Efficacy and safety of generic amphotericin B in experimental pulmonary aspergillosis.
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.
Petraitis
Vidmantas
V
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.
Petraitiene
Ruta
R
Lin
Pengxin
P
Calis
Karim
K
Kelaher
Amy M
AM
Muray
Heidi A
HA
Mya-San
Christine
C
Mickiene
Diana
D
Bacher
John
J
Walsh
Thomas J
TJ
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
D000935:Antifungal Agents; D016568:Drugs, Generic; D000666:Amphotericin B