pharmacopeia
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/api/v1/drug/silver-sulfadiazine

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

Indications

Sourced from openFDA
  • 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

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

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 The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

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 )

Approval history

Sourced from openFDA
  • Nov 26, 1973NDANDA017381King Pharms Llc
  • Feb 25, 1982NDANDA018578Dr Reddys
  • Dec 23, 1985NDANDA018810Thepharmanetwork Llc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,245 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Pain1546.9%
  2. 2Off Label Use1526.8%
  3. 3Fatigue1516.7%
  4. 4Product Use In Unapproved Indication1416.3%
  5. 5Nausea1376.1%
  6. 6Death1225.4%
  7. 7Diarrhoea1195.3%
  8. 8Drug Ineffective1114.9%
  9. 9Chronic Kidney Disease1074.8%
  10. 10Dyspnoea1034.6%
  11. 11Rash974.3%
  12. 12Anxiety954.2%
  13. 13Pneumonia934.1%
  14. 14Fall924.1%
  15. 15Acute Kidney Injury904.0%

Literature

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Recent PubMed references pinned to Silver Sulfadiazine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 114 ClinicalTrials.gov registrations naming Silver Sulfadiazine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Silver Sulfadiazine work?
Mechanism-of-action class: Unknown Cellular or Molecular Interaction.
What is Silver Sulfadiazine used for?
According to FDA labeling, Silver Sulfadiazine carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Silver Sulfadiazine?
Silver Sulfadiazine is classified as Sulfonamides, Sulfonamide Antibacterial, Unknown Cellular or Molecular Interaction, Cell Membrane Alteration, Cell Wall Alteration.
What are the brand names for Silver Sulfadiazine?
Silver Sulfadiazine is marketed under brand names including Baytril Otic, Enropro Silver, Enrosite Silver, SSD, Silvadene, Thermazene.
What are the contraindications for Silver Sulfadiazine?
Silver Sulfadiazine labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for silver-sulfadiazine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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