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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:
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Each gram of Plexion™ (Sodium Sulfacetamide 10% and Sulfur 5%) Cleanser contains 100 mg. of Sodium Sulfacetamide and 50 mg. of Sulfur in a cleanser base containing Water, Sodium Methyl Oleyltaurate, Sodium Cocoyl Isethionate, Disodium Oleamido MEA Sulfosuccinate, Cetyl Alcohol NF, Glyceryl Stearate (and) PEG-100 Stearate, Stearyl Alcohol NF, PEG-55 Propylene Glycol Oleate, Magnesium Aluminum Silicate NF, Methylparaben NF, Disodium EDTA, Butylated Hydroxytoluene NF, Sodium Thiosulfate, Fragrance, Xanthan Gum NF, and Propylparaben NF.
Each gram of Plexion™ (Sodium Sulfacetamide 10% and Sulfur 5%) Lotion contains 100 mg. of Sodium Sulfacetamide and 50 mg. of Sulfur in a lotion containing Water, Propylene Glycol, Isopropyl Myristate, Light Mineral Oil, Polysorbate 60, Sorbitan Monostearate, Cetyl Alcohol, Hydrogenated Coco-Glycerides, Stearyl Alcohol, Fragrances, Benzyl Alcohol, Glyceryl Stearate (and) PEG-100 Stearate, Dimethicone, Zinc Ricinoleate, Xanthan Gum, Disodium EDTA, and Sodium Thiosulfate.
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.
PLEXION Cleanser and Lotion are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
PLEXION Cleanser and Lotion are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Cleanser and Lotion are not to be used by patients with kidney disease.
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 tube tightly closed.
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.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy: Category C. Animal reproduction studies have not been conducted with PLEXION Cleanser or Lotion. It is also not known whether PLEXION Cleanser and Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PLEXION Cleanser and Lotion should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of PLEXION Cleanser or Lotion. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when PLEXION Cleanser or Lotion are administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children under the age of 12 have not been established.
Although rare, sodium sulfacetamide may cause local irritation.
PLEXION Cleanser: Wash affected areas once or twice daily, 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 for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often.
PLEXION Lotion: Cleanse affected areas. Apply a thin film of PLEXION Lotion to affected areas 1 to 3 times daily, or as directed by a physician.
Plexion™ (sodium sulfacetamide 10% and sulfur 5%) Cleanser is available in 6 oz. (170.3 g) tube,
NDC 99207-741-06 and 12 oz. (340.2 g) bottle,
NDC 99207-741-12.
Plexion™ (sodium sulfacetamide 10% and sulfur 5%) Lotion is available in 30 g tube (NDC 99207-742-30) and 60 g tube (NDC 99207-742-60).
Store at: 15°-25°C (59°-77°F).
Manufactured for:
MEDICIS, The Dermatology Company®
Scottsdale, AZ 85258
by: Contract Pharmaceuticals Limited
Mississauga, Ontario CANADA
74106-08M 9/00