FOSCAVIR

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Foscarnet sodium

Available from:

Clinect Pty Ltd

Class:

Medicine Registered

Summary of Product characteristics

 
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FOSCAVIR
®
 PRODUCT INFORMATION 
(Foscarnet sodium solution for infusion) 
NAME OF THE MEDICINE 
Foscarnet sodium hexahydrate 
DESCRIPTION 
Foscarnet sodium is trisodium phosphonoformate hexahydrate or 
phosphonoformic acid trisodium salt hexahydrate, MW 300.0. 
Structural Formula:  
.6H
2
O 
CAS Number:  34156-56-4 
A clear, sterile, isotonic solution of foscarnet sodium in Water for
Injections, 
adjusted to pH 7.4 with hydrochloric acid. No preservatives or buffers
are 
contained in FOSCAVIR. 
PHARMACOLOGY 
Foscarnet is an antiviral agent with a broad antiviral spectrum which
inhibits all 
known human viruses of the herpes group (Herpes simplex type 1 and 2,
human 
herpes virus 6), varicella zoster virus, Epstein-Barr virus and
cytomegalovirus 
(CMV) and some retroviruses including human immunodeficiency virus
(HIV) at 
concentrations not affecting normal cell growth.  Foscarnet also
inhibits the viral 
DNA polymerases from hepatitis B virus.  Foscarnet exerts its
antiviral activity by a 
direct inhibition of viral specific DNA polymerase and reverse
transcriptase.  
Foscarnet does not require activation by thymidine kinase or other
kinases and 
therefore is active _in vitro_ against herpes simplex virus (HSV)
mutants deficient in 
thymidine kinase (TK). 
_In vitro_
 systems are of limited value in predicting _in
vivo_ effectiveness.  The mean 
foscarnet 50% inhibition value (ID
50
) for more than one hundred clinical CMV 
isolates is approximately 270 micromol/L, while a reversible
inhibition of normal 
cell growth is observed at about 1000 micromol/L. 

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In several animal species foscarnet is rapidly cleared from blood and
other soft 
tissues after intravenous administration.  However, dose
proportional 
concentrations have been observed in bone and cartilage in all animal
species 
studied.  
Investigations in dogs have shown that foscarnet has no effect on
calcium 
homoeostasis. 
Foscarnet was shown to have clastogenic activity in the