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Pronunciation
(SIL ver sul fa DYE a zeen)
Generic Available (U.S.)
Yes
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Prevention and treatment of infection in second and third degree burns
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies. Because of the theoretical increased risk for hyperbilirubinemia and kernicterus, sulfadiazine is contraindicated for use near term, on premature infants, or on newborn infants during the first 2 months of life (refer to Sulfadiazine monograph).
Lactation
Excretion unknown/not recommended
Breast-Feeding Considerations
It is not known if sulfadiazine is found in breast milk following topical application; however, sulfonamide serum concentrations may reach therapeutic levels following application to extensive areas. Oral sulfadiazine is contraindicated in nursing mothers since sulfonamides cross into the milk and may cause kernicterus in the newborn (refer to Sulfadiazine monograph).
Contraindications
Hypersensitivity to silver sulfadiazine or any component of the formulation; premature infants or neonates <2 months of age (sulfonamides may displace bilirubin and cause kernicterus); pregnancy (approaching or at term)
Warnings/Precautions
Concerns related to adverse effects:
• Sulfonamide allergy: Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated in product labeling, however, a risk of cross-reaction exists in patients with allergy to any of these compounds; avoid use when previous reaction has been severe.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• Systemic effects: Systemic absorption may be significant and adverse reactions may occur.
DIsease-related concerns:
• G6PD deficiency: Use with caution in patients with G6PD deficiency; hemolysis may occur.
• Hepatic impairment: Use with caution in patients with hepatic impairment; sulfadiazine may accumulate.
• Renal impairment: Use with caution in patients with renal impairment; sulfadiazine may accumulate.
Concurrent drug therapy issues:
• Analgesics: Use of an analgesic might be needed before application.
Adverse Reactions
Frequency not defined.
Dermatologic: Discoloration of skin, erythema multiforme, itching, photosensitivity, rash
Hematologic: Agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia
Hepatic: Hepatitis
Renal: Interstitial nephritis
Miscellaneous: Allergic reactions may be related to sulfa component
Metabolism/Transport Effects
None known.
Drug Interactions
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Storage
Discard if cream is darkened (reacts with heavy metals resulting in release of silver).
Mechanism of Action
Acts upon the bacterial cell wall and cell membrane. Bactericidal for many gram-negative and gram-positive bacteria and is effective against yeast. Active against Pseudomonas aeruginosa, Pseudomonas maltophilia, Enterobacter species, Klebsiella species, Serratia species, Escherichia coli, Proteus mirabilis, Morganella morganii, Providencia rettgeri, Proteus vulgaris, Providencia species, Citrobacter species, Acinetobacter calcoaceticus, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus species, Candida albicans, Corynebacterium diphtheriae, and Clostridium perfringens
Pharmacodynamics/Kinetics
Absorption: Significant percutaneous absorption of silver sulfadiazine can occur especially when applied to extensive burns
Half-life elimination: 10 hours; prolonged with renal impairment
Time to peak, serum: 3-11 days of continuous therapy
Excretion: Urine (~50% as unchanged drug)
Dosage
Children and Adults: Topical: Apply once or twice daily with a sterile-gloved hand; apply to a thickness of 1/16”; burned area should be covered with cream at all times
Administration: Topical
Apply with a sterile-gloved hand. Apply to a thickness 1/16”. Burned area should be covered with cream at all times.
Monitoring Parameters
Serum electrolytes, urinalysis, renal function tests, CBC in patients with extensive burns on long-term treatment
Patient Education
Usually applied by professional in burn care setting. Report rash or skin irritation.
Geriatric Considerations
No specific recommendations for use in the elderly.
Additional Information
Contains methylparaben and propylene glycol
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
May cause leukopenia; use caution with clozapine and carbamazepine
Nursing: Physical Assessment/Monitoring
Assess allergy history before treatment (sulfonamides). Monitor for development of granulation, rash, or irritation of unburned areas. Monitor for hepatic, renal, or hematological response effects with long-term use or use over large areas.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, topical: 1% (20 g, 25 g, 50 g, 85 g, 400 g)
Silvadene®: 1% (20 g, 50 g, 85 g, 400 g, 1000 g)
SSD AF®: 1% (50 g, 400 g)
SSD®: 1% (25 g, 50 g, 85 g, 400 g)
Thermazene®: 1% (20 g, 50 g, 85 g, 400 g, 1000 g)
Pricing: U.S. (www.drugstore.com)
Cream (Silvadene)
1% (20): $27.99
1% (50): $24.99
1% (85): $38.99
1% (400): $73.99
Cream (Silver Sulfadiazine)
1% (25): $13.99
1% (85): $19.99
1% (400): $32.99
Cream (SSD)
1% (50): $14.99
1% (400): $32.99
Cream (Thermazene)
1% (20): $15.38
References
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 Plast Surg, 1985, 14(5):407-18.
Lockhart SP, Rushworth A, Azmy AA, et al, “Topical Silver Sulfadiazine: Side Effects and Urinary Excretion,” Burns Incl Therm Inj, 1983, 10(1):9-12.
International Brand Names
Lexi-Comp.com
Last full review/revision December 2011
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