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Sulfur and Sulfacetamide

Pronunciation

(SUL fur & sul fa SEE ta mide)

Index Terms

  • Sodium Sulfacetamide and Sulfur
  • Sulfacetamide and Sulfur
  • Sulfur and Sulfacetamide Sodium

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cleanser, topical: Sulfur 2% and sulfacetamide sodium 10% (227 g), Sulfur 4.8% and sulfacetamide sodium 9.8% (285 g), Sulfur 5% and sulfacetamide sodium 10% (170 g, 340 g)

AVAR: Sulfur 5% and sulfacetamide sodium 10% (227 g) [contains benzyl alcohol]

AVAR LS: Sulfur 2% and sulfacetamide sodium 10% (227 g) [contains benzyl alcohol]

Plexion: Sulfur 4.8% and sulfacetamide sodium 9.8% (285 g) [contains benzyl alcohol]

Prascion: Sulfur 5% and sulfacetamide sodium 10% (170 g [DSC], 340 g [DSC])

Rosanil: Sulfur 5% and sulfacetamide sodium 10% (170 g)

Cream, topical: Sulfur 2% and sulfacetamide sodium 10% (57 g), Sulfur 4.8% and sulfacetamide sodium 9.8% (57 g), Sulfur 5% and sulfacetamide sodium 10% (28 g)

AVAR-e: Sulfur 5% and sulfacetamide sodium 10% (45 g [DSC], 57 g) [contains benzyl alcohol]

AVAR-e Green: Sulfur 5% and sulfacetamide sodium 10% (45 g [DSC], 57 g) [contains benzyl alcohol; color corrective cream]

AVAR-e LS: Sulfur 2% and sulfacetamide sodium 10% (45 g [DSC], 57 g) [contains benzyl alcohol]

Clenia: Sulfur 5% and sulfacetamide sodium 10% (28 g) [DSC]

Plexion: Sulfur 4.8% and sulfacetamide sodium 9.8% (57 g) [contains benzyl alcohol]

Prascion RA: Sulfur 5% and sulfacetamide sodium 10% (45 g [DSC]) [contains benzyl alcohol and sunscreen]

SSS 10-5: Sulfur 5% and sulfacetamide sodium 10% (28 g)

Virti-sulf: Sulfur 5% and sulfacetamide sodium 10% (28 g) [DSC]

Foam, topical: Sulfur 5% and sulfacetamide sodium 10% (60 g)

AVAR: Sulfur 5% and sulfacetamide sodium 9.5% (100 g) [contains benzyl alcohol]

AVAR LS: Sulfur 2% and sulfacetamide sodium 10% (100 g) [contains benzyl alcohol]

Clarifoam EF: Sulfur 5% and sulfacetamide sodium 10% (60 g [DSC], 100 g [DSC])

SSS 10-5: Sulfur 5% and sulfacetamide sodium 10% (60 g, 100 g)

Gel, topical: Sulfur 5% and sulfacetamide sodium 10% (45 g)

Lotion, topical: Sulfur 4.8% and sulfacetamide sodium 9.8% (57 g)

Plexion: Sulfur 4.8% and sulfacetamide sodium 9.8% (57 g) [contains benzyl alcohol]

Pad, topical [cleansing cloth]: Sulfur 4% and sulfacetamide sodium 10% (60s)

Avar: Sulfur 5% and sulfacetamide sodium 9.5% (30s, 60s)

Avar LS: Sulfur 2% and sulfacetamide sodium 10% (30s, 60s)

Plexion: Sulfur 4.8% and sulfacetamide sodium 9.8% (60s) [contains benzyl alcohol]

Prascion FC: Sulfur 5% and sulfacetamide sodium 10% (30s [DSC], 60s [DSC])

Rosula: Sulfur 5% and sulfacetamide sodium 10% (30s, 60s)

Sumaxin: Sulfur 4% and sulfacetamide sodium 10% (60s) [contains aloe]

Suspension, topical: Sulfur 4% and sulfacetamide sodium 8% (473 mL), sulfur 5% and sulfacetamide sodium10% (30 g)

SulfaCleanse 8/4: Sulfur 4% and sulfacetamide sodium 8% (473 mL) [contains aloe]

Sumaxin TS: Sulfur 4% and sulfacetamide sodium 8% (473 mL) [contains aloe]

Wash, topical: Sulfur 4% and sulfacetamide sodium 9% (480 mL); Sulfur 4.5% and sulfacetamide sodium 9% (454 g)

BP 10-1: Sulfur 1% and sulfacetamide sodium 10% (170 g)

BP Cleansing Wash: Sulfur 5% and sulfacetamide sodium 10% (480 mL) [contains urea]

Rosula Wash: Sulfur 4.5% and sulfacetamide sodium 10% (340.2 g)

Sumaxin: Sulfur 4% and sulfacetamide sodium 9% (473 mL) [contains aloe]

Zencia: Sulfur 4% and sulfacetamide sodium 9% (480 mL) [contains aloe]

Wash, topical [emulsion-based]:

BP Cleansing Wash: Sulfur 4% and sulfacetamide sodium 10% (473 mL) [contains urea]

Claris: Sulfur 4% and sulfacetamide sodium 10% (473 mL) [contains urea 10%] [DSC]

Sumadan: Sulfur 4.5% and sulfacetamide sodium 9% (454 g)

Sumadan XLT: Sulfur 4.5% and sulfacetamide sodium 9% (454 g) [packaged in a kit with Niseko sunscreen SPF 25]

Brand Names: U.S.

  • AVAR
  • AVAR LS
  • AVAR-e
  • AVAR-e Green
  • AVAR-e LS
  • BP 10-1
  • BP Cleansing Wash
  • Clarifoam EF [DSC]
  • Claris [DSC]
  • Clenia [DSC]
  • Plexion
  • Prascion FC [DSC]
  • Prascion RA [DSC]
  • Prascion [DSC]
  • Rosanil
  • Rosula Cleansing Cloths
  • Rosula Wash
  • SSS 10-5
  • SulfaCleanse 8/4
  • Sumadan
  • Sumadan XLT
  • Sumaxin
  • Sumaxin TS
  • Virti-sulf [DSC]
  • Zencia

Pharmacologic Category

  • Acne Products
  • Antibiotic, Sulfonamide Derivative
  • Antiseborrheic Agent, Topical
  • Topical Skin Product, Acne

Pharmacology

Sulfacetamide interferes with bacterial growth by inhibiting bacterial folic acid synthesis through competitive antagonism of para-aminobenzoic acid (PABA). Sulfur is a keratolytic. Used in combination to inhibit the growth of acne-causing bacteria.

Absorption

Sulfur, topical: ~1%

Use: Labeled Indications

Acne rosacea, acne vulgaris, seborrheic dermatitis: Treatment of acne vulgaris, acne rosacea, and seborrheic dermatitis.

Contraindications

Hypersensitivity to sulfur, sulfonamides, or any component of the formulation; renal disease

Note: Although the FDA-approved product labeling states this medication is contraindicated with other sulfonamide-containing drug classes, the scientific basis of this statement has been challenged. See "Warnings/Precautions" for more detail.

Dosing: Adult

Acne vulgaris, acne rosacea, seborrheic dermatitis:

Cream, gel, lotion, suspension, emollient cream: Apply a thin film to affected area 1 to 3 times daily.

Cleanser, cleansing cloth/pads: Wash affected area 1 to 2 times daily.

Emollient foam: Apply to affected area 1 to 3 times daily; foam may remain on skin or may be rinsed off after 1 to 10 minutes.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

Use is contraindicated.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

For external use only. Wash hands prior to use. Avoid contact with eyes, eyelids, lips, and mucous membranes.

Cleanser: Apply to wet skin and massage gently into skin working into full lather for 10 to 20 seconds; rinse skin completely and pat dry skin.

Cleansing cloths/cleansing pads: Moisten skin and cloth/pad with water, work cloth/pad into lather, and massage into skin for 10 to 20 seconds; rinse skin completely and pat dry skin. Dispose in trash; do not flush.

Cream, lotion, gel, emollient cream: Apply to clean, dry skin; massage into skin completely.

Emollient foam: Apply to clean, dry skin. Prime can prior to initial use (refer to manufacturer’s labeling for priming instructions); shake can vigorously and tap bottom of can onto palm of other hand or a hard surface at least 3 times prior to each use. Foam may remain on skin or may be rinsed off after 1 to 10 minutes.

Suspension: Shake well prior to use. Apply to clean, dry skin; massage into skin completely.

Storage

Store at room temperature; protect from freezing and excessive heat. Some products may darken slightly on storage; efficacy or safety is not affected. A slight yellowish discoloration may occur when an excessive amount of product is used and comes in contact with white fabrics; this discoloration it is readily removed by ordinary laundering.

Foam: Contents under pressure; do not expose to heat or store at temperatures >49°C (>120°F). Store upright.

Drug Interactions

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Adverse Reactions

Frequency not defined, but reactions are reported to be rare.

Central nervous system: Drug fever

Dermatologic: Contact dermatitis, erythema, exfoliative dermatitis, pruritus, Stevens-Johnson syndrome, xeroderma

Hematologic & oncologic: Agranulocytosis, hemolytic anemia (acute), immune thrombocytopenia

Hepatic: Jaundice

Local: Local irritation

Warnings/Precautions

Concerns related to adverse effects:

• Autoimmune diseases: Fatalities associated with severe reactions, including drug-induced systemic lupus erythematosus, have occurred with sulfonamides (regardless of administration route).

• Blood dyscrasias: Fatalities associated with severe reactions, including agranulocytosis, acute hemolytic anemia, aplastic anemia, purpura hemorrhagica, and other blood dyscrasias, have occurred with sulfonamides (regardless of route).

• Dermatologic reactions: Fatalities associated with severe reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug fever, have occurred with sulfonamides (regardless of route). In addition, contact dermatitis, reddening, and scaling of the skin may occur.

• Hepatic effects: Fatalities associated with severe reactions, including fulminant hepatic necrosis and jaundice, have occurred with sulfonamides (regardless of route).

• Hypersensitivity reactions: Skin rash or other reactions have occurred in patients with no prior history of sulfonamide hypersensitivity. Discontinue use at the first sign of hypersensitivity or rash.

• Sulfonamide ("sulfa") allergy: Traditionally, concerns for cross-reactivity have extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur, or at the very least this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides and antibiotic sulfonamides. A nonantibiotic sulfonamide compound which contains the arylamine structure and therefore may cross-react with antibiotic sulfonamides is sulfasalazine (Zawodniak 2010). T-cell-mediated (type IV) reactions (eg, maculopapular rash) are less understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.

• Systemic effects: Systemic absorption is increased with application to large, infected, abraded, denuded, or burned skin.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with eyes, eyelids, lips, and mucous membranes. Use with caution if areas of denuded or abraded skin are involved. Discontinue use if irritation, rash, or signs of hypersensitivity occur.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. Refer to the sulfacetamide monograph for additional information.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry skin or itching. Have patient report immediately to prescriber severe skin irritation or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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