Plavix

Clopidogrel bisulfate

Secondary prevention of atherothrombotic events in adults suffering from MI (from a few days until <35 days), ischemic stroke (from 7 days until <6 mth) or established peripheral arterial disease; in combination w/ ASA for non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) including patients undergoing stent placement following percutaneous coronary intervention & ST segment elevation acute MI in medically treated patients eligible for thrombolytic therapy. In combination w/ ASA for moderate to high-risk transient ischemic attack (TIA) or minor ischemic stroke (IS) in adults w/in 24 hr of either TIA or IS event. In combination w/ ASA for prevention of atherothrombotic & thromboembolic events in atrial fibrillation including stroke in adults who have at least 1 risk factor for vascular events, are not suitable for treatment w/ vit K antagonists & who have low bleeding risk.

Adult & elderly 75 mg single daily dose. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) Initially 300 mg single loading dose, then continue at 75 mg once daily w/ ASA 75-325 mg daily. ST segment elevation acute MI 75 mg single daily dose, initiated w/ 300 mg loading dose in combination w/ ASA & w/ or w/o thrombolytics. Patient >75 yr Initiate treatment w/o loading dose. Moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) 300 mg loading dose, followed by 75 mg once daily & ASA (75-100 mg once daily). Start treatment w/in 24 hr of the event & continue for 21 days followed by single antiplatelet therapy. Atrial fibrillation 75 mg single daily dose in combination w/ ASA (75-100 mg daily).

May be taken with or without food.

Hypersensitivity. Severe hepatic impairment. Active pathological bleeding eg, peptic ulcer or intracranial hemorrhage.

Cross-reactivity among thienopyridines (eg, ticlopidine, prasugrel). Risk of bleeding & haematological adverse reactions. Discontinue use 7 days prior to elective surgery. Very rare reports of TTP. Reports of acquired haemophilia. Concomitant use of strong or moderate CYP2C19 inhibitors or strong CYP2C19 inducers is discouraged. Caution when co-administered w/ CYP2C8 substrate medicinal products. Not to be taken in patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May cause stomach upset & diarrhoea due to hydrogenated castor oil. Caution in patients w/ renal impairment or moderate hepatic disease. Not to be used during pregnancy & lactation. Not to be used in childn. Moderate to high-risk TIA or minor IS: No data regarding the benefit-risk of short term dual antiplatelet therapy in patients w/ history of (non-traumatic) intracranial hemorrhage. Dual antiplatelet therapy is not recommended in patients for whom treatment w/ carotid endarterectomy or intravascular thrombectomy is indicated, or in patients planned for thrombolysis or anticoagulant therapy. Clopidogrel monotherapy in non-minor IS patients should be started only after the 1st 7 days of the event. Dual antiplatelet therapy in non-minor IS patients (NIHSS >4) is not recommended.

Haematoma; epistaxis; GI hemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; puncture site bleeding.

Increased risk of bleeding w/ medicinal products associated w/ bleeding risk, oral anticoagulants, glycoprotein IIb/IIIa inhibitors, ASA, heparin, thrombolytics, NSAIDs, SSRIs. Increased levels of clopidogrel active metabolite w/ CYP2C19 inducers eg, rifampicin. Reduced levels of clopidogrel active metabolite w/ strong or moderate CYP2C19 inhibitors eg, omeprazole & esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, & efavirenz. High risk of vascular events w/ boosted anti-retroviral therapy in HIV patients. Increased exposure of CYP2C8 substrate medicinal products eg, repaglinide & paclitaxel. Potentially delayed & reduced absorption w/ opioid agonists.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.

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