Efficacy and safety of generic amphotericin B in experimental pulmonary aspergillosis

Petraitis, V.; Petraitiene, R.; Lin, P.; Calis, K.; Kelaher, A.M.; Muray, H.A.; Mya-San, C.; Mickiene, D.; Bacher, J.; Walsh, T.J.

Antimicrobial Agents and ChemoTherapy 49(4): 1642-1645

2005


ISSN/ISBN: 0066-4804
PMID: 15793161
DOI: 10.1128/aac.49.4.1642-1645.2005
Accession: 004425269

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Abstract
The recent shortage of the brand name drug Fungizone has necessitated a change to generic formulations of amphotericin B deoxycholate. Clinical trials cannot be conducted in a timely manner to provide data on the safety and efficacy of these formulations. We therefore compared generic amphotericin B and Fungizone for activity and safety in the treatment of experimental invasive pulmonary aspergillosis (IPA) in persistently neutropenic rabbits. Fungizone and generic amphotericin B are similar in efficacy, pharmacokinetics, and safety in the treatment of experimental IPA.