Embedded Files
Pharmacologic Category
Dosing: Adult
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.
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling; use with caution; drug accumulation may occur.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling; use with caution; drug accumulation may occur.
Dosing: Pediatric
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 (Caruso 2006; de Graaf 2016, Schonfeld 1990)
Dosing: Renal Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling; use with caution; drug accumulation may occur.
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling; use with caution; drug accumulation may occur.
Use: Labeled Indications
Burn treatment: As an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.
* See Uses in AHFS Essentials for additional information.
Administration: Topical
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.
Administration: Pediatric
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.
Storage/Stability
Store at 20°C to 25°C (68°F to 77°F).
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to avoid or treat skin infections in patients with burns.
• It may be given to you for other reasons. Talk with the doctor.
Frequently reported side effects of this drug
• Skin discoloration
• Skin irritation
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Infection
• Liver problems like dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes
• Unable to pass urine
• Change in amount of urine
• Chills
• Sore throat
• Bruising
• Bleeding
• Severe loss of strength and energy
• Severe abdominal pain
• Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Contraindications
Hypersensitivity to silver sulfadiazine or any component of the formulation; pregnant women approaching or at term; premature infants or neonates ≤2 months of age.
Documentation of allergenic cross-reactivity for drugs in this class is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
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. 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.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
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.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
No specific recommendations for use in the elderly.
Warnings: Additional Pediatric Considerations
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).
Pregnancy Considerations
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).
Breast-Feeding Considerations
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).
Adverse Reactions
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
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Test Interactions
Propylene glycol may affect the interpretation of laboratory tests.
Genes of Interest
Monitoring Parameters
Serum electrolytes, urinalysis, renal function tests, CBC in patients with extensive burns on long-term treatment. Serum sulfa concentrations, if clinically indicated.
Advanced Practitioners 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.
Nursing Physical Assessment/Monitoring
Assess allergy history before treatment (sulfonamides). Monitor for development of granulation, rash, or irritation of unburned areas.
Dosage Forms: US
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)
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Flamazine: 1% (20 g, 50 g, 500 g) [contains cetyl alcohol, polysorbate 80, propylene glycol]
Generic: 1% ([DSC])
Anatomic Therapeutic Chemical (ATC) Classification
- D06BA01
Generic Available (US)
Yes
Pricing: US
Cream (Silvadene External)
1% (per gram): $0.30
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.
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: 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)
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
No significant effects or complications reported
Effects on Bleeding
No information available to require special precautions
Pharmacotherapy Pearls
Contains methylparaben and propylene glycol
Index Terms
Silver Sulphadiazine
References
Caruso DM, Foster KN, Blome-Eberwein SA, et al. Randomized clinical study of Hydrofiber dressing with silver or silver sulfadiazine in the management of partial-thickness burns. J Burn Care Res. 2006;27(3):298-309.[PubMed 16679897]
de Graaf E, van Baar ME, Baartmans MG, et al. Partial-thickness scalds in children: A comparison of different treatment strategies. Burns. 2016.[PubMed 28040360]
"Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]
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.[PubMed 4083697]
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.[PubMed 6640389]
Sano S, Fujimori R, Takashima M, Itokawa Y. Absorption, excretion and tissue distribution of silver sulphadiazine. Burns Incl Therm Inj. 1982;8:278-285.[PubMed 7066727]
Schonfeld N. Outpatient management of burns in children. Pediatr Emerg Care. 1990;6(3):249-253.[PubMed 2216929]
Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259.[PubMed 19188870]
Silvadene (silver sulfadiazine) [prescribing information]. New York, NY: Pfizer; October 2016.
SSD (silver sulfadiazine) [prescribing information]. Shreveport, LA: Dr. Reddy’s Laboratories; June 2013.
Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219.[PubMed 17555487]
Brand Names: International
Aldo-Silvederma (HK); Argentafil (CR, DO, GT, HN, NI, PA, SV); Argentamicina (PE); Argenzil (UY); Bactin (LK); Bactrazine (ZW); Burnazin (EG, ID); Burnsil (PH); Burnzorb (PH); Canflame (TW); Dermazin (HK, HU, PL, RU, SI, SK, TH, UA); Diasilve (EG); Falmmazine (VN); Flamazine (AE, AU, BH, CY, DK, FI, GB, IE, IQ, IR, IS, JO, KW, LB, LY, MT, NO, NZ, OM, PK, SA, SY, TH, TW, YE, ZA); Flammazine (AT, BE, BG, CH, DE, ES, FR, GR, LU, NL, PH, PT); Flugen (TW); No-Burn (JO); Platsul-A (AR, CL); Silbecor (ZW); Silmazin (HK, KR); Silvadene (MX, TR, TW); Silvadex (LK, ZW); Silvadiazin (AE, KW); Silvadiazine (BH); Silvadin (EC); Silvederma (ES, LB, PH, VE); Silvedex (PH); Silverderm (TH); Silverdiazina (PE); Silverin (JO, SA); Silvertin (PH); Silvex (HK, LK); Silvirin (IN, VN); Silzine (LK); Sofargen (IT); Sterizol (PH); Sulfadiacina de Plata (PY); Sulfaplata (CO, DO, EC, GT, HN, NI, PA, SV); Sulfargin (EE); Sulfasil (BE); Synvodex (PH)
Last Updated 2/13/20
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