SODIUM SULFACETAMIDE

Exact-Rx, Inc.

SODIUM SULFACETAMIDE 10% WASH (sodium sulfacetamide 10%) Rx Only

FULL PRESCRIBING INFORMATION: CONTENTS*

• PACKAGE LABEL - 12 oz (354.8 mL)

FULL PRESCRIBING INFORMATION

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

DESCRIPTION: Each gram contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of: cocamidopropyl betaine, disodium EDTA, methyl paraben, PEG-60 almond triglyceride, PEG-6 caprylic/capric glycerides, PEG-150 pentaerythrityl tetrastearate, purified water, sodium laureth sulfate, and sodium thiosulfate.

Chemically, it is Acetamide N-[4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula:

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.

CLINICAL PHARMACOLOGY: 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 are no clinical data available on the degree and rate of systemic competition with para-aminobenzoic acid absorption of Sodium Sulfacetamide 10% Wash when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported. The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.

Uses

INDICATIONS AND USAGE: Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dematoses: seborrheic dermatitis and sebonthea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

CONTRAINDICATIONS: Sodium Sulfacetamide 10% 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 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.

PRECAUTIONS: For external use only. Not for ophthalmic use. 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 Sodium Sulfacetamide 10% 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 Sodium Sulfacetamide 10% Wash if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Sodium Sulfacetamide 10% Wash also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop.

Drug Interactions: Sodium Sulfacetamide 10% Wash is incompatible with silver preparations.

Pharmacology: Sodium Sulfacetamide 10% Wash has a bacterlostatic effect against Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on Sodium Sulfacetamide 10% Wash to date. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sulfacetamide sodium has been reported. The significance of this finding to the topical use of sulfacetamide sodium in the human is unknown.

Pregnancy Category C: Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% Wash. It also is not known whether Sodium Sulfacetamide 10% Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% Wash should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

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 Sodium Sulfacetamide 10% Wash is administered to a nursing woman.

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

ADVERSE REACTIONS: 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 .) Call your doctor for medical advice about side effects.

OVERDOSAGE: The oral LD₅₀ of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately. Manifestations: Overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluiria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center.

DOSAGE AND ADMINISTRATION: Seborrheic dermatitis including seborrhea sicca - Sodium Sulfacetamide 10% Wash: 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/pat dry and repeat after 10-20 seconds. 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 Sodium Sulfacetamide 10% 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 Sodium Sulfacetamide 10% 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 for 10-20 seconds 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.

HOW SUPPLIED: Sodium Sulfacetamide Wash 10% is available in a 6 oz. (177 mL) bottle, NDC 42808-0100-06, and in a 12 oz. (354.8 mL) bottle, NDC 42808-0100-12.

STORAGE: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

Note: Store upright. Protect from freezing and excessive heat. The wash may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product.

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 is readily removed by ordinary laundering without bleaches.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0100-99-205-00

Iss:5/11

PACKAGE LABEL - 12 oz (354.8 mL)

For External Use Only

NDC 42808-0100-06        Rx Only

Sodium
Sulfacetamide

10%

WASH

Exact-Rx.
INCORPORATED

Net Wt. 12 oz (354.8 ml)