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Sodium Sulfacetamide
Overview
What is Seb Prev?
Each gram (0.95 mL) of SEB-Prev™ Wash contains 100 mg of Sulfacetamide Sodium, USP in a vehicle consisting of cocamidopropyl betaine, edetate disodium, methylparaben, PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, PEG-150 pentaerythrityl tetrastearate, purified water, sodium laureth sulfate, and sodium thiosulfate.
Sulfacetamide sodium is CHNNa0S•H0 with a molecular weight of 254.24. Chemically, it is Acetamide N-[(4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula:
Sulfacetamide sodium 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 Seb Prev look like?
What are the available doses of Seb Prev?
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What should I talk to my health care provider before I take Seb Prev?
Sorry No records found
How should I use Seb Prev?
SEB-Prev™ Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
Wash affected areas twice daily (morning and evening), 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 working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently.
Regular shampooing following SEB-Prev™ Wash is not necessary, but the hair should be shampooed at least once a week. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of SEB-Prev™ Wash should be reinitiated as at the beginning of treatment.
What interacts with Seb Prev?
SEB-Prev™ Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.
What are the warnings of Seb Prev?
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What are the precautions of Seb Prev?
General -
Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If SEB-Prev™ Wash produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed.
Information For Patients -
Patients should discontinue SEB-Prev™ Wash if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. SEB-Prev™ Wash also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop.
For external use only. Avoid contact with eyes and mucous membranes.
Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or poison control center immediately (see ).
Drug Interactions -
SEB-Prev™ Wash is incompatible with silver preparations.
Carcinogenesis, Mutagenesis, Impairment of Fertility -
Long-term animal studies for carcinogenic potential have not been performed on SEB-Prev™ Wash to date. Studies on reproduction and fertility also have not been performed. One author detected chromosomal nondisjunction in the yeast, following application of sulfacetamide sodium. The significance of this finding to the topical use of sulfacetamide sodium in the human is unknown.
Pregnancy:
Nursing Mothers -
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SEB-Prev™ Wash is administered to a nursing woman.
Pediatric Use -
Safety and effectiveness in children under the age of 12 years have not been established.
What are the side effects of Seb Prev?
Reports of irritation and hypersensitivity to sulfacetamide sodium are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sulfacetamide sodium, 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 has been reported (see ).
What should I look out for while using Seb Prev?
SEB-Prev™ Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.
Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sulfacetamide sodium 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 Seb Prev?
The oral LD of sulfacetamide in mice is 16.5 g/kg. The LD for topical administration of sulfacetamide has not been determined. Oral overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. In the event of overdosage, call a physician or poison control center; emergency treatment should be started immediately.
Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of eight to twelve fluid ounces
of water. If emesis does not occur within 15 minutes, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Isotonic and one-half isotonic saline are the lavage solutions of choice. Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and, therefore, may be valuable for their action in rapid dilution of bowel content. After emergency treatment, the patient should continue to be medically monitored.
Observe kidney function for up to 1 week and have the patient ingest copious amounts of fluid during this period. Mannitol infusions may be helpful at the first sign of oliguria. Alkalinization of the urine by ingestion of bicarbonate is very helpful in preventing crystallization of sulfa drug in the kidney.
How should I store and handle Seb Prev?
Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.SEB-Prev™ Wash is available as follows:340 mL bottle (NDC 45802--02)SEB-Prev™ Wash is available as follows:340 mL bottle (NDC 45802--02)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Sulfacetamide sodium 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 aminobenzoic acid. There are no clinical data available on the degree and rate of systemic absorption of SEB-Prev™ Wash when applied to the skin or scalp. However, significant absorption
of sulfacetamide sodium through the skin has been reported.
The following data are available but their clinical significance is unknown. Organisms which show susceptibility to sulfacetamide sodium are: species, and
Non-Clinical Toxicology
SEB-Prev™ Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sulfacetamide sodium 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.
SEB-Prev™ Wash is incompatible with silver preparations.
Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If SEB-Prev™ Wash produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed.
Reports of irritation and hypersensitivity to sulfacetamide sodium are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sulfacetamide sodium, 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 has been reported (see ).
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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