Avozine 5mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVOCETIRIZINE DIHYDROCHLORIDE

Boleh didapati daripada:

Abio Marketing Sdn Bhd

INN (Nama Antarabangsa):

LEVOCETIRIZINE DIHYDROCHLORIDE

Unit dalam pakej:

10tablet Tablets; 100tablet Tablets; 30tablet Tablets

Dikeluarkan oleh:

NANG KUANG PHARM CO

Risalah maklumat

Page 1 of 2 pages
_Consumer Medication Information leaflet (RiMUP) _
AVOZINE 5MG TABLET
Levocetirizine dihydrochloride 5mg
WHAT IS IN THIS LEAFLET:_ _
a)
What Avozine is used for
b)
How Avozine works
c)
Before you use Avozine
d)
How to use Avozine
e)
While you are using Avozine
f)
Side effects
g)
Storage and disposal of Avozine
h)
Product description
i)
Manufacturer
j)
Product Registration Holder
k)
Date of revision
WHAT AVOZINE IS USED FOR:
The
name
of
your
medicine
is
Avozine
5
mg
Tablet
(called
‘Avozine’
in
this
leaflet).
Avozine
contains
a
medicine
called
Levocetirizine dihydrochloride.
Avozine is an anti-allergic medication,
used for treatment of signs of illness
(symptoms) associated with allergic
condition such as:
• allergic rhinitis (including
persistent allergic rhinitis);
• nettle rash (urticaria).
HOW AVOZINE WORKS:
AVOZINE is a prescription medicine.
It acts by blocking the Histamine H1
receptor
site
and
this
prevents
the
allergic reactions.
BEFORE YOU USE AVOZINE
WHEN YOU MUST NOT USE IT:
Do not take this
medicine and tell
your doctor if:

You are under the age of 12

You have a severe impairment of
kidney function

You are allergic (hypersensitive) to
Levocetirizine or any of the other
ingredients of Avozine
BEFORE YOU START TO USE IT:
Check with your doctor or pharmacist
before taking this medicine :

If you are pregnant or planning to
become pregnant.

If
you
are
breast
feeding.
You
should choose to bottle feed your
baby or not take Avozine.

If you have kidney problems.

If you intend to drive or operate
heavy machineries
TAKING OTHER MEDICINES:
Tell
your
doctor
about
all
the
medicines
you
take,
including
prescription
and
nonprescription
medicines,
vitamins,
and
herbal
supplements. AVOZINE and certain
other
medicines
may
interact
with
each other. Especially tell your doctor
if you are taking any alcoholic drinks.
HOW TO USE AVOZINE
HOW MUCH TO USE?:
The usual dose given by your doctor
is one tablet daily. But this may be
varies depending on your conditions.
Hence,
al

Ciri produk

AVOZINE 5MG TABLETS
COMPOSITION:
Each tablet contains:
Levocetirizine dihydrochloride 5 mg
equivalent to 4.2mg of Levocetirizine
PRODUCT DESCRIPTION:
Avozine 5mg Tablet is a white to off-white biconvex ellipse
film-coated
tablet, with ‘486 imprinted on one side and ‘NK’ on the other
side.
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMI
c
PROPERTIES
ATC code : R06A E09
Levocetirizine is the active component of cetirizine. It is a
selective
competitive inhibitor for the H1-histamine receptor, both in vitro and
in
vivo.
PHARMACOKINETIC PROPERTIES
ABSORPTION
Levocetirizine is rapidly and extensively absorbed following oral
administration. Steady state is achieved after 2 days. Peak
concentrations are
typically 270 and 308 ng/mL following a single and repeated 5mg once
daily
dose, respectively. The extent of absorption is dose-independent and
is not
altered by food. However, the peak concentration is reduced and
delayed.
Therefore, levocetirizine can be administered with or without food.
DISTRIBUTION
No tissue distribution data are available in humans. Levocetirizine is
90%
bound to plasma proteins. The distribution of levocetirizine as the
volume of
distribuition is 0.4 L/kg,
METABOLISM
The extent of metabolism of levocetirizine in humans is less than 14%
of the
dose
and
therefore
differences
resulting
from
genetic
polymorphism
or
concomitant
intake
of
hepatic
drug
metabolizing
enzyme
inhibitors
are
expected to be negligible. Metabolic pathways include aromatic
oxidation,
N- and O-dealkylation, and taurine conjugation. Dealkylation pathways
are
primarily mediated by CYP 3A4 while aromatic oxidation involves
multiple
and/or unidentified CYP isoforms.
ELIMINATION
The plasma half-life in adult healthy subjects is 7.9 +/- 1.9 hours.
The mean
oral total body clearance for levocetirizine is 0.63 mL/kg/min. The
major
route of excretion of levocetirizine and its metabolites is via urine.
Excretion via faeces accounts for only 12.9% of the dose.
Levocetirizine is
excreted both by glomerular filtration and active tubular secr