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| Product NDC Code | 59762-0131 | ||||||||||||||
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| Drug Name | Silver sulfadiazine |
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| Type | Generic | ||||||||||||||
| Pharm Class | Sulfonamide Antibacterial [EPC], Sulfonamides [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||
| Dosage Form | CREAM | ||||||||||||||
| RxCUI drug identifier | 106351 | ||||||||||||||
| Application Number | NDA017381 | ||||||||||||||
| Labeler Name | Greenstone LLC | ||||||||||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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 2 to 4 days of initiation of therapy. Rebound to normal leukocyte levels follows onset within 2 to 3 days. Recovery is not influenced by continuation of silver sulfadiazine therapy. An increased incidence of leukopenia has been reported 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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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 1% Concentration of Silver Sulfadiazine Number of Sensitive Strains/Total Number of Strains Tested Genus & Species 50 μg/mL 100 μg/mL Pseudomonas aeruginosa 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 Providencia species 1/1 1/1 Proteus vulgaris 2/2 2/2 Citrobacter species 10/10 10/10 Acinetobacter calcoaceticus 10/11 11/11 Staphylococcus aureus 100/101 100/101 Staphylococcus epidermidis 51/51 51/51 β-Hemolytic Streptococcus 4/4 4/4 Enterococcus species 52/53 53/53 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.
| Genus & Species | 50 μg/mL | 100 μg/mL |
|---|---|---|
| 130/130 | 130/130 | |
| 7/7 | 7/7 | |
| 48/50 | 50/50 | |
| 24/24 | 24/24 | |
| 53/54 | 54/54 | |
| 63/63 | 63/63 | |
| 27/28 | 28/28 | |
| 53/53 | 53/53 | |
| 10/10 | 10/10 | |
| 2/2 | 2/2 | |
| 1/1 | 1/1 | |
| 2/2 | 2/2 | |
| 10/10 | 10/10 | |
| 10/11 | 11/11 | |
| 100/101 | 100/101 | |
| 51/51 | 51/51 | |
| β-Hemolytic | 4/4 | 4/4 |
| 52/53 | 53/53 | |
| 2/2 | 2/2 | |
| 0/2 | 2/2 | |
| 43/50 | 50/50 |
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Silver Sulfadiazine Cream 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 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.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Silver Sulfadiazine Cream 1% is a soft, white, water-miscible cream containing the antimicrobial agent silver sulfadiazine in micronized form, which has the following structural formula: Each gram of silver sulfadiazine cream 1% contains 10 mg of micronized silver sulfadiazine. The cream vehicle consists of white petrolatum, stearyl alcohol, isopropyl myristate, sorbitan monooleate, polyoxyl 40 stearate, propylene glycol, and water, with methylparaben 0.3% as a preservative. Silver Sulfadiazine Cream 1% spreads easily and can be washed off readily with water. Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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, and silver sulfadiazine cream 1% is applied under sterile conditions. The burn areas should be covered with silver sulfadiazine cream 1% at all times. The cream should be applied once to twice daily to a thickness of approximately 1/16 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 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Silver Sulfadiazine Cream 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.
Spl product data elements
Usually a list of ingredients in a drug product.SILVER SULFADIAZINE silver sulfadiazine SILVER SULFADIAZINE SULFADIAZINE
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.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 1% revealed no evidence of carcinogenicity.
Laboratory tests
Information on laboratory tests helpful in following the patient’s response to the drug or in identifying possible adverse reactions. If appropriate, information may be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.Laboratory Tests In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 mg% to 12 mg%). 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.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 20 gram Tube Label NDC 59762-0131-0 GREENSTONE ® BRAND silver sulfadiazine cream 1% 20 grams FOR TOPICAL USE ONLY. Avoid contact with the eye. DOSAGE AND USE See accompanying prescribing information. KEEP OUT OF REACH OF CHILDREN Store at Controlled Room Temperature 20° to 25°C (68° to 77°F). Rx only GREENSTONE LOT / EXP PRINCIPAL DISPLAY PANEL - 20 gram Tube Label
PRINCIPAL DISPLAY PANEL - 20 gram Tube Carton NDC 59762-0131-0 GREENSTONE ® BRAND silver sulfadiazine cream 1% 20 grams Rx only PRINCIPAL DISPLAY PANEL - 20 gram Tube Carton
PRINCIPAL DISPLAY PANEL - 50 gram Jar Label NDC 59762-0131-6 GREENSTONE ® BRAND silver sulfadiazine cream 1% 50 grams Rx only FOR TOPICAL USE ONLY Avoid contact with the eye. PRINCIPAL DISPLAY PANEL - 50 gram Jar Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.LAB-0773-2.0 October 2016 Logo
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.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. This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Geriatric Use Of the total number of subjects in clinical studies of silver sulfadiazine cream 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.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers It is not known whether silver sulfadiazine is excreted in human milk. However, sulfonamides are known to be excreted in human milk, and all sulfonamide 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.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use Safety and effectiveness in pediatric patients have not been established (see CONTRAINDICATIONS ).
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Teratogenic Effects 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 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 ).
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Teratogenic Effects 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 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 ).
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Silver Sulfadiazine Cream 1% is available in jars containing 50 g ( NDC 59762-0131-6) and 400 g ( NDC 59762-0131-4), and tubes containing 20 g ( NDC 59762-0131-0), 25 g ( NDC 59762-0131-2), 50 g ( NDC 59762-0131-5) and 85 g ( NDC 59762-0131-8). Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).
Storage and handling
Information about safe storage and handling of the drug product.Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General If hepatic and renal functions become impaired and elimination of drug decreases, accumulation may occur, and discontinuation of silver sulfadiazine cream 1% should be weighed against the therapeutic benefit being achieved. In considering the use of topical proteolytic enzymes in conjunction with silver sulfadiazine cream 1%, the possibility should be noted that silver may inactivate such enzymes. Silver Sulfadiazine Cream 1% is for topical use only. Avoid contact of silver sulfadiazine cream 1% with the eye.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General If hepatic and renal functions become impaired and elimination of drug decreases, accumulation may occur, and discontinuation of silver sulfadiazine cream 1% should be weighed against the therapeutic benefit being achieved. In considering the use of topical proteolytic enzymes in conjunction with silver sulfadiazine cream 1%, the possibility should be noted that silver may inactivate such enzymes. Silver Sulfadiazine Cream 1% is for topical use only. Avoid contact of silver sulfadiazine cream 1% with the eye. Laboratory Tests In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 mg% to 12 mg%). 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 1% revealed no evidence of carcinogenicity. Pregnancy Teratogenic Effects 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 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 It is not known whether silver sulfadiazine is excreted in human milk. However, sulfonamides are known to be excreted in human milk, and all sulfonamide 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 Of the total number of subjects in clinical studies of silver sulfadiazine cream 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 Safety and effectiveness in pediatric patients have not been established (see CONTRAINDICATIONS ).
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 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 1% in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API