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Sulfacetamide (Topical)

Pronunciation

(sul fa SEE ta mide)

Index Terms

  • Sodium Sulfacetamide
  • Sulamyd
  • Sulfacetamide Sodium

Dosage Forms

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

Cream, External, as sodium:

Ovace Plus: 10% (57 g) [contains benzyl alcohol, butylparaben, cetyl alcohol, disodium edta, ethylparaben, methylparaben, propylparaben]

Foam, External:

Ovace Plus: 9.8% (100 g) [contains benzyl alcohol, cetyl alcohol, propylene glycol]

Gel, External, as sodium:

APOP: 10% (57 g [DSC]) [contains benzyl alcohol, cetyl alcohol, disodium edta]

Ovace Plus Wash: 10% (355 mL) [contains cetearyl alcohol, edetate disodium dihydrate, methylparaben]

Generic: 10% (355 mL)

Liquid, External, as sodium:

Ovace Plus Wash: 10% (180 mL, 473 mL) [contains cetearyl alcohol, edetate disodium, methylparaben]

Ovace Wash: 10% (180 mL, 355 mL, 480 mL) [contains edetate disodium, methylparaben]

Seb-Prev Wash: 10% (340 mL) [contains edetate disodium, methylparaben]

Generic: 10% (177 mL, 180 mL, 354.8 mL, 355 mL, 480 mL)

Lotion, External, as sodium:

Klaron: 10% (118 mL) [contains disodium edta, methylparaben, propylene glycol, sodium metabisulfite]

Ovace Plus: 9.8% (57 g, 113 g) [contains benzyl alcohol, cetyl alcohol, disodium edta]

Seb-Prev: 10% (118 mL [DSC]) [contains methylparaben, sodium metabisulfite]

Generic: 10% (118 mL)

Pad, External, as sodium:

Generic: 10% (30 ea [DSC])

Shampoo, External, as sodium:

Ovace Plus: 10% (237 mL) [contains cetearyl alcohol, methylparaben, propylparaben]

Generic: 10% (237 mL)

Suspension, External, as sodium:

Generic: 10% (118 mL)

Brand Names: U.S.

  • APOP [DSC]
  • Klaron
  • Ovace Plus
  • Ovace Plus Wash
  • Ovace Wash
  • Seb-Prev Wash
  • Seb-Prev [DSC]

Pharmacologic Category

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

Pharmacology

Interferes with bacterial growth by inhibiting bacterial folic acid synthesis through competitive antagonism of PABA

Absorption

Significant absorption through skin has been reported; percutaneous absorption about 4%.

Metabolism

Sulfanilamide (major metabolite)

Excretion

Urine 0.08% to 0.33%

Half-Life Elimination

7 to 13 hours

Use: Labeled Indications

Acne (Klaron lotion, topical suspension): Treatment of acne vulgaris.

Bacterial infections (cream, wash, Ovace Plus lotion and foam): Treatment of bacterial infections of the skin.

Scaling dermatoses (cream, shampoo, wash, Ovace Plus lotion and foam): Treatment of scaling dermatoses (seborrheic dermatitis and seborrhea sicca [dandruff]).

Contraindications

Known or suspected hypersensitivity to sulfonamides or any component of the formulation; kidney disease (Ovace Plus Wash, Ovace Plus lotion, Ovace Plus foam)

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: Topical: Klaron lotion, topical suspension: Apply thin film to affected area twice daily

Bacterial infections: Topical:

Cream, Ovace Plus lotion: Apply to affected areas twice daily for 8 to 10 days.

Foam: Apply to affected areas 1 to 3 times daily

Wash: Apply to affected areas 1 to 2 times daily for 8 to 10 days.

Scaling dermatoses: Topical:

Cream, Ovace Plus lotion: Apply to affected areas twice daily for 8 to 10 days. Dosing interval may be lengthened as eruption subsides. Applications once or twice weekly, or every other week may be used for prevention. If treatment needs to be reinitiated, start therapy as a twice-daily regimen.

Foam: Apply to affected areas 1 to 3 times daily

Shampoo: Wash hair at least twice weekly.

Wash:

Ovace Plus Wash Liquid, Ovace Plus Wash cleansing gel, Ovace wash: Wash affected areas twice with a 10- to 20-second interval between washings; repeat twice daily for 8 to 10 days. Dosing interval may be lengthened as eruption subsides. Applications once or twice weekly, or every other week may be used for prevention. If treatment needs to be reinitiated, start therapy as a twice-daily regimen.

SEB-Prev: Wash affected areas twice daily for 8 to 10 days. Dosing interval may be lengthened as eruption subsides. Applications once or twice weekly, or every other week may be used for prevention. If treatment needs to be reinitiated, start therapy as a twice-daily regimen.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Acne, seborrheic dermatitis, or secondary cutaneous bacterial infections: Topical: Children ≥12 years and Adolescents: Refer to adult dosing.

Administration

Topical: Avoid contact with eyes and mucous membranes.

Foam: Cleanse affected skin thoroughly and pat dry before each application. Shake well prior to use. Dispense into palm of hand. Massage into affected areas and wait 10 minutes; rinse thoroughly with water and pat dry.

Lotion, topical suspension: Shake well prior to use.

Shampoo: Apply to wet hair and massage vigorously into scalp; thoroughly rinse hair.

Wash: Apply to wet skin and massage into a full lather, rinse thoroughly with plain water, and pat dry. If skin dryness occurs, rinse off early or use less frequently. When used for scaling dermatitis, regular shampooing after use is not necessary; however, hair should be shampooed at least once weekly.

Storage

Cream, shampoo, Ovace Plus lotion: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from freezing and excess heat. May darken slightly on storage; efficacy or safety is not affected. Keep tightly closed.

Foam: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F). Brief exposures to temperatures up to 40°C (104°F) may be tolerated provided the mean temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Contents under pressure, do not puncture or incinerate.

Klaron lotion, topical suspension: Store at 20°C to 25°C (68°F to 77°F). Keep tightly closed.

Wash: May darken slightly on storage; efficacy or safety is not affected. Keep tightly closed.

Ovace Plus Wash cleansing gel: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from freezing and excess heat.

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

SEB-Prev: Store at 20°C to 25°C (68°F to 77°F). Protect from freezing and excess heat.

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; adverse events may vary based on formulation.

Dermatologic: Burning sensation of skin, erythema, pruritus, Stevens-Johnson syndrome, stinging of the skin, toxic epidermal necrolysis

Hematologic & oncologic: Agranulocytosis, aplastic anemia, hematologic abnormality

Hepatic: Fulminant hepatic necrosis

Hypersensitivity: Hypersensitivity reaction

Local: Local irritation, localized edema

Neuromuscular & skeletal: Systemic lupus erythematosus

Warnings/Precautions

Concerns related to adverse effects:

• Autoimmune effects: 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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information

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 suggests 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; not for ophthalmic use; avoid contact with eyes and mucous membranes. Discontinue use if irritation, rash, or signs of hypersensitivity occur. Monitor closely for local irritation and/or sensitization during long-term therapy.

• Infection: Application to infected area containing nonsusceptible organisms may cause proliferation of the organism.

• Metabisulfites: Some products contain sodium metabisulfite which may cause allergic reactions in certain individuals (eg, asthmatic patients).

• Other topical products: Not compatible with silver-containing products.

Monitoring Parameters

Response to therapy, signs of local irritation and/or sensitization, especially during long-term therapy.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. The amount of sulfacetamide available systemically following topical administration is unknown. Use of systemic sulfonamides during pregnancy may cause kernicterus in the newborn.

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?)

• Have patient report immediately to prescriber signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs), 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), severe skin irritation, severe loss of strength and energy, jaundice, bruising, bleeding, chills, or pharyngitis (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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