Dosage Forms
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)
Pharmacology
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
Pharmacokinetics/Pharmacodynamics
Absorption
Negligible (superficial and deep burns and normal skin); increased absorption with blister removal (Sano 1982)
Excretion
Silver: Feces; slow excretion rate; Sulfadiazine: Urine (6.6% within 5 days) (Sano 1982)
Half-Life Elimination
Sulfadiazine: ~24 hours (Sano 1982)
Use: Labeled Indications
Burn treatment: As an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.
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.
Dosage and Administration
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.
Dosing: Geriatric
Refer to adult dosing.
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)
Administration
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.
Storage
Store at 20°C to 25°C (68°F to 77°F).
Drug Interactions
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). 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. 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. Consider therapy modification
Test Interactions
Propylene glycol may affect the interpretation of laboratory tests.
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
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.
Monitoring Parameters
Serum electrolytes, urinalysis, renal function tests, CBC in patients with extensive burns on long-term treatment. Serum sulfa concentrations, if clinically indicated.
Pregnancy
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).
Patient Education
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
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.
- Blood in the urine
- Unable to pass urine
- Bruising
- Bleeding
- Severe loss of strength and energy
- Severe abdominal pain
- Severe skin irritation
- 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.
