PLAVIX clopidogrel (as hydrogen sulfate) 75 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clopidogrel hydrogen sulfate

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

clopidogrel hydrogen sulfate

Authorization status:

Registered

Summary of Product characteristics

plavix-ccdsv27-piv-20-06jan21
1
AUSTRALIAN PRODUCT INFORMATION – PLAVIX
® (CLOPIDOGREL
HYDROGEN SULFATE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Clopidogrel hydrogen sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plavix 75 mg contains 97.875 mg of clopidogrel hydrogen sulfate which
is the molar
equivalent of 75 mg of clopidogrel base. Plavix 300 mg contains 391.5
mg of clopidogrel
hydrogen sulfate which is the molar equivalent of 300 mg of
clopidogrel base.
Excipient with known effect: the coating contains lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
75 mg film coated tablets - pink round slightly biconvex film coated
tablets, engraved “75”
on one side and “1171” on the other side.
300 mg film coated tablets - pink oblong film coated tablets, engraved
“300” on one side and
“1332” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
Plavix 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). Plavix is indicated for the treatment of
acute coronary
syndrome whether or not patients undergo cardiac revascularisation
(surgical or PCI,
with or without stent).
•
ST-segment elevation acute myocardial infarction in order to prevent
atherothrombotic events. In this population, Plavix has been shown to
reduce the rate
plavix-ccdsv27-piv-20-06jan21
2
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Clopidogrel should be taken once a day with or without food.