Clopidogrel + Aspirin capsules should be given as a single daily 75 mg/75 mg dose.
Clopidogrel + Aspirin capsules fixed-dose combination is used following initiation of therapy with Clopidogrel and ASA given separately, and replaces the individual Clopidogrel and ASA products.
In patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): 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. If the use of Clopidogrel + Aspirin capsules is discontinued, patients may benefit with continuation of one antiplatelet medicinal product.
In patients with ST segment elevation acute myocardial infarction: 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 ASA beyond four weeks has not been studied in this setting. If the use of Clopidogrel + Aspirin capsules is discontinued, patients may benefit with continuation of one antiplatelet medicinal product.
If a dose is missed: Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
Pediatrics population: The safety and efficacy of Clopidogrel + Aspirin capsules in children and adolescents under 18 years old have not been established. Clopidogrel + Aspirin capsules is not recommended in this population.
Renal impairment: Clopidogrel + Aspirin capsules must not be used in patients with severe renal impairment. Therapeutic experience is limited in patients with mild to moderate renal impairment. Therefore, Clopidogrel + Aspirin capsules should be used with caution in these patients.
Hepatic impairment: Clopidogrel + Aspirin capsules must not be used in patients with severe hepatic impairment.
Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
Therefore, Clopidogrel + Aspirin capsules should be used with caution in these patients.
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