CLOPIDOGREL® 75

Composition: Clopidogrel bisulfate equivalent to clopidogrel……….. 75 mg.

Excipients: Microcrystalline cellulose, mannitol, hydroxypropyl cellulose, wheat starch, crospovidone, silicon dioxide, talc, stearic acid, hydroxypropyl methylcellulose, polyethylene glycol 6000, titanium dioxide, iron oxide dye.

Dosage Form : Film-coated tablet
Packaging: Box of 10 blisters x 10 tablets
Indications: Treatment of hypertension, can be used alone or in combination
Mô tả sản phẩm
  • Indications & Usage:
  • Secondary prevention of atherothrombotic events: Clopidogrel is indicated in:
    • Adult patients with myocardial infarction (from a few days to less than 35 days), ischemic stroke (from 7 days to less than 6 months), or established peripheral arterial disease.
    • Adult patients with acute coronary syndrome:
      • Non-ST-segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients with a stent placed during percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
      • ST-segment elevation acute myocardial infarction, in combination with ASA in medically treated patients with or without 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 cardiovascular events, who are not candidates for vitamin K antagonists (VKA), and who have a low risk of bleeding, clopidogrel in combination with ASA is indicated for the prevention of atherothrombotic and thromboembolic events, including stroke.
  • Dosage & Administration:
  • Administration: Oral use. Can be taken with or without food.
  • Dosage:
    • Adults and elderly: Clopidogrel should be used at a single dose of 75 mg/day.
    • Acute coronary syndrome:
      • Non-ST-segment elevation: Start with a single 300 mg loading dose, then continue with 75 mg once daily (in combination with 75 mg – 325 mg/day ASA). Due to the higher bleeding risk with higher ASA doses, ASA should not exceed 100 mg. The optimal duration of treatment has not been formally established. Clinical trial data support use for up to 12 months, with maximum benefit observed after 3 months.
      • ST-segment elevation acute myocardial infarction: Start with a 300 mg loading dose of clopidogrel in combination with ASA, then continue with 75 mg daily in combination with ASA, with or without thrombolytic therapy. For patients over 75 years of age, a loading dose is not needed. The combination therapy should be initiated as early as possible after symptom onset and continued for at least 4 weeks. The benefit of combining clopidogrel with ASA after 4 weeks has not been studied.
    • Atrial fibrillation: Take a single dose of 75 mg clopidogrel once daily, in combination with ASA (75-100 mg).
  • Children: Clopidogrel is not recommended for use in children under 18 years of age due to insufficient efficacy data.
  • Renal Impairment: Limited experience with clopidogrel in patients with renal impairment.
  • Hepatic Impairment: Limited experience with clopidogrel in patients with moderate to mild hepatic impairment, who may have a predisposition to bleeding.
  • Contraindications:
    • Hypersensitivity to clopidogrel or any component of the medication.
    • Severe hepatic impairment.
    • Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
  • Storage & Quality:
      • Storage: Store in a cool, dry place at a temperature below 30°C, away from light.
      • Shelf Life: 36 months from the manufacturing date.
      • Quality Standard: Manufacturer’s Standard
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