PIAX

What it is

PIAX is a film-coated tablet containing 75 mg of clopidogrel as hydrogen sulfate. The tablet is white, round, biconvex with a bevelled edge, debossed with "M" on one side and "C27" on the other.

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. — In combination with aspirin for patients with unstable angina or non-ST-elevation myocardial infarction to prevent early and long-term atherothrombotic events. — Treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or percutaneous coronary intervention, with or without stent). — Prevention of atherothrombotic events in ST-segment elevation acute myocardial infarction.

Dosing overview

PIAX should be taken once a day with or without food, generally at a single daily dose of 75 mg. For acute coronary syndrome, dosing varies by type. In unstable angina or non-ST-elevation myocardial infarction, treatment should be initiated with a single 300 mg loading dose and then continued long-term at 75 mg once a day with aspirin 75–325 mg daily. In ST-segment elevation acute myocardial infarction, the dose is 75 mg once daily initiated with or without a 300 mg loading dose in combination with aspirin and with or without thrombolytics. No dosage adjustment is necessary for elderly patients or patients with renal impairment. Alternative treatment or treatment strategies should be considered in patients identified as CYP2C19 poor metabolisers.

Key safety warnings

PIAX 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, and in patients receiving treatment with acetylsalicylic acid, heparin, glycoprotein IIb/IIIa inhibitors, non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or CYP2C19 strong inducers. If a patient is to undergo elective surgery and an anti-platelet effect is not desired, PIAX should be discontinued at least 5 days prior to surgery. When coronary artery bypass surgery is to be performed, PIAX should be suspended at least 5 days before surgery to reduce the risk of bleeding. Thrombotic thrombocytopenic purpura (TTP) has been reported very rarely following the use of PIAX, sometimes after short exposure. It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with neurological findings, renal dysfunction or fever. TTP is a potentially fatal condition requiring prompt treatment, including plasmapheresis. Acquired haemophilia has been reported following use of PIAX. In cases of confirmed isolated activated partial thromboplastin time prolongation with or without bleeding, acquired haemophilia should be considered. Patients with confirmed acquired haemophilia should be managed and treated by specialists and PIAX should be discontinued.

Contraindications

PIAX is contraindicated in patients with hypersensitivity to clopidogrel or any of the excipients. Severe liver impairment is a contraindication. PIAX should not be used in patients with active pathological bleeding such as peptic ulcer and intracranial haemorrhage. PIAX is contraindicated in breast-feeding.

Regulatory history

PIAX clopidogrel 75 mg film-coated tablet was first registered on the Australian Register of Therapeutic Goods on 21 May 2010.