FAMCICLOVIR FBM famciclovir 500 mg tablet blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

famciclovir

Beszerezhető a:

Southern Cross Pharma Pty Ltd

INN (nemzetközi neve):

Famciclovir

Engedélyezési státusz:

Registered

Termékjellemzők

Famciclovir_PI FBM_September 2
Page 1 of 20
PRODUCT INFORMATION
FAMCICLOVIR FBM TABLETS 250 MG AND 500 MG
NAME OF THE MEDICINE
Active ingredient: famciclovir
Chemical name: 9-(4-acetoxy-3-acetoxymethylbut-1-yl)-2-aminopurine
CAS number: 104227-87-4
Molecular weight: 321.3
Molecular formula: C
14
H
19
N
5
O
4
The chemical structure of famciclovir is:
DESCRIPTION
Famciclovir is a synthetic guanine derivative. It is a white to pale
yellow
crystalline solid. Excipients in FAMCICLOVIR FBM tablets are
microcrystalline
cellulose,
crospovidone,
colloidal
anhydrous
silica,
copovidone,
sodium
stearylfumarate and Opadry White YS-22-18096 (PI 4171).
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Famciclovir is a synthetic guanine derivative antiviral agent, ATC
code:
JO5A B09.
_VIROLOGY._ Famciclovir is the oral form of the antiviral compound
penciclovir.
Famciclovir
is
rapidly
converted
_in _
_vivo_
into
penciclovir,
which
has
demonstrable _in vitro_ activity against herpes simplex viruses (HSV
types 1 and
2) and varicella zoster virus (VZV). The antiviral effect of orally
administered
famciclovir has been demonstrated in several animal models. This
effect is
due to in vivo conversion to penciclovir.
Famciclovir_PI FBM_September 2
Page 2 of 20
Penciclovir targets virus infected cells where it is rapidly converted
into
penciclovir triphosphate (mediated via virus induced thymidine
kinase). The
triphosphate
inhibits
viral
DNA
polymerase
by
competition
with
deoxyguanosine triphosphate and is incorporated into the extending DNA
chain, preventing significant chain elongation. Consequently, viral
DNA
synthesis and, therefore, viral replication are inhibited.
The triphosphate persists in infected cells for in excess of 12 hours.
The long
intracellular half-life of penciclovir triphospate ensures prolonged
antiviral
activity, as demonstrated in cell cultures with HSV-1 and HSV-2 and in
animal
studies.
Penciclovir is only readily phosphorylated in virus infected cells. In
uninfected
cells treated with penciclovir, concentrations of pencicl