Application Nr Approved Date Route Status External Links
NDA050740 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Am B Isome Is Indicated For The Following: • Empirical Therapy For Presumed Fungal Infection In Febrile, Neutropenic Patients. • Treatment Of Cryptococcal Meningitis In Hiv-Infected Patients (See Description Of Clinical Studies ). • Treatment Of Patients With Aspergillus Species, Candida Species And/or Cryptococcus Species Infections (See Above For The Treatment Of Cryptococcal Meningitis) Refractory To Amphotericin B Deoxycholate, Or In Patients Where Renal Impairment Or Unacceptable Toxicity Precludes The Use Of Amphotericin B Deoxycholate. • Treatment Of Visceral Leishmaniasis. In Immunocompromised Patients With Visceral Leishmaniasis Treated With Am B Isome, Relapse Rates Were High Following Initial Clearance Of Parasites (See Description Of Clinical Studies ). See Dosage And Administration For Recommended Doses By Indication.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Amphotericin B

Comments