FDA Label for Sodium Sulfacetamide 8% And Sulfur 4%

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Description

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

structure.jpg - structure

Each mL of Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension contains 80 mg of Sodium Sulfacetamide and 40 mg of Sulfur in a formulation containing aloe vera gel, benzyl alcohol, butylated hydroxytoluene, cetyl alcohol, glyceryl monostearate, green tea extract, magnesium aluminum silicate, PEG- 40 stearate, phenoxyethanol, polyethylene glycol 400, polyethylene glycol 150, propylene glycol, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol, xanthan gum

Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

Indications

Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications:

Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is not to be used by patients with kidney disease.

Warnings

Although rare, sensitivity to sodium sulfacetaminde may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

Precautions

General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Information for patients

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

PREGNANCY:

Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension. It is not known whether Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS:

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is administered to a nursing woman.

PEDIATRIC USE:

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

Adverse Reactions

Although rare, sodium sulfacetamide may cause local irritation.

Dosage And Administration

Apply Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension once or twice daily to affected areas, or as directed by your physician. 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. If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension sooner or using less often.

How Supplied

Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is available in 16 fl oz (473 mL) bottles, NDC 71399-0487-6.