Axcel Clopidogrel

Axcel Clopidogrel



Kotra Pharma


Kotra Pharma
Concise Prescribing Info
Secondary prevention of atherothrombotic events in MI (few days until <35 days), ischaemic stroke (7 days until <6 mth) or established peripheral arterial disease. Acute coronary syndrome: In combination w/ ASA for non-ST segment elevation (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 prevention of atherothrombotic & thromboembolic events in atrial fibrillation including stroke.
Dosage/Direction for Use
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 & 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. Atrial fibrillation 75 mg single daily dose w/ ASA 75-100 mg daily.
May be taken with or without food.
Hypersensitivity. Active pathological bleeding eg, peptic ulcer or intracranial haemorrhage. Severe hepatic impairment.
Special Precautions
History of hypersensitivity to thienopyridines eg, clopidogrel, ticlopidine or prasugrel. Discontinue use if acquired haemophilia is diagnosed. Not recommended during 1st 7 days after acute ischaemic stroke. Increased risk of bleeding from trauma, surgery or other pathological conditions; GI & intraocular lesions w/ propensity to bleed; TTP. Patients w/ genetically reduced CYP2C19 function. May cause stomach upset & diarrhoea due to hydrogenated castor oil. Discontinue use 7 days prior to elective surgery. Not recommended in concomitant use w/ oral anticoagulants. Concomitant use w/ ASA, heparin, glycoprotein IIb/IIIa inhibitors, NSAIDs (eg, COX-2 inhibitors), SSRIs or other medicinal products associated w/ bleeding risk eg, pentoxifylline; strong or moderate CYP2C19 inhibitors; CYP2C8 substrates. Moderate hepatic disease w/ bleeding diatheses. Renal impairment. Not to be used during pregnancy & lactation. Not to be used in childn.
Adverse Reactions
Haematoma; epistaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; puncture site bleeding, fever.
Drug Interactions
Increased risk of bleeding w/ medicinal products associated w/ bleeding risk, oral anticoagulants, ASA, heparin, SSRIs. Increased occult GI blood loss w/ NSAIDs eg, naproxen. Reduced drug levels w/ strong or moderate CYP2C19 inhibitors eg, omeprazole, esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, efavirenz. Decreased exposure w/ PPIs eg, omeprazole, esomeprazole. Increased plasma conc w/ CYP2C8 substrates eg, repaglinide, paclitaxel. Glycoprotein IIb/IIIa inhibitors, thrombolytics, NSAIDs eg, COX-2 inhibitors.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Axcel Clopidogrel FC tab 75 mg
10 × 10's;100 × 10's;3 × 10's;50 × 10's
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