Silver sulfadiazine: Difference between revisions
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|authorTag={{AJ}} | |authorTag={{AJ}} | ||
|genericName=Silver sulfadiazine | |genericName=Silver sulfadiazine | ||
|aOrAn= | |aOrAn=an | ||
|drugClass=antimicrobial agent | |drugClass=antimicrobial agent | ||
|indicationType=treatment | |indicationType=treatment | ||
|indication= | |indication=[[Wound|wound sepsis]] in patients with [[burns|second and third degree burns]] | ||
|adverseReactions=[[burning]] | |adverseReactions=[[skin changes|burning sensation]] and [[rashes]] | ||
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | ||
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | ||
| Line 15: | Line 15: | ||
<!--FDA-Labeled Indications and Dosage (Adult)--> | <!--FDA-Labeled Indications and Dosage (Adult)--> | ||
|fdaLIADAdult=* Silver sulfadiazine cream, | |fdaLIADAdult=* Silver sulfadiazine cream, is a [[antibiotic|topical antimicrobial drug]] indicated as an adjunct for the prevention and treatment of [[sepsis|wound sepsis]] in patients with [[burns|second and third degree burns]]. | ||
=====Dosing Information===== | =====Dosing Information===== | ||
* Prompt institution of appropriate regimens for care of the [[burned]] patient is of prime importance and includes the control of shock and pain. The | * Prompt institution of appropriate regimens for care of the [[burns|burned]] patient is of prime importance and includes the control of [[shock]] and [[pain]]. The [[burn|burn wounds]] are then cleansed and [[Debridement|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 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, | * 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 drug should not be withdrawn from the [[therapeutic]] regimen while there remains the possibility of [[infection]] except if a significant [[adverse reaction]] occurs. | ||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | ||
| Line 44: | Line 43: | ||
|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. | |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, | * 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. | ||
|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]]. | |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|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]]. | * 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. | * [[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, | * The use of silver sulfadiazine cream, in some cases of [[G6PD deficiency|glucose-6-phosphate dehydrogenase-deficient]] individuals may be hazardous, as [[hemolysis]] may occur. | ||
====Precautions==== | ====Precautions==== | ||
| Line 57: | Line 56: | ||
======General====== | ======General====== | ||
* If [[hepatic]] and [[renal]] | * If [[liver function test|hepatic]] and [[renal function test|renal functions]] become impaired and elimination of the drug decreases accumulation may occur. Discontinuation of silver sulfadiazine cream, should be weighed against the therapeutic benefit being achieved. | ||
* In considering the use of topical proteolytic enzymes in conjunction with Silver sulfadiazine cream, | * In considering the use of topical [[Protease|proteolytic enzymes]] in conjunction with Silver sulfadiazine cream, the possibility should be noted that silver may inactivate such [[enzymes]]. | ||
=====Laboratory Tests===== | =====Laboratory Tests===== | ||
| Line 65: | Line 64: | ||
* 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. | * 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. | * Absorption of the [[propylene glycol]] vehicle has been reported to affect [[Osmolarity|serum osmolality]], which may affect the interpretation of laboratory tests. | ||
|clinicalTrials=* 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. | |clinicalTrials=* 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 [[CBC|neutrophil count]]. Maximal [[neutropenia|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. | * Other infrequently occurring events include [[skin changes|skin necrosis]], [[erythema multiforme]], [[skin discoloration]], [[skin|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. | * Reduction in [[bacterial]] growth after application of topical [[antibiotics|antibacterial agents]] has been reported to permit spontaneous [[healing]] of [[burns|deep partial-thickness burns]] by preventing conversion of the [[sepsis|partial thickness to full thickness by sepsis]]. However, reduction in [[bacteria|bacterial colonization]] has caused delayed separation, in some cases necessitating [[escharotomy]] in order to prevent [[contracture]]. | ||
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | ||
|drugInteractions=There is limited information regarding <i>Drug nteractions</i> of {{PAGENAME}} in the drug label. | |drugInteractions=There is limited information regarding <i>Drug nteractions</i> of {{PAGENAME}} in the drug label. | ||
|FDAPregCat=B | |FDAPregCat=B | ||
|useInPregnancyFDA=* 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. | |useInPregnancyFDA=* 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. | ||
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category''' | |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category''' | ||
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | ||
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | |useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | ||
|useInNursing=* 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. | |useInNursing=* 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. | ||
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients. | |useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients. | ||
|useInGeri=* Of the total number of subjects in clinical studies of silver sulfadiazine cream, | |useInGeri=* Of the total number of subjects in clinical studies of silver sulfadiazine cream, 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. | ||
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations. | |useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations. | ||
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations. | |useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations. | ||
| Line 165: | Line 164: | ||
| melting_point = 285 | | melting_point = 285 | ||
}} | }} | ||
|mechAction=* It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast | |mechAction=* It is [[bactericidal]] for many [[gram-negative]] and [[gram-positive bacteria]] as well as being effective against [[yeast]]. | ||
<!--Structure--> | <!--Structure--> | ||
| Line 172: | Line 171: | ||
* This active agent has the following structural formula: | * This active agent has the following structural formula: | ||
[[File:Silver Sulphadiazine formula structure.png|thumb|none| | [[File:Silver Sulphadiazine formula structure.png|thumb|none|400px|This image is provided by the National Library of Medicine.]] | ||
<!--Pharmacodynamics--> | <!--Pharmacodynamics--> | ||
|PD=====Microbiology==== | |PD=====Microbiology==== | ||
* 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. | * Silver sulfadiazine has [[antimicrobial|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. | * 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. | * 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. | ||
[[File:Silver Sulphadiazine microbiology.png|thumb|none| | [[File:Silver Sulphadiazine microbiology.png|thumb|none|400px|This image is provided by the National Library of Medicine.]] | ||
* Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated. | * Silver sulfadiazine is not a [[Carbonic anhydrase inhibitors|carbonic anhydrase inhibitor]] and may be useful in situations where such agents are [[contraindicated]]. | ||
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label. | |PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label. | ||
| Line 194: | Line 193: | ||
|clinicalStudies======Carcinogenesis, Mutagenesis===== | |clinicalStudies======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. | * 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]]. | ||
|howSupplied=Silver sulfadiazine cream, USP 1% - white to off-white cream | |howSupplied=Silver sulfadiazine cream, USP 1% - white to off-white cream | ||
| Line 212: | Line 211: | ||
67877-124-10 1000g jar | 67877-124-10 1000g jar | ||
Manufactured for: | Manufactured for: | ||
| Line 239: | Line 237: | ||
Silver Sulfadiazine Cream, USP 1% Net Wt. 25g | Silver Sulfadiazine Cream, USP 1% Net Wt. 25g | ||
|storage=Store at room temperature. 15°-30°C (56°-86°F). | |storage=Store at room temperature. 15°-30°C (56°-86°F). | ||
|packLabel=<!--Patient Counseling Information--> | |packLabel=<!--Patient Counseling Information--> | ||
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | |fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | ||
| Line 257: | Line 257: | ||
}} | }} | ||
<!--Pill Image--> | <!--Pill Image--> | ||
<!--Label Display Image--> | <!--Label Display Image--> | ||
<!--Category--> | <!--Category--> | ||
[[Category:Drug]] | [[Category:Drug]] | ||
Latest revision as of 17:08, 20 August 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Silver sulfadiazine is an antimicrobial agent that is FDA approved for the treatment of wound sepsis in patients with second and third degree burns. Common adverse reactions include burning sensation and rashes.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- 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.
Dosing Information
- 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 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, 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Silver sulfadiazine in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Silver sulfadiazine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Silver sulfadiazine in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Silver sulfadiazine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Silver sulfadiazine in pediatric patients.
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, 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, 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, should be weighed against the therapeutic benefit being achieved.
- In considering the use of topical proteolytic enzymes in conjunction with Silver sulfadiazine cream, 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.
Adverse Reactions
Clinical Trials Experience
- 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.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Silver sulfadiazine in the drug label.
Drug Interactions
There is limited information regarding Drug nteractions of Silver sulfadiazine in the drug label.
Use in Specific Populations
Pregnancy
- 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.
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Silver sulfadiazine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Silver sulfadiazine during labor and delivery.
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.
Pediatric Use
There is no FDA guidance on the use of Silver sulfadiazine with respect to pediatric patients.
Geriatic Use
- Of the total number of subjects in clinical studies of silver sulfadiazine cream, 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.
Gender
There is no FDA guidance on the use of Silver sulfadiazine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Silver sulfadiazine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Silver sulfadiazine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Silver sulfadiazine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Silver sulfadiazine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Silver sulfadiazine in patients who are immunocompromised.
Administration and Monitoring
Administration
- Topical
Monitoring
There is limited information regarding Monitoring of Silver sulfadiazine in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Silver sulfadiazine in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Silver sulfadiazine in the drug label.
Pharmacology
Mechanism of Action
- It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast.
Structure
- 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:
Pharmacodynamics
Microbiology
- 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.
- Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Silver sulfadiazine in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Silver sulfadiazine in the drug label.
Clinical Studies
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.
How Supplied
Silver sulfadiazine cream, USP 1% - white to off-white cream
NDC Number Size
67877-124-20 20g tube
67877-124-25 25g tube
67877-124-05 50g tube
67877-124-85 85g tube
67877-124-50 50g jar
67877-124-40 400g jar
67877-124-10 1000g jar
Manufactured for:
Ascend Laboratories, LLC
Montvale, NJ 07645
Manufactured by:
Crown Laboratories, Inc.
Johnson City, TN 37604
Product information: 1-877-272-7901
P1840.01
PRINCIPAL DISPLAY PANEL - 25g
NDC 67877-124-25
Ascend Rx
Laboratories, LLC ONLY
Silver Sulfadiazine Cream, USP 1% Net Wt. 25g
Storage
Store at room temperature. 15°-30°C (56°-86°F).
Images
Drug Images
{{#ask: Page Name::Silver sulfadiazine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Silver sulfadiazine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Silver sulfadiazine in the drug label.
Precautions with Alcohol
- Alcohol-Silver sulfadiazine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
SILVER SULFADIAZENE®
Look-Alike Drug Names
There is limited information regarding Silver sulfadiazine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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