SODIUM SULFACETAMIDE and SULFUR

Rochester Pharmaceuticals

FULL PRESCRIBING INFORMATION: CONTENTS*

• SODIUM SULFACETAMIDE AND SULFUR DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS
• SODIUM SULFACETAMIDE AND SULFUR CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• Carcinogenesis, Mutagenesis and Impairment of Fertility
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE:
• SODIUM SULFACETAMIDE AND SULFUR ADVERSE REACTIONS
• SODIUM SULFACETAMIDE AND SULFUR DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• Label and Carton

FULL PRESCRIBING INFORMATION

SODIUM SULFACETAMIDE AND SULFUR DESCRIPTION

Rx Only

Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension In a vehicle containing Green Tea and Aloe

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

Each mL of Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension contains 80mg of sodium sulfacetamide and 40mg of sulfur in a formulation consisting of:  aloe vera, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, disodium EDTA, fragrance, glyceryl stearate green tea extract, magnesium aluminum silicate, methyl paraben, PEG 100 stearate, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocyltaurate, sodium thiosulfate, stearyl alcohol and 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 unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS

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

SODIUM SULFACETAMIDE AND SULFUR CONTRAINDICATIONS

Sodium Sulfacetamide 8% and 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% and Sulfur 4% Topical Suspension is not to be used by patients with kidney disease.

WARNINGS

Although rare, sensitivity to sodium sulfacetamide 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% and Sulfur 4% Topical Suspension. It is also not known whether Sodium Sulfacetamide 9% and Sulfur 4% Topical Suspension can cause fetal harm whe8 administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 8% and 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% and 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% and Sulfur 4% Topical Suspension is administered to a nursing woman.

PEDIATRIC USE:

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

SODIUM SULFACETAMIDE AND SULFUR ADVERSE REACTIONS

Although rare, sodium sulfacetamide may cause local irritation.

SODIUM SULFACETAMIDE AND SULFUR DOSAGE AND ADMINISTRATION

Apply Sodium Sulfacetamide 8% and 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 lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension sooner or using less often.

HOW SUPPLIED

Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is available in a 16 oz. (473 mL) bottle, NDC 49908-273-73.

Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized. Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for:
Rochester Pharmaceuticals
Rochester, NY 14624
1-866-458-1772
www.RochesterPharm.com

SS8S4-PI-0813

Label and Carton