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Cardiovascular Agents

Clopistad

 

Pack size:

Box of 3 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains clopidogrel (bisulfate) 75 mg.

 

Shelf-life: 

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.
 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Prevention of atherothrombotic events
    Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
    Adult patients suffering from acute coronary syndrome: 
    - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with aspirin.
    - ST segment elevation acute myocardial infarction, in combination with in aspirin medically treated patients eligible for thrombolytic therapy.
  • Prevention of atherothrombotic and thromboembolic events in atrial fibrillation 
    In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with for the prevention of aspirin atherothrombotic and thromboembolic events, including stroke. 
     
  • Administered orally with or without food.

    Adults and elderly:
    A single daily dose of 75 mg. 
    In patients suffering from acute coronary syndrome:
    Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): Clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with aspirin 75 - 325 mg daily). Since higher doses of aspirin were associated with higher bleeding risk it is recommended that the dose of aspirin should not be higher than 100 mg. The optimal duration of treatment has not been formally established. Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months.
    ST segment elevation acute myocardial infarction: Clopidogrel should be given as a single daily dose of 75 mg initiated with a 300 mg loading dose in combination with aspirin and with or without thrombolytics. For patients over 75 years of age clopidogrel should be initiated without a loading dose. Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks. The benefit of the combination of clopidogrel with aspirin beyond four weeks has not been studied in this setting.
    In patients with atrial fibrillation:
    A single daily dose of 75 mg. Aspirin (75 - 100 mg daily) should be initiated and continued in combination with clopidogrel.


Or as prescribed by physicians.
 

  • Known hypersensitivity to clopidogrel or any ingredient of the drug.
  • Presence of active pathological bleeding (e.g., peptic ulcer, intracranial hemorrhage).
  • Severe hepatic impairment.

     

Common

  • Haematoma.
  • Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia.
  • Bruising.
  •  Epistaxis.

Uncommon

  • Thrombocytopenia, leucopenia, eosinophilia.
  • Intracranial bleeding (some cases were reported with fatal outcome), headache, paraesthesia, dizziness.
  • Eye bleeding (conjunctival, ocular, retinal).
  • Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence.
  • Rash, pruritus, skin bleeding (purpura).
  • Haematuria.
  • Bleeding time prolonged, neutrophil count decreased, platelet count decreased.

Rare

  • Neutropenia, including severe neutropenia.
  • Retroperitoneal haemorrhage.
  • Vertigo.

     

  • Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment. As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions. Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery. The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings.
  • If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery. Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken. Clopidogrel prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular).
  • Patients should be told that it might take longer than usual to stop bleeding when they take clopidogrel (alone or in combination with aspirin), and that they should report any unusual bleeding to their physician.
  • Thrombotic thrombocytopenic purpura has been reported very rarely following the use of clopidogrel, sometimes after a short exposure. It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever. Thrombotic thrombocytopenic purpura is a potentially fatal condition requiring prompt treatment including plasmapheresis.
  • In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
  • Therapeutic experience with clopidogrel is limited in patients with renal impairment. Therefore clopidogrel should be used with caution in these patients.
  • Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses. Clopidogrel should therefore be used with caution in this population.
  • Pregnancy: There are no adequate and well-controlled studies in pregnant women, clopidogrel should be used during pregnancy only if clearly needed.
  • Lactation: Not known whether the drug is distributed into milk in humans. Discontinue nursing or the drug because of potential for severe adverse effects in infants.
  • Effects on ability to drive and use machines: Adverse reactions like headache, dizziness and eye bleeding (uncommon frequency) and vertigo (rare frequency) have been reported when taking clopidogrel. Patients experiencing these adverse reactions should not drive or use machines.

     

Contact us

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