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Sulfacetamide Sodium and Sulfur
Overview
What is Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam?
Sodium sulfacetamide is a sulfonamide with antibacterial activity. 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 SSS 10 - 5 Emollient Foam contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in an aqueous based emollient foam vehicle containing: Butane, Butylene Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Dimethicone, Glycerin, Magnesium Aluminum Silicate, Polysorbate 20, Propane, Titanium Dioxide, Water.
What does Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam look like?
What are the available doses of Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam?
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What should I talk to my health care provider before I take Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam?
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How should I use Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam?
SSS 10 - 5 Emollient Foam is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Wash affected areas before use, 1 to 2 times daily as directed by physician.
Before each use,
Wash affected areas and apply foam 1 or 2 times a day as directed by a physician. Avoid contact with the eyes.
Wash-off Application:
Leave-on Application:
What interacts with Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam?
SSS 10 - 5 Emollient Foam is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SSS 10 - 5 Emollient Foam is not to be used by patients with kidney disease.
What are the warnings of Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam?
Although rare, sensitivity to sodium sulfacetamide may occur. Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. At the first sign of hypersensitivity or skin rash, discontinue use of this preparation. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.
FOR EXTERNAL USE ONLY.
What are the precautions of Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam?
General
The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the skin. 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 -
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy
Animal reproduction studies have not been conducted with SSS 10 - 5 Emollient Foam. When administered to a pregnant woman, it also is not known whether SSS 10 - 5 Emollient Foam can affect reproduction capacity or cause fetal harm. SSS 10 - 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 human milk following topical use of SSS 10 - 5 Emollient Foam. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised when SSS 10 - 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.
What are the side effects of Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam?
Although rare, sodium sulfacetamide may cause local irritation.
What should I look out for while using Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam?
SSS 10 - 5 Emollient Foam is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SSS 10 - 5 Emollient Foam is not to be used by patients with kidney disease.
Although rare, sensitivity to sodium sulfacetamide may occur. Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. At the first sign of hypersensitivity or skin rash, discontinue use of this preparation. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.
FOR EXTERNAL USE ONLY.
What might happen if I take too much Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam?
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How should I store and handle Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam?
Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478 Mfg. Rev. 04/14 AV Rev. 08/14 (P) Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478 Mfg. Rev. 04/14 AV Rev. 08/14 (P) Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478 Mfg. Rev. 04/14 AV Rev. 08/14 (P) Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478 Mfg. Rev. 04/14 AV Rev. 08/14 (P) SSS 10 - 5 Emollient Foam is available in a 60g aluminum can, NDC 42192-143-60. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).Storage:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Please note: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency. No representation is made as to generic status or bioequivalency.SSS 10 - 5 Emollient Foam is available in a 60g aluminum can, NDC 42192-143-60. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).Storage:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Please note: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency. No representation is made as to generic status or bioequivalency.SSS 10 - 5 Emollient Foam is available in a 60g aluminum can, NDC 42192-143-60. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).Storage:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Please note: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency. No representation is made as to generic status or bioequivalency.SSS 10 - 5 Emollient Foam is available in a 60g aluminum can, NDC 42192-143-60. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).Storage:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Please note: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency. No representation is made as to generic status or bioequivalency.
Clinical Information
Chemical Structure
No Image foundClinical 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 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 is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. Furthermore, in combination with sulfacetamide, sulfur has been reported to inhibit the growth of Propionibacterium acnes, thereby adding to the product’s antibacterial activity and reducing associated inflammation.
Non-Clinical Toxicology
SSS 10 - 5 Emollient Foam is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SSS 10 - 5 Emollient Foam is not to be used by patients with kidney disease.Although rare, sensitivity to sodium sulfacetamide may occur. Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. At the first sign of hypersensitivity or skin rash, discontinue use of this preparation. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.
FOR EXTERNAL USE ONLY.
Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with atenolol plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope or postural hypotension.
Calcium channel blockers may also have an additive effect when given with atenolol. (See ).
Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta blockers.
Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers.
Beta blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta blocker should be withdrawn several days before the gradual withdrawal of clonidine. If replacing clonidine by beta blocker therapy, the introduction of beta blockers should be delayed for several days after clonidine administration has stopped.
Concomitant use of prostaglandin synthase inhibiting drugs, e.g., indomethacin, may decrease the hypotensive effects of beta-blockers.
Information on concurrent usage of atenolol and aspirin is limited. Data from several studies, i.e., TIMI-II, ISIS-2, currently do not suggest any clinical interaction between aspirin and beta blockers in the acute myocardial infarction setting.
While taking beta blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Although rare, sodium sulfacetamide may cause local irritation.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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