CASE REPORT
Year : 2014  |  Volume : 5  |  Issue : 2  |  Page : 158-160

Skin rash during treatment with generic itraconazole


1 Department of General Medicine, Cosenza; Department of Health Science, Regional Center on drug information, Mater Domini University Hospital, Italy
2 Department of Health Science, Regional Center on drug information, Mater Domini University Hospital; Chair of Pharmacology, School of Medicine, University of Catanzaro, Italy

Correspondence Address:
Luca Gallelli
Department of Health Science, Chair of Pharmacology, School of Medicine, University of Catanzaro, Clinical Pharmacology Unit, Mater Domini University Hospital, Viale Europa, Germaneto 88100 Catanzaro
Italy
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0976-500X.130086

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Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re-challenge confirmed the association between itraconazole and skin rash. Both Naranjo probability scale and World Health Organization causality assessment scale documented a probable association between generic-itraconazole and skin rash. The switch from generic formulation to brand one induced an improvement of symptoms. Since we are unable to evaluate the role of each excipient in the development of skin rash, we cannot rule out their involvement. However, more data are necessary to better define the similarities or differences between branded and generic formulations.


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