VALACICLOVIR AN 500mg

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valaciclovir hydrochloride

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

valaciclovir hydrochloride

Authorization status:

Registered

Patient Information leaflet

_Valaciclovir AN tablets – Consumer Medicine Information _
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_Doc ID: 104.AN.CMI.1.0 _
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_Page 1 _
VALACICLOVIR AN TABLETS
_valaciclovir (as hydrochloride) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
VALACICLOVIR AN tablets. It
does not contain all of the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
VALACICLOVIR AN tablets
against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT
VALACICLOVIR AN
TABLETS ARE USED FOR
_HOW VALACICLOVIR AN _
_TABLETS WORK _
VALACICLOVIR AN
tablets
belong to a group of medicines
called antivirals. VALACICLOVIR
AN tablets are used for the
treatment of genital herpes
infection, shingles (infection
zoster), ophthalmic zosters
(shingles affecting the eye
region), cold sores (herpes
labialis) and for the prevention of
Cytomegalovirus (CMV) infection
in people following an organ
transplant.
VALACICLOVIR AN tablets work
by stopping the multiplication of
the virus which causes herpes,
shingles and cold sores. They
can reduce the length and
severity of an outbreak of
herpes, shingles and cold sores
and the duration of pain and
shorten the time to healing of
crusts associated with herpes.
GENITAL HERPES
VALACICLOVIR AN tablets do
not eliminate the herpes virus
from the body. The herpes virus
is also known as the Herpes
Simplex Virus, or HSV.
VALACICLOVIR AN tablets help
the blisters to heal more quickly.
If you start taking them as soon
as you feel an outbreak starting,
you may actually prevent the
blisters from developing.
VALACICLOVIR AN tablets can
also be taken long term to help
prevent the HSV infection
coming back.
VALACICLOVIR AN tablets can
also reduce the risk of
transmitting the virus that causes
genital herpes in patients who

Summary of Product characteristics

_Valaciclovir_ _AN Product Information_
_Amneal Pharma Australia _ Pty Ltd
Valaciclovir AN PI v1.2
Page 1 of 22
VALACICLOVIR AN
_(VALACICLOVIR HYDROCHLORIDE TABLETS) _
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PRODUCT INFORMATION
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NAME OF THE MEDICINE
The name of the medicine is valaciclovir as valaciclovir
hydrochloride.
CHEMICAL NAME: 2-[(2-amino-1, 6-dihydro-6-oxo-9H-purin-9-yl) methoxy]
ethyl-l-valinate
hydrochloride
MOLECULAR FORMULA: C
13
H
20
N
6
O
4
.HCl
MOLECULAR WEIGHT: 360.84
CAS REGISTRY NUMBER: _[_
_124832-27-5_
_]_
DESCRIPTION
Valaciclovir is the L-valine ester of aciclovir. Aciclovir is a purine
nucleoside analogue.
Valaciclovir hydrochloride is a white or almost white powder. It is
freely soluble in water,
practically insoluble in ethanol and 1-octanol.
INACTIVE: Microcrystalline cellulose, crospovidone, povidone,
magnesium stearate and opadry
Blue 13B50578 (PI-ARTG No. 106487).
PHARMACOLOGY
MODE OF ACTION
Valaciclovir is rapidly and almost completely converted in man to
aciclovir probably by the
enzyme valaciclovir hydrolase. Aciclovir is a specific inhibitor of
the herpes viruses with _in vitro _
activity against herpes simplex viruses (HSV) type 1 and type 2 (IC
50
0.1 – 3.0μM), varicella-
zoster virus (VZV) (IC
50
1.6 – 5.1μM) and human cytomegalovirus (HCMV) (IC
50
10 - >
200μM). Aciclovir inhibits herpes virus DNA synthesis once it has
been phosphorylated to the
active triphosphate form. The first stage of phosphorylation requires
the activity of a virus-
specific enzyme: thymidine kinase in HSV and VZV infected cells or
protein kinase in HCMV
infected cells. This requirement for activation of aciclovir by a
virus specific enzyme largely
explains its unique selectivity. The phosphorylation process is
completed (conversion from
mono-
to triphosphate) by cellular kinases. Aciclovir triphosphate
competitively inhibits the virus DNA
_Valaciclovir_ _AN Product Information_
_Amneal Pharma Australia _ Pty Ltd
Valaciclovir AN PI v1.2
Page 2 of 22
polymerase and incorporation of this nucleoside analogue results in
obligate