VIPLEX

What it is

VIPLEX 75 contains clopidogrel hydrogen sulfate equivalent to clopidogrel 75 mg per tablet. The tablets are pink coloured, round, biconvex, film coated tablets, 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 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, whether or not patients undergo cardiac revascularisation.

Dosing overview

VIPLEX 75 should be taken once a day with or without food, generally as a single daily dose of 75 mg. For patients with 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 a day in combination with aspirin 75 mg–325 mg daily. For ST-segment elevation acute myocardial infarction, VIPLEX 75 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 elderly patients or patients with renal impairment.

Key safety warnings

VIPLEX 75 prolongs bleeding time and should be used with caution in patients at risk of increased bleeding from trauma, surgery or other pathological conditions. Although clopidogrel has shown a lower incidence of gastrointestinal bleeding compared to aspirin in a large controlled clinical trial, it should be used with caution in patients who have lesions with a propensity to bleed, particularly gastrointestinal and intraocular. Patients should be told that it may take longer than usual for bleeding to stop when they take VIPLEX 75 alone or in combination with aspirin, and that they should report any unusual bleeding to their physician. When coronary artery bypass surgery is to be performed, VIPLEX 75 should be suspended at least 5 days before surgery to reduce the risk of bleeding. The metabolism of clopidogrel to its active metabolite can be impaired by genetic variations in CYP2C19 and by concomitant medications that interfere with CYP2C19. In patients who are CYP2C19 poor metabolisers, clopidogrel at recommended doses forms less of the active metabolite and has a smaller effect on platelet function. Poor metabolisers with acute coronary syndrome or undergoing percutaneous coronary intervention may exhibit higher cardiovascular event rates than patients with normal CYP2C19 function. Consider alternative treatment or treatment strategies 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. — Breast-feeding.

Regulatory history

VIPLEX 75 was first listed on the ARTG on 9 August 2011, with two registered variants: a blister pack formulation (ARTG 171365) and a bottle formulation (ARTG 171362), both sponsored by Strides Pharma Science.