Dosing and uses of Silvadene, Thermazene (silver sulfadiazine)
Adult dosage forms and strengths
cream
- 1%
Burn Wound Infections (2°/3°)
1% cream: Apply qDay-q12hr to burn
Pediatric dosage forms and strengths
cream
- 1%
Burn Wound Infections (2°/3°)
<2 months: Contraindicated
>2 months (1% cream): Apply qDay-q12hr to burn
Silvadene, Thermazene (silver sulfadiazine) adverse (side) effects
Frequency not defined
Pain
Burning
Itching
Rash
Necrosis of the skin
Erythema multiforme
Transient skin discoloration
Hemolytic anemia (in patients with G6PD deficiency)
Agranulocytosis
Aplastic anemia
Thrombocytopenia
Leukopenia
Dermatologic and hypersensitivity reactions (eg, Stevens-Johnson syndrome, TEN)
Adverse GI effects
Hepatitis and hepatocellular necrosis
Adverse nervous system effects
Toxic nephrosis
Interstitial nephritis
Warnings
Contraindications
Sulfa allergy
G6PD deficiency
Hypersensitivity
Sulfonamides may increase possibility of kernicterus; therefore, do not use during near-term pregnancy, in premature infants, or in infants below age 2 months
Cautions
Not recommended for use in pregnant women unless the burned area covers more than 20% of body surface or therapeutic benefits to patient outweigh the possible risks to the fetus
Although silver sulfadiazine is minimally absorbed, it reacts with body fluids to release sulfadiazine, which is absorbed and may reach substantial serum concentrations
Absorption of silver sulfadiazine varies depending on the percent of body surface area and the extent of the tissue damage; it is possible that any adverse reaction associated with sulfonamides may occur including blood dyscrasias, dermatologic and allergic reactions (including life-threatening cutaneous reactions [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), exfoliative dermatitis]), GI reactions, hepatitis and hepatocellular necrosis, CNS reactions, and toxic nephrosis
Hepatic/renal impairment
Pregnancy and lactation
Pregnancy category: C, X (near term)
Lactation: Not known if distributed into breast milk; use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Silvadene, Thermazene (silver sulfadiazine)
Mechanism of action
Acts on cell membrane and cell walL
Absorption
Peak plasma time: 3-11 days
Elimination
Half-life: 10 hr
Excretion: Urine (50%)
