Sulfamylon
Mafenide Acetate
Rising Pharma Holdings, Inc.
Human Prescription Drug
NDC 16571-723Sulfamylon also known as Mafenide Acetate is a human prescription drug labeled by 'Rising Pharma Holdings, Inc.'. National Drug Code (NDC) number for Sulfamylon is 16571-723. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Sulfamylon drug includes Mafenide Acetate - 85 mg/g . The currest status of Sulfamylon drug is Active.
Drug Information:
| Drug NDC: | 16571-723 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sulfamylon |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Mafenide Acetate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rising Pharma Holdings, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | MAFENIDE ACETATE - 85 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 18 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA016763 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Rising Pharma Holdings, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 201185
311406
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | RQ6LP6Z0WY
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Methylated Sulfonamide Antibacterial [EPC]
Methylated Sulfonamides [EXT]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 16571-723-12 | 1 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBE | 18 May, 2020 | N/A | No |
| 16571-723-48 | 453.6 g in 1 JAR (16571-723-48) | 18 May, 2020 | N/A | No |
| 16571-723-60 | 1 TUBE in 1 CARTON (16571-723-60) / 56.7 g in 1 TUBE | 18 May, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Sulfamylon mafenide acetate mafenide acetate mafenide cetyl alcohol stearyl alcohol polyoxyl 40 stearate peg-8 stearate glycerin water methylparaben propylparaben sodium metabisulfite edetate disodium soft white
Indications and Usage:
Indications and usage sulfamylon cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.
Warnings:
Warnings fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with sulfamylon cream. contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. the overall prevalence of sulfite sensitivity in the general population is unknown and probably low. sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Dosage and Administration:
Dosage and administration prompt institution of appropriate measures for controlling shock and pain is of prime importance. the burn wounds are then cleansed and debrided, and sulfamylon cream is applied with a sterile gloved hand. satisfactory results can be achieved with application of the cream once or twice daily, to a thickness of approximately 1/16 inch; thicker application is not recommended. the burned areas should be covered with sulfamylon cream at all times. therefore, whenever necessary, the cream should be reapplied to any areas from which it has been removed (e.g., by patient activity). the routine of administration can be accomplished in minimal time, since dressings usually are not required, if individual patient demands make them necessary, however, only a thin layer of dressings should be used. when feasible, the patient should be bathed daily to aid in debridement. a whirlpool bath is particularly helpful, but the patient may be bathed in bed or in a shower. the dura
Read more...tion of therapy with sulfamylon cream depends on each patientâs requirements. treatment is usually continued until healing is progressing well or until the burn site is ready for grafting. sulfamylon cream should not be withdrawn from the therapeutic regimen while there is the possibility of infection. however, if allergic manifestations occur during treatment with sulfamylon cream, discontinuation of treatment should be considered. if acidosis occurs and becomes difficult to control, particularly in patients with pulmonary dysfunction, discontinuing therapy sulfamylon cream for 24 to 48 hours while continuing fluid therapy may aid in restoring acid-base balance.
Contraindications:
Contraindications sulfamylon is contraindicated in patients who are hypersensitive to it. it is not known whether there is cross sensitivity to other sulfonamides.
Adverse Reactions:
Adverse reactions it is frequently difficult to distinguish between an adverse reaction to sulfamylon cream and the effect of a severe burn. a single case of bone marrow depression and a single case of acute attack of porphyria have been reported following therapy with sulfamylon cream. fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with sulfamylon cream. dermatologic: the most frequently reported reaction was pain on application or a burning sensation. rare occurrences are excoriation of new skin and bleeding of skin. allergic: rash itching, facial edema, swelling, hive, blisters, erythema, and eosinophilia. respiratory: tachypnea or hyperventilation, decrease in arterial pco 2 . metabolic: acidosis, increase in serum chloride. accidental ingestion of sulfamylon cream has been reported to cause diarrhea. to report suspected adverse reactions, contact rising ph
Read more...arma holdings, inc. at 1-844-874-7464 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Description:
Description sulfamylon cream is a soft, white, nonstaining, water-miscible, anti-infective cream for topical administration to burn wounds. sulfamylon cream spreads easily, and can be washed off readily with water. it has a slight acetic odor. each gram of sulfamylon cream contains mafenide acetate equivalent to 85 mg of the base. the cream vehicle consists of cetyl alcohol, steryl alcohol, cetyl esters wax, polyoxyl 40 stearate, polyoxyl 8 stearate, glycerin, and water, with methylparaben, propylparaben, sodium metabisulfite, and edetate disodium as preservatives. chemically, mafenide acetate is α-amino-Ï-toluenesulfonamide monoacetate and has the following structural formula: structure
Clinical Pharmacology:
Clinical pharmacology sulfamylon cream, applied topically produces a marked reduction in the bacterial population present in the avascular tissues of second- and third-degree burns. reduction in bacterial growth after application of sulfamylon cream has also been reported to permit spontaneous healing of deep partial-thickness burns, and thus prevent conversion of burn wounds from partial-thickness to full-thickness. it should be noted, however, that delayed eschar separation has occurred in some cases. absorption and metabolism applied topically, sulfamylon cream diffuses through devascularized areas, is absorbed, and rapidly converted to a metabolite (Ï-carboxybenzenesulfonamide) which is cleared through the kidneys. sulfamylon is active in the presence of pus and serum, and its activity is not altered by changes in the acidity of the environment. antibacterial activity sulfamylon exerts bacteriostatic action against many gram-negative and gram-positive organisms, including pseudo
Read more...monas aeruginosa and certain strains of anaerobes.
How Supplied:
How supplied 16 oz. plastic jar (453.6 g) - ndc 16571-723-48 4 oz. tube (113.4 g) - ndc 16571-723-12 2 oz. tube (56.7 g) - ndc 16571-723-60 avoid exposure to excessive heat (temperature above 104° f or 40° c). for external use only. keep this and all medications out of the reach of children. rx only manufactured for: rising pharma holdings, inc. east brunswick, nj 08816 revised: 08/2020 pir72348-00
Package Label Principal Display Panel:
Package label.principal display panel ndc 16571-723-60 rising ® sulfamylon ® cream (mafenide acetate cream, usp) rx only 2 oz. (56.7 g) for topical use only each gram contains mafenide acetate equivalent to 85 mg base in a water-miscible cream of cetyl alcohol, stearyl alcohol, cetyl esters wax, polyoxyl 40 stearate, polyoxyl 8 stearate, glycerin, and water, with methylparaben, propylparaben, sodium metabisulfite, and edetate disodium as preservatives. for dosage and administration, read accompanying package insert. avoid exposure to excessive heat (temperatures above 104°f or 40°c). for external use only. keep this and all medications out of the reach of children. 2oz