FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Each gram of OVACE®
Plus Cream (sodium sulfacetamide 10% w/w) contains 100 mg of sodium sulfacetamide in a vehicle consisting of benzyl alcohol, butylparaben, C13-14 isoparaffin, caprylic/capric triglyceride, cetyl alcohol, dimethicone, disodium EDTA, ethylparaben, glycerin, glyceryl stearate, laureth-7, methylparaben, PEG-100 stearate, phenoxyethanol, polyacrylamine, propylparaben, sodium thiosulfate, water and zinc oxide.
Sodium sulfacetamide is C8
O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.
Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of OVACE®
Plus Cream when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported.
The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sulfacetamide sodium are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.
INDICATIONS AND USAGE:
Plus Cream is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
Plus Cream is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.
Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF THE REACH OF CHILDREN.
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If OVACE®
Plus Cream produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed.
Information for Patients:
Patients should discontinue OVACE®
Plus Cream if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. OVACE®
Plus Cream also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop.
Plus Cream is incompatible with silver preparations.
Plus Cream has a bacteriostatic effect against Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections.
Carcinogenesis, Mutagenesis and Impairment of Fertility:
Long-term animal studies for carcinogenic potential have not been performed on OVACE®
Plus Cream to date. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction has been reported in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown.
Category C. Animal reproduction studies have not been conducted with OVACE®
Plus Cream. It is also not known whether OVACE®
Plus Cream can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. OVACE®
Plus Cream should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when OVACE®
Plus Cream is administered to a nursing woman.
Safety and effectiveness in children under the age of 12 years have not been established.
Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS). You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-800-298-1087.
The oral LD50
of sulfacetamide in mice is 16.5 g/kg. The LD50
for topical administration of sulfacetamide has not been determined. Oral overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact local Poison Control Center.
DOSAGE AND ADMINISTRATION:
Seborrheic dermatitis including seborrhea sicca -
Apply to affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Repeat application as described for eight to ten days. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of OVACE®
Plus Cream should be reinitiated as at the beginning of treatment.
Secondary cutaneous bacterial infections -
Apply to affected areas twice daily for eight to ten days.
Plus Cream is available in a 2 oz (57 g) bottle, NDC 0178-0495-02.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
See USP Controlled Room Temperature.
Note: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep bottle tightly closed.
Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by rdinary laundering without bleaches.
MISSION PHARMACAL COMPANY
San Antonio, TX 78230 1355