Cloverta

MI (from few days until <35 days), ischaemic stroke (from 7 days until <6 mth) or established peripheral arterial disease in adults. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) in adults including patients undergoing stent placement following percutaneous coronary intervention in combination w/ ASA. ST segment elevation acute MI in combination w/ ASA in medically treated adult patients eligible for thrombolytic therapy. In combination w/ ASA for prevention of atherothrombotic & thromboembolic events, including stroke, in adults w/ atrial fibrillation 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 & older people 75 mg as single daily dose. Patient suffering from acute coronary syndrome Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) Initiate w/ single 300-mg loading dose then continue at 75 mg once daily (w/ ASA 75-325 mg daily). Dose of ASA should not be >100 mg. ST segment elevation acute MI 75 mg as single daily dose initiated w/ 300-mg loading dose in combination w/ ASA & w/ or w/o thrombolytics. For patient >75 yr, initiate w/o loading dose. Start combined therapy as early as possible after symptoms start & continue for at least 4 wk. Patient w/ atrial fibrillation 75 mg as single daily dose. Initiate ASA 75-100 mg daily & continue in combination w/ clopidogrel.

May be taken with or without food.

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

Promptly consider blood cell count determination &/or other appropriate testing whenever clinical symptoms suggestive of bleeding arise during treatment. Caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions & patients receiving treatment w/ ASA, heparin, glycoprotein IIb/IIIa inhibitors or NSAIDs including COX-2 inhibitors, SSRIs, or other medicinal products associated w/ bleeding risk eg, pentoxifylline; patients who are poor CYP2C19 metabolisers. Carefully monitor for any signs of bleeding including occult bleeding, especially during 1st wk of treatment &/or after invasive cardiac procedures or surgery. Discontinue use 7 days prior to surgery if patient is to undergo elective surgery & antiplatelet effect is temporarily not desirable. Advise patients to inform physicians & dentists before any surgery is scheduled & before any new medicinal product is taken. Very rare report of TTP following treatment. Reports of acquired haemophilia. Not recommended during the 1st 7 days after acute ischaemic stroke. Reports of cross-reactivity among thienopyridines. May cause stomach upset & diarrhea due to hydrogenated castor oil. Not recommended w/ oral anticoagulants. Concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged. Caution w/ concomitant CYP2C8 substrates medicinal products. Limited therapeutic experience in patients w/ renal impairment & patients w/ moderate hepatic disease who may have bleeding diatheses. Preferable not to use during pregnancy. Breastfeeding should not be continued during treatment. Not to be used in childn.

Haematoma; epistaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia, gastric & duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence; bruising, rash, pruritus, skin bleeding (purpura); haematuria; bleeding at puncture site.

Intensity of bleedings may be increased w/ oral anticoagulants. Increased risk of bleeding w/ warfarin; glycoprotein IIb/IIIa inhibitors; ASA; heparin; thrombolytic agents; SSRIs. Potentiated effect of ASA on collagen-induced platelet aggregation. Increased occult GI blood loss w/ naproxen. Increased risk of GI bleeding w/ NSAIDs including COX-2 inhibitors. Reduced drug levels of clopidogrel active metabolite w/ strong or moderate CYP2C19 inhibitors eg, omeprazole & esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine & efavirenz. Decreased exposure of clopidogrel active metabolite w/ omeprazole & esomeprazole. Risk of increased plasma conc of drugs primarily cleared by CYP2C8 metabolism (eg, repaglinide, paclitaxel).

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

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

Rx