Silvederma Special Precautions

Silver sulfadiazine may be absorbed following topical application and produce systemic effects similar to those of other sulfonamides. Fungal superinfection may occur. Use is not recommended in premature or newborn infants up to 2 months of age. Sulfa medicines may cause liver problems in these infants.
Transient leukopenia does not usually require withdrawal of silver sulfadiazine, but blood counts should be monitored to ensure they return to normal within a few days. Systemic absorption of silver, resulting in argyria, can occur when silver sulfadiazine is applied to large area wounds or over prolonged periods.
Significant quantities of sulfadiazine can be absorbed following prolonged treatment of extensive burns. Monitoring of serum levels during prolonged treatment is not necessary except possibly, in patients with impaired renal or hepatic function.
It is difficult to eliminate free sulfadiazine that is absorbed through the wound in patients with impaired renal or hepatic function. An accumulation of the medicinal product may occur as the elimination decreases.
The application on open lesions should be avoided in these cases, especially in ulcers. Due caution is advised in order to avoid crystalluria, although this kind of toxicity is not demonstrated. Adequate fluid intake is necessary to reduce the risk of possible crystalluria.
Precaution is required in patients known to be sensitive to systemic sulfonamides and in individuals who are known to have glucose-6-phosphate dehydrogenase deficiency.
Sunlight may produce a grey coloring of silver sulfadiazine. It is therefore recommended to avoid exposure of areas treated with Silver sulfadiazine (SILVEDERMA) cream to direct sunlight.
Absorption of sulfadiazine by application of Silver sulfadiazine (SILVEDERMA) Cream: Approximately 10% of the sulfadiazine contained in silver sulfadiazine is absorbed (5 g of silver sulfadiazine contains approximately 3 g of sulfadiazine).
In an extensive burn, 500 g of cream may be applied. In this case, 300 mg of sulfadiazine may be absorbed in 5 g of silver sulfadiazine. This is an insignificant amount to cause renal problems.
However, in patients with very extensive burns, the presence of sulfa crystals in urine should be monitored. Its volume should remain at 50-100 mL/hour with the corresponding administration of parenteral or oral liquid preparations (electrolytes solutions, etc.).
Silver sulfadiazine decreases autolysis of eschar because it attenuates or eliminates local antibacterial action. As such, hydrotherapy and debridement should be performed daily to enhance the rapid removal of eschar in patients with third-degree burns.
Effects on the Ability to Drive Vehicles or Operate Machinery: Silver sulfadiazine (SILVEDERMA) cream has no effects on the ability to drive vehicles or operate machinery.