Silver Sulfadiazine
Advanced Rx Pharmacy Of Tennessee, Llc
Human Prescription Drug
NDC 80425-0221Silver Sulfadiazine is a human prescription drug labeled by 'Advanced Rx Pharmacy Of Tennessee, Llc'. National Drug Code (NDC) number for Silver Sulfadiazine is 80425-0221. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Silver Sulfadiazine drug includes Silver Sulfadiazine - 10 mg/g . The currest status of Silver Sulfadiazine drug is Active.
Drug Information:
| Drug NDC: | 80425-0221 |
| 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: | Advanced Rx Pharmacy Of Tennessee, Llc |
| 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 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: | 12 Jan, 2023 |
| 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: | NDA018810 |
| 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, 2024 |
| 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: | Advanced Rx Pharmacy of Tennessee, LLC
|
| 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 |
|---|
| 80425-0221-1 | 50 g in 1 TUBE (80425-0221-1) | 12 Jan, 2023 | 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 silver sulfadiazine sulfadiazine
Indications and Usage:
Indications and usage silver sulfadiazine cream, usp 1% 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 and Cautions:
Warnings and precautions 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 including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, and hemolytic anemia; dermatologic and allergic reactions, including life-threatening cutaneous reactions [stevens-johnson syndrome (sjs), toxic epidermal necrolysis (ten) and exfoliative dermatitis]; gastrointestinal reactions, hepatitis and hepatocellular necrosis; cns reactions; and toxic nephrosis. 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 particula
Read more...r 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, usp 1% in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur. general. if hepatic and renal functions become impaired and elimination of the drug decreases accumulation may occur. discontinuation of silver sulfadiazine cream, usp 1% should be weighed against the therapeutic benefit being achieved. in considering the use of topical proteolytic enzymes in conjunction with silver sulfadiazine cream, usp 1% the possibility should be noted that silver may inactivate such enzymes. laboratory tests. in the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 to 12mg %). therefore, in these patients it would be advisable to monitor serum sulfa concentrations. renal function should be carefully monitored and the urine should be checked for sulfa crystals. absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests. 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, usp 1% revealed no evidence of carcinogenicity.
Dosage and Administration:
Dosage and administration 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, usp 1% is then applied under sterile conditions. the burn areas should be covered with silver sulfadiazine cream, usp 1% 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 by 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, usp 1% should be continued until satisfactory healing has occurred or until the burn site is ready for grafting. the drug should not be withdrawn
Read more... from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.
Contraindications:
Contraindications silver sulfadiazine cream, usp 1% 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, usp 1% 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 leukopenia have been reported in patients receiving silver sulfadiazine therapy 1,2,3 leukopenia 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. an increased 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 thickness to full thickness by sepsis. however, reduction in bac
Read more...terial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.
Use in Pregnancy:
Pregnancy: teratogenic effects 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, usp 1% 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)
Pediatric Use:
Pediatric use pediatric use. safety and effectiveness in children have not been established. (see contraindications)
Geriatric Use:
Geriatric use geriatric use. of the total number of subjects in clinical studies of silver sulfadiazine cream, usp 1% seven percent were 65 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Description:
Description silver sulfadiazine cream, usp 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application. each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine. this active agent has the following structural formula: silver sulfadiazine cream contains 1% w/w silver sulfadiazine. the vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative. description
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 membrane and cell wall to produce its bactericidal effect. results of in vitro testing with silver sulfadiazine cream, usp 1% concentration of silver sulfadiazine number of sensitive strains / total number of strains tested genus and species 50 µg/ml 100 µg/ml pseudomonas aerugi
Read more...nosa 130/130 130/130 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 100/101 100/101 staphylococcus epidermidis 51/51 51/51 β-hemolytic streptococcus 4/4 4/4 enterococcus species 52/53 52/53 corynebacterium diphtheriae 2/2 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.
How Supplied:
How supplied silver sulfadiazine cream, usp 1% - white to off-white cream 50g tube ndc: 80425-0221-01 store at room temperature. 15°-30°c (59°-86°f). manufactured for: ascend laboratories, llc parsippany, nj 07054 manufactured by: crown laboratories, inc. johnson city, tn 37604 product information: 1-877-272-7901 dist.by; advanced rx pharmacy of tennessee, llc revised: dec 2018 p1840.05
Package Label Principal Display Panel:
Principal display panel label1