Class: Local Anti-infectives, Miscellaneous
ATC Class: D06BA01
VA Class: DE500
CAS Number: 22199-08-2
Brands: Silvadene, SSD, Thermazene
Introduction
Sulfonamide; synthetic anti-infective agent.a b c e g h i j l
Uses for Silver Sulfadiazine
Prevention and Treatment of Burn Infections
Silver sulfadiazine cream is used topically as adjunct therapy to prevent and treat wound sepsis in second- and third-degree burns after resuscitative measures (e.g., control of shock and pain, correction of electrolyte imbalance) have been instituted.a b c e g h i j l
Control of bacterial growth may prevent conversion of deep, second-degree (partial-thickness) wounds to third-degree (full-thickness) wounds by sepsis.a b c i
Concomitant administration of appropriate systemic anti-infective agents may be necessary if infection present or suspected.c
Although controlled, comparative studies are lacking, silver sulfadiazine and mafenide are considered by many clinicians to be among the topical anti-infective agents of choice in burn patients.c g h i j
Mafenide appears to penetrate burn eschar better than silver sulfadiazine and may be more effective in minimizing the growth of bacteria and early treatment of wound sepsis.c j
Unlike mafenide, a carbonic anhydrase inhibitor, silver sulfadiazine does not alter acid-base balance and does not have a limited duration of therapy and area of topical application.a b c f
Softening action of silver sulfadiazine cream may aid in eschar removal and preparation of wound for grafting. c
Silver Sulfadiazine Dosage and Administration
General
Topically apply 1% silver sulfadiazine cream after appropriate regimens for burn care have been promptly instituted, including control of shock and pain.a b c l
Administration
Topical Administration
Cream
Apply 1% cream topically to cleansed, debrided burn wounds under sterile conditions (e.g., using a sterile-gloved hand).a b c
Topical cream should not be applied to the eye.a b
If possible, bathe patient daily to aid in debridement.c
Dressings usually not required but may be used.a b c
Dosage
Available as silver sulfadiazine; dosage expressed in terms of the salt.a b
Adults
Prevention and Treatment of Burn Infections
Topical
Apply 1% cream in a thickness of approximately 16 mm (1/16 inch) 1 or 2 times daily; cover burn area with cream at all times.a b c Reapply cream to any areas from which it has been removed by patient activity and reapply immediately following hydrotherapy.a b c
Continue applying cream as long as there is a possibility of infection unless a clinically important adverse reaction occurs.a b c Usually continue until healing is progressing well or site is ready for grafting.a b c
Special Populations
No special population dosage and administration recommendations at this time.a b c
Cautions for Silver Sulfadiazine
Contraindications
Pregnant women approaching or at term.a b c
Premature neonates or neonates ≤2 months of age.a b c
Known hypersensitivity to silver sulfadiazine or any ingredient in the formulation (e.g., methylparaben).a b c
Warnings/Precautions
Warnings
Systemic Absorption and Toxicity
When applied to extensive areas of the body and/or tissue damage is present, sulfadiazine may be absorbed systemically and produce adverse reactions characteristic of the sulfonamides, including hematologic effects (e.g., agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia), dermatologic and hypersensitivity reactions (e.g., Stevens-Johnson syndrome, exfoliative dermatitis), adverse GI effects, hepatitis and hepatocellular necrosis, adverse CNS effects, and toxic nephrosis.a b c d l m Skin discoloration (including argyria) also reported with topical application of silver sulfadiazine cream.a b c
Fungal Infections
Possible fungal proliferation in and below eschar; however, low reported incidence of fungal superinfection.a b c
Leukopenia
Transient leukopenia, principally manifested as decreased ANC, reported in an average of 20% of patients.a b c d e l m Maximal WBC count decrease occurs within the first 2–4 days after initiating therapy, and WBC count usually returns to normal within 2–3 days after onset of leukopenia regardless of whether silver sulfadiazine therapy is continued or discontinued.a b c d e m (See Specific Drugs under Interactions.)
Patients with G6PD Deficiency
Hemolysis may occur in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.a b c
Sensitivity Reactions
Sensitivity Reactions and Cross-sensitivity
Possible sensitivity reactions (e.g., blood dyscrasias, skin reactions [dermatitis, rashes, facial edema, pruritus], jaundice, hepatitis).a b c e g h k If allergic reaction occurs, consider discontinuance of drug.a b c
Possible cross-sensitivity with other sulfonamides and related compounds (e.g., sulfonylureas, carbonic anhydrase inhibitors, thiazides, loop diuretics).a b c (See Contraindications.)
General Precautions
Laboratory Testing and Propylene Glycol
In patients with extensive burns, monitor serum sulfonamide concentrations, carefully monitor renal function, and examine urine for sulfonamide crystals.a b c
Absorption of propylene glycol (contained in silver sulfadiazine cream) may affect serum osmolality, which may affect interpretation of some laboratory test results.a b c l
Delayed Wound Healing
Possible delay in wound healing; reduced bacterial growth may result in delayed eschar separation, which in some cases may require escharotomy.a b c h
Specific Populations
Pregnancy
Category B.a b
Because sulfonamides may cause kernicterus in neonates, silver sulfadiazine cream is contraindicated in pregnant women approaching or at term.a b c
Lactation
Not known whether topically applied silver sulfadiazine cream is distributed into milk.a b c However, because sulfonamides are distributed into milk and may cause kernicterus in premature neonates and neonates ≤2 months of age, discontinue nursing or the drug.a b c
Pediatric Use
The manufacturer states that safety and efficacy have not been established in pediatric patients;a b c however, silver sulfadiazine cream has been successfully used in some pediatric burn patients.e i
Because sulfonamide therapy has produced kernicterus in neonates, silver sulfadiazine cream is contraindicated in premature neonates or neonates ≤2 months of age.a b c (See Contraindications under Cautions.)
Hepatic Impairment
Possible sulfadiazine accumulation; consider discontinuance if therapeutic benefits to the patient do not outweigh possible risks.a b c
Renal Impairment
Possible sulfadiazine accumulation; consider discontinuance if therapeutic benefits to the patient do not outweigh possible risks.a b c (See Laboratory Testing and Propylene Glycol under Cautions.)
Common Adverse Effects
Local effects (pain, burning, itching, rash),a b c e k leukopenia.a b c d e m
Interactions for Silver Sulfadiazine
No formal drug interaction studies to date.a b c Since systemic sulfadiazine absorption may occur following topical application, consider possible drug interactions such as those reported with systemic administration of sulfonamides and related drugs.a b c
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Cimetidine | Increased incidence of leukopenia when used concomitantly with topical silver sulfadiazinea b m | |
Proteolytic enzymes, topical (e.g., collagenase, sutilains [no longer commercially available in the US]) | Silver contained in silver sulfadiazine cream potentially may inactivate topical proteolytic enzymes used for debridementa b c |
Silver Sulfadiazine Pharmacokinetics
Absorption
Bioavailability
Silver sulfadiazine itself does not appear to be absorbed following topical administration.a b c When in contact with body tissues and fluids, silver sulfadiazine slowly reacts with sodium chloride, sulfhydryl groups, and protein, resulting in sulfadiazine release.c Sulfadiazine may then be systemically absorbed from the site of application, particularly when silver sulfadiazine is applied to extensive areas and/or to damaged tissue.a b c e l
Plasma Concentrations
When applied to extensive burns, serum sulfadiazine concentrations of ≤12 mg/dL reported.a b c Patients treated with 5–10 g of silver sulfadiazine daily applied as a 1% cream had blood sulfadiazine concentrations of 1–2 mg/dL.c
Distribution
Extent
Not known whether topically applied silver sulfadiazine cream is distributed into milk; however, sulfonamides are distributed into milk.a b c
Elimination
Elimination Route
Systemically absorbed sulfadiazine excreted in urine.a b c e
Stability
Storage
Topical
Cream
15–30°C.a c
Actions and SpectrumActions
Mechanism of action of silver sulfadiazine appears to differ from sulfadiazine and silver nitrate; acts on cell membrane and cell wall to produce bactericidal effects.a b c g
Wide spectrum of activity against most burn pathogens, including species of both gram-positive and gram-negative organisms, including most species of Klebsiella, Proteus, Pseudomonas, and Staphylococcus.a b c Also inhibits Escherichia coli, Corynebacterium diphtheriae, and species of Acinetobacter, Citrobacter, Enterobacter, Providencia, Serratia, and streptococci.a b c Also has some activity against Candida albicans, Herpesvirus hominis, and Clostridium perfringens.a b c
Resistance reported occasionally.c
Advice to Patients
Importance of understanding that topical silver sulfadiazine preparations are intended for external use only.a b c
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.a b c
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.a b c
Importance of informing patients of other important precautionary information.a b c (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Cream | 1%* | Silvadene (with methylparaben and propylene glycol) | Monarch |
SSD (with cetyl alcohol, methylparaben, and propylene glycol) | Par | |||
SSD AF (with methylparaben and propylene glycol) | Par | |||
Thermazene (with propylene glycol) | Kendall |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Silvadene 1% Cream (MONARCH PHARMACEUTICALS): 85/$38.99 or 255/$93.97
Silvadene 1% Cream (MONARCH PHARMACEUTICALS): 20/$27.99 or 60/$52.97
Silvadene 1% Cream (MONARCH PHARMACEUTICALS): 400/$73.99 or 1200/$198.96
Silver Sulfadiazine 1% Cream (WATSON LABS): 25/$13.99 or 50/$17.97
Silver Sulfadiazine 1% Cream (WATSON LABS): 400/$30 or 1200/$85
Silver Sulfadiazine 1% Cream (WATSON LABS): 50/$21.99 or 100/$29.97
Silver Sulfadiazine 1% Cream (WATSON LABS): 85/$19.99 or 170/$29.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
a. Par Pharmaceutical, Inc. SSD (1% silver sulfadiazine) and SSD AF (1% silver sulfadiazine) cream prescribing information. Spring Valley, NY; 1999 May.
b. Monarch Pharmaceuticals, Inc. Silvadene cream 1% (silver sulfadiazine) prescribing information. Bristol, TN; 2003 Jul.
c. AHFS drug information 2008. McEvoy GK, ed. Silver Sulfadiazine. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3570-71.
d. Choban PS, Marshall WJ. Leukopenia secondary to silver sulfadiazine: frequency, characteristics and clinical consequences. Am Surg. 1987; 53:515-7. [PubMed 3631764]
e. Lockhart SP, Rushworth A, Azmy AAF et al. Topical silver sulphadiazine: side effects and urinary excretion. Burns. 1983; 10:9-12.
f. Liebman PR, Kennelly MM, Hirsch EF. Hypercarbia and acidosis associated with carbonic anhydrase inhibition: a hazard of topical mafenide acetate use in renal failure. Burns Incl Therm Inj. 1982; 8:95-8.
g. Castellano JJ, Shafii SM, Ko F et al. Comparative evaluation of silver-containing antimicrobial dressings and drugs. Int Wound J. 2007; 4:114-22. [PubMed 17651227]
h. Atiyeh BS, Costagliola M, Hayek SN et al. Effect of silver on burn wound infection control and healing: review of the literature. Burns. 2007; 33:139-48. [PubMed 17137719]
i. Palmieri TL, Greenlaugh DG. Topical treatment of pediatric patients with burns: a practical guide. Am J Clin Dermatol. 2002; 3:529-34. [PubMed 12358554]
j. Monafo WW, West MA. Current treatment recommendations for topical burn therapy. Drugs. 1990; 40:364-73. [PubMed 2226220]
k. McKenna SR, Latenser BA, Jones LM et al. Serious silver sulphadiazine and mafenide acetate dermatitis. Burns. 1995; 21:310-2. [PubMed 7662136]
l. Kulick MI, Wong R, Okarma TB et al. Prospective study of side effects associated with the use of silver sulfadiazine in severely burned patients. Ann Plastic Surgery. 1985; 14:407-19.
m. Caffee HH, Bingham HG. Leukopenia and silver sulfadiazine. J Trauma. 1982; 22:586-7. [PubMed 7097818]
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