No

Antibiotic, Topical

Prevention and treatment of infection in second and third degree burns

B

Hypersensitivity to silver sulfadiazine or any component; premature infants or neonates <2 months of age because sulfonamides compete with bilirubin for protein binding sites which may displace bilirubin and cause kernicterus, pregnant women approaching or at term

Use with caution in patients with G-6-PD deficiency, renal impairment, or history of allergy to other sulfonamides; sulfadiazine may accumulate in patients with impaired hepatic or renal function; fungal superinfection may occur; use of analgesic might be needed before application; systemic absorption is significant and adverse reactions may occur

1% to 10%:

Dermatologic: Itching, rash, erythema multiforme, discoloration of skin

Hematologic: Hemolytic anemia, leukopenia, agranulocytosis, aplastic anemia

Hepatic: Hepatitis

Renal: Interstitial nephritis

Miscellaneous: Allergic reactions may be related to sulfa component

<1%: Photosensitivity

Decreased effect: Topical proteolytic enzymes are inactivated

Silvadene® cream will occasionally darken either in the jar or after application to the skin. This color change results from a light catalyzed reaction which is a common characteristic of all silver salts. A similar analogy is the oxidation of silverware. The product of this color change reaction is silver oxide which ranges in color from gray to black. Silver oxide has rarely been associated with permanent skin discoloration. Additionally, the antimicrobial activity of the product is not substantially diminished because the color change reaction involves such a small amount of the active drug and is largely a surface phenomenon.

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: Significant percutaneous absorption of silver sulfadiazine can occur especially when applied to extensive burns

Half-life: 10 hours and is prolonged in patients with renal insufficiency

Time to peak serum concentration: Within 3-11 days of continuous therapy

Elimination: ~50% excreted unchanged in urine

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

Serum electrolytes, urinalysis, renal function tests, CBC in patients with extensive burns on long-term treatment

None reported

May cause leukopenia; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Usually applied by professional in burn care setting. Patient instruction should be appropriate to extent of burn, patient understanding, etc.

Evaluate the development of granulation

Cream, topical: 1% [10 mg/g] (20 g, 50 g, 85 g, 400 g, 1000 g)

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.