Usage And Safety
Dosage
Aspirin, Clopidogrel
Side Effects
Uncommon: Thrombocytopenia, leucopenia, eosinophiliaRare: Neutropenia, including severe neutropeniaVery rare: Thrombotic thrombocytopenic purpura (TTP), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
Drug Interactions
Oral anticoagulants , Heparin , Thrombolytics , NSAIDs , SSRIs . Clopidogrel : Inducers of CYP2C19 , Inhibitors of CYP2C19 , Proton Pump Inhibitors (PPI) , Anti-retroviral therapies (ART) . Aspirin : Uricosurics (benzbromarone, probenecid, sulfinpyrazone) , Methotrexate , Tenofovir , Valproic acid , Alcohol.
Indication
It is indicated for the prevention of ischemic events, myocardial infarction, stroke and cardiovascular death in patients with Acute Coronary Syndrome (ACS).
When not to Use
Due to the presence of both components of the medicinal product, Clopidogrel/Aspirin is contraindicated in case of:• Hypersensitivity to the active substances or to any of the excipients.• Severe hepatic impairment.• Active pathological bleeding such as peptic ulcer or intracranial haemorrhage
Warnings
Warning 1
Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery. The concomitant administration of Clopidogrel/Aspirin with oral anticoagulants is not recommended since it may increase the intensity of bleeding.
Warning 2
Acquired haemophilia has been reported following use of clopidogrel. In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered. Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and clopidogrel should be discontinued.
Warning 3
In patients with recent transient ischaemic attack or stroke who are at high risk of recurrent ischaemic events, the combination of ASA and clopidogrel 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.
