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:
Ovace Plus Wash: 10% (355 mL) [contains benzyl alcohol, cetearyl alcohol, propylene glycol]
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 [DSC]) [contains edetate disodium, methylparaben]
Seb-Prev Wash: 10% (340 mL [DSC]) [contains edetate disodium, methylparaben]
Sodium Sulfacetamide Wash: 10% (360 mL, 480 mL) [fragrance free; contains cetearyl alcohol, edetate disodium, methylparaben]
Generic: 10% (177 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 [DSC]) [contains benzyl alcohol, cetyl alcohol, disodium edta]
Generic: 10% (118 mL)
Shampoo, External, as sodium:
Ovace Plus: 10% (237 mL) [contains cetearyl alcohol, methylparaben, propylparaben]
Generic: 10% (237 mL)
Pharmacology
Mechanism of Action
Interferes with bacterial growth by inhibiting bacterial folic acid synthesis through competitive antagonism of PABA
Pharmacokinetics/Pharmacodynamics
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.
Dosage and Administration
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: Children ≥12 years and Adolescents: Topical: Lotion 10%: Apply thin film to affected area twice daily
Seborrheic dermatitis, including seborrhea sicca: Children ≥12 years and Adolescents: Topical:
Cream, Lotion 9.8%: 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
Gel, Wash: Wash affected area twice with a 10- to 20-second interval between washings; repeat application 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.
Shampoo: Wash hair at least twice weekly
Bacterial infections (secondary), cutaneous: Children ≥12 years and Adolescents: Topical:
Cream, Lotion 9.8%: Apply to affected areas twice daily for 8 to 10 days
Foam: Apply to affected areas 1 to 3 times daily
Gel: Wash affected area once daily for 8 to 10 days
Wash: Wash affected area once or twice daily for 8 to 10 days
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
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
What is this drug used for?
- It is used to treat bacterial infections.
- It is used to control seborrheic dermatitis.
- It is used to treat dandruff.
- It is used to treat pimples (acne).
Frequently reported side effects of this drug:
- Skin irritation
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Lupus like 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
- Severe sulfonamide reaction like rash; red, swollen, blistered, or peeling skin; red or irritated eyes; mouth, throat, nose, or eye sores; fever, chills, or sore throat; cough that is new or worse; loss of strength and energy; any bruising or bleeding; or liver problems like dark urine, fatigue, lack of appetite, nausea or abdominal pain, light-colored stools, vomiting, or yellow skin
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
