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For the use only of a Registered Medical Practitioner of a Hospital or a Laboratory
PRESENTATION

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.

COMPOSITION
Each ml of FUNGISOME i.v. contains 1mg of AmphotericinB IP/USP in liposomes.
DESCRIPTION

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.  

PHARMACOLOGY
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.)

T (h)
(h1)
Area under curve (g h/ml)
Total clearance (ml/h/kg)
Volume of distribution (lit.)
Peak Concentration (g/ml)
Trough Concentration (g/ml)
17.2 + 1.76
0.042 + 0.004
11.426 + 0.914
91.7 + 8.9
2.285 + 0.304
1.012 + 0.055
0.237 + 0.017

For conventional Amphotericin B peak and trough concentrations were 0.9 and 0.28 µg/ml.

Pharmacokinetics, after multiple dose administration of FUNGISOME i.v. in adults-

Peak Concentration (g/ml)
Trough Concentration (g/ml)
1.66 ± 0.19
0.48 ± 0.07

INDICATIONS
FUNGISOME i.v. is indicated as prophylactic, empirical or treatment of disseminated and invasive systemic fungal infections and also in patients of leishmaniaisis.

FUNGISOME i.v. has been found to be effective even in cases resistant to standard antifungal drugs and antileishmanial drugs.

PREPARATION FOR ADMINISTRATION
Read this section carefully and follow the instructions before administration of FUNGISOME i.v.
DILUTION OF FUNGISOME i.v.

Follow the instructions given in product insert.

DOSES & ADMINISTRATION

The recommended dose of FUNGISOME i.v. Is 1-3mg/kg body weight/day. For details, refer to Product insert

The duration of treatment should be decided on the basis of clinical, radiological, histopathological and microbiological assessment.                  

SAFETY
FUNGISOME i.v. therapy has been administered for as long as 8.5 months (256 days) and maximum total dose of 11.23gms of Amphotericin B was administered without significant toxicity4 .
LEISHMANIASIS
PEDIATRIC PATIENTS

Pediatric patients of systemic fungal infections and visceral leishmaniasis have been treated successfully with doses comparable to adults on a per kilogram body weight basis without any significant adverse effect.

NEONATES
GERIATRIC PATIENTS

Based on studies done till now, no specific dosage alteration or precautions are recommended.

RENAL AND LIVER DISEASES
PREGNANCY OR LACTATION

FUNGISOME should be administrered after ascertaining that benefits outweight the risks.

CONTRAINDICATIONS
 
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