Classes
DEA Class; Rx
Common Brand Names; Silvadene, Thermazene, SSD Cream
- Antibacterials, Topical
Description
Topical sulfonamide antiinfective; wide spectrum of activity against Candida and gram-positive and gram-negative bacteria; used to prevent and treat serious burn and wound infections.
Indications
Indicated for wound management including the treatment of burn wound infection and burn wound infection prophylaxis in persons with second- and third-degree burns.
Contraindications
Sulfa allergy
Hypersensitivity
Pregnant women at term or near term; premature infants, or in infants 2 months or younger
Adverse Effects
- 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
Use caution in G6PD deficiency; hemolysis may occur
For topical use only; avoid contact with eyes
Prolonged use may result in bacterial or fungal superinfection
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
Use caution in hepatic/renal impairment
For topical use only; avoid contact with eye
Pregnancy and Lactation
Pregnancy category: C, X (near term)
Lactation: Not known if distributed into breast milk; use caution
Maximum Dosage
2 applications/day; additional applications may be necessary if cream is removed by activity.
2 applications/day; additional applications may be necessary if cream is removed by activity.
2 applications/day; additional applications may be necessary if cream is removed by activity.
2 applications/day; additional applications may be necessary if cream is removed by activity.
>= 2 months: 2 applications/day; additional applications may be necessary if cream is removed by activity.
< 2 months: Safety and efficacy have not been established.
How supplied
Silver sulfadiazine
cream
- 1%
