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SULFACETAMIDE SODIUM, SULFUR
Overview
What is Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?
Each gram of Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser contains 98 mg of Sodium Sulfacetamide and 48 mg of Sulfur in a formulation containing Aloe Barbadensis (Aloe Vera) Leaf Extract, Butylated Hydroxytoluene, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl Alcohol, Disodium Oleamido MEA Sulfosuccinate, Edetate Disodium, Fragrance, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Propylparaben, Purified Water, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol and 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:
What does Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser look like?
What are the available doses of Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?
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What should I talk to my health care provider before I take Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?
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How should I use Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?
Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Wash affected areas once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10 to 20 seconds, working into a full lather, rinse thoroughly and pat dry. If skin dryness occurs, it may be controlled by rinsing off sooner or using less frequently.
What interacts with Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?
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What are the warnings of Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?
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What are the precautions of Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?
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What are the side effects of Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?
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What should I look out for while using Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?
Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is not to be used by patients with kidney disease.
Although rare, sensitivity to sodium sulfonamide 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.
Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
What might happen if I take too much Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?
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How should I store and handle Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser?
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) Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is supplied in a 10 oz (285 g) bottle (NDC 42192-156-10).
Clinical Information
Chemical Structure
No Image foundClinical 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 not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
Non-Clinical Toxicology
Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is not to be used by patients with kidney disease.Although rare, sensitivity to sodium sulfonamide 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. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
Concurrent use of PYLERA with oral contraceptive may make oral contraceptives less effective due to an interaction with the tetracycline component of PYLERA. Breakthrough bleeding has been reported. Advise women of child-bearing potential to use a different or additional form of contraception while taking PYLERA [ ].
PYLERA may alter the anticoagulant effects of warfarin and other oral coumarin anticoagulants. Metronidazole has been reported to potentiate the anticoagulant effect of warfarin, and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. Tetracycline has been shown to depress plasma prothrombin activity. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if PYLERA is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding [ ].
In patients stabilized on relatively high doses of lithium, short-term use of PYLERA may cause elevation of serum lithium concentrations and signs of lithium toxicity due to the interaction between metronidazole and lithium. Monitor serum lithium and serum creatinine concentrations daily for several days after beginning treatment with PYLERA to detect any increase that may precede clinical symptoms of lithium toxicity [ ].
Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Do not administer PYLERA concomitantly with busulfan unless the benefit outweighs the risk. If no therapeutic alternatives to PYLERA are available, and concomitant administration with busulfan is medically needed, Monitor for busulfan toxicity and busulfan plasma concentrations and adjust the busulfan dose accordingly [ ].
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 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
Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser. It is not known whether Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser 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 9.8% - Sulfur 4.8% Cleanser. 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 9.8% - Sulfur 4.8% Cleanser is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children under the age of 12 have not been established.
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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