title: Efficacy and safety of generic amphotericin B in experimental pulmonary aspergillosis.
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.
authors.affiliation: Immunocompromised Host Section, Pediatric Oncology Branch, National Cancer Institute, Building 10, CRC, Rm. 1W-5740, 10 Center Dr., MSC 1100, Bethesda, Maryland 20892-1100, USA.
authors.forename: Vidmantas
authors.initials: V
authors.lastname: Petraitis
authors.forename: Ruta
authors.initials: R
authors.lastname: Petraitiene
authors.forename: Pengxin
authors.initials: P
authors.lastname: Lin
authors.forename: Karim
authors.initials: K
authors.lastname: Calis
authors.forename: Amy M
authors.initials: AM
authors.lastname: Kelaher
authors.forename: Heidi A
authors.initials: HA
authors.lastname: Muray
authors.forename: Christine
authors.initials: C
authors.lastname: Mya-San
authors.forename: Diana
authors.initials: D
authors.lastname: Mickiene
authors.forename: John
authors.initials: J
authors.lastname: Bacher
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Walsh
mesh_terms: D000666:Amphotericin B / Q000009:adverse effects / Q000627:therapeutic use; D000818:Animals; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use; D001228:Aspergillosis / Q000188:drug therapy*; D016568:Drugs, Generic / Q000009:adverse effects / Q000627:therapeutic use*; D008172:Lung Diseases, Fungal / Q000188:drug therapy*; D009503:Neutropenia / Q000150:complications; D011817:Rabbits
chemical_list: D000935:Antifungal Agents; D016568:Drugs, Generic; D000666:Amphotericin B