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Silver Sulfadiazine

Pronunciation

(SIL ver sul fa DYE a zeen)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

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]

Thermazene: 1% (20 g [DSC], 50 g [DSC], 85 g [DSC], 400 g [DSC], 1000 g [DSC]) [contains methylparaben, propylene glycol]

Generic: 1% (20 g, 25 g, 50 g, 85 g, 400 g)

Brand Names: U.S.

  • Silvadene
  • SSD
  • Thermazene [DSC]

Pharmacologic Category

  • Antibiotic, Topical

Pharmacology

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)

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.

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

Burn treatment: Infants ≥2 months, Children, and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

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.

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. 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: 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

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 Risk Factor

B

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

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience skin discoloration. Have patient report immediately to prescriber signs of infection, signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), hematuria, urinary retention, bruising, bleeding, severe loss of strength and energy, severe abdominal pain, severe skin irritation, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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