Version May 2024
Burn treatment: Topical: Apply to a thickness of 1/16 inch once or twice daily; reapply as needed to areas where the cream is removed by patient activity as the burned area should be covered with cream at all times. Continue use until healing has occurred or the burn site is ready for grafting. Do not discontinue therapy if the possibility of infection exists unless a significant adverse reaction has occurred.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution; drug accumulation may occur.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution; drug accumulation may occur.
Refer to adult dosing.
(For additional information see "Silver sulfadiazine: Pediatric drug information")
Note: Continue use until healing has occurred or the burn site is ready for grafting. Do not discontinue therapy if the possibility of infection exists unless a significant adverse reaction has occurred.
Burn treatment: Infants >2 months, Children, and Adolescents: Limited data available in infants and children: Topical: Apply to a thickness of 1/16 inch once or twice daily; reapply as needed; burned area should be covered with cream at all times (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution; drug accumulation may occur.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution; drug accumulation may occur.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Dermatologic: Erythema multiforme, pruritus, skin discoloration, skin photosensitivity, skin rash
Hematologic & oncologic: Agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia
Hepatic: Hepatitis
Hypersensitivity: Hypersensitivity reaction (may be related to sulfa component)
Renal: Interstitial nephritis
Hypersensitivity to silver sulfadiazine or any component of the formulation; pregnant women approaching or at term; premature infants or neonates ≤2 months of age.
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. Fungal proliferation may rarely occur in and below the eschar.
• 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.
Dosage form specific issues:
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).
Other warnings/precautions:
• Appropriate use: For topical use only. Avoid contact with eyes.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Silvadene: 1% (20 g, 25 g, 50 g, 85 g, 400 g, 1000 g) [contains methylparaben, propylene glycol]
SSD: 1% (25 g, 50 g, 85 g, 400 g) [contains cetyl alcohol, methylparaben, propylene glycol]
Generic: 1% (20 g, 25 g, 50 g, 85 g, 400 g)
Yes
Cream (Silvadene External)
1% (per gram): $0.31
Cream (Silver sulfADIAZINE External)
1% (per gram): $0.30
Cream (SSD External)
1% (per gram): $0.30
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Flamazine: 1% (20 g, 50 g, 500 g) [contains cetyl alcohol, polysorbate 80, propylene glycol]
For topical use only; avoid contact with eyes. Apply with a sterile-gloved hand. Burned area should be covered with cream at all times; reapply to areas where cream has been removed by patient activity. Dressings may be used if necessary. Reapply immediately after hydrotherapy.
Topical: For topical use only; avoid contact with eyes. Apply with a sterile-gloved hand to cleansed, debrided burned areas. Burned area should be covered with silver sulfadiazine cream at all times; reapply to areas where cream has been removed by patient activity. Dressings may be used if necessary. Reapply immediately after hydrotherapy.
Burn treatment: As an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.
KIDs List: Sulfonamides, when used in neonates, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be avoided due to risk of kernicterus (weak recommendation; very low quality of evidence) (PPA [Meyers 2020]).
None known.
There are no known significant interactions.
Adverse events were not observed in animal reproduction studies. Because of the theoretical increased risk for hyperbilirubinemia and kernicterus, silver 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).
It is not known if silver sulfadiazine is found in breast milk following topical application; however, sulfonamide serum concentrations may reach therapeutic levels following application to extensive areas. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother. Oral sulfadiazine is contraindicated in nursing mothers since sulfonamides cross into the milk and may cause kernicterus in the newborn (refer to Sulfadiazine monograph).
Serum electrolytes, urinalysis, renal function tests, CBC in patients with extensive burns on long-term treatment. Serum sulfa concentrations, if clinically indicated.
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
Absorption: Negligible (superficial and deep burns and normal skin); increased absorption with blister removal (Sano 1982)
Half-life elimination: Sulfadiazine: ~24 hours (Sano 1982)
Excretion: Silver: Feces; slow excretion rate; Sulfadiazine: Urine (6.6% within 5 days) (Sano 1982)
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