Description

Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the glycoprotein GPllb/lIla complex, thereby inhibiting platelet aggregation. Clopidogrel also inhibits platelet aggregation induced by agonists other than ADP.

Presentation

    Clocard Tablet: Each film coated tablet contains Clopidogrel Bisulfate USP equivalent to Clopidogrel 75 mg.  
     

Indications

    Clocard is indicated for: Recent Ml, recent stroke or established peripheral arterial disease: For patients with a history of recent myocardial infarction (Ml), recent stroke or established peripheral arterial disease, Clocard has been shown to reduce the rate of Ml and stroke.
    Acute coronary syndrome: For patients with acute coronary syndrome including patients who are to be managed with medically and those who are to be managed with percutaneous coronary intervention, Clocard has been shown to decrease the rate of Ml and stroke.   

Dosage & Administration

    Recent Ml, recent stroke or established peripheral arterial disease: The recommended dose for recent Ml, recent stroke or established peripheral arterial disease is Clocard 75 mg tablet once daily orally. Acute coronary syndrome: For Acute coronary syndrome, initiate with a single 300-mg oral loading dose of Clopidogrel (4 tablets of Clocard) and then continue at 75 mg once daily .

Contrainidications

    The use of Clopidogrel is contraindicated in hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
     

Warning & Precautions

    If a patient is to undergo elective surgery and an antiplatelet effect is not desired, Clopidogrel should be discontinued 5 days prior to surgery. It prolongs the bleeding time. So, it should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions (particularly gastrointestinal and intraocular). Patients should be informed that it may take them longer time than usual to stop bleeding when they take this drug and they should report any unusual bleeding to the physicians. Avoid concomitant use of Omeprazole or Esomeprazole with Clopidogrel. Thrombotic thrombocytopenic purpura (TTP) and cross-reactivity among thienopyridines has been reported.  

Side effects

    Clopidogrel is generally well tolerated. A few common side effects like hemorrhage (including gastrointestinal and intracranial), abdominal discomfort, nausea, vomiting, diarrhea, headache, dizziness, vertigo, paraesthesia, rash, pruritus, hepatic and biliary disorder, neutropenia etc. may occur.  
     

Drug interaction

    CYP2C19 Inhibitors: Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of drugs like Omeprazole & Esomeprazole that inhibit the activity of this enzyme results in reduced plasma concentrations of the active metabolite of Clopidogrel and a reduction in platelet inhibition. Opioids: Decreased exposure to Clopidogrel. Consider use of parenteral antiplatelet agent. Warfarin:Because of the increased risk of bleeding, the concomitant administration of Warfarin with Clopidogrel should be undertaken with caution.  NSAIDs: NSAIDs and Clopidogrel should be co-administered with caution. Concomitant administration of Clopidogrel with Naproxen is associated with gastrointestinal blood loss. Others: No clinically significant pharmacodynamic interactions are observed when Clopidogrel is coadministered with Atenolol, Nifedipine or both Atenolol and Nifedipine.  
     

Use in special groups

    Pregnancy: There were no adequate and well controlled studies in pregnant women. Clopidogrel should be used during pregnancy only if clearly needed. Lactation: It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the nursing woman. Pediatric use: Safety and efficacy have not been established in pediatric patients. Geriatric use: Dosage adjustment based solely on age does not appear to be necessary in geriatric patients. Renal impairment: This drug should be used with caution in renal impaired patients. Hepatic Impairment: No dosage adjustment is necessary in patients with hepatic impairment.   

Packing

    Clocard Tablet: Each box contains 30 tablets in Alu-Alu blister pack.