Prescribing information (package insert) - Sodium Sulfacetamide and Sulfer Emulsion
DESCRIPTION
Each gram of Sodium Sulfacetamide 10% and Sulfur 1% Emulsion contains 100 mg of sodium sulfacetamide and 10 mg of sulfur in a formulation containing Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl
Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl Alcohol, Triacetin, Xanthan Gum.
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:
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 known, but it has been
reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
INDICATIONS
Sodium Sulfacetamide 10% - Sulfur 1% Emulsion is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS
Sodium Sulfacetamide 10% and Sulfur 1% Emulsion is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.
Sodium Sulfacetamide 10% and Sulfer 1% Emulsion is not to be used by patietns 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.
In case of accidental ingestion contact a poison control center immediately. Keep
container tightly closed.
PRECAUTIONS
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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 longterm 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
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Category C
Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfer 1% Emulsion. It is not known whether Sodium Sulfacetamide 10% and Sulfer 1% Emulsion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Silfacetamide 10% and Sulfer 1% Emulsion 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 10% and Sulfur 1% Emulsion. 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 10%
and Sulfur 1% Emulsion 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.
Call your doctor for medical advice about side effects. To report a serious
adverse event, please contact Trifluent Pharma, LLC at 1-888-927-5191.
DOSAGE AND ADMINISTRATION
Apply Sodium Sulfacetamide 10% and Sulfur 1% Emulsion 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 10% and Sulfur 1% Emulsion sooner or using less often.
HOW SUPPLIED
Sodium Sulfacetamide 10% and Sulfur 1% Emulsion is available
in 177 mL bottles, NDC 73352-750-01.
STORAGE AND HANDLING
Store at controlled room temperature, 15° - 30°C (59° - 86°F). Protect from freezing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Distributed by
Trifluent Pharma, LLC.
San Antonio, Tx 78213
All prescription substitutions and or recommendations using this product shall be made subject to state and federal statutes as applicable. Note: This is not an Orange Book product. No representation is made as to the generic satus or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendationss based on each such person's professonal opinion and knowlege, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation provided herein.