Silver Sulfadiazine
Asclemed Usa, Inc.
Human Prescription Drug
NDC 76420-208Silver Sulfadiazine is a human prescription drug labeled by 'Asclemed Usa, Inc.'. National Drug Code (NDC) number for Silver Sulfadiazine is 76420-208. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Silver Sulfadiazine drug includes Silver Sulfadiazine - 10 g/1000g . The currest status of Silver Sulfadiazine drug is Active.
Drug Information:
| Drug NDC: | 76420-208 |
| 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: | Silver Sulfadiazine |
| 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: | Silver Sulfadiazine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Asclemed Usa, 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: | SILVER SULFADIAZINE - 10 g/1000g
|
| 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: | 04 May, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 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: | NDA018578 |
| 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: | Asclemed USA, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 106351
|
| 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. |
| NUI: | N0000175503
M0020790
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | W46JY43EJR
|
| 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 EPC: | Sulfonamide Antibacterial [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Sulfonamides [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Sulfonamide Antibacterial [EPC]
Sulfonamides [CS]
|
| 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 |
|---|
| 76420-208-25 | 25 g in 1 TUBE (76420-208-25) | 09 Mar, 2022 | N/A | No |
| 76420-208-50 | 50 g in 1 TUBE (76420-208-50) | 09 Mar, 2022 | 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:
Silver sulfadiazine silver sulfadiazine water cetyl alcohol stearyl alcohol petrolatum polyoxyl 40 stearate propylene glycol isopropyl myristate sorbitan monooleate methylparaben silver sulfadiazine sulfadiazine
Indications and Usage:
Indications and usage silver sulfadiazine cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.
Warnings:
Warning there is a potential cross-sensitivity between silver sulfadiazine and other sulfonamides. if allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction. fungal proliferation in and below the eschar may occur. however, the incidence of clinically reported fungal superinfection is low. the use of silver sulfadiazine cream in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.
Dosage and Administration:
Dosage and administration: for topical use only - not for ophthalmic use: prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain. the burn wounds are then cleansed and debrided; silver sulfadiazine cream is then applied under sterile conditions. the burn areas should be covered with silver sulfadiazine cream at all times. the cream should be applied once to twice daily to a thickness of approximately one sixteenth of an inch. whenever necessary, the cream should be reapplied to any areas from which it has been removed due to patient activity. administration may be accomplished in minimal time because dressings are not required. however, if individual patient requirements make dressings necessary, they may be used. reapply immediately after hydrotherapy. treatment with silver sulfadiazine cream should be continued until satisfactory healing has occurred or until the burn site is ready for grafting. the
Read more...drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.
Contraindications:
Contraindications silver sulfadiazine cream is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation. because sulfonamide therapy is known to increase the possibility of kernicterus, silver sulfadiazine cream should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life.
Adverse Reactions:
Adverse reactions several cases of transient leucopenia have been reported in patients receiving silver sulfadiazine therapy. leucopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. maximal white blood cell depression occurs within two to four days of initiation of therapy. rebound to normal leukocyte levels follows onset within two to three days. recovery is not influenced by continuation of silver sulfadiazine therapy. the incidence of leucopenia in various reports averages about 20%. a higher incidence has been seen in patients treated concurrently with cimetidine. other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis. reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial thickness burns by preventing conversion of the partial thickn
Read more...ess to full thickness by sepsis. however, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture. absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur. some of the reactions which have been associated with sulfonamides are as follows: blood dyscrasias, agranulocytosis, aplastic anemia, thrombocytopenia, leucopenia, hemolytic anemia, dermatologic reactions, allergic reactions, stevens-johnson syndrome, exfoliative dermatitis, gastrointestinal reactions, hepatitis, hepatocellular necrosis, cns reactions, and toxic nephrosis.
Description:
Descrpition 1% silver sulfadiazine cream are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. the active moiety is contained within an opaque, white, water miscible cream base. each 1000 grams of 1% silver sulfadiazine cream contains 10 grams of silver sulfadiazine. inactive ingrediants: cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative. silver sulfadiazine has an emprical formula of c 10 h 9 agn 4 o 2 s, molecular weight of 357.14 and structural formula as shown: structure for silver sulfadiazine
Clinical Pharmacology:
Clinical pharmacology silver sulfadiazine has broad antimicrobial activity. it is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast. results from in vitro testing are listed below. sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine. studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine. silver sulfadiazine acts only on the cell wall to produce its bactericidal effect. results of in vitro testing with silver sulfadiazine cream, 1% concentration of silver sulfadiazine number of sensitive strains / total number of strains tested genus and species 50 micrograms/ml 100 micrograms/ml pseudomonas aeruginosa 130/130
Read more... 130/130 xanthomonas (pseudomonas) maltophilia 7/7 7/7 enterobacter species 48/50 50/50 enterobacter cloacae 24/24 24/24 klebsiella species 53/54 54/54 escherichia coli 63/63 63/63 serratia species 27/28 28/28 proteus mirabilis 53/53 53/53 morganella morganii 10/10 10/10 providencia rettgeri 2/2 2/2 proteus vulgaris 2/2 2/2 providencia species 1/1 1/1 citrobacter species 10/10 10/10 acinetobacter calcoaceticus 10/11 11/11 stahylococcus aureus 100/101 101/101 staphylococcus epidermidis 51/51 51/51 b-hemolytic streptococcus 4/4 4/4 enterococcus species 52/53 53/53 corynebacterium diphtheriae 2/2 2/2 clostridium perfringens 0/2 2/2 clostridium perfringens 0/2 2/2 candida albicans 43/50 50/50 silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility long-term dermal toxicity studies of 24 months duration in rats and 18 months in mice with concentrations of silver sulfadiazine three to ten times the concentration in silver sulfadiazine cream revealed no evidence of carcinogenicity. pregnancy: pregnancy category b. a reproductive study has been performed in rabbits at doses up to three to ten times the concentration of silver sulfadiazine in silver sulfadiazine cream and has revealed no evidence of harm to the fetus due to silver sulfadiazine. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term. (see contraindications ) nursing mother: it is not known whether silver sulfadiazine cream is excreted in human milk. however, sulfonamides are known to be excrete
Read more...d in human milk and all sulfonamides derivatives are known to increase the possibility of kernicterus. because of the potential for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. pediatric use: safety and effectiveness in children have not been established. (see contraindications )
How Supplied:
How supplied 1% silver sulfadiazine cream : white to off-white cream. 25 gram tube ndc 76420-208-25 (relabeled from ndc 43598-210-25) 50 gram tube ndc 76420-208-50 (relabeled from ndc 43598-210-50) store at controlled room temperature 15° - 30°c (59° - 86°f) ssd is a trademark of dr. reddy's laboratories, inc. relabeled by: enovachem pharmaceuticals torrance, ca 90501
Package Label Principal Display Panel:
Container label for 25 g tube silver sulfadiazine 1%
Container label for 50 g tube silver sulfadiazine 1%