Each film-coated tablet contains: Clopidogrel (as Bisulfate) USP 75 mg.
Pharmacology: Pharmacokinetics: Clopidogrel is rapidly but incompletely absorbed after oral doses; absorption appears to be at least 50%. It is a prodrug and is extensively metabolized in the liver, mainly to the inactive carboxylic acid derivative. The active metabolite appears to be a thiol derivative but has been identified in plasma. Clopidogrel and the carboxylic acid derivative are highly protein bound. Clopidogrel and its metabolites are excreted in urine and in faeces; about 50% of an oral dose is recovered from the urine and about 46% from faeces.
For the reduction of atherosclerotic events (myocardial infarction, stroke or vascular death) in patients with atherosclerosis documented by recent stroke, myocardial infarction, or established peripheral arterial disease. For the treatment of patients suffering from non-ST segment elevation, acute coronary syndrome (unstable angina or non-Q wave myocardial infarction) including patient undergoing stent placement following percutaneous coronary intervention or combination with ASA in medically treated patients eligible from thrombolytic therapy.
Acute coronary syndrome: Loading dose of 300 mg followed by 75 mg daily.
For patients with NON-ST segment elevation Acute Coronary Syndrome, Clapidz should be initiated with 300 mg loading dose and continued to 75 mg daily with recommended Acetylsalicylic acid of not more than 100 mg to avoid the risk of bleeding.
For patients with ST-segment elevation acute Myocardial Infarction: 75 mg single daily dose with 300 mg loading dose with Acetylsalicylic acid and with or without thrombolytics. 75 years old patients should not receive a loading dose of 300 mg and recommended to start with 75 mg of Clapidz.
For patients with atrial fibrillation: Clapidz should be given 75 mg single dose daily while giving in combination with ASA of doses 75 mg-100 mg daily.
Prophylaxis of thromboembolic events: the usual dose is 75 mg once daily.
Management of acute coronary syndromes, unstable angina and non-Q wave myocardial infarction: 300 mg loading dose, followed by 75 mg once daily.
Or as prescribed by the physician.
Clopidogrel is contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in the formulations. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
Thrombotic thrombocytopenic purpura sometimes after a short exposure (less than 2 weeks).
Acquired Haemophilia has been reported with the use of clopidogrel. Clopidogrel should be stopped once manifestation occurs.
Should not be administered to patients with haematopoietic disorders such as neutropenia or thrombocytopenia, hemorrhagic diathesis or other haemorrhagic disorders associated by a prolonged bleeding time or conditions with an increased risk of bleeding such as gastrointestinal ulcers, acute cerebral hemorrhage or severe liver dysfunction.
Full blood counts should be performed before starting treatment and every two (2) weeks during first three months of therapy. If discontinued, a full blood count should be performed within (2) weeks of stopping treatment. Consideration should be given to stopping Clopidogrel therapy 10-14 days before elective surgery.
Gastrointestinal disturbances, skin rashes, blood dyscrasias including neutropenia and thrombocytopenic purpura, hemorrhagic disorders, hepatitis and cholestatic jaundice.
Aspirin: Potentiates the effect of aspirin on collagen-induced platelet aggregation.
NSAID: Risk of increased occult gastrointestinal blood loss.
Phenytoin, tamoxifen, tolbutamide, warfarin, torsemide, fluvastatin: Since Clopidogrel inhibits CYP4502C9 it may interfere with the metabolism of these drugs.
Store at temperatures not exceeding 30ºC.
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
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