CLOPITHROMB

What it is

Clopithromb 75 contains clopidogrel 75 mg (as clopidogrel hydrogen sulfate) in film coated tablets. The tablets are pink coloured, round, biconvex, and debossed with "Cl" on one 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, whether or not patients undergo cardiac revascularisation (surgical or percutaneous coronary intervention, with or without stent). — ST-segment elevation acute myocardial infarction in combination with aspirin to prevent atherothrombotic events.

Dosing overview

Clopithromb should be taken once a day with or without food. The standard dose for adults is 75 mg once daily. For unstable angina or non-ST-elevation myocardial infarction, treatment should be initiated with a 300 mg loading dose and then continued long-term at 75 mg once daily (with aspirin 75–325 mg daily). For ST-segment elevation acute myocardial infarction, clopidogrel is 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.

Key safety warnings

Clopithromb 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, Clopithromb should be discontinued at least 5 days prior to surgery. Although Clopithromb 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 Clopithromb. When coronary artery bypass surgery is to be performed, Clopithromb should be suspended at least 5 days before surgery to reduce the risk of bleeding. In patients with recent transient ischaemic attack or stroke who are at high risk of recurrent ischaemic events, the combination of aspirin and Clopithromb 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. CYP2C19 poor metaboliser status is associated with diminished antiplatelet response to Clopithromb; although a higher dose regimen in poor metabolisers increases antiplatelet response, an appropriate dose regimen for this patient population has not been established in clinical outcome trials, and alternative treatment or treatment strategies should be considered in patients identified as CYP2C19 poor metabolisers.

Contraindications

— Hypersensitivity to clopidogrel or any of the excipients. — Severe liver impairment. — Active pathological bleeding such as peptic ulcer and intracranial haemorrhage.

Regulatory history

Clopithromb 75 (clopidogrel 75 mg film coated tablets) was first listed on the ARTG on 17 May 2012; two variants are registered—ARTG 187043 (bottle pack) and ARTG 187040 (blister pack).