Acne SSS Lotion

Salicylic Acid

Salicylic acid is a topical keratolytic agent. It is used to remove excess keratin in hyperkeratotic skin disorders such as common and plantar warts, psoriasis, seborrheic dermatitis, calluses, and corns. Salicylic acid also is used to treat acne. Salicylic acid works by causing desquamation of the horny layer of skin. Prolonged or repeated daily use over large areas of skin may result in salicylism, especially in children and patients with renal or hepatic impairment. This drug was approved by the FDA in 1939.

Sulfacetamide

Sulfacetamide is a synthetic sulfonamide antibiotic for ophthalmic or topical administration. Sulfacetamide, because it is water soluble and because a 30% solution has a pH of 7.4, is an ideal sulfonamide for ophthalmic administration. Despite the favorable pharmaceutical properties, use of sulfonamides in general has declined due to development of resistance. Sulfacetamide is used topically for the treatment of acne, scaling dermatoses such as seborrheic dermatitis and seborrheic sicca, and also for topical bacterial skin infection caused by susceptible organisms. Sulfacetamide was approved by the FDA in 1946 for the treatment of conjunctivitis, corneal ulcers and other superficial eye infections caused by susceptible organisms.

Salicylic Acid

Salicylic acid exhibits keratolytic action by dissolution of intercellular cement substance causing desquamation of the horny layer of skin.

Sulfacetamide

Sulfacetamide inhibits bacterial dihydrofolate synthetase. This action interferes with the conversion of p-aminobenzoic acid (PABA) into folic acid, an essential component of bacterial development. Folic acid is a coenzyme responsible for the transport of one-carbon fragments from one molecule to another and is crucial during the synthesis of thymidine, purines, and certain amino acids. Sulfonamides do not affect bacterial cells that use preformed (dietary) folic acid or mammalian cells. Organisms that show susceptibility to sulfacetamide sodium are: streptococci, staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia, and Actinomyces.

Salicylic Acid

Salicylic acid preparations are contraindicated in patients who have previously exhibited salicylate hypersensitivity.

Topical salicylic acid preparations in concentrations greater than 6% are contraindicated in patients with diabetes mellitus and other conditions of poor blood circulation such as peripheral vascular disease. Do not use these preparations on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.

Prolonged use of salicylic acid over large areas, especially in children and patients with renal impairment or hepatic disease may increase the risk for development of salicylism. In such patients, limit the treated area and closely monitor the patient for signs of salicylate toxicity such as nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, and psychic disturbances. When the potential for toxicity is present, advise patients not to apply occlusive dressings, clothing or other occlusive topical products such as petrolatum-based ointments to prevent excessive systemic exposure to salicylic acid. Concomitant use of other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin and other salicylate containing medications, such as sports injury creams) should be avoided. Discontinue use of salicylic acid if salicylic acid toxicity occurs and treat appropriately.

The potential for Reye’s syndrome should be considered with administration of salicylic acid products in children and adolescents with varicella or influenza.

Avoid accidental exposure of salicylic acid products to the eyes, lips, mucus membranes and inflamed or broken skin as increased absorption may occur. If unintended mucus membrane or ocular exposure occurs, thoroughly rinse affected areas with water.

Sulfacetamide

The vehicles used in ophthalmic ointments have been implicated in retarding corneal wound healing, which may be sustained as a result of ocular trauma or ocular surgery. Improvements in ophthalmic ointment vehicles have largely addressed this situation, however manufacturers still warn that sulfacetamide sodium ophthalmic ointment may retard corneal wound healing.

Sulfacetamide sodium ophthalmic ointment is not effective against fungal infection, viral infection, or against all types of bacterial infection. Continued use may result in overgrowth of non-susceptible organisms. Purulent exudate which contains para-aminobenzoic acid can inactivate sulfacetamide antibacterial activity.

Because of structural similarity, sulfonamides should be used cautiously in patients with known allergic reactions to oral sulfonylureas, thiazide diuretics, or carbonic anhydrase inhibitors. Despite the chemical similarities between furosemide and sulfonamides and the logical conclusion that cross-sensitivity would occur, a thorough review of the published literature and direct communication with the manufacturer revealed no data supporting the conclusion that patients with sensitivity to sulfonamides also develop sensitivity to furosemide.11 Less is known regarding the cross-sensitivity between sulfonamides and the other agents, although some clinicians doubt that significant risk exists.12 Nevertheless, sulfacetamide should be used cautiously in patients with furosemide hypersensitivity, thiazide diuretic hypersensitivity, sulfonylurea hypersensitivity, or carbonic anhydrase inhibitor hypersensitivity. Significant systemic absorption from topical use of sulfacetamide has been reported, therefore, the possibility of a hypersensitivity reaction exists. Patients known to have sulfonamide hypersensitivity should not be treated with sulfacetamide ophthalmic or topical preparations.

Safe and effective use of sulfonamides, such as sulfacetamide, in children has not been widely studied; some established indications in children exist (see Dosage). Sulfonamides should be avoided in infants and neonates less than 2 months of age because systemic sulfonamides may increase the risk of kernicterus in young infants by displacing bilirubin from plasma proteins.

It is not known if sulfacetamide is excreted in human milk after topical use; however, small amounts of orally administered sulfonamides have been reported in human milk. Because of the potential for the development of kernicterus in neonates, discontinue breast-feeding or sulfacetamide.13141516 Some experts may consider sulfacetamide compatible with breast-feeding in healthy infants with cautious use in infants with jaundice, hyperbilirubinemia, or glucose-6 phosphate dehydrogenase deficiency (G6PD) or in infants who are critically ill, stressed, or premature.

It is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. Sulfacetamide should only be given during pregnancy when the benefit to the mother outweighs the risk to the fetus. Overall, sulfonamides should not be given in pregnancy near term because systemic sulfonamides may increase the risk of kernicterus in the newborn by displacing bilirubin from plasma proteins. In general, topical and ophthalmic sulfacetamide as classified as pregnancy category C.13141516 Systemic sulfonamides are generally considered category D when used near term due to the potential for jaundice, hemolytic anemia, and kernicterus in the newborn.18 Sulfonamides readily cross the placenta with fetal concentrations averaging 70% to 90% of maternal concentrations.18 In the Collaborative Perinatal Project, 1,455 mothers had first trimester exposure to sulfonamides and 5,689 had exposure anytime during pregnancy. No evidence was found to suggest a relationship between sulfonamide use during pregnancy and large categories of major or minor fetal malformations. Thus, sulfonamides (as single agents) do not appear to pose a significant teratogenic risk.18

Photosensitivity can occur with sulfonamide treatment, so patients should avoid or limit sunlight (UV) exposure, including sunlamps and tanning booths.19 Sunscreens should be employed, but may provide limited protection for this reaction. Discontinue sulfacetamide use at the first sign of erythema.

According to the manufacturer, Ovace 10% topical wash is contraindicated in patients with renal disease.20 Although other manufacturers have not made such a recommendation for other topical dosage forms of sulfacetamide, it may be prudent to avoid use in this population.

Salicylic Acid

There are no adequate and well-controlled studies in pregnant women. Salicylic acid products should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus.

Sulfacetamide

It is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. Sulfacetamide should only be given during pregnancy when the benefit to the mother outweighs the risk to the fetus. Overall, sulfonamides should not be given in pregnancy near term because systemic sulfonamides may increase the risk of kernicterus in the newborn by displacing bilirubin from plasma proteins. In general, topical and ophthalmic sulfacetamide as classified as pregnancy category C.13141516 Systemic sulfonamides are generally considered category D when used near term due to the potential for jaundice, hemolytic anemia, and kernicterus in the newborn.18 Sulfonamides readily cross the placenta with fetal concentrations averaging 70% to 90% of maternal concentrations.18 In the Collaborative Perinatal Project, 1,455 mothers had first trimester exposure to sulfonamides and 5,689 had exposure anytime during pregnancy. No evidence was found to suggest a relationship between sulfonamide use during pregnancy and large categories of major or minor fetal malformations. Thus, sulfonamides (as single agents) do not appear to pose a significant teratogenic risk.

Salicylic Acid

It is not known whether topically applied salicylic acid is excreted into breast milk. According to the manufacturer, salicylic acid should not be used during breastfeeding. However, if the drug is used by nursing mothers, care should be taken to avoid application to the skin of the breast during lactation; oral ingestion by the infant could be harmful.569 Consider the benefits of breastfeeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breastfeeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

Sulfacetamide

It is not known if sulfacetamide is excreted in human milk after topical use; however, small amounts of orally administered sulfonamides have been reported in human milk. Because of the potential for the development of kernicterus in neonates, discontinue breast-feeding or sulfacetamide.13141516 Some experts may consider sulfacetamide compatible with breast-feeding in healthy infants with cautious use in infants with jaundice, hyperbilirubinemia, or glucose-6 phosphate dehydrogenase deficiency (G6PD) or in infants who are critically ill, stressed, or premature.

Salicylic Acid

Prolonged and repeated daily use over large areas, especially in children and patients with significant renal or hepatic impairment increases the potential for development of salicylism.

Topical application of salicylic acid is generally well tolerated, but may result in skin irritation including transient stinging, burning, or pruritus. Excessive erythema, peeling of the skin, and scaling may also occur, particularly if used on open skin lesions. Advise patients to discontinue use and consult a physician if excessive burning, stinging, or peeling occurs.

Topical over-the-counter (OTC) acne products, including salicylic acid, have been associated with rare but serious and potentially life-threatening hypersensitivity reactions. These reactions may occur within minutes to a day or longer after use of the product. Instruct patients to stop using topical acne products if they experience signs of anaphylactoid reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. The product should also be discontinued in patients who develop urticaria or pruritus. Based on the information reported to the FDA, it is uncertain whether the reactions are caused by the active ingredients benzoyl peroxide or salicylic acid, the inactive ingredients or a combination of both. When initiating therapy with an OTC topical acne product, advise patients to apply a small amount to one or two small affected areas for 3 days and monitor for signs of a hypersensitivity reaction. If no discomfort occurs, the instructions on the Drug Facts label may be followed.

Sulfacetamide

Ocular irritation, accompanied by stinging and burning may occur with sulfacetamide sodium ophthalmic preparations. Less frequently reported ocular adverse events include non-specific conjunctivitis, conjunctival hyperemia, and allergic reactions.

The use of topical or ophthalmic sulfacetamide sodium may precipitate a hypersensitivity reaction in patients who have previously demonstrated sulfonamide hypersensitivity. Instances of Stevens-Johnson syndrome following sulfacetamide sodium ophthalmic administration have occurred. Local hypersensitivity has also progressed to a lupus syndrome displaying lupus-like symptoms, in one case with a fatal outcome. Fatalities, although rare, have occurred due to severe reactions to sulfonamides including toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.

Skin irritation to the skin after topical administration is uncommon. If irritation does occur, it is generally transient, but if persistent the medication should be discontinued. In studies, < 1% of patients had erythema, pruritus, and edema.

Overgrowth of nonsuceptible organisms may lead to superinfection with the use of sulfacetamide. Bacterial and fungal corneal ulcers have developed during treatment with ophthalmic preparations.

Store this medication at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.

1.Compound W (salicylic acid 17%) package insert. Tarrytown, NY: Prestige Brands; 2013 Mar.
2.Compound W gel (salicylic acid 17% gel) package insert. Tarrytown, NY: Prestige Brands; 2013 April.
3.Hydrisalic gel (salicylic acid 17%) package insert. Farmingdale, NY: Pedinol Pharmacal Inc.; 2011 Nov.
4.Virasal (salicylic acid 27.5%) package insert. Vernon Hills, IL: Elorac, Inc.; 2011 Jan.
5.Salex 6% (salicylic acid) cream and lotion package insert. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2019 Jan.
6.Salacyn 6% (salicylic acid 6%) cream or lotion package insert. Miami, Fl: Stratus Pharmaceuticals Inc.; 2010 Nov..
7.Salitech (salicylic acid 5% lotion) package insert. Peoria, AZ: Solutech Pharmaceuticals; 2016 Dec.
8.Salisol (salicylic acid 23% topical solution) package insert. Peoria, AZ: Solutech Pharmaceuticals; 2016 Dec.
9.Salvax 6% foam (salicylic acid) package insert. Newtown, PA: Quinnova Pharmaceuticals, Inc.; 2009 Apr.
10.Curad mediplast (salicylic acid 40%) package insert. Mundelein, IL: Medline Industries, Inc.; 2013 Feb.
11.Schneiweiss F. Cross-sensitivity between sulfonamides and furosemide. Clin Pharm 1983;2:510.
12.Sullivan TJ. Cross-reactions among furosemide, hydrochlorothiazide, and sulfonamides. JAMA 1991;265:120-1.
13.Bleph-10 (sodium sulfacetamide ophthalmic) package insert. Irvine, CA: Allergan Inc.; 2014 May.
14.Klaron (sulfacetamide sodium lotion) package insert. Bridgewater, NJ: Bausch Health US, LLC; 2020 Aug.
15.sodium sulfacetamide 10% topical gel package insert. Alpharetta, GA: Acella Pharmaceuticals, LLC; 2014 Sept.
16.Sulfacetamide sodium 10% topical suspension package insert. Melville NY: E. Fougera and Co.; 2011 Oct.
17.Chin KG, McPherson CE, Hoffman M, et al. Use of anti-infective agents during lactation: part 2 – aminoglycosides, macrolides, quinolones, sulfnamides, trimethoprim, tetracyclines, chloramphenicol, and metronidazole. J Hum Lact 2001;17:54-65.
18.Sulfonamides. In: Drugs in Pregnancy and Lactation. A Reference Guide to Fetal and Neonatal Risk. Briggs GG, Freeman RK, Yaffe SJ, (eds.) 9th ed., Philadelphia. PA. Lippincott Williams and Wilkins. 2011; 1371-4.
19.Moore DE. Drug-induced cutaneous photosensitivity: incidence, mechanism, prevention and management. Drug Saf 2002;25:345-72.
20.Ovace (sulfacetamide sodium) liquid package insert. San Antonio, TX: Mission Pharmacal Company; 2014 Jan.
21.Food and Drug Administration MedWatch. Over-The-Counter Topical Acne Products: Drug Safety Communication – Rare But Serious Hypersensitivity Reactions. Retrieved June 25, 2014. Available on the World Wide Web http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402722.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
22.Bleph-10 (sodium sulfacetamide ophthalmic) package insert. Allergan Inc.; 2005.
23.Seb-Prev Wash (sodium sulfacetamide) package insert. Coral Gables, FL: Stiefel Laboratories, Inc.; Aug 2010.