LEVOZIN (Levocetirizine Dihydrochloride Tablets USP 5 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVOCETIRIZINE DIHYDROCHLORIDE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

LEVOCETIRIZINE DIHYDROCHLORIDE

Unit dalam pakej:

200Tablet Tablets; 50 Tablets

Dikeluarkan oleh:

FDC LIMITED

Risalah maklumat

LEVOZIN (LEVOCETIRIZINE DIHYDROCHLORIDE
CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
TABLETS USP 5MG)
WHAT IS IN THIS LEAFLET
1.
What LEVOZIN is used for
2.
How LEVOZIN works
3.
Before you use LEVOZIN
4.
How to use LEVOZIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
LEVOZIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT LEVOZIN IS USED FOR
LEVOZIN is an anti-allergic agent. It is
used to treat symptoms
associated
with
allergic conditions, such

hronic unknown cause of hives.

allergic rhinitis
(inflammation of the lining
inside the nose)
HOW LEVOZIN WORKS
LEVOZIN helps to relieve allergic
symptoms by blocking a certain natural
substance (histamine) that your body
makes during an allergic reaction.
BEFORE YOU USE LEVOZIN
- When you must not use it
Do not take LEVOZIN if

You are allergic
(hypersensitive) to
LEVOZIN, or any
other related
substance, or any of the other ingredients
of LEVOZIN contains.

You have severe kidney
impairment

You have been told by your
doctor that you have intolerance to
some sugars
- Before you start to use it
Check with your doctor of pharmacist
before taking LEVOZIN :

If you suffer from kidney
impairment, you may
require a lower dosage
and should discuss your
situation with your doctor.
PREGNANCY AND BREAST-FEEDING
No information is available on the safe
use of LEVOZIN during pregnancy or
breast-feeding. When you are pregnant
or breast-feeding you should only use
LEVOZIN if there is a clear benefit
outweighing the possible risks. Your
doctor will make this decision for you.
- Taking other medicines
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from a
pharmacy, supermarket or health food
shop. Other medicines may be affected
by LEVOZIN. They, in turn, may affect
how well LEVOZIN works.
HOW TO USE LEVOZIN
- How much to use
Always use LEVOZIN exactly as
your doctor has told you. You
should check with your doctor or
pharmacist.
Adults

Ciri produk

For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory.
(LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS USP 5 MG /
LEVOCETIRIZINE DIHYDROCHLORIDE SYRUP)
LEVOZIN TABLETS 5 MG
LEVOZIN SYRUP 2.5 MG/5ML
(LEVOCETIRIZINE DIHYDROCHLORIDE SYRUP 2.5MG/5ML):
DESCRIPTION AND COMPOSITION: Orange coloured syrup pleasantly
flavoured having a
sweet taste and no
sediment filled in amber colour bottle, sealed with ROPP cap labeled
and placed in a printed carton. Each
5ml contains: Levocetirizine Dihydrochloride 2.5mg and sunset yellow
as permitted colour.
LEVOCETIRIZINE TABLETS 5MG (LEVOCETIRIZINE DIHYDROCHLORIDE TABLET
5MG):
DESCRIPTION AND COMPOSITION: Yellow coloured circular, biconvex film
coated tablets plain on both sides.
Each film coated tablet contains: Levocetirizine Dihydrochloride 5mg,
Titanium dioxide and Quinoline yellow
as colouring agents.
PHANNACODYNAMICS
Levocetirizine is the active component of Cetirizine. It is a
selective competitive inhibitor for the H 1- histamine
receptor, both in vitro and in vivo. There is no evidence of any
binding with other receptors at concentrations
500 fold higher than those displacing a H1- ligand. It is effective in
antagonizing histamine effects in both
cutaneous and pulmonary models after IV and PO administration of
0.1-0.2 mg/kg.
As with cetirzine safety
pharmacology studies indicate a high margin of safety for adverse
effects on the CNS, GI, immune and
cardiovascular systems. Levocetirizine is
unlikely to be involved in torsades de pointes or other arrhythmias.
In addition, as
levocetirizine is mainly excreted unchanged in man and does not
inhibit the major GYP
isoforms in human liver microsomes, cardiac and other adverse effects
due to
pharmacokinetic interactions
are also unlikely.
PHANNACOKINETICS
The pharmacokinetic profile of levocetirizine is linear and
time-independent with low inter-subject variability.
The clearance of levocetirizine differs slightly in men and women.
This difference is clearance, however, does
not
necessitate
the
use
of
a
differ