Ovace Plus

Ophthalmological Anti-infectives
Topical Rosacea Agents
Topical Scalp Antipsoriasis and Seborrheic Dermatitis Agents, including Keratolytics
Topical Sulfonamides
Topical Sulfur Agents for Acne

Sodium sulfacetamide topical skin preparations are available in many different formulations. All are for topical use only. Avoid contact with eyes and mucus membranes.

Topical Cream and Lotion Administration:
Rub cream or lotion gently into cleansed affected area.[63878]
 
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.

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.[63953]

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.

toxic epidermal necrolysis / Delayed / 0-1.0
agranulocytosis / Delayed / 0-1.0
lupus-like symptoms / Delayed / 0-1.0
Stevens-Johnson syndrome / Delayed / 0-1.0
hepatic necrosis / Delayed / 0-1.0
aplastic anemia / Delayed / 0-1.0

edema / Delayed / 0-1.0
erythema / Early / 0-1.0
conjunctival hyperemia / Early / Incidence not known
conjunctivitis / Delayed / Incidence not known
superinfection / Delayed / Incidence not known

skin irritation / Early / 1.0-10.0
pruritus / Rapid / 0-1.0
ocular irritation / Rapid / Incidence not known

AK-Sulf, Bleph-10, Carmol, Cetamide, Klaron, Mexar, Ocu-Sul, Ovace, Ovace Plus, RE-10, Rosula NS, Seb-Prev, Sodium Sulamyd, Sulf-10

Rx

Sulfonamide antibiotic used for ophthalmic or topical administration; used commonly for conjunctivitis or superficial eye infections; also for scaling dermatoses.

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.

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.

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.

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.

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.

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.

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.

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.

Apply topically 1- to 3-times daily to affected area. The foam may be left on or washed off with water after 10 minutes.

Apply topically 1- to 3-times daily to affected area. The foam may be left on or washed off with water after 10 minutes.

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.

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.

Apply medicated pad to the affected area(s) 1- to 2-times daily.

Apply medicated pad to the affected area(s) 1- to 2-times daily.

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.

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.

Apply to affected areas twice daily (morning and evening) for 8 to 10 days.

Apply to affected areas twice daily (morning and evening) for 8 to 10 days.

Wash affected areas twice daily (morning and evening). Repeat for 8 to 10 days.

Wash affected areas twice daily (morning and evening). Repeat for 8 to 10 days.

Apply topically 1- to 3-times daily to affected area. The foam may be left on or washed off with water after 10 minutes.

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.

Apply to affected areas twice daily (morning and evening) for 8 to 10 days.

Apply to affected areas twice daily (morning and evening) for 8 to 10 days.

Apply medicated pad to the affected area(s) 1- to 2-times daily until the infection has cleared.

Apply medicated pad to the affected area(s) 1- to 2-times daily until the infection has cleared.

Apply to affected areas twice daily (morning and evening) for 8 to 10 days.

Apply to affected areas twice daily (morning and evening) for 8 to 10 days.

Apply a thin film to the affected area twice per day.

Apply a thin film to the affected area twice per day.

Apply medicated pad to the affected area(s) 1- to 2-times daily until the infection has cleared.

Apply medicated pad to the affected area(s) 1- to 2-times daily until the infection has cleared.

2 drops in the affected eye(s) every 2 hours plus systemic therapy.

2 drops in the affected eye(s) every 2 hours plus systemic therapy.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

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.
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.
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.

AK-Sulf/Bleph-10/Cetamide/Ocu-Sul/Sulfacetamide/Sulfacetamide Sodium Ophthalmic Ointment: 10%
Bleph-10/Ocu-Sul/Sodium Sulamyd/Sulf-10/Sulfacetamide/Sulfacetamide Sodium Ophthalmic Sol: 10%
Carmol/Klaron/RE-10/Sulfacetamide/Sulfacetamide Sodium Topical Susp: 10%
Carmol/Ovace Plus/Sulfacetamide/Sulfacetamide Sodium Topical Lotion: 9.8%, 10%
Mexar/Ovace/Ovace Plus/Seb-Prev/Sulfacetamide/Sulfacetamide Sodium Topical Emulsion: 10%
Ovace Plus Topical Cream: 10%
Ovace Plus Topical Foam: 9.8%
Ovace Plus/Sulfacetamide/Sulfacetamide Sodium Topical Shampoo: 10%
Ovace/Ovace Plus/Seb-Prev/Sulfacetamide/Sulfacetamide Sodium Topical Gel: 10%
Rosula NS/Sulfacetamide/Sulfacetamide Sodium Topical Swab: 10%

The maximum dosage is dependent on route of administration and indication for therapy.

The maximum dosage is dependent on route of administration and indication for therapy.

The maximum dosage is dependent on route of administration and indication for therapy.

The maximum dosage is dependent on route of administration and indication for therapy.

Mechanism of Action: 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[23464] -acetylation and the metabolites have no antibacterial activity. Excretion of parent drug and metabolites is via the kidneys through glomerular filtration.

No pharmacokinetic data are available regarding systemic absorption of sulfacetamide following topical application to the head and scalp, but significant absorption has been reported.

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.

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.

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.