AVAR

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AVAR

Classes

Bulk Agents for Compounding
Topical Rosacea Agents
Topical Scalp Antipsoriasis and Seborrheic Dermatitis Agents, including Keratolytics
Topical Sulfonamides
Topical Sulfur Agents for Acne

Adverse Reactions
Severe

Stevens-Johnson syndrome / Delayed / 0-1.0
agranulocytosis / Delayed / 0-1.0
hemolytic anemia / Delayed / 0-1.0
exfoliative dermatitis / Delayed / Incidence not known

Moderate

erythema / Early / 1.0-10.0
edema / Delayed / 1.0-10.0
jaundice / Delayed / 0-1.0
contact dermatitis / Delayed / 0-1.0

Mild

skin irritation / Early / 1.0-10.0
pruritus / Rapid / 1.0-10.0
fever / Early / 0-1.0
photosensitivity / Delayed / 0-1.0
purpura / Delayed / 0-1.0

Common Brand Names

AVAR, Avar Green, AVAR LS, Avar-E, Avar-e Green, AVAR-e LS, BP 10-1 Wash, BP Cleansing Wash, Clarifoam EF, Claris, Clenia, Garimide, Nicosyn, Plexion, Plexion SCT, Plexion TS, Prascion, Prascion AV, Prascion RA, Prascion TS, Rosac, Rosaderm, Rosanil, Rosula, SE 10-5 SS, SSS 10-4, SSS 10-5, Sulfacet-R, SulfaCleanse 8/4, Sulfatol, Sulfatol C, Sulfatol SS, SulZee, Sumadan, Sumaxin, Sumaxin Cleansing Pads, Sumaxin TS, Suphera, Topisulf, VIRTI-SULF, Zencia, Zetacet, Zma Clear

Dea Class

Rx

Description

Combination of an sulfonamide antimicrobial (sulfacetamide) and an antimicrobial and keratolytic agent (sulfur)
Used to treat acne rosacea, acne vulgaris, and seborrheic dermatitis
Widespread historical use in dermatology, but not formally evaluated by the FDA for clinical efficacy or safety.

Dosage And Indications
For the treatment of acne vulgaris, acne rosacea, and seborrheic dermatitis as an adjunct.
NOTE: These drug products have not been evaluated by the FDA for safety and efficacy for the stated dermatologic conditions.
Topical dosage (cream, gel, lotion, or suspension) Adults

Apply a thin layer topically to the affected skin area(s) 1 to 3 times daily. To minimize potential dryness, start with 1 application daily and gradually increase to 2 to 3 times daily.

Children and Adolescents 12 to 17 years

Apply a thin layer topically to the affected skin area(s) 1 to 3 times daily. To minimize potential dryness, start with 1 application daily and gradually increase to 2 to 3 times daily.

Topical dosage (wash or cleanser) Adults

Apply a liberal amount topically to the affected area(s) of wet skin and massage into a lather 1 to 2 times daily, then rinse thoroughly.

Children and Adolescents 12 to 17 years

Apply a liberal amount topically to the affected area(s) of wet skin and massage into a lather 1 to 2 times daily, then rinse thoroughly.

Topical dosage (foam) Adults

Apply a small amount topically to the affected area(s) 1 to 3 times daily, then rinse thoroughly or leave-on application.

Children and Adolescents 12 to 17 years

Apply a small amount topically to the affected area(s) 1 to 3 times daily, then rinse thoroughly or leave-on application.

Dosing Considerations
Hepatic Impairment

No dosage adjustments are needed.

Renal Impairment

Per the manufacturers, sulfacetamide; sulfur products, including creams, washes and other topical preparations, are not for use by patients with kidney disease.

Drug Interactions

Aliskiren; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Amiloride; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Atenolol; Chlorthalidone: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Azilsartan; Chlorthalidone: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Benazepril; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Candesartan; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Captopril; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Chlorothiazide: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Chlorpropamide: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of sulfonylureas. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Chlorthalidone: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Chlorthalidone; Clonidine: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Enalapril; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Eprosartan; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Fosinopril; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Gentamicin: (Moderate) Based on the possibility of in vitro antagonism, avoid using sulfacetamide sodium concomitantly with gentamicin sulfate.
Glimepiride: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of sulfonylureas. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Glipizide: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of sulfonylureas. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Glipizide; Metformin: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of sulfonylureas. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Glyburide: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of sulfonylureas. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Glyburide; Metformin: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of sulfonylureas. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Hydrochlorothiazide, HCTZ; Methyldopa: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Hydrochlorothiazide, HCTZ; Moexipril: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Irbesartan; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Lisinopril; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Losartan; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Methoxsalen: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of photosensitizing agents used during photodynamic therapy.
Methyclothiazide: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Metolazone: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Metoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Olmesartan; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Photosensitizing agents (topical): (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of photosensitizing agents used during photodynamic therapy.
Pioglitazone; Glimepiride: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of sulfonylureas. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Propranolol; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Quinapril; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Silver Nitrate: (Major) Topical and ophthalmic sulfonamides are incompatible with preparations containing silver. Sulfacetamide sodium should not be applied to the same sites as products containing silver salts, including preparations such as silver nitrate, silver sulfadiazine, or mild silver protein.
Silver Sulfadiazine: (Major) Topical and ophthalmic sulfonamides are incompatible with preparations containing silver. Sulfacetamide sodium should not be applied to the same sites as products containing silver salts, including preparations such as silver nitrate, silver sulfadiazine, or mild silver protein.
Spironolactone; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Sulfonylureas: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of sulfonylureas. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Telmisartan; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Thiazide diuretics: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Tolazamide: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of sulfonylureas. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Tolbutamide: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of sulfonylureas. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Triamterene; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
Voriconazole: (Moderate) Voriconazole is metabolized by the CYP2C9 isoenzyme, and drugs that are known to be inhibitors of CYP2C9 may theoretically lead to elevated plasma levels of voriconazole when coadministered. Drugs that are known to be inhibitors of CYP2C9 include sulfonamides.

How Supplied

AVAR/Avar Green/Rosula/Sulfacetamide Sodium, Sulfur, pharmaceutical/Sulfacetamide, Sulfur/Sulfatol Topical Gel: 10-5%
AVAR/AVAR LS/BP Cleansing Wash/Claris/Clenia/Plexion/Plexion TS/Prascion/Prascion AV/Prascion TS/Rosaderm/Rosanil/Rosula/Sulfacetamide Sodium, Sulfur, pharmaceutical/Sulfacetamide, Sulfur/SulfaCleanse 8/4/Sulfatol/Sumaxin TS/Zetacet/Zma Clear Topical Susp: 10-2%, 10-4%, 10-4.5%, 10-5%, 8-4%, 9-4%, 9-4.25%, 9-4.5%, 9.8-4.8%
AVAR/AVAR LS/Clarifoam EF/Rosula/SSS 10-4/SSS 10-5/Sulfacetamide Sodium, Sulfur, pharmaceutical/Sulfacetamide, Sulfur Topical Foam: 10-2%, 10-4%, 10-5%, 9.5-5%
AVAR/AVAR LS/Plexion/Rosula/Sulfacetamide Sodium, Sulfur, pharmaceutical/Sulfacetamide, Sulfur/Sumaxin/Sumaxin Cleansing Pads Topical Swab: 10-2%, 10-4%, 10-5%, 9.5-5%, 9.8-4.8%
Avar-E/Avar-e Green/AVAR-e LS/Clenia/Plexion/Plexion SCT/Prascion RA/SE 10-5 SS/Sulfacetamide Sodium, Sulfur, pharmaceutical/Sulfacetamide, Sulfur/Sulfatol C/Sulfatol SS/Suphera/Topisulf/VIRTI-SULF Topical Cream: 10-2%, 10-5%, 9.8-4.8%
BP 10-1 Wash/BP Cleansing Wash/Garimide/Rosac/Sulfacetamide Sodium, Sulfur, pharmaceutical/Sulfacetamide, Sulfur/SulZee/Sumadan/Sumaxin/Zencia Topical Sol: 10-1%, 9-4%, 9-4.5%
Nicosyn/Plexion/Sulfacetamide Sodium, Sulfur, pharmaceutical/Sulfacetamide, Sulfur/Sulfacet-R/Zetacet Topical Lotion: 10-5%, 9.8-4.8%

Maximum Dosage
Adults

3 applications/day for creams, gels, lotions, and foam; 2 applications/day for washes and cleansers.

Geriatric

3 applications/day for creams, gels, lotions, and foam; 2 applications/day for washes and cleansers.

Adolescents

3 applications/day for creams, gels, lotions, and foam; 2 applications/day for washes and cleansers.

Children

>= 12 years: 3 applications/day for creams, gels, lotions, and foam; 2 applications/day for washes and cleansers.
< 12 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

Sulfacetamide; sulfur is used for the topical treatment of acne vulgaris, acne rosacea, and seborrheic dermatitis.
 
Sulfacetamide: Sulfacetamide interferes with bacterial synthesis of folic acid by competitively blocking the incorporation of para-aminobenzoic acid (PABA) into tetrahydropteroic acid. Folic acid is a coenzyme required by bacterial cells for the synthesis of nucleotides and ultimately bacterial cell growth. Sulfacetamide does not affect bacterial cells that use preformed (dietary) folic acid or mammalian cells. Sulfacetamide displays in vitro bacteriostatic activity against Enterobacter species, Escherichia coli, Haemophilus influenzae, Klebsiella species, Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus viridans group.
Sulfur: The exact mechanism of action for sulfur is currently unknown; however, it has been suggested that observed keratolytic activity results from an interaction between sulfur and the cysteine content of keratinocytes. When administered concurrently with sulfacetamide, sulfur inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

Pharmacokinetics

Sulfacetamide, sulfur is administered topically in a variety of vehicles, including washes, creams, lotions and gels. Some sulfacetamide is absorbed following topical administration, but precise systemic bioavailability is not available for the various products. Systemic absorption would be increased dependent on area of topical application and the presence of denuded or abraded skin. Following systemic absorption, sulfacetamide is eliminated primarily unchanged by the kidneys through glomerular filtration. The half-life of sulfacetamide following oral administration ranges between 7—12.8 hours.

Topical Route

Sulfacetamide: The rate and extent of sulfacetamide absorption through intact skin has not been determined.
Sulfur: Approximately 1% of a topically applied dose of sulfur is absorbed systemically.

Pregnancy And Lactation
Pregnancy

Adequate, well-controlled studies are not available for sulfacetamide; sulfur use in pregnant women and animal reproductive studies have not been conducted. It is unknown whether sulfacetamide; sulfur can cause harm to the fetus or affect the reproductive system. Sulfacetamide; sulfur should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.[42976] Conservative measures, such as gentle skin care, sunscreens, and avoidance of aggravating factors are often recommended first line for patients during pregnancy.

According to the manufacturers, caution is advised if sulfacetamide; sulfur topical products are administered to breast-feeding women. It is not known whether topically administered sulfacetamide; sulfur is excreted in human milk; however, orally administered sulfonamides have been isolated in human breast milk. Sulfacetamide; sulfur may be considered for use when breast-feeding healthy infants; however, caution should be used when nursing infants with jaundice, hyperbilirubinemia, or G-6-PD deficiency or nursing those infants who are critically ill, stressed, or premature. Conservative measures, such as gentle skin care, sunscreens, and avoidance of aggravating factors are often recommended first line for patients with rosacea during pregnancy and lactation. Alternative treatments for patients with acne vulgaris include the use of topical benzoyl peroxide, which is generally considered to be of low risk to a nursing infant. Avoid application to skin that the nursing infant might come into contact with orally, and preferably use water-miscible products. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse reaction related to the maternally ingested drug, health care providers are encouraged to report the adverse effect to the FDA.