Efficacy and safety of generic amphotericin B in experimental pulmonary aspergillosis

Antimicrob Agents Chemother. 2005 Apr;49(4):1642-5. doi: 10.1128/AAC.49.4.1642-1645.2005.

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.

MeSH terms

  • Amphotericin B* / adverse effects
  • Amphotericin B* / therapeutic use
  • Animals
  • Antifungal Agents* / adverse effects
  • Antifungal Agents* / therapeutic use
  • Aspergillosis / drug therapy*
  • Drugs, Generic* / adverse effects
  • Drugs, Generic* / therapeutic use*
  • Lung Diseases, Fungal / drug therapy*
  • Neutropenia / complications
  • Rabbits

Substances

  • Antifungal Agents
  • Drugs, Generic
  • Amphotericin B