Clopidogrel Sandoz Film Coated Tablet 75mg

NOVARTIS (SINGAPORE) PTE LTD

SANDOZ SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 Posology and method of administration** _**Posology**_ - Adults and elderly Clopidogrel should be given as 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 acetylsalicylic acid (ASA) 75mg–325 mg daily). Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA 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 (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - 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 ASA 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 ASA beyond four weeks has not been studied in this setting (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Adult patients with moderate to high-risk TIA or minor IS: Adult patients with moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) should be given a loading dose of clopidogrel 300 mg followed by clopidogrel 75 mg once daily and ASA (75 mg –100 mg once daily). Treatment with clopidogrel and ASA should be started within 24 hours of the event and be continued for 21 days followed by single antiplatelet therapy. In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75–100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Pharmacogenetics CYP2C19 poor metaboliser status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolisers increases antiplatelet response (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), an appropriate dose regimen for this patient population has not been established. - Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Hepatic impairment Therapeutic experience is limited in patients with moderate hepatic disease who mayhave bleeding diatheses (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Method of administration**_ For oral use. It may be given with or without food. 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.