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Antimicrobial Agents and Chemotherapy, April 2005, p. 1642-1645, Vol. 49, No. 4
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.4.1642-1645.2005

Efficacy and Safety of Generic Amphotericin B in Experimental Pulmonary Aspergillosis

Vidmantas Petraitis,1,2 Ruta Petraitiene,1,2 Pengxin Lin,1 Karim Calis,3 Amy M. Kelaher,1 Heidi A. Muray,1 Christine Mya-San,1 Diana Mickiene,1 John Bacher,4 and Thomas J. Walsh1*

Immunocompromised Host Section, Pediatric Oncology Branch, National Cancer Institute,1 Surgery Service, Veterinary Resources Program, Office of Research Services, National Institutes of Health,4 Pharmacy Department, Warren-Grant Magnuson Clinical Center, Bethesda,3 SAIC-Frederick, Inc., Frederick, Maryland2

Received 13 July 2004/ Returned for modification 11 October 2004/ Accepted 20 December 2004

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.

* Corresponding author. Mailing address: Immunocompromised Host Section, Pediatric Oncology Branch, National Cancer Institute, Building 10, CRC, Rm. 1W-5740, 10 Center Dr., MSC 1100, Bethesda, MD 20892-1100. Phone: (301) 402-0023. Fax: (301) 480-2308. E-mail: walsht{at}mail.nih.gov.

Antimicrobial Agents and Chemotherapy, April 2005, p. 1642-1645, Vol. 49, No. 4
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.4.1642-1645.2005




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  • Wiederhold, N. P., Tam, V. H., Chi, J., Prince, R. A., Kontoyiannis, D. P., Lewis, R. E. (2006). Pharmacodynamic Activity of Amphotericin B Deoxycholate Is Associated with Peak Plasma Concentrations in a Neutropenic Murine Model of Invasive Pulmonary Aspergillosis. Antimicrob. Agents Chemother. 50: 469-473 [Abstract] [Full Text]  


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