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CoPlavix

CoPlavix Dosage/Direction for Use

clopidogrel + aspirin

Manufacturer:

sanofi-aventis

Distributor:

sanofi-aventis
Full Prescribing Info
Dosage/Direction for Use
Dosage: Adults and elderly: Clopidogrel bisulfate + Aspirin (CoPlavix) 75 mg/100 mg film-coated tablets: Clopidogrel bisulfate + Aspirin (CoPlavix) should be given as a single daily 75 mg/100 mg dose.
Clopidogrel bisulfate + Aspirin (CoPlavix) fixed-dose combination is used following initiation of therapy with Clopidogrel and Aspirin given separately, and replaces the individual clopidogrel and Aspirin 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 (see Pharmacology: Pharmacodynamics under Actions). If the use of Clopidogrel bisulfate + Aspirin (CoPlavix) is discontinued, patients may benefit with continuation of one antiplatelet medicinal product.
In patients with ST segment elevation acute myocardial infarction: For medically treated patients, Clopidogrel bisulfate + Aspirin (CoPlavix) 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 (see Pharmacology: Pharmacodynamics under Actions). If the use of Clopidogrel bisulfate + Aspirin (CoPlavix) is discontinued, patients may benefit with continuation of one antiplatelet medicinal product.
When PCI is intended, Clopidogrel bisulfate + Aspirin (CoPlavix) treatment should be started as early as possible after symptoms start and continued up to 12 months (see Pharmacology: Pharmacodynamics under Actions).
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.
Paediatric population: The safety and efficacy of Clopidogrel bisulfate + Aspirin (CoPlavix) in children and adolescents under 18 years old have not been established. Clopidogrel bisulfate + Aspirin (CoPlavix) is not recommended in this population.
Renal impairment: Clopidogrel bisulfate + Aspirin (CoPlavix) must not be used in patients with severe renal impairment (see Contraindications). Therapeutic experience is limited in patients with mild to moderate renal impairment (see Precautions). Therefore, Clopidogrel bisulfate + Aspirin (CoPlavix) should be used with caution in these patients.
Hepatic impairment: Clopidogrel bisulfate + Aspirin (CoPlavix) must not be used in patients with severe hepatic impairment (see Contraindications). Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see Precautions). Therefore, Clopidogrel bisulfate + Aspirin (CoPlavix) should be used with caution in these patients.
Method of administration: For oral use.
It may be given with or without food.
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