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Each mL of Sulfacet-R® Lotion (sodium sulfacetamide 10% and sulfur 5%) as dispensed contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a tinted lotion of 2-bromo-2-nitropropane-1, 3 diol, attapulgite, butylparaben, hydroxyethyl cellulose, iron oxides, lauramide DEA (and) diethanolamine, methylparaben, polyethylene glycol 400 monolaurate, propylene glycol, purified water, silicone emulsion, sodium chloride, sodium metabisulfite, sodium polynaphthalenesulfonate, talc, titanium dioxide, xanthan gum, and zinc oxide. Color Blender contains an additional inactive ingredient, polyethylene glycol 400, NF.
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:
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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 p. acnes and the formation of free fatty acids.
Sulfacet-R® Lotion is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Sulfacet-R Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur, or any other component of this preparation. Sulfacet-R Lotion is not to be used by patients with kidney disease.
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.
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
General: If irritation develops, use of the product should be discontinued and appropriate therapy instituted. For external use only. Keep away from eyes. 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 epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Keep out of the reach of children.
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 Sulfacet-R Lotion. It is also not known whether Sulfacet-R Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacet-R Lotion 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 Sulfacet-R Lotion. 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 Sulfacet-R Lotion is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.
Although rare, sodium sulfacetamide may cause local irritation.
Shake well before using. Apply a thin film to affected areas with light massaging to blend in each application 1 to 3 times daily. Each package contains a Dermik Color Blendertrademark which enables the patient to alter the basic shade of the lotion so that it matches the skin color exactly.
(Important to the Pharmacist: At the time of dispensing, add contents of Sulfa-Pak™ vial* to the bottle. Shake well and/or stir with a glass rod to insure uniform dispersion. Place expiration date of four (4) months on bottle label.) *Sulfa-Pak™ vial contains 2.1 g of sodium sulfacetamide.
25 g bottles (NDC 0066-0028-25).
CAUTION: Federal law prohibits dispensing without prescription.
Dermik Laboratories, Inc.
A Rhone-Poulenc Rorer Company Rev. 11/96
Collegeville, PA, USA 19426 CR-5055R