Prescription Drugs

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.

Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) DESCRIPTION Each mL of Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) as dispensed contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a lotion of 2-bromo-2-nitropropane-1,3-diol, butylparaben, colloidal activated attapulgite, diethanolamine, hydroxyethyl cellulose, iron oxides, lauramide DEA, methylparaben, polyethylene glycol 400 monolaurate, propylene glycol, purified water, simethicone emulsion, sodium chloride, sodium metabisulfite, sodium polynaphthalenesulfonate, talc, xanthan gum, and zinc oxide. 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:

INDICATIONS Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. DOSAGE AND ADMINISTRATION Shake well before using. Apply a thin film to affected areas with light massaging, 1 to 3 times daily, or as directed by a physician. (Important to the Pharmacist: At the time of dispensing, add contents of sodium sulfacetamide 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.) *Sodium Sulfacetamide vial contains 2.1 g of sodium sulfacetamide. HOW SUPPLIED Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) is available as follows: 25 g bottle (NDC 45802-950-01) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured by Stiefel Laboratories, Inc. Coral Gables, Fl 33134. Distributed by, Perrigo, Allegan, MI 49010. FDA rev date: n/a

PATIENT INFORMATION No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

OVERDOSE No information provided. CONTRAINDICATIONS Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur, or any other component of this preparation. This drug is not to be used by patients with kidney disease.

SIDE EFFECTS Although rare, sodium sulfacetamide may cause local irritation. DRUG INTERACTIONS No information provided.

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 bottle tightly closed. 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. 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 epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Pregnancy Teratogenic Effects Pregnancy Category C-Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free). It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether sodium sulfacetamide is excreted in human milk following topical use of Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free). 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 this drug is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established.