a quirky Seb-Prev Gel Generic Name: sodium sulfacetamide Dosage Form: gel Overview Side Effects Dosage Professional Reviews More Support Group Q & A Pricing & Coupons Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. SEB-PREV GEL (SODIUM SULFACETAMIDE 10%) Seb-Prev Gel (Sodium Sulfacetamide 10%) Rx Only FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE Slideshow Cancer Prevention: Live Longer With These Simple Steps Seb-Prev Gel Description Each gram of Seb-Prev Gel contains 100 mg of Sulfacetamide Sodium USP in a vehicle consisting of edetate disodium, glycerin, methylparaben, propylene glycol, purified water, sodium thiosulfate, and xanthan gum. Sulfacetamide sodium is C8H9N2NaO3S H2O 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. Seb-Prev Gel - Clinical 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 para -aminobenzoic acid. There are no clinical data available on the degree and rate of systemic absorption of Seb-Prev Gel when applied to the skin or scalp. However, significant absorption of sulfacetamide sodium through the skin has been reported. The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sulfacetamide sodium are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces. Indications and Usage for Seb-Prev Gel Seb-Prev Gel 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. Contraindications Seb-Prev Gel is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product. Warnings 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. Precautions 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 Gel 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 Gel if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Seb-Prev Gel 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 OVERDOSAGE ). Drug Interactions Seb-Prev Gel is incompatible with silver preparations. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies for carcinogenic potential have not been performed on Seb-Prev Gel to date. Studies on reproduction and fertility also have not been performed. One author detected chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sulfacetamide sodium. The significance of this finding to the topical use of sulfacetamide sodium in the human is unknown. Pregnancy Teratogenic effects Pregnancy Category C Animal reproduction studies have not been conducted with Seb-Prev Gel. It also is not known whether Seb-Prev Gel can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Seb-Prev Gel should be given to a pregnant woman only if clearly needed. 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 Gel is administered to a nursing woman. Pediatric Use Safety and effectiveness in children under the age of 12 years have not been established. Adverse Reactions 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 WARNINGS ). Overdosage The oral LD50 of sulfacetamide in mice is 16.5 g/kg. The LD50 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. Seb-Prev Gel Dosage and Administration Seborrheic dermatitis including seborrhea sicca: Apply to affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Repeat application as described for eight to ten days. 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 Gel should be reinitiated as at the beginning of treatment. Secondary cutaneous bacterial infections: Apply to affected areas twice daily for eight to ten days. How is Seb-Prev Gel Supplied Seb-Prev Gel is available as follows: 30 g tube (NDC 45802- 960 -94) 60 g tube (NDC 45802- 960 -96) Store at 20 -25 C (68 -77 F) [see USP Controlled Room Temperature]. Do not freeze. Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration is readily removed by ordinary laundering without bleaches. MANUFACTURED BY STIEFEL LABORATORIES, INC. CORAL GABLES, FL 33134 DISTRIBUTED BY PERRIGO ALLEGAN, MI 49010 Rev. 10/07 81084 : 5P600 RC J1 Principal Display Panel - 30 g Carton Seb-Prev Gel (Sodium Sulfacetamide 10%) For Dermatologic Use Only. Not for Ophthalmic Use. Rx Only Seb-Prev(tm) Gel - 30 g Carton Principal Display Panel - 30 g Tube Seb-Prev Gel (Sodium Sulfacetamide 10%) For Dermatologic Use Only. Not for Ophthalmic Use. Rx Only Seb-Prev(tm) Gel - 30 g Tube Principal Display Panel - 60 g Carton Seb-Prev Gel (Sodium Sulfacetamide 10%) For Dermatologic Use Only. Not for Ophthalmic Use. Rx Only Seb-Prev(tm) Gel - 60 g Carton Principal Display Panel - 60 g Tube Seb-Prev Gel (Sodium Sulfacetamide 10%) For Dermatologic Use Only. Not for Ophthalmic Use. Rx Only Seb-Prev(tm) Gel - 60 g Tube PERRIGO SEB PREV sodium sulfacetamide gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:45802-960 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg in 1 g Product Characteristics Color YELLOW (clear to pale yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:45802-960-94 1 TUBE (TUBE) in 1 CARTON 1 30 g in 1 TUBE 2 NDC:45802-960-96 1 TUBE (TUBE) in 1 CARTON 2 60 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 08/19/2008 Labeler - Perrigo New York Inc (078846912) Revised: 11/2009 Perrigo New York Inc Next User Reviews Print this page Add to My Med List More about Seb-Prev (sulfacetamide sodium topical) Side Effects Dosage Information Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: topical antibiotics Consumer resources Seb-Prev Professional resources Seb-Prev (FDA) Seb-Prev Cream (FDA) Seb-Prev Wash (FDA) Other brands: Klaron , Ovace , Ovace Plus Related treatment guides Seborrheic Dermatitis Secondary Cutaneous Bacterial Infections} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Manufacturer Perrigo Company Drug Class Topical antibiotics Related Drugs topical antibiotics mupirocin topical , erythromycin topical , Bactroban , neomycin topical , gentamicin topical , bacitracin topical Seborrheic Dermatitis prednisone , hydrocortisone topical , ketoconazole topical , dexamethasone , Decadron , Deltasone , ciclopirox topical , fluocinolone topical , Westcort , More... Secondary Cutaneous Bacterial Infections mupirocin topical , Bactroban , Bactroban Nasal , Klaron , sulfacetamide sodium topical , Mexar , Centany , Centany AT Kit , Centany AT , Ovace , More... Seb-Prev Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } locate
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