Plexion

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Description for Plexion

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 gram of Plexion® (sodium sulfacetamide USP 10% and sulfur USP 5%) Cleanser contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a cleanser base containing: Purified Water USP, 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, Methylparaben NF, Edetate Disodium USP, Butylated Hydroxytoluene, Sodium Thiosulfate USP, Fragrance, Xanthan Gum NF, and Propylparaben NF.

Each cloth of Plexion® (sodium sulfacetamide USP 10% and sulfur USP 5%) Cleansing Cloths is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP. The cleanser base consists of: Purified Water USP, Sodium Methyl Oleyltaurate, Sodium Cocoyl Isethionate, Disodium Laureth Sulfosuccinate (and) Sodium Lauryl Sulfoacetate, Disodium Oleamido MEA Sulfosuccinate, Glycerine USP, Sorbitan Monooleate NF, Glyceryl Stearate (and) PEG-100 Stearate, Stearyl Alcohol NF, Propylene Glycol (and) PEG-55 Propylene Glycol Oleate, Cetyl Alcohol NF, Edetate Disodium USP, Methylparaben NF, PEG-150 Pentaerythrityl Tetrastearate, Butylated Hydroxytoluene NF, Sodium Thiosulfate USP, Aloe Vera Gel Decolorized, Allantoin, Alpha Bisabolol Natural, Fragrance, Propylparaben NF.

Each gram of Plexion SCT® (sodium sulfacetamide USP 10% and sulfur USP 5%) contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a cream containing: Purified Water USP, Kaolin USP, Glyceryl Stearate (and) PEG-100 Stearate, Witch Hazel USP, Silicon Dioxide, Magnesium Aluminum Silicate, Benzyl Alcohol NF, Water (and) Propylene Glycol (and) Quillaia Saponaria Extract, Xanthan Gum NF, Sodium Thiosulfate USP, Fragrance.

Each gram of Plexion® (sodium sulfacetamide USP 10% and sulfur USP 5%) Topical Suspension contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a suspension containing: Purified Water USP, Propylene Glycol USP, Isopropyl Myristate NF, Light Mineral Oil NF, Polysorbate 60, Sorbitan Monostearate NF, Cetyl Alcohol NF, Hydrogenated Coco-Glycerides, Stearyl Alcohol NF, Fragrances, Benzyl Alcohol NF, Glyceryl Stearate (and) PEG-100 Stearate, Dimethicone NF, Zinc Ricinoleate, Xanthan Gum NF, Edetate Disodium USP, and Sodium Thiosulfate USP.

Uses for Plexion

This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage for Plexion

Wash affected areas with this product once or twice daily or as directed by a physician. Moisten skin and cleansing cloth with water. Work cloth into full lather and massage gently into skin for 10 to 20 seconds, rinse thoroughly and pat dry. Discard cloth in refuse container. If drying occurs, it may be controlled by rinsing affected area sooner or using product less frequently.

HOW SUPPLIED

60 count carton, NDC 57883-404-60

To report a serious adverse event or obtain product information, call 1-855-899-4237.

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic
temperature does not exceed 25°C (77°F); however, such exposure should be minimized.

NOTICE: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product.

Occasionally, a slight discoloration of fabric may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily
removed by ordinary laundering without bleaches.

Manufactured for: Artesa Labs, LLC., 13785 Research Blvd, Suite 125., Austin, TX 78750. Revised: Jul 2018.

Side Effects for Plexion

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 for Plexion

This product is incompatible with silver preparations.

Warnings for Plexion

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.

Precautions for Plexion

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. 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

Carcinogenesis, Mutagenesis, 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.

Overdose Information for Plexion

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.

Contraindications for Plexion

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.

Clinical Pharmacology for Plexion

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 paraaminobenzoic 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 Propionibacterium acnes and the formation of free fatty acids.

Patient Information for Plexion

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.