TERRY WHITE CHEMISTS VALACICLOVIR valaciclovir hydrochloride monohydrate 500mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valaciclovir hydrochloride monohydrate

Available from:

Apotex Pty Ltd

INN (International Name):

Valaciclovir hydrochloride monohydrate

Authorization status:

Registered

Patient Information leaflet

TERRY WHITE CHEMISTS
VALACICLOVIR
_FOR GENITAL HERPES SIMPLEX_
_Contains the active ingredient valaciclovir hydrochloride
monohydrate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about valaciclovir. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet
•
if you are worried about taking
your medicine
•
to obtain the most up-to-date
information
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is Terry
White Chemists Valaciclovir. It
contains the active ingredient
valaciclovir hydrochloride
monohydrate.
It is used to treat genital herpes
simplex infection.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Valaciclovir belongs to a group of
medicines called antivirals.
Valaciclovir works by stopping the
multiplication of the virus which
causes herpes. It can reduce the
length and severity of an outbreak of
herpes, the duration of pain and
shorten the time to healing of crusts
associated with herpes. They do not
eliminate the herpes virus from the
body. The herpes virus is also known
as

Summary of Product characteristics

Product Information – Australia
Terry White Chemists Valaciclovir Tablets
Page 1 of 21
TERRY WHITE CHEMISTS VALACICLOVIR TABLETS
NAME OF THE MEDICINE
Valaciclovir Hydrochloride Monohydrate
Chemical Name:
(1) L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9_H_-purin-9-
yl)methoxy]ethylester, monohydrochloride(2) L-Valine, ester with
9-[(2-hydroxyethoxy) methyl] guanine, monohydrochloride
Structural Formula:
Molecular Formula:
C
13
H
20
N
6
O
4
HCl.H
2
O
Molecular Weight:
378.8
CAS Registry Number:
124832-27-5
DESCRIPTION
Valaciclovir is the L-valine ester of aciclovir. Aciclovir is a purine
nucleoside analogue. The
maximum solubility of valaciclovir hydrochloride monohydrate in water
is 174 mg/mL at 25°C.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
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
polymerase and incorporation of this nucleoside analogue results in
obligate chain termination,
halting virus DNA synthesis and thus blocking virus replication.
Product Information – Australia
Terry White Chemists Valaciclovir Tablets
Page 2 of 21
PHARMACODYNAMIC EFFECTS
PHARMACODYNAMICS/ RESISTANCE DEVELOPMENT:
Resistance to aciclovir is normall