Clopidogrel & Aspirin combination is indicated for the prevention of atherosclerotic events in patients with history of symptomatic atherosclerotic disease (ischemic stroke, myocardial infarction, peripheral arterial disease.) Antiplatelet drugs decrease platelet aggregation and may inhibit thrombus formation in the arterial circulation, while anti-coagulants have little effect. It is also used for its antiplatelet activity in the initial treatment of cardiovascular disorders such as myocardial infarction and for the prevention of cardiovascular events in a variety of conditions or procedures for patients at risk.
selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Clopidogrel also inhibits platelet aggregation induced by agonists other than ADP.
Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.
The recommended dose is one tablet once daily. Orally it is only recommended for adult.
Use in hepatic impaired patients: Experience in limited in patients with severe hepatic disease, who may have bleeding diatheses. Clopidogrel should be used with caution in this population.
Salicylates should be used with caution in patients with a history of peptic ulceration or coagulation abnormalities. They may also induce gastro-intestinal haemorrhage occasionally major. Aspirin should be used with caution in patients with impaired renal function, hepatic function (avoid if severe) or in patients who are dehydrated. In large doses, it may also decrease insulin requirements.
Hypersensitivity to Clopidogrel & Aspirin. Hypo-prothrombinaemia, haemophilia and active peptic ulceration, active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Salicylates may induce hypersensitivity, asthma, urate kidney stones, chronic gastro intestinal blood loss, tinnitus, nausea and vomiting. The clinically important adverse reactions of Clopidogrel are as follows-Gastrointestinal haemorrhage, agranulocytosis dyspepsia, gastritis, constipation, diarrhoea, rash, palpitation, vomiting, paresthesia, neuralgia, gout, arthritis, clotting disorder, anemia, anxiety, insomnia, cataract, conjunctivitis, leukopenia, granulocytopenia, urticaria.
: There are, however, no adequate and welcontrolled studies in pregnant women. It should be avoided during last 3 months of pregnancy and should be used during pregnancy only if clearly needed.
Lactation: As Aspirin is excreted in breast milk, it should not be taken by patients who are breastfeeding.
Clopidogrel should be avoided for the first few days after myocardial infarction and for seven days after ischemic disease. Clopidogrel is not recommended in unstable angina, coronary artery bypass grafting and percuteneous transluminal coronary angioplasty. Clopidogrel is not recommended in patients at risk of increased bleeding from trauma, surgery or other pathological conditions. Clopidogrel should be discontinued seven days before surgery if antiplatelet effect is not desirable. GI bleeding: Clopidogrel prolongs the bleeding time. Clopidogrel should be used with caution in patients who have lesions with a propensity to bleed (such as ulcers). Drugs that might induce such lesions such as non-steroidal anti inflammatory drugs (NSAIDs) should be used with caution in patients taking Clopidogrel.
It should not be given to children, particularly those under 12 years, unless the expected benefits outweight the possible risks. Aspirin may be a contributory factor in the causation of Reye’s syndrome in some children.
Store in a cool and dry place, protected from light.