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    Journal of Pharmacology and PharmacotherapeuticsNOW IN
    Article

    Skin rash during treatment with generic itraconazole

    Antonio De Vuono1,2, Caterina Palleria2,3, Francesca Scicchitano2,3, Aida Squillace2,3, Giovambattista De Sarro2,3, Luca Gallelli2,3★★ Corresponding author

    1. 1Department of General Medicine, Cosenza.
    2. 2Department of Health Science, Regional Center on drug information, Mater Domini University Hospital.
    3. 3Chair of Pharmacology, School of Medicine, University of Catanzaro, Italy.

    CORRESPONDENCE

    Luca Gallelli

    Department of Health Science, Regional Center on drug information, Mater Domini University Hospital.

    gallelli@unicz.it

    Received: 15-04-2013; Revised: 04-06-2013; Accepted: 12-07-2013.

    Volume 5, Issue 2 · pp. 158–160 · PUBLISHED 2014 · DOI: 10.4103/0976-500X.130086

    View on J Pharmacol. Pharmacother. original site ↗

    ABSTRACT

    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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      Vuono, A. D., Palleria, C., Scicchitano, F., Squillace, A., Sarro, G. D., & Gallelli, L. (2014). Skin rash during treatment with generic itraconazole. Journal of Pharmacology and Pharmacotherapeutics, 5(2), 158–160. https://doi.org/10.4103/0976-500X.130086