Herpevex 800mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ACYCLOVIR

Boleh didapati daripada:

APEX PHARMACY MARKETING SDN. BHD.

INN (Nama Antarabangsa):

ACYCLOVIR

Unit dalam pakej:

36Tablet Tablets

Dikeluarkan oleh:

DELORBIS PHARMACEUTICALS LTD.

Risalah maklumat

HERPEVEX TABLET
Acyclovir (400mg, 800mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What HERPEVEX is used for
2.
How HERPEVEX works
3.
Before you take HERPEVEX
4.
How to take HERPEVEX
5.
While you are taking HERPEVEX
6.
Side Effects
7.
Storage and Disposal of
HERPEVEX
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT HERPEVEX IS USED FOR
HERPEVEX
belongs
to
a
group
of
medicines called antivirals and it is used
to
treat
herpes
simplex
infections.
HERPEVEX is indicated for:

The treatment of herpes simplex virus
infections
of
the
skin
and
mucous
membranes
including
initial
and
recurrent genital herpes.

The
suppression
(prevention
of
recurrences)
of
recurrent
herpes
simplex
infections
in
immunocompetent patients.

The
prophylaxis
of
herpes
simplex
infections
in
immunocompromised
patients.

The
treatment
of
varicella
(chickenpox)
and
herpes
zoster
(shingles) infections. Early treatment
of shingles with HERPEVEX has a
beneficial
effect
on
pain
and
can
reduce the incidence of post-herpetic
neuralgia (zoster-associated pain).
Ask your doctor why you have to take
this medicine.
HOW HERPEVEX WORKS
HERPEVEX
works
by
killing
or
stopping the growth of viruses.
BEFORE YOU TAKE HERPEVEX
-
_When you must not take it _

In
case
of
hypersensitivity
to
Acyclovir or valAcyclovir or to
any of the other ingredients

If
you
are
pregnant
or
breast
feeding mother
-
_Before you start to take it _
BE CAUTIOUS WITH HERPEVEX
The
dose
of
HERPEVEX
must
be
adjusted
in
patients
with
kidney
problems and elderly as acyclovir is
eliminated
by
kidney.
Both
elderly
patients
and
patients
with
kidney
problems
are
at
increased
risk
and
should be closely monitored. In the
reported cases, these reactions were
generally
reversible
on
discontinuation of treatment. Patients
receiving
higher
oral
doses
of
acyclovir should drink more water.
PREGNANCY
Ask
your
doctor’s
or
pharmacist’s
advice before you take any medicine.
LACTATION
Ask
you

Ciri produk

HERPEVEX
TABLET
COMPOSITION
Herpevex 400mg Tablet: Aciclovir 400.00 mg
Herpevex 800mg Tablet: Aciclovir 800.00 mg
DESCRIPTION
Herpevex 400mg Tablet: White to off-white, flat,
circular tablets, 12mm diameter, scored on one side.
Herpevex 800mg Tablet: White to off-white, oblong
tablets, scored on one side.
PHARMACODYNAMICS
Aciclovir 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 aciclovir for HSV I, HSV
II
and
VZV
is
highly
selective.
The
enzyme
thymidine kinase (TK) of normal uninfected cells
does not use aciclovir effectively as a substrate, hence
toxicity of mammalian host cells is low. However, TK
encoded by HSV and VZV converts aciclovir to
aciclovir monophosphate, a nucleoside, analogue
which is further converted to the diphosphate and
finally to the triphosphate by cellular enzymes.
Aciclovir triphosphate interferes with the viral DNA
polymerase and inhibits viral DNS replication with
resultant chain termination following its incorporation
into the viral DNA.
Prolonged or repeated courses of aciclovir is severely
immune- compromised individuals may result in the
selective of virus strains with reduced sensitivity,
which
may
not
respond
to
continued
aciclovir treatment. Most of the clinical isolates with
reduced sensitivity have been relatively deficient in
viral TK. However, strains with altered viral TK or
DNA polymerase have also been reported. In vitro
exposure of HSV isolates to aciclovir can also lead to
the
emergence
of
less
sensitive
strains.
The
relationship
between
the
in
vitro
determined
sensitivity of HSV isolate and clinical response to
aciclovir therapy is not clear.
PHARMACOKINETICS
The absorption of Aciclovir from the gut is only
partial. Following doses of 200 mg, 400 mg and 800
mg, administered four-hourly, the mean steady state
peak
plasma
concentrations
(C
ss
Max)
were
3.1
micromol
(0.7
micrograms/ml),
5.3
m