Sodium Sulfacetamide and Sulfur
Metacon Labs
Onset Dermatologics LLC
Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam
FULL PRESCRIBING INFORMATION: CONTENTS*
- SODIUM SULFACETAMIDE AND SULFUR DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS
- SODIUM SULFACETAMIDE AND SULFUR CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- SODIUM SULFACETAMIDE AND SULFUR ADVERSE REACTIONS
- SODIUM SULFACETAMIDE AND SULFUR DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
FULL PRESCRIBING INFORMATION
SODIUM SULFACETAMIDE AND SULFUR 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:
Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in an aqueous based emollient foam vehicle containing cetyl alcohol NF, emulsifying wax NF, lactic acid USP, methylparaben NF, propylene glycol USP, propylparaben NF, steareth-10, water USP. Also contains: Propellant HFA-134A (1,1,1,2-tetrafluoroethane).
CLINICAL PHARMACOLOGY
Sodium sulfacetamide exhibits antibacterial activity. 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 paraaminobenzoic 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.
It is estimated that 1% of topically applied sulfur is absorbed. Although the exact mode of keratolytic activity of sulfur is unknown, it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. In combination with sulfacetamide, sulfur has been reported to inhibit the growth of Propionibacterium acnes thereby reducing the associated inflammation.
INDICATIONS
Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
SODIUM SULFACETAMIDE AND SULFUR CONTRAINDICATIONS
Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam is not to be used by patients with kidney disease.
WARNINGS
Although rare, hypersensitivity reactions to products containing sodium sulfacetamide may occur, including Stevens-Johnson syndrome and exfoliative dermatitis. 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 the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120ºF (49ºC).
PRECAUTIONS
General
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. 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.
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 10% and Sulfur 5% Emollient Foam. It is also not known whether Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam 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 5% Emollient Foam. 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 5% Emollient Foam is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children under the age of 12 have not been established.
SODIUM SULFACETAMIDE AND SULFUR ADVERSE REACTIONS
Although rare, sodium sulfacetamide may cause local irritation.
SODIUM SULFACETAMIDE AND SULFUR DOSAGE AND ADMINISTRATION
IMPORTANT. Prime Can Before Initial
Use.
To Prime Can:
Grasp can in one hand. Shake can vigorously until product
moves inside can. Firmly strike bottom of can onto palm of other hand or
a hard surface at least three times.
To Dispense Product on Initial Use:
After priming can, hold can upright. Direct initial spray to a
non-skin surface, such as into cap of can. Press down on actuator for 1
to 3 seconds until foam begins to dispense. If foam does not dispense
within 3 seconds, repeat entire process.
Shake Can Vigorously Before Each Use.
Hold can upright when dispensing product.
WASH-OFF APPLICATION: Cleanse affected skin thoroughly and pat dry before each application. Dispense product onto the fingertips. Massage the dispensed foam into the affected area and wait 10 minutes. Rinse thoroughly with water and pat dry. Treat the affected area 1 to 3 times daily, or as directed by a physician.
LEAVE-ON APPLICATION: Cleanse affected skin thoroughly and pat dry before each application. Dispense product onto the fingertips. Massage the dispensed foam into the affected area 1 to 3 times daily, or as directed by a physician.
Wipe off any excess foam from actuator after use.
HOW SUPPLIED
Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam is supplied in a 60g (NDC 49808-154-60) aluminum can.
Store between 59° and 86°F (15° and 30°C). Protect from freezing. Store upright.
Manufactured For:
Metacon Labs
Cumberland, RI
02864
866-777-4633
www.metaconlabs.com
Patent Pending
P/N 2617 Rev. 0
PACKAGE LABEL - PRINCIPAL DISPLAY - Metacon Can
Rx Only
Sodium Sulfacetamide 10% and
Sulfur 5% Emollient Foam
NDC 49808-154-60
Net Weight 60g
PACKAGE LABEL - PRINCIPAL DISPLAY - Metacon Box
Rx Only
Sodium Sulfacetamide 10% and
Sulfur 5% Emollient Foam
NDC 49808-154-60
Net Weight 60g
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM AEROSOL, FOAM
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