Sulfacetamide is a synthetic sulfonamide antibiotic for ophthalmic or topical administration. Sulfacetamide sodium ophthalmic solution is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunct to systemic sulfonamide treatment of trachoma. Because sulfacetamide is water-soluble and because a 30% solution has a pH of 7.4, it is an ideal sulfonamide for ophthalmic administration. Prolonged use of topical antibacterial agents may give rise to overgrowth of nonsusceptible organisms, including fungi. Bacterial resistance to sulfonamides may also develop. Despite the favorable pharmaceutical properties, use of sulfonamides in general has declined due to development of resistance. Sulfacetamide is also indicated in the topical treatment of acne vulgaris, scaling dermatoses such as seborrheic dermatitis and seborrheic sicca (dandruff), and also for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-Sodium sulfacetamide topical skin preparations are available in many different formulations. All are for topical use only. Avoid contact with eyes and mucus membranes.
Cream/Ointment/Lotion Formulations
Topical Cream and Lotion Administration:
-Rub cream or lotion gently into cleansed affected area.
Topical Scalp Treatment Lotion Administration:
-If the hair and scalp are oily or greasy, or if there is considerable debris, the application should be preceded by use of a non-irritating shampoo. Cleansing of the affected skin should be as frequent as necessary to ensure intimate contact with the medication.
-Rub lotion gently into cleansed affected area of the scalp.
Other Topical Formulations
Skin Wash Administration
-Wet skin and liberally apply to areas to be cleansed. Massage gently into the skin working into a full lather, rinse thoroughly with plain water and pat dry.
Topical Foam Administration
-Shake well before use.
-Clean affected skin thoroughly and pat dry before each application.
-Holding the can upright, dispense foam into hand.
-Gently massage foam onto affected areas. Wipe away any excess foam.
-The foam may be left on to dry or washed away with water after 10 minutes of contact with the affected area.
Ophthalmic Administration
-Apply topically to the eye taking care to avoid contamination. For ophthalmic use only.
-Instruct patient on proper instillation of eye ointment or solution into the lower conjunctival sac (see Patient Information).
-Do not to touch the tip of the dropper or tube to the eye, fingertips, or other surface.
-The ointment may be applied at night in combination with daytime use of the solution or before application of an eye patch.
-Do not share eye products between patients.
Ocular irritation, accompanied by stinging and burning may occur with sulfacetamide sodium ophthalmic preparations. Less frequently reported ocular adverse events include non-specific conjunctivitis, conjunctival hyperemia, and allergic reactions.
The use of topical or ophthalmic sulfacetamide sodium may precipitate a hypersensitivity reaction in patients who have previously demonstrated sulfonamide hypersensitivity. Instances of Stevens-Johnson syndrome following sulfacetamide sodium ophthalmic administration have occurred. Local hypersensitivity has also progressed to a lupus syndrome displaying lupus-like symptoms, in one case with a fatal outcome. Fatalities, although rare, have occurred due to severe reactions to sulfonamides including toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.
Skin irritation to the skin after topical administration is uncommon. If irritation does occur, it is generally transient, but if persistent the medication should be discontinued. In studies, less than 1% of patients had erythema, pruritus, and edema.
Overgrowth of nonsusceptible organisms may lead to superinfection with the use of sulfacetamide. Bacterial and fungal corneal ulcers have developed during treatment with ophthalmic preparations.
The vehicles used in ophthalmic ointments have been implicated in retarding corneal wound healing, which may be sustained as a result of ocular trauma or ocular surgery. Improvements in ophthalmic ointment vehicles have largely addressed this situation, however manufacturers still warn that sulfacetamide sodium ophthalmic ointment may retard corneal wound healing.
Sulfacetamide sodium ophthalmic ointment is not effective against fungal infection, viral infection, or against all types of bacterial infection. Continued use may result in overgrowth of non-susceptible organisms. Purulent exudate which contains para-aminobenzoic acid can inactivate sulfacetamide antibacterial activity.
Because of structural similarity, sulfonamides should be used cautiously in patients with known allergic reactions to oral sulfonylureas, thiazide diuretics, or carbonic anhydrase inhibitors. Despite the chemical similarities between furosemide and sulfonamides and the logical conclusion that cross-sensitivity would occur, a thorough review of the published literature and direct communication with the manufacturer revealed no data supporting the conclusion that patients with sensitivity to sulfonamides also develop sensitivity to furosemide. Less is known regarding the cross-sensitivity between sulfonamides and the other agents, although some clinicians doubt that significant risk exists. Nevertheless, sulfacetamide should be used cautiously in patients with furosemide hypersensitivity, thiazide diuretic hypersensitivity, sulfonylurea hypersensitivity, or carbonic anhydrase inhibitor hypersensitivity. Significant systemic absorption from topical use of sulfacetamide has been reported, therefore, the possibility of a hypersensitivity reaction exists. Patients known to have sulfonamide hypersensitivity should not be treated with sulfacetamide ophthalmic or topical preparations.
Safe and effective use of sulfonamides, such as sulfacetamide, in children has not been widely studied; some established indications in children exist (see Dosage). Sulfonamides should be avoided in infants and neonates less than 2 months of age because systemic sulfonamides may increase the risk of kernicterus in young infants by displacing bilirubin from plasma proteins.
It is not known if sulfacetamide is excreted in human milk after topical use; however, small amounts of orally administered sulfonamides have been reported in human milk. Because of the potential for the development of kernicterus in neonates, discontinue breast-feeding or sulfacetamide. Some experts may consider sulfacetamide compatible with breast-feeding in healthy infants with cautious use in infants with jaundice, hyperbilirubinemia, or glucose-6 phosphate dehydrogenase deficiency (G6PD) or in infants who are critically ill, stressed, or premature.
It is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. Sulfacetamide should only be given during pregnancy when the benefit to the mother outweighs the risk to the fetus. Overall, sulfonamides should not be given in pregnancy near term because systemic sulfonamides may increase the risk of kernicterus in the newborn by displacing bilirubin from plasma proteins.
Photosensitivity can occur with sulfonamide treatment, so patients should avoid or limit sunlight (UV) exposure, including sunlamps and tanning booths. Sunscreens should be employed, but may provide limited protection for this reaction. Discontinue sulfacetamide use at the first sign of erythema.
According to the manufacturer, Ovace 10% topical wash is contraindicated in patients with renal disease. Although other manufacturers have not made such a recommendation for other topical dosage forms of sulfacetamide, it may be prudent to avoid use in this population.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Chlamydia trachomatis, Cutibacterium acnes, Enterobacter sp., Escherichia coli, Haemophilus influenzae (beta-lactamase negative), Haemophilus influenzae (beta-lactamase positive), Klebsiella pneumoniae, Klebsiella sp., Staphylococcus aureus (MSSA), Streptococcus pneumoniae, Viridans streptococci
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
This drug may also have activity against the following microorganisms: Actinomyces sp., Nocardia sp., Proteus vulgaris, Salmonella sp., Streptococcus pyogenes (group A beta-hemolytic streptococci), Streptococcus sp.
NOTE: Some organisms may not have been adequately studied during clinical trials; therefore, exclusion from this list does not necessarily negate the drug's activity against the organism.
For the treatment of ophthalmic infection, including bacterial conjunctivitis or corneal abrasion*:
-for the treatment of bacterial conjunctivitis:
Ophthalmic dosage (10% ophthalmic solution):
Adults: 1 to 2 drops in the affected eye(s) every 2 to 3 hours for 7 to 10 days. Taper dose by increasing the time interval between doses as the condition responds.
Infants, Children, and Adolescents 2 months to 17 years: 1 to 2 drops in the affected eye(s) every 2 to 3 hours for 7 to 10 days. Taper dose by increasing the time interval between doses as the condition responds.
Ophthalmic dosage (10% ophthalmic ointment):
Adults: 0.5 inch ribbon in the affected eye(s) every 3 to 4 hours and at bedtime for 7 to 10 days. Taper dose by increasing the time interval between doses as the condition responds. The ointment may be used adjunctively with sulfacetamide ophthalmic solution.
Infants, Children, and Adolescents 2 months to 17 years: 0.5 inch ribbon in the affected eye(s) every 3 to 4 hours and at bedtime for 7 to 10 days. Taper dose by increasing the time interval between doses as the condition responds. The ointment may be used adjunctively with sulfacetamide ophthalmic solution.
-for the treatment of corneal abrasion*:
Ophthalmic dosage (10% ophthalmic solution):
Adults: 1 to 2 drops in the affected eye(s) 4 times daily for 3 to 5 days.
Infants, Children, and Adolescents 2 months to 17 years: 1 to 2 drops in the affected eye(s) 4 times daily for 3 to 5 days.
For the topical treatment of scaling dermatoses, such as seborrheic dermatitis, and seborrhea sicca:
Topical dosage (10% lotion):
Adults: Apply to affected areas twice daily (morning and evening). Repeat for 8 to 10 days. As the condition subsides, lengthen the interval between applications. Application once or twice per week or every other week may prevent recurrence. If condition recurs, reinitiate therapy as at the beginning of treatment.
Children and Adolescents 12 years and older: Apply to affected areas twice daily (morning and evening). Repeat for 8 to 10 days. As the condition subsides, lengthen the interval between applications. Application once or twice per week or every other week may prevent recurrence. If condition recurs, reinitiate therapy as at the beginning of treatment.
Topical dosage (10% wash):
Adults: Wash affected areas twice daily (morning and evening). Repeat for 8 to 10 days. Use less frequently if skin becomes dry. As the condition subsides, lengthen the interval between applications. Application once or twice per week or every other week may prevent recurrence. If condition recurs, reinitiate therapy as at the beginning of treatment.
Children and Adolescents 12 years and older: Wash affected areas twice daily (morning and evening). Repeat for 8 to 10 days. Use less frequently if skin becomes dry. As the condition subsides, lengthen the interval between applications. Application once or twice per week or every other week may prevent recurrence. If condition recurs, reinitiate therapy as at the beginning of treatment.
Topical dosage (10% foam):
Adults: Apply topically 1- to 3-times daily to affected area. The foam may be left on or washed off with water after 10 minutes.
Children and Adolescents 12 years and older: Apply topically 1- to 3-times daily to affected area. The foam may be left on or washed off with water after 10 minutes.
Topical dosage (10% cream):
Adults: Apply topically to affected areas twice daily (morning and evening) for 8 to 10 days. As the condition subsides, lengthen the interval between applications. Application once or twice per week or every other week may prevent recurrence. If condition recurs, reinitiate therapy as at the beginning of treatment.
Children and Adolescents 12 years and older: Apply topically to affected areas twice daily (morning and evening) for 8 to 10 days. As the condition subsides, lengthen the interval between applications. Application once or twice per week or every other week may prevent recurrence. If condition recurs, reinitiate therapy as at the beginning of treatment.
Topical dosage (10% medicated pads):
Adults: Apply medicated pad to the affected area(s) 1- to 2-times daily.
Children and Adolescents 12 years and older: Apply medicated pad to the affected area(s) 1- to 2-times daily.
Topical dosage (10% gel):
Adults: Wash affected areas twice daily (morning and evening). Repeat for 8 to 10 days. Use less frequently if skin becomes dry. As the condition subsides, lengthen the interval between applications. Application once or twice per week or every other week may prevent recurrence. If condition recurs, reinitiate therapy as at the beginning of treatment.
Children and Adolescents 12 years and older: Wash affected areas twice daily (morning and evening). Repeat for 8 to 10 days. Use less frequently if skin becomes dry. As the condition subsides, lengthen the interval between applications. Application once or twice per week or every other week may prevent recurrence. If condition recurs, reinitiate therapy as at the beginning of treatment.
For the treatment of secondary bacterial skin and skin structure infections due to organisms susceptible to sulfonamides:
Topical dosage (10% lotion):
Adults: Apply to affected areas twice daily (morning and evening) for 8 to 10 days.
Children and Adolescents 12 years and older: Apply to affected areas twice daily (morning and evening) for 8 to 10 days.
Topical dosage (10% wash):
Adults: Wash affected areas twice daily (morning and evening). Repeat for 8 to 10 days.
Children and Adolescents 12 years and older: Wash affected areas twice daily (morning and evening). Repeat for 8 to 10 days.
Topical dosage (10% foam):
Adults: Apply topically 1- to 3-times daily to affected area. The foam may be left on or washed off with water after 10 minutes.
Children and Adolescents 12 years and older: Apply topically 1- to 3-times daily to the affected area. The foam may be left on or washed off with water after 10 minutes.
Topical dosage (10% cream):
Adults: Apply to affected areas twice daily (morning and evening) for 8 to 10 days.
Children and Adolescents 12 years and older: Apply to affected areas twice daily (morning and evening) for 8 to 10 days.
Topical dosage (10% medicated pads):
Adults: Apply medicated pad to the affected area(s) 1- to 2-times daily until the infection has cleared.
Children and Adolescents 12 years and older: Apply medicated pad to the affected area(s) 1- to 2-times daily until the infection has cleared.
Topical dosage (10% gel):
Adults: Apply to affected areas twice daily (morning and evening) for 8 to 10 days.
Children and Adolescents 12 years and older: Apply to affected areas twice daily (morning and evening) for 8 to 10 days.
For the treatment of acne vulgaris:
Topical dosage (10% topical lotion):
Adults: Apply a thin film to the affected area twice per day.
Children and Adolescents 12 years and older.: Apply a thin film to the affected area twice per day.
Topical dosage (10% medicated pads):
Adults: Apply medicated pad to the affected area(s) 1- to 2-times daily until the infection has cleared.
Children and Adolescents 12 years and older: Apply medicated pad to the affected area(s) 1- to 2-times daily until the infection has cleared.
For the treatment of trachoma:
Ophthalmic dosage (10% ophthalmic solution):
Adults: 2 drops in the affected eye(s) every 2 hours plus systemic therapy.
Infants, Children, and Adolescents 2 months to 17 years: 2 drops in the affected eye(s) every 2 hours plus systemic therapy.
Maximum Dosage Limits:
-Adults
The maximum dosage is dependent on route of administration and indication for therapy.
-Elderly
The maximum dosage is dependent on route of administration and indication for therapy.
-Adolescents
The maximum dosage is dependent on route of administration and indication for therapy.
-Children
The maximum dosage is dependent on route of administration and indication for therapy.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
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.
Aminolevulinic Acid: (Moderate) Sulfonamides may cause photosensitization and may increase the photosensitizing effects of photosensitizing agents used during photodynamic therapy.
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.
Chlorthalidone: (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; 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.
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.
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.
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.
Sulfacetamide inhibits bacterial dihydrofolate synthetase. This action interferes with the conversion of p-aminobenzoic acid (PABA) into folic acid, an essential component of bacterial development. Folic acid is a coenzyme responsible for the transport of one-carbon fragments from one molecule to another and is crucial during the synthesis of thymidine, purines, and certain amino acids. Sulfonamides do not affect bacterial cells that use preformed (dietary) folic acid or mammalian cells. Organisms that show susceptibility to sulfacetamide sodium are: streptococci, staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia, and Actinomyces.
Sulfacetamide is administered topically and ophthalmically. Sulfonamides are metabolized in the liver by N -acetylation and the metabolites have no antibacterial activity. Excretion of parent drug and metabolites is via the kidneys through glomerular filtration.
-Route-Specific Pharmacokinetics
Topical Route
No pharmacokinetic data are available regarding systemic absorption of sulfacetamide following topical application to the head and scalp, but significant absorption has been reported.
Other Route(s)
Ophthalmic Route
Ophthalmic sulfacetamide sodium penetrates ocular fluid and tissues. Systemic absorption produces concentrations that are inadequate for therapy but may be sufficient for sensitization to occur upon readministration.