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Dermazin

Dermazin Special Precautions

silver sulfadiazine

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of sulfadiazine.
Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment.
If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, sulfadiazine treatment should be discontinued. The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of sulfadiazine, sulfadiazine must not be re-started in this patient at any time.
Since sulfonamides may cause kernicterus, sulfadiazine silver should not be used in late pregnancy, in premature infants or infants younger than 2 months unless the expected benefit outweighs the potential risk.
Caution should be exercised when treating patients with hypersensitivity to sulfonamides, kidney failure and damage to liver parenchyma.
If signs for leukopenia are observed or if the patient is hypersensitive to sulfonamides, a white blood cell count is recommended.
Mainly under the influence of sunlight a gray discoloration of the skin may occur.
Patients with glucose-6-phosphate dehydrogenase deficiency, or in whom it is suspected, should be carefully monitored.
Important information about some of excipients of Dermazin: The cream contains methylparahydroxybenzoate and propylparahydroxybenzoate which may cause allergic reaction (possibly delayed). Dermazin contains arachis oil (peanut oil). If the patient is allergic to peanut or soya, do not use this medicinal product. It contains also propylene glycol, which may cause skin irritation.
Effects on ability to drive and use machines: There are no studies on the effect on the ability to drive or operate machines.
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