AVORAX TABLET 400MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ACYCLOVIR

Boleh didapati daripada:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

ACYCLOVIR

Unit dalam pakej:

25 Tablets

Dikeluarkan oleh:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AVORAX TABLET
Acyclovir (200mg, 400mg)
1
WHAT IS IN THIS LEAFLET:
1.
What Avorax Tablet is used for
2.
How Avorax Tablet works
3.
Before you use Avorax Tablet
4.
How to use Avorax Tablet
5.
While you are using Avorax Tablet
6.
Side Effects
7.
Storage and Disposal of Avorax Tablet
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
_ _
WHAT AVORAX TABLET IS USED FOR
It is used to treat:

herpes
simplex
viral
infection
(cold
sores) on the skin, including initial and
recurrent viral infection of the eye, lips
and genital area.

chicken pox

shingles,
a
painful
skin
rash
with
blisters.
HOW AVORAX TABLET WORKS
Avorax
Tablet
contains
an
active
ingredient,
Acyclovir.
Acyclovir
is
the
anti-viral
which
inhibits
the
growth
of
virus by preventing the spreading of virus
in the body.
BEFORE YOU USE AVORAX TABLET
_When you must not use it _
Do
not
use
Avorax
Tablet
if
you
are
allergic
to
Acyclovir
or
any
other
ingredients in this medicine.
_ _
_Before you start to use it _
Tell your doctor or pharmacist before using
Avorax Tablet if you:

are pregnant or plan to pregnant.

are
breast-feeding
or
plan
to
start
breast-feeding.

have kidney failure.

are dehydrated (loss of body’s fluid).
_Taking other medicines _
Tell your doctor or pharmacist if you are
taking Probenecid and Zidovudine or
having recently taken any other medicines.
This includes any medicines which you
have bought without a prescription.
HOW TO USE AVORAX TABLET
_How much to use _

_For _
_treatment _
_of _
_herpes _
_simplex _
_viral _
_infection: _
Adults: 200mg 5 times or 4 hourly daily.
For 5- 10 days.
Can be increased to 400mg for patients
with impaired absorption from the gut.
Children more than 2 years: as per adult
dose.
Children less than 2 years: half of the
adult dose.
Kidney failure patients: 200mg every 12
hours.

_For _
_treatment _
_of _
_recurrent _
_herpes _
_simplex _
_viral _
_infection _
_in _
_immune _
_deficiency patients:

Ciri produk

COMPOSITION
AVORAX 200mg: Each tablet contains Acyclovir 200mg.
AVORAX 400mg: Each tablet contains Acyclovir 400mg.
PHARMACODYNAMICS
Acyclovir is a synthetic purine nucleoside analogue with in vitro and
in vivo inhibitory activity against human herpes
viruses, including herpes simplex virus (HSV) types I and II and
varicella zoster virus (VZV).
The inhibitory activity of acyclovir for HSV I, HSV II and VZV is
highly selective. The enzyme thymidine kinase (TK) of
normal, uninfected cells does not use acyclovir effectively as a
substrate, hence toxicity of mammalian host cells is
low; however, TK encoded by HSV and VZV converts acyclovir to
acyclovir monophosphate, a nucleoside analogue
which is further converted to the diphosphate and finally to the
triphosphate by cellular enzymes. Acyclovir triphosphate
interferes with the viral DNA polymerase and inhibits viral DNA
replication with resultant chain termination following its
incorporation into the viral DNA.
Prolonged or repeated courses of acyclovir in severely
immune-compromised individuals may result in the selection of
virus strains with reduced sensitivity, which may not respond to
continued acyclovir treatment. Most of the clinical
isolates with reduced sensitivity have been relatively deficient in
viral TK, however, strains with altered viral TK or viral
DNA polymerase have also been reported. In vitro exposure of HSV
isolates to acyclovir can also lead to the
emergence of less sensitive strains. The relationship between the in
vitro determined sensitivity of HSV isolates and
clinical response to acyclovir therapy is not clear.
PHARMACOKINETICS
Acyclovir is only partially absorbed from the gut. Mean steady state
peak plasma concentrations (C
ss
max) following
doses of 200 mg administered four-hourly were 3.1 microMol (0.7
micrograms/ml) and equivalent trough plasma levels
(C
ss
min) were 1.8 microMol (0.4 micrograms/ml). Corresponding C
ss
max levels following doses of 400 mg and 800 mg
administered four-hourly were 5.3 microMol (1.2 micrograms/ml) and 8
m