CLOPITHROMB 75, clopidogrel (as hydrogen sulfate) 75 mg, film coated tablets, blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clopidogrel hydrogen sulfate, Quantity: 97.875 mg (Equivalent: clopidogrel, Qty 75 mg)

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

clopidogrel hydrogen sulfate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; hydrogenated castor oil; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; microcrystalline cellulose

Administration route:

Oral

Units in package:

280 Tablets in blister pack, 50 Tablets in blister pack, 30 Tablets in blister pack, 112 Tablets in blister pack, 14 Tablets in blister pack, 7 Tablets in blister pack, 4 Tablets in blister pack, 28 Tablets in blister pack, 84 Tablets in blister pack, 56 Tablets in blister pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ,Acute Coronary Syndrome: Clopidogrel Tablets is indicated in combination with aspirin for patients with: ,- Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Clopidogrel Tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or PCI, with or without stent); ,- ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, Clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

Product summary:

Visual Identification: Pink coloured, round, biconvex, film coated tablets, debossed with 'Cl' on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2012-05-17

Patient Information leaflet

CLOPITHROMB
CONSUMER MEDICINE INFORMATION
Version: 2.0
-2013- Page: 1 of 5
CLOPITHROMB 75
(CLOPIDOGREL TABLETS 75 MG
)
CONSUMER MEDICINE INFORMATION
Please read this leaflet carefully before you start taking
Clopithromb. You may wish to keep it to read again.
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Clopithromb.
It
does
not
contain
all
the
available
information.
Some
of
the information it contains may
not apply to you.
It
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist.
All medicines have benefits and
risks.
In
deciding
to
give
you
Clopithromb,
your
doctor
has
weighed the risks of you taking
Clopithromb against the expected
benefits it will have for you.
Always
follow
the
instructions
that your doctor and pharmacist
give you about Clopithromb.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT CLOPITHROMB IS
USED FOR
Clopithromb contain the
medicine clopidogrel.
Clopithromb belong to a group of
medicines called antiplatelet
medicines.
Platelets are very small blood
cells which clump together
during blood clotting. By
preventing this clumping, anti-
platelet medicines reduce the
chances of blood clots forming (a
process called thrombosis).
Clopithromb is used to prevent
blood clots forming in hardened
blood vessels (a process known
as atherothrombosis)
which can lead to events such as
stroke, heart attack or death.
You may have been prescribed
Clopithromb
to
help
prevent
blood
clots
forming
and
to
reduce the risk of stroke, heart
attack and death because:

You
have
previously
suffered
a
heart
attack,
stroke or have a condition
known as peripheral arterial
disease
(leg
pain
on
walking or at rest).

You
have
suffered
Acute
Coronary Syndrome (either
a severe type of chest pain
called unstable angina, or a
heart
attack).
In
this
case
you may also be prescribed
aspirin.
Your
doctor
may
have
prescribed
this
medicine
for
another use. If you want more
information, ask your doctor.
Clopithromb is only available on
a doctor's prescri

Summary of Product characteristics

Clopithromb 75 (Clopidogrel Tablets 75 mg) Version 2.0
-2013- Page: 1 of 25
PRODUCT INFORMATION
CLOPITHROMB 75
(CLOPIDOGREL TABLETS 75 MG)
NAME OF THE MEDICINE
Clopidogrel (as clopidogrel hydrogen sulfate)
DESCRIPTION
Clopidogrel
hydrogen
sulfate
is
designated
chemically
as
Methyl
(+)-(
_S_
)-α-(o-
chlorophenyl)-6,7-dihydrothieno [3,2-c] pyridine-5(4
_H_
)-acetate, sulfate (1:1)
The empirical formula of clopidogrel hydrogen sulfate is C
16
H
16
ClNO
2
S.H
2
SO
4
and its
molecular weight is 419.9.
Clopidogrel hydrogen sulfate has the following chemical structure:
CAS Number: 120202-66-6 (Clopidogrel hydrogen sulfate),
113 665-84-2 (Clopidogrel base).
Clopidogrel hydrogen sulfate is a white to off-white powder. It is
practically insoluble in
water at neutral pH but freely soluble at pH 1. It is freely soluble
in methanol, sparingly
soluble in methylene chloride and is practically insoluble in ethyl
ether. It has a specific
optical rotation of about + 56º.
Each
tablet
contains
microcelac
100
(microcrystalline
cellulose
+
lactose),
low
substituted hydroxypropylcellulose, hydrogenated castor oil, colloidal
anhydrous silica.
The coating contains Opadry II 31K34575 Pink (lactose, hypromellose,
titanium dioxide,
glycerol triacetate and iron oxide red) [PI No. 106397].
Each tablet contains clopidogrel hydrogen sulfate equivalent to
clopidogrel 75 mg.
Clopithromb 75 (Clopidogrel Tablets 75 mg) Version 2.0
-2013- Page: 2 of 25
PHARMACOLOGY
PHARMACODYNAMICS
Clopidogrel is a specific and potent inhibitor of platelet
aggregation. Platelets have an
established role in the pathophysiology of atherosclerotic disease and
thrombotic events.
Long term use of anti-platelet drugs has shown consistent benefit in
the prevention of
ischaemic stroke, myocardial infarction and vascular death in patients
at increased risk of
such
outcomes,
including
those
with
established
atherosclerosis
or
a
history
of
atherothrombosis.
The active metabolite, a thiol derivative, is formed by oxidation of
clopidogrel to 2-
oxoclopidogrel
and
subsequent
hy