Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
(Acetylsalicylic acid layer) Acetylsalicylic acid (as Acetylsalicylic acid granulated with starch); (Clopidogrel layer) Clopidogrel (as Clopidogrel hydrogen sulfate form II)
SANOFI-AVENTIS SINGAPORE PTE. LTD.
B01AC30
100 mg
TABLET, FILM COATED
(Acetylsalicylic acid layer) Acetylsalicylic acid (as Acetylsalicylic acid granulated with starch) 100 mg; (Clopidogrel layer) Clopidogrel (as Clopidogrel hydrogen sulfate form II) 75 mg
ORAL
Prescription Only
SANOFI WINTHROP INDUSTRIE
ACTIVE
2008-08-08
Page 1 of 19 COPLAVIX FILM-COATED TABLET 75MG/100 MG QUALITATIVE AND QUANTITATIVE COMPOSITION Clopidogrel hydrogen sulphate 97.875 mg (molar equivalent of 75 mg of clopidogrel base) and 111.11 mg of acetylsalicylic acid granulated with maize-starch corresponding to 100 mg of acetylsalicylic acid (ASA). Excipients: lactose 8 mg, hydrogenated castor oil 3.3 mg. For a full list of excipients, see section “_List of excipients_”. PHARMACEUTICAL FORM Film-coated tablet. CoPlavix tablets are light pink, oval, slightly biconvex, film-coated, engraved with «C75» on one side and «A100» on the other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS CoPlavix is indicated for the prevention of atherothrombotic events in patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q- wave myocardial infarction). - ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy For further information please refer to section “_Pharmacodynamic properties_”. POSOLOGY AND METHOD OF ADMINISTRATION Adults and elderly CoPlavix should be given as a single daily 75 mg/100 mg dose. CoPlavix is used in adult patients already taking both clopidogrel and ASA. It may be given with or without food. - In patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), treatment should be initiated with a single 300 mg loading dose of clopidogrel and an appropriate dose of ASA and then continued with CoPlavix 75 mg/100 mg once a day. 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 section “_Pharmacodynamic properties_”). - In patients with ST segment elevation acute myocardial infarction: Therapy sho Read the complete document
SG/COP/0822/CCDSv21 Page 1 of 23 COPLAVIX FILM-COATED TABLET 75MG/100 MG QUALITATIVE AND QUANTITATIVE COMPOSITION Clopidogrel hydrogen sulphate 97.875 mg (molar equivalent of 75 mg of clopidogrel base) and 111.11 mg of acetylsalicylic acid granulated with maize-starch corresponding to 100 mg of acetylsalicylic acid (ASA). Excipients: lactose 8 mg, hydrogenated castor oil 3.3 mg. For a full list of excipients, see section “_List of excipients_”. PHARMACEUTICAL FORM Film-coated tablet. CoPlavix tablets are light pink, oval, slightly biconvex, film-coated, engraved with «C75» on one side and «A100» on the other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS CoPlavix is indicated for the secondary prevention of atherothrombotic events in patients suffering from acute coronary syndrome: - NON-ST SEGMENT elevation acute coronary syndrome (unstable angina or non-Q- wave myocardial infarction). - ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy For further information please refer to section “_Pharmacodynamic properties_”. POSOLOGY AND METHOD OF ADMINISTRATION Adults and elderly CoPlavix fixed dose combination (FDC) should be given as a single daily 75 mg/100 mg dose. CoPlavix FDC is used in adult patients already taking both clopidogrel and ASA given separately at the appropriate dose, and replaces the individual clopidogrel and ASA product. It may be given with or without food. - In patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), treatment should be initiated with a single 300 mg loading dose of clopidogrel and an appropriate dose of ASA and then continued with CoPlavix 75 mg/100 mg once a day. 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 section “_Pharmacodynamic properties_”). - In patients with ST segment elevation acute myocardial infarction: Read the complete document