AM B ISOME SUMMARY
Am B isome for Injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains 50 mg of amphotericin B, USP, intercalated into a liposomal membrane consisting of approximately 213 mg hydrogenated soy phosphatidylcholine; 52 mg cholesterol, NF; 84 mg distearoylphosphatidylglycerol; 0.64 mg alpha tocopherol, USP; together with 900 mg sucrose, NF; and 27 mg disodium succinate hexahydrate as buffer. Following reconstitution with Sterile Water for Injection, USP, the resulting pH of the suspension is between 5-6.
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
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.
Published Studies Related to AM B Isome (Amphotericin B)
CryptoDex: a randomised, double-blind, placebo-controlled phase III trial of
adjunctive dexamethasone in HIV-infected adults with cryptococcal meningitis:
study protocol for a randomised control trial. 
BACKGROUND: Cryptococcal meningitis (CM) is a severe AIDS-defining illness with
90-day case mortality as high as 70% in sub-Saharan Africa, despite treatment.
The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) study: a
randomized, double-blinded, placebo-controlled trial. 
was conducted... CONCLUSIONS: Patients with mucormycosis treated with deferasirox had a higher
Randomized clinical trial of perioperative selective decontamination of the digestive tract versus placebo in elective gastrointestinal surgery. [2011.10]
BACKGROUND: This randomized clinical trial analysed the effect of perioperative selective decontamination of the digestive tract (SDD) in elective gastrointestinal surgery on postoperative infectious complications and leakage... CONCLUSION: Perioperative SDD in elective gastrointestinal surgery combined with standard intravenous antibiotics reduced the rate of postoperative infectious complications and anastomotic leakage compared with standard intravenous antibiotics alone. Perioperative SD.D should be considered for patients undergoing gastrointestinal surgery. Registration number: P02.1187L (Dutch Central Committee on Research Involving Human Subjects). Copyright (c) 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) study: a randomized, double-blinded, placebo-controlled trial. [2011.09.20]
ObjectivesHost iron availability is fundamental to mucormycosis pathogenesis. The combination of liposomal amphotericin B (LAmB) and deferasirox iron chelation therapy synergistically improved survival in diabetic mice with mucormycosis...
Economic evaluation of caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia in Sweden. [2011.07]
OBJECTIVE: To evaluate the cost-effectiveness of caspofungin versus liposomal amphotericin B (L-AmB) for empirical antifungal therapy in patients with persistent fever and neutropenia in Sweden... CONCLUSION: Given the underlying assumptions and data used, caspofungin is expected to be cost-effective with at least comparable outcomes compared to L-AmB for the empirical treatment of patients with suspected fungal infections in Sweden.
Page last updated: 2015-08-10