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SULFACETAMIDE SODIUM, SULFUR

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Overview

What is SULFACETAMIDE SODIUM, SULFUR?

Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium magnesium silicate, sodium thiosulfate, stearyl alcohol and xanthan gum.

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C H N NaO S·H O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.



What does SULFACETAMIDE SODIUM, SULFUR look like?



What are the available doses of SULFACETAMIDE SODIUM, SULFUR?

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What should I talk to my health care provider before I take SULFACETAMIDE SODIUM, SULFUR?

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How should I use SULFACETAMIDE SODIUM, SULFUR?

This product is indicated for use 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. 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 product off sooner or using less frequently.


What interacts with SULFACETAMIDE SODIUM, SULFUR?

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What are the warnings of SULFACETAMIDE SODIUM, SULFUR?

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What are the precautions of SULFACETAMIDE SODIUM, SULFUR?

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What are the side effects of SULFACETAMIDE SODIUM, SULFUR?

Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).


What should I look out for while using SULFACETAMIDE SODIUM, SULFUR?

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.


What might happen if I take too much SULFACETAMIDE SODIUM, SULFUR?

The oral LD of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately.

Manifestations:


How should I store and handle SULFACETAMIDE SODIUM, SULFUR?

This product is supplied in the following size(s): 8 oz. (227 g) bottles, 44523-560-08 To reportManufactured for: BIOCOMP PHARMA , INC San Antonio, TX 78230 1355This product is supplied in the following size(s): 8 oz. (227 g) bottles, 44523-560-08 To reportManufactured for: BIOCOMP PHARMA , INC San Antonio, TX 78230 1355This product is supplied in the following size(s): 8 oz. (227 g) bottles, 44523-560-08 To reportManufactured for: BIOCOMP PHARMA , INC San Antonio, TX 78230 1355This product is supplied in the following size(s): 8 oz. (227 g) bottles, 44523-560-08 To reportManufactured for: BIOCOMP PHARMA , INC San Antonio, TX 78230 1355


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported.

The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.

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 and the formation of free fatty acids.

Non-Clinical Toxicology
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.

Because of possible effects on blood pressure, METADATE CD should be used cautiously with pressor agents.

Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), phenylbutazone and some antidepressants (tricyclics and selective serotonin reuptake inhibitors). Downward dose adjustment of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing concomitant methylphenidate.

In theory, there is a possibility that the clearance of methylphenidate might be affected by urinary pH, either being increased with acidifying agents or decreased with alkalizing agents. This should be considered when methylphenidate is given in combination with agents that alter urinary pH.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

General:

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. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. 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. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. 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:

Drug Interactions:

Carcinogenesis, Mutagenesis and Impairment of Fertility:

Pregnancy:

Category C.

Nursing Mothers:

Pediatric Use:

Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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