RIVA-CLOPIDOGREL

2 Recommended Dose and Dosage Adjustment MI, Stroke or Established Peripheral Arterial Disease The recommended dose of RIVA-CLOPIDOGREL is 75 mg once daily long term with or without food. Acute Coronary Syndrome For patients with non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI), RIVA-CLOPIDOGREL should be initiated with a 300 mg loading dose and continued long-term at 75 mg once a day with ASA (80 mg – 325 mg daily) (see 14 CLINICAL TRIALS).

For patients with ST-segment elevation acute myocardial infarction, the recommended dose of RIVA- CLOPIDOGREL is 75 mg once daily, administered in combination with ASA, with or without thrombolytics. RIVA-CLOPIDOGREL may be initiated with or without a loading dose (300 mg was used in CLARITY) (see 14 CLINICAL TRIALS).

No dosage adjustment is necessary for elderly patients or patients with renal impairment (see 10 CLINICAL PHARMACOLOGY). Atrial Fibrillation For patients with atrial fibrillation who have at least one risk factor for vascular events, who have a low risk of bleeding, and who are unsuitable for anticoagulation therapy, the recommended dose of RIVA- CLOPIDOGREL is 75 mg once daily, administered in combination with ASA (75 – 100 mg daily) (see 14 CLINICAL TRIALS).

Pharmacogenetics CYP2C19 poor metaboliser status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metaboliser healthy subjects increases antiplatelet response, an appropriate dose regimen for this patient population has not been established in clinical outcome trials (see 10 CLINICAL PHARMACOLOGY).

4 Administration For oral use. 5 Missed Dose If a dose of RIVA-CLOPIDOGREL is missed, it should be taken as soon as possible. However, if it is close to the time of the next dose, disregard the missed dose and return to the regular dosing schedule.

Do not double doses. RIVA-CLOPIDOGREL (clopidogrel) Page 6 of 52

). Patients should be told that it may take longer than usual to stop bleeding when they take clopidogrel alone or in combination with ASA, and that they should report any unusual bleeding (site or duration) to their physician. Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new drug is taken.

In patients with recent (TIA) or stroke and who are at high risk of recurrent ischemic events, the combination of ASA and clopidogrel bisulfate has not been shown to be more effective than clopidogrel bisulfate alone, but the combination has been shown to increase major bleeding (see

, Endocrine and Metabolism 10/2022 7 WARNINGS AND PRECAUTIONS, Hematologic TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................

2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................

4 1 INDICATIONS .............................................................................................................. 1 Pediatrics...................................................................................................................

2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS.................................................................................................

4 4 DOSAGE AND ADMINISTRATION................................................................................. 2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration ..........................................................................................................

5 Missed Dose .............................................................................................................. 5 5 OVERDOSAGE.............................................................................................................

6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations ...................................................................................................

RIVA-CLOPIDOGREL (clopidogrel bisulfate) is contraindicated in:  Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph.

 Patients with active bleeding such as peptic ulcer and intracranial hemorrhage (ICH). RIVA-CLOPIDOGREL (clopidogrel) Page 5 of 52  Patients with significant liver impairment or cholestatic jaundice.  Patients who are using repaglinide (see 9 DRUG INTERACTIONS).