FUNGISOME® i.v. is a sterile, yellow liquid product for intravenous infusion. Each ml of FUNGISOME® i.v. infusion contains 1mg of Amphotericin B intercalated in liposomes. It is available in three presentations of 10ml, 25ml and 50ml.
Each ml of FUNGISOME® i.v. contains 1mg of AmphotericinB IP/USP in liposomes.
Amphotericin B is a macrolide polyene antibiotic produced by strain of Streptomyces nodosus.
Liposomes are artificial vesicles, composed of concentric lipid bilayers which enclose an aqueous space. Amphotericin B being lipophilic is intercalated into the lipid bilayer.
Amphotericin B shows a high order of in vitro activity against many species of fungi viz. Histoplasma capsulatum, Cryptococcus immitis, Candida sp., Blastomyces dermatitidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenckii, Mucor sp., Aspergillus sp., Malassezia furfur, Trichosporon beigelii, Saccharomyces cerevisiae, Scedosporium sp., Paecilomyces sp., Penicillium sp., Fusarium sp., Bipolaris sp., Exophiala sp., Cladophialophora sp., Absidia sp., Apophysomyces sp., Cunninghamella sp., Rhizomucor sp., Rhizopus sp. and Saksenaea sp.These fungi are inhibited by concentrations of Amphotericin B ranging from 0.03 to 1 µg/ml in vitro. Amphotericin B also has activity against species of Leishmania and is found to be effective in the treatment of Kala-Azar. It has minimal or no effect on bacteria and viruses.
Patients treated with conventional*Amphotericin B develop toxicities such as nephrotoxicity, cardiotoxicity, CNS toxicity, electrolyte disturbances besides acute reactions like fever, chills, nausea, vomiting, etc.
FUNGISOME® i.v. is a liposomal formulation strategically designed to provide remarkably improved therapeutic efficacy and much less toxicity as compared to conventional Amphotericin B .
In Aspergillus pneumonia FUNGISOME® i.v. delivered higher drug concentration for longer duration in lungs while it allowed lower concentrations in kidneys as compared to conventional Amphotericin B. In leishmaniasis FUNGISOME® i.v. was better tolerated even in higher single dose of 10-15mg/kg.
In clinical studies, FUNGISOME® i.v. was effective in systemic fungal infections and leishmaniasis cases that did not respond to conventional Amphotericin B and other standard drugs.
Pharmacokinetics, after single dose administration of FUNGISOME® i.v.
(1 mg/kg body wt.)