Seb-Prev Wash

Name: Seb-Prev Wash

SEB-Prev™ Wash (Sodium Sulfacetamide 10%)

For Dermatologic Use Only

Rx Only

Not For Ophthalmic OrIntravaginal Use

Seb-Prev Wash - Clinical Pharmacology

Sulfacetamide sodium 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 are no clinical data available on the degree and rate of systemic absorption of SEB-Prev™ Wash when applied to the skin or scalp. However, significant absorption

of sulfacetamide sodium through the skin has been reported.

The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sulfacetamide sodium are: Streptococci, Staphylococci, E. coli, Klebsiellapneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardiaand Actinomyces.

Contraindications

SEB-Prev™ Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.

Warnings

Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sulfacetamide sodium 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.

Precautions

General -

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 SEB-Prev™ Wash 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, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed.

Information For Patients -

Patients should discontinue SEB-Prev™ Wash if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. SEB-Prev™ Wash also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop.

For external use only. Avoid contact with eyes and mucous membranes.

Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or poison control center immediately (see OVERDOSAGE).

Drug Interactions -

SEB-Prev™ Wash is incompatible with silver preparations.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

Long-term animal studies for carcinogenic potential have not been performed on SEB-Prev™ Wash to date. Studies on reproduction and fertility also have not been performed. One author detected chromosomal nondisjunction in the yeast, Saccharomycescerevisiae, following application of sulfacetamide sodium. The significance of this finding to the topical use of sulfacetamide sodium in the human is unknown.

Pregnancy:

Teratogenic effects:

Pregnancy Category C -

Animal reproduction studies have not been conducted with SEB-Prev™ Wash. It also is not known whether SEB-Prev™ Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SEB-Prev™ Wash should be given to a pregnant woman only if clearly needed.

Nursing Mothers -

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 SEB-Prev™ Wash is administered to a nursing woman.

Pediatric Use -

Safety and effectiveness in children under the age of 12 years have not been established.

Seb-Prev Wash Dosage and Administration

Seborrheic dermatitis including seborrhea sicca:

Wash affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently.

Regular shampooing following SEB-Prev™ Wash is not necessary, but the hair should be shampooed at least once a week. 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 SEB-Prev™ Wash should be reinitiated as at the beginning of treatment.

Secondary cutaneous bacterial infections:

Wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.

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