Each 100 grams of SILVEDERMA cream contains 1 g of micronized silver sulfadiazine and excipients (cetostearyl alcohol, vaseline, isopropyl myristate, propylene glycol, polyoxyl 40 stearate, sorbitan oleate, methylparaben and purified water), s.q.
Sulfadiazine absorption in SILVEDERMA application: Approximately 10% of the sulfadiazine contained in silver sulfadiazine is absorbed (5 g of silver sulfadiazine contains approximately 3 g of sulfadiazine).
In extensive burns, 500 g of cream can be applied, that means 5 g of silver sulfadiazine of which 0.3 g can be absorbed. This quantity cannot cause any renal problem. However, in patients with very extensive burns, sulfadiazine crystals can be observed in urine. Urine excretion of 50-100 ml/hour should be maintained, with the help of the appropriate administration of parenteral or oral liquids (electrolytic solutions, etc.).
It is necessary to be aware that the local absorption of substances in burns is very variable, because sometimes less active ingredients are absorbed through third-degree burns than through second-degree burns, possibly due to the presence of eschars in carbonized tissue.
Topical antibacterial. Prevention and healing of infections caused by Pseudomonas and Staphylococcus in all kinds of injuries and ulcers, and especially in burns.
Other uses of silver sulfadiazine: Because of its capacity to fight the infection without interfering in the epithelial regeneration, silver sulfadiazine has been used in other skin lesions such as bedsores. In such cases, healing has been excellent.
Application and usual dosage: Application in grave and extensive burns: The cream should be applied to the burnt area after the cleansing and debridement of the wound, usually once a day, wearing a sterile glove, to a thickness of 1 mm, making sure that all interstices and crevices of the irregular burnt surface are treated. Silver sulfadiazine should be applied more frequently to burnt areas from which the cream might be removed by any involuntary movement of the patient. The therapy should be continued until a satisfactory healing has been achieved or until the burnt area is ready for grafting.
Dressings are unnecessary but covering with fine mesh gauze and bandage will be more convenient for the majority of the patients. Hydrotherapy and mechanical debridement are advisable in patients with third-degree burns.
The therapy with sulphonamide is usually contraindicated in premature babies and in newborns of less than two months, since it can cause kernicterus.
Because of these theoretical reasons, it is better not to use silver sulfadiazine in patients sensitive to sulphonamides and in pregnant women. Due to the hazards of sepsis with severe burns, the use of silver sulfadiazine in such patients should be determined individually.
In order to attenuate or suppress the local bacterial action, silver sulfadiazine reduces the autolysis of eschars. For this reason, the treatment should include daily hydrotherapy and debridement, which enhances the quick detachment of eschars in patients with third-degree burns.
Warnings about excipients: Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Propylene glycol may cause skin irritation.
Significant quantities of sulfadiazine can be absorbed after the long treatment of extensive burns.
SILVEDERMA cream should be used with caution in the presence of significant hepatic or renal impairment. Caution of use is required in patients known to be sensitive to systemic sulphonamides and in individuals known to have glucose-6-phosphate dehydrogenase deficiency.
The monitoring of the plasmatic levels of sulfadiazine is not necessary, except, possibly in patients with impaired hepatic or renal functions when the drug is applied to an extensive surface under occlusive bandage or to damaged skin (especially if burnt).
Should a massive absorption of the drug occur, its elimination through the urine should be enhanced with the help of the ingestion of abundant bicarbonated liquids.
In the event of serious crystalluria, urethral catheterization might be necessary.
Patients should consult their physician or pharmacist.
Due to theoretical reasons, silver sulfadiazine should not be used in pregnant or nursing women. However, due to the grave risk of sepsis in patients with serious burns, its use in such patients should be determined individually.
The application of SILVEDERMA is painless and it usually has a good tolerance, but a few percentage (2.5%) of patients experience rash, pruritus or a burning sensation.
Rarely, reversible leukopenia may occur, such leukopenia is characterized by a decrease in the neutrophil count. The maximum white blood cell 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.
Silver sulfadiazine has an optimal tolerance even in lengthy treatments, whereas some recommend a 1% coating of cream of 1 mm of thickness, others use a thickness ten times greater, that means 1 cm, without the appearance of any toxic effect.
Patients should inform their physician or pharmacist if they are taking or have recently taken any other medicament, even those obtained without medical prescription.
Dispensing conditions: With medical prescription.
Directions for the correct administration of the preparation: See Dosage & Administration.
The tube has a seal whose opening is carried out following the instructions: 1. Unscrew cap from tube.
2. Insert the cap and make it coincide with the jagged head of the tube.
3. Rotate it until the head comes off.
Incompatibilities: None known.
Store in a cool place (below 30°C) protected from light.
D06BA01 - silver sulfadiazine ; Belongs to the class of topical sulfonamides used in the treatment of dermatological diseases.
Silvederma cream 1%
50 g x 1's
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