SILVEDERMA Cream Ref.[51139] Active ingredients: Silver sulfadiazine

Precautions

In patients with serious renal or hepatic insufficiency 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.

Precaution is required in patients known to be sensitive to systemic sulphonamides and in individuals who are known to have glucose-6-phosphate dehydrogenase deficiency.

Sunlight may produce a grey colouring of silver sulfadiazine. It is therefore recommended to avoid the exposure of areas treated with SILVEDERMA cream to direct sunlight.

Absorption of sulfadiazine by application of SILVEDERMA

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 can be applied, which means 5 g of silver sulfadiazine, of which 0.3 g of sulfadiazine can be absorbed, it is an insignificant amount to cause renal problems.

However, in patients with very extensive burns, the presence of sulpha crystals in urine should be monitored. Its volume should remain at 50-100 ml/hour, by the corresponding administration of parenteral or oral liquids (solutions of electrolytes, etc).

It is necessary to reckon that the local absorption of substances in burns is very variable, because sometimes less active ingredients are absorbed through third-degree burns than through seconddegree burns, possibly due to the presence of eschars of carbonized tissue.

Warnings

In order to attenuate or suppress the local bacterial action, silver sulfadiazinereduces the autolysis of eschars. For this reason, the treatment should include daily hydrotherapy and debridement, which enhances the quick detachment of eschars inpatients with third-degree burns.

When topical proteolytic enzymes are used simultaneously, the possible inactivationby silver should be taken into account.

A reproduction study has been carried out on rabbits at doses up to three to ten times the concentration of silver sulfadiazine in SILVEDERMA cream and no harmto the foetus due to silver sulfadiazine has been evidenced. However, there are no adequate and well controlled studies in pregnant women.

As reproductive studies in animals are not always predictive of human response, this drug should be used during pregnancy only if it is clearly justified, especially in pregnant women approaching or at term.

It is not known whether silver sulfadiazine is excreted in human milk. However, sulphonamides are known to be excreted in human milk, and that all sulphonamide derivatives increase the possibility of kernicterus. Because of the possibility of serious adverse reactions in nursing infants from sulphonamides, it should bedecided whether to discontinue nursing or discontinue the treatment, taking into account the importance of the drug for the mother.

SILVEDERMA cream has no effects on the ability to drive vehicles or operate machinery.

SILVEDERMA cream is very well tolerated in general, and its application is painlessfor the majority of the patients.

However, a little percentage suffer troublesome reactions, such as pruritus, andslight burning sensation.

Rarely reversible leukopenia may occur, such leukopenia is characterized by a decrease in the neutrophil count. The maximum white blood cells depression occurs within 2 to 4 days of the commencement of the therapy. Leukopenia rebounds to normality sometimes spontaneously and always when discontinuing the treatment.

Although cases of argyria have not been reported, the risk cannot be excluded.

The absorption of silver sulfadiazine varies depending on the percentage of body surface area and on the extent of the tissue damage. Although very few cases havebeen reported, it is possible that any adverse reaction associated with sulphonamides may occur. Some of these reactions are: blood dyscrasias, including granulocytosis, aplastic anemia, thrombocytopenia, leukopenia and haemolytic anemia, dermatologic and allergic reactions, including Stevens-Johnson syndrome and exfoliative dermatitis, gastrointestinal reactions, hepatitis and hepatocellular necrosis, CNS reactions and toxic nephrosis.

None known.