CLASSES
Bulk Agents for Compounding
Topical Rosacea Agents
Topical Scalp Antipsoriasis and Seborrheic Dermatitis Agents, including Keratolytics
Topical Sulfonamides
Topical Sulfur Agents for Acne
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.
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
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%
DOSAGE & INDICATIONS
For the adjunctive treatment of acne vulgaris, acne rosacea, and seborrheic dermatitis.
NOTE: These drug products have not been evaluated by the FDA for safety and efficacy for the stated dermatologic conditions.
Topical dosage (creams, gels, lotions, and suspensions)
Adults
Apply a thin film to affected areas 1- to 3-times per day. Massage lightly to blend into skin. If skin dryness is a concern, initiate therapy with 1 application daily and gradually increase to 2- to 3-times per day.
Children and Adolescents 12 years and older
Apply a thin film to affected areas 1- to 3-times per day. Massage lightly to blend into skin. If skin dryness is a concern, initiate therapy with 1 application daily and gradually increase to 2- to 3-times per day.
Topical (washes and cleansers)
Adults
Wash affected area(s) as directed for 10 to 20 seconds once or twice per day.
Children and Adolescents 12 years and older
Wash affected area(s) as directed for 10 to 20 seconds once or twice per day.
Topical dosage (foam)
Adults
Massage into affected area(s) as directed 1- to 3-times per day. Following each administration, the foam may either be left on or washed off; if foam is to be washed off, wait 10 minutes prior to rinsing with water.
Children and Adolescents 12 years and older
Massage into affected area(s) as directed 1- to 3-times per day. Following each administration, the foam may either be left on or washed off; if foam is to be washed off, wait 10 minutes prior to rinsing with water.
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.
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.
STORAGE
Generic:
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
AVAR:
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
Avar Green:
- Protect from freezing
- Store at room temperature (between 59 to 86 degrees F)
AVAR LS:
- Avoid excessive heat (above 104 degrees F)
- Brief exposure up to 104 degrees F does not adversely affect product
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Avar-E:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Avar-e Green:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
AVAR-e LS:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
BP 10-1 Wash:
- Store at room temperature (between 59 to 86 degrees F)
BP Cleansing Wash:
- Store at room temperature (between 59 to 86 degrees F)
CERISA:
- Protect from freezing
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
Clarifoam EF:
- Do Not Store at Temperatures Above 120 degrees F (49 degrees C)
- Protect from freezing
- Store at room temperature (between 59 to 86 degrees F)
- Store upright
Claris:
- Store at room temperature (between 59 to 86 degrees F)
Clenia :
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Garimide:
- Brief exposure up to 104 degrees F does not adversely affect product
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Nicosyn:
- Avoid excessive heat (above 104 degrees F)
- Brief exposure up to 104 degrees F does not adversely affect product
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Plexion:
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
Plexion Cloths:
- Store at controlled room temperature (between 68 and 77 degrees F)
Plexion SCT:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Plexion TS:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Prascion:
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
Prascion AV:
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
Prascion FC:
- Store at controlled room temperature (between 68 and 77 degrees F)
Prascion RA:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Prascion TS:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Rosac:
- Store at room temperature (between 59 to 86 degrees F)
Rosac with Sunscreens:
- Store at room temperature (between 59 to 86 degrees F)
Rosaderm :
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
Rosanil:
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
Rosula:
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
SE 10-5 SS :
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
SSS 10-4 :
- Exposure to temperatures above 120 degrees F may cause bursting
- Protect from freezing
- Store between 68 to 77 degrees F
- Store upright
SSS 10-5:
- Do Not Store at Temperatures Above 120 degrees F (49 degrees C)
- Protect from freezing
- Store at room temperature (between 59 to 86 degrees F)
- Store upright
Sulfacet-R:
- Avoid excessive heat (above 104 degrees F)
- Brief exposure up to 104 degrees F does not adversely affect product
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
SulfaCleanse 8/4:
- Avoid excessive heat (above 104 degrees F)
- Brief exposure up to 104 degrees F does not adversely affect product
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Sulfamez:
- Protect from freezing
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
Sulfatol :
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
Sulfatol C:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Sulfatol SS:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Sulfatol-M:
- Protect from freezing
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
SulZee:
- Store at room temperature (between 59 to 86 degrees F)
Sumadan:
- Brief exposure up to 104 degrees F does not adversely affect product
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Sumaxin:
- Protect from freezing
- Store at room temperature (between 59 to 86 degrees F)
Sumaxin Cleansing Pads:
- Avoid excessive heat (above 104 degrees F)
- Brief exposure up to 104 degrees F does not adversely affect product
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Sumaxin TS:
- Avoid excessive heat (above 104 degrees F)
- Brief exposure up to 104 degrees F does not adversely affect product
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Suphera:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Topisulf:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
VIRTI-SULF:
- Avoid excessive heat (above 104 degrees F)
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Zencia:
- Protect from freezing
- Store at room temperature (between 59 to 86 degrees F)
Zetacet:
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
Zma Clear:
- Protect from freezing
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
CONTRAINDICATIONS / PRECAUTIONS
Carbonic anhydrase inhibitor hypersensitivity, sulfonamide hypersensitivity, sulfonylurea hypersensitivity, thiazide diuretic hypersensitivity
Patients known to have sulfonamide hypersensitivity should not be treated with sulfacetamide; sulfur topical preparations. Less is known regarding the cross-sensitivity between sulfonamides and the other agents, although some clinicians doubt that significant risk exists. Nevertheless, sulfacetamide; sulfur products should be used cautiously in patients with thiazide diuretic hypersensitivity, sulfonylurea hypersensitivity, or carbonic anhydrase inhibitor hypersensitivity due to some slight structural similarities. Particular caution should be employed if areas of denuded or abraded skin are involved since systemic exposure might be more likely to produce allergic/toxic reactions in sensitive individuals.
Renal disease, renal failure, renal impairment
Administration of sulfacetamide; sulfur products to patients with renal disease (renal impairment and renal failure) is contraindicated. Systemically absorbed sulfacetamide is cleared via the kidneys; therefore, renally impaired patients receiving sulfacetamide; sulfur products may experience increased systemic exposure and be at increased risk for adverse events.
Accidental exposure, ocular exposure, skin abrasion
Sulfacetamide; sulfur is only to be administered topically. Use caution when applying to areas of denuded skin or areas with skin abrasion as these conditions may increase absorption and risk of adverse systemic reactions. Additionally, measures should be taken during the application process to avoid ocular exposure. Rinse with water if accidental contact occurs. Avoid accidental exposure via the oral route; in case of accidental ingestion contact a poison control center immediately.
Skin photosensitivity disorder, sunlight (UV) exposure
Sulfonamide containing products, such as sulfacetamide; sulfur, may cause photosensitization and should be avoided in patients with a skin photosensitivity disorder. Instruct patients who are using sulfacetamide; sulfur preparations to avoid sunlight (UV) exposure, tanning booths, and to wear sunscreen (and if possible protective clothing) on exposed, treated skin. Some, but not all, topical sulfacetamide; sulfur products contain sunscreen as a component.
Children, infants, neonates
The safety and efficacy of sulfacetamide; sulfur products have not been established in neonates, infants, or children < 12 years.
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.
Breast-feeding
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.
Asthma, sulfite hypersensitivity
Certain products of sulfacetamide; sulfur (i.e., lotion products from Perrigo) contain sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite hypersensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in those with asthma than in non-asthmatic people.
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
DRUG INTERACTIONS
Acetohexamide: (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.
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.
Bendroflumethiazide; Nadolol: (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.
Glimepiride; Rosiglitazone: (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.
Hydralazine; Hydrochlorothiazide, HCTZ: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of thiazide diuretics.
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.
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.
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.