PLAVICOR

What it is

PLAVICOR contains clopidogrel 75 mg as clopidogrel hydrogen sulfate. PLAVICOR 75 is a pink coloured, round, biconvex, film coated tablet, debossed with "Cl" on one side and plain on the other side.

Approved indications

— Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. — Unstable angina or non-ST-elevation myocardial infarction in combination with aspirin in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). — ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events, with PLAVICOR 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.

Dosing overview

PLAVICOR should be taken once a day with or without food, and generally should be given as a single daily dose of 75 mg. In acute coronary syndrome with unstable angina or non-ST-elevation myocardial infarction, treatment should be initiated with a 300 mg loading dose then continued long-term at 75 mg once daily with aspirin 75 mg–325 mg daily. For ST-segment elevation acute myocardial infarction, PLAVICOR should be given as a single daily dose of 75 mg initiated with or without a 300 mg loading dose in combination with aspirin and with or without thrombolytics. No dosage adjustment is necessary for either elderly patients or patients with renal impairment.

Key safety warnings

PLAVICOR prolongs bleeding time and should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions. If a patient is to undergo elective surgery and an anti-platelet effect is not desired, PLAVICOR should be discontinued at least 5 days prior to surgery. Although PLAVICOR has shown a lower incidence of gastrointestinal bleeding compared to aspirin in a large controlled clinical trial, it prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed, particularly gastrointestinal and intraocular. Drugs that might induce such lesions (such as aspirin and Non-Steroidal Anti-Inflammatory Drugs) should be used with caution in patients taking PLAVICOR. In patients with recent transient ischaemic attack or stroke who are at high risk of recurrent ischaemic events, the combination of aspirin and PLAVICOR has been shown to increase major bleeding. Therefore, such addition should be undertaken with caution outside of clinical situations where the combination has proven to be beneficial. Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of PLAVICOR, sometimes after a short exposure.

Contraindications

PLAVICOR is contraindicated in hypersensitivity to clopidogrel or any of the excipients, severe liver impairment, and active pathological bleeding such as peptic ulcer and intracranial haemorrhage.

Regulatory history

PLAVICOR 75 was first registered on the ARTG on 17 May 2012 in two presentations: as a film coated tablet in a bottle pack (ARTG 187038) and in a blister pack (ARTG 187039).