NDC 50090-0717 Silver Sulfadiazine

Silver Sulfadiazine

NDC Product Code 50090-0717

NDC CODE: 50090-0717

Proprietary Name: Silver Sulfadiazine What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Silver Sulfadiazine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used with other treatments to help prevent and treat wound infections in patients with serious burns. Silver sulfadiazine works by stopping the growth of bacteria that may infect an open wound. This helps to decrease the risk of the bacteria spreading to surrounding skin, or to the blood where it can cause a serious blood infection (sepsis). Silver sulfadiazine belongs to a class of drugs known as sulfa antibiotics. Silver sulfadiazine must not be used on premature babies or on newborns during the first 2 months of life because of the risk of serious side effects.

NDC Code Structure

  • 50090 - A-s Medication Solutions

NDC 50090-0717-0

Package Description: 50 g in 1 TUBE

NDC Product Information

Silver Sulfadiazine with NDC 50090-0717 is a a human prescription drug product labeled by A-s Medication Solutions. The generic name of Silver Sulfadiazine is silver sulfadiazine. The product's dosage form is cream and is administered via topical form.

Labeler Name: A-s Medication Solutions

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Silver Sulfadiazine Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SILVER SULFADIAZINE 10 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • METHYLPARABEN (UNII: A2I8C7HI9T)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Sulfonamide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Sulfonamides - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: A-s Medication Solutions
Labeler Code: 50090
FDA Application Number: NDA018810 What is the FDA Application Number?
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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 12-23-1985 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Silver Sulfadiazine

Silver Sulfadiazine is pronounced as (sil' ver sul fa dye' a zeen)

Why is silver sulfadiazine medication prescribed?
Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections of second- and third-degree burns. It kills a wide variety of bacteria.This medication is somet...
[Read More]

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Silver Sulfadiazine Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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 SilverSulfadiazine Cream, USP 1% Concentration ofSilver Sulfadiazine Number of Sensitive Strains /Total Number of Strains TestedGenus and Species50 µg/mL100 µg/mLPseudomonas aeruginosa130/130130/130Xanthomonas (Pseudomonas) Maltophilia7/77/7Enterobacter species48/5050/50Enterobacter cloacae24/2424/24Klebsiella species53/5454/54Escherichia coli63/6363/63Serratia species27/2828/28Proteus mirabilis53/5353/53Morganella morganii10/1010/10Providencia rettgeri2/22/2Proteus vulgaris2/22/2Providencia species1/11/1Citrobacter species10/1010/10Acinetobacter calcoaceticus10/11   11/11Stahylococcus aureus100/101100/101Staphylococcus epidermidis51/5151/51β-Hemolytic Streptococcus4/44/4Enterococcus species52/5352/53Corynebacterium diphtheriae2/22/2Clostridium perfringens0/22/2Candida albicans43/5050/50Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.

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.

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.

Warnings

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 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, USP 1% in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

Precautions

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

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.

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)

Nursing Mothers

Nursing Mothers. It is not known whether silver sulfadiazine cream, USP 1% is excreted in human milk. However, sulfonamides are known to be excreted in human milk and all sulfonamides derivatives are known to increase the possibility of kernicterus. Because of the possibility 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.

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.

Pediatric Use

Pediatric Use. Safety and effectiveness in children have not been
established. (See CONTRAINDICATIONS)

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 bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.

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 from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

References

  • Caffee F, Bingham H. Leukopenia and silver sulfadiazine. J Trauma. 1982;22: 586–587.Jarret F, Ellerbe S, Demling R. Acute leukopenia during topical burn therapy with silver sulfadiazine. Amer J Surg. 1978;135:818–819.Kiker RG, Carvajal HF, Micak RP, Larson DL. A controlled study of the effects of silver sulfadiazine on white blood cell counts in burned children. J Trauma. 1977; 17:835–836.

How Supplied

Product: 50090-0717NDC: 50090-0717-0 50 g in a TUBE

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