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ACZONE (DAPSONE): WARNINGS AND PRECAUTIONS
Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern and Mediterranean ancestry.
There was no evidence of clinically relevant hemolysis or anemia in patients treated with Aczone, including patients who were G6PD deficient. Some subjects with G6PD deficiency using Aczone gel developed laboratory changes suggestive of mild hemolysis.
If signs and symptoms suggestive of hemolytic anemia occur, Aczone gel 5% should be discontinued. This drug should not be used in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of Aczone (Dapsone) gel with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency.
Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical Aczone (Dapsone) gel 5% treatment.
Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical Dapsone (Aczone) treatment.
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