly closed.
General Precautions:
General if irritation develops, use of the product should be discontinued and appropriate therapy instituted. patients should be carefully observed for possible local irritation or sensitization during long-term therapy. 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 apply sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash once or twice daily to affected areas, or as directed by your physician. 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. if drying occurs, it may be controlled by rinsing off sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash sooner or using less often.
Contraindications:
Contraindications sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash is not to be used by patients with kidney disease.
Adverse Reactions:
Adverse reactions: although rare, sodium sulfacetamide may cause local irritation.
Use in Pregnancy:
Pregnancy category c animal reproduction studies have not been conducted with sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash . it is also not known whether sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness in children under the age of 12 have not been established.
Description:
Description sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. chemically sodium sulfacetamide is n-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. the structural formula is: each ml of sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: butylated hydroxytoluene, c12-15 alkyl benzoate, caprylyl glycol, cetyl alcohol, cholesterol, chrysanthemum dendranthema, dimethicone, disodium oleamido mipa sulfosuccinate, edetate disodium, ethylene brassilate, glyceryl stearate, hexylene glycol, lemon oil, magnesium aluminum silicate, magnesium chloride, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, niacinamide, nonoxynol-20, octoxynol-5, purified water, peg-100 stearate, phenoxyethanol, propylene glycol, sodium cocoyl isotheionite, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum. chemical structure
Clinical Pharmacology:
Clinical pharmacology the most widely accepted mechanism of action of sulfonamides is the woods-fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (paba), an essential component for bacterial growth. while absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. the biological half-life has variously been reported as 7 to 12.8 hours. 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 propionibacterium acnes and the formation of free fatty acids.
Mechanism of Action:
The most widely accepted mechanism of action of sulfonamides is the woods-fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (paba), an essential component for bacterial growth. while absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. the biological half-life has variously been reported as 7 to 12.8 hours. 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 propionibacterium acnes and the formation of free fatty acids.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis and impairment of fertility long-term studies in animals have not been performed to evaluate carcinogenic potential.
How Supplied:
How supplied sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash is available in a net wt. 16 oz. (454 g) bottle, ndc 43538-190-16. sumadan ® kit contents one unit of sumadan ® wash , net wt. 16 oz. (454 g) and one unit of rehyla ® wash, 16 oz. bottle, ndc 43538-191-16. store at controlled room temperature 15°- 30° c (59°- 86° f). protect from freezing. keep this and all medications out of the reach of children. to report suspected adverse reactions , contact medimetriks pharmaceuticals, inc., at 1-973-882-7512 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Information for Patients:
Information for patients avoid contact with eyes, eyelids, lips and mucous membranes. if accidental contact occurs, rinse with water. if excessive irritation develops, discontinue use and consult your physician.
Package Label Principal Display Panel:
Principal display panel - 454 g bottle carton ndc 43538-190-16 r x only sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash in a moisturizing novasome ® vehicle net wt. 16 oz. (454 g) medimetriks pharmaceuticals, inc. principal display panel - 454 g bottle carton
Principal display panel - kit carton ndc 43538-191-16 r x only sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) kit contents: 1 - sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) wash (net wt. 16 oz.) 1- rehyla ® wash moisturizing daily wash (16 fl. oz.) medimetriks pharmaceuticals, inc. principal display panel - kit carton