APO-VALACICLOVIR valaciclovir hydrochloride monohydrate 1000mg tablet blitster pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

Valaciclovir hydrochloride monohydrate

Boleh didapati daripada:

Apotex Pty Ltd

INN (Nama Antarabangsa):

Valaciclovir hydrochloride monohydrate

Risalah maklumat

APO-VALACICLOVIR
_FOR CYTOMEGALOVIRUS_
_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 APO-
Valaciclovir. It contains the active
ingredient valaciclovir hydrochloride
monohydrate.
Valaciclovir belongs to a group of
medicines called antivirals.
It is used to prevent cytomegalovirus
(CMV) infection and disease,
following solid organ transplantation.
CMV is another type of herpes virus.
It can cause symptoms similar to
glandular fever (high temperature,
sore throat and swollen glands).
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.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
THERE IS NOT ENOUGH INFORMATION TO
RECOMMEND THE USE OF THIS
MEDICINE IN CHILDREN.
BEFORE YOU TAKE THIS
MEDICINE
_W

Ciri produk

Product Information – Australia
APO-Valaciclovir Tablets
Page 1 of 21
APO-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
APO-Valaciclovir Tablets
Page 2 of 21
PHARMACODYNAMIC EFFECTS
PHARMACODYNAMICS/ RESISTANCE DEVELOPMENT:
Resistance to aciclovir is normally due to a thymidine kinase
deficient phenotype. In