VITRAQ FILM-COATED TABLET 75MG

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

CLOPIDOGREL BISULPHATE

Tilgjengelig fra:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (International Name):

CLOPIDOGREL BISULPHATE

Enheter i pakken:

3 x 10tablet Tablets; 9x10 Tablets; 10x10 Tablets

Produsert av:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_____________________________________________________________________________________________________________________________
_
1
WHAT IS IN THIS LEAFLET
1.
What Vitraq is used for
2.
How Vitraq works
3.
Before you use Vitraq
4.
How to use Vitraq
5.
While you are using Vitraq
6.
Side effects
7.
Storage and Disposal of Vitraq
8.
Product description
9.
Manufactured and Registration Holder
10.
Date of Revision
WHAT VITRAQ IS USED FOR
It is used to prevent the atherothrombotic
events where the arteries (blood vessels)
become hard and narrow due to the plaque
formation and thus restrict the blood flow
to the organs.
HOW VITRAQ WORKS
Clopidogrel prevent the plaque formation
under the lining of arteries by inhibits the
platelet from being clumped together.
BEFORE YOU USE VITRAQ
_WHEN YOU MUST NOT TO USE IT _
Do not use this medicine if you:

are
allergic
(hypersensitivity)
to
the
clopidogrel and any other ingredients in
this medicine.

have severe liver impairment.

have ulcer in the stomach or intestine.

have bleeding within the skull.
_BEFORE YOU START TO USE IT _
Tell your doctor or pharmacist if you:

have bleeding or blood disorders.

have kidneys and/or liver impairment.

recently have stroke.

are pregnant or breast-feeding.
_TAKING OTHER MEDICINES _
Please tell your doctor or pharmacist if you
are taking or having recently
taken any
other
medicines.
This
includes
any
medicines which you have bought without
a prescription.
You should specifically tell your doctor if
you take:

anticoagulants, medicines used to
reduce blood clotting.

a non steroidal anti-inflammatory
(NSAIDs) medicine, used to treat
painful and/or inflammatory
conditions of muscle or joints.

heparin or any other injectable
medicine used to reduce blood clotting.

omeprazole, esomeprazole or
cimetidine, medicines to treat upset
stomach.

fluconazole, voriconazole,
ciprofloxacin, or chloramphenicol,
medicines to treat bacterial and fungal
infections.

flu

Preparatomtale

Important information. Please read carefully.
VITRAQ"
CLOPIDOGREL 75MG
Film-Coated Tablet
COMPOSITION
Each film-coated tablet contains 75mg Clopidogrel (as Clopidogrel
Bisulfate).
PHARMACODYNAMICS
Clopidogrel is a prodrug that inhibits platelet aggregation after
metabolized by the
enzyme, CYP 450 to produce the active metabolite. The active
metabolite of clopidogrel
selectively and irreversibly inhibits the adenosine diphosphate (ADP)
from binding to the
P2Y
11
platelet receptor, and the subsequent ADP-mediated activation of the
glycoprotein
GPllb/llla complex, thus inhibits platelet aggregation.
Due to the irreversible binding, platelets exposed are affected for
the remainder of their
lifespan (approximately 7-10 days) and recovery of normal platelet
function occurs at rate
consistent with platelet turnover.
Platelet aggregation induced by agonists other than ADP is also
inhibited by blocking the
amplification of platelet activation by released ADP.
PHARMACOKINETICS
Clopidogrel is rapidly but incompletely absorbed after oral doses,
absorption appears to
- be at least50%.
- It is a prod
rug and is extensively metabolized in the liver,
mainly to the inactive carboxylic
=
acid derivatives. Metabolism is mediated by the CYP 450 isoenzymes
including CYP 3A4,
CYP 266 and to a lesser extent by CYP 1A2, CYP 1A1, and CYP 2C19.
The active metabolite appears to be a thiol derivative, which has been
identified
_in vitro _
but appears to be too unstable to be isolated from plasma.
Clopidogrel and the carboxylic acid derivative are highly protein
bound. Clopidogrel and
its metabolites are excreted in the urine and faeces. About 50% of an
oral dose is
recovered from the urine and about 46% from the faeces.
INDICATIONS
For the prevention of atherothrombotic events in:
• Peripheral arterial disease, myocardial infarction, ischemic
stroke.
• Acute coronary syndrome
- Non-ST segment elevation (unstable angina or non-Q-wave myocardial
infarction)
that including patients undergoing a
stent placement following
percutaneous
corona