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RBX-CLOPIDOGREL is a brand name for Clopidogrel, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: RBX-CLOPIDOGREL (clopidogrel bisulfate) is indicated: • for the secondary prevention of atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with atherosclerosis documented by stroke, myocardial infarction, or established peripheral arterial disease. • in combination with…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment MI, Stroke or Established Peripheral Arterial Disease The recommended dose of RBX-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), RBX-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 RBX-CLOPIDOGREL is 75 mg once daily, administered in combination with ASA, with or without thrombolytics. RBX-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 RBX-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 RBX-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 PrRBX-CLOPIDOGREL (Clopidogrel Tablets USP) Page 6 of 55 schedule.
Do not double doses.
). 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 RBX-CLOPIDOGREL has not been shown to be more effective than RBX- CLOPIDOGREL alone, but the combination has been shown to increase major bleeding (see
). 2 Geriatrics No differences in platelet aggregation or bleeding time were observed in the elderly (≥75 years) volunteers compared to young healthy subjects (see 10 CLINICAL PHARMACOLOGY). 2 CONTRAINDICATIONS RBX-CLOPIDOGREL (clopidogrel bisulfate) is contraindicated in: PrRBX-CLOPIDOGREL (Clopidogrel Tablets USP) Page 5 of 55 • 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). • Patients with significant liver impairment or cholestatic jaundice.
• Patients who are using repaglinide (see 9 DRUG INTERACTIONS). 2 Recommended Dose and Dosage Adjustment MI, Stroke or Established Peripheral Arterial Disease The recommended dose of RBX-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), RBX-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 RBX-CLOPIDOGREL is 75 mg once daily, administered in combination with ASA, with or without thrombolytics. RBX-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 RBX-CLOPIDOGREL is 75 mg once daily, administered in combination with ASA (75-100 mg daily) (see 14 CLINICAL TRIALS).
RBX-CLOPIDOGREL (clopidogrel bisulfate) is contraindicated in:
PrRBX-CLOPIDOGREL (Clopidogrel Tablets USP) Page 5 of 55 • 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). • Patients with significant liver impairment or cholestatic jaundice. • Patients who are using repaglinide (see 9 DRUG INTERACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Clopidogrel in Canada.
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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 RBX-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 PrRBX-CLOPIDOGREL (Clopidogrel Tablets USP) Page 6 of 55 schedule.
Do not double doses. 5 OVERDOSAGE Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. Appropriate therapy should be considered if bleeding is observed or suspected.
A single oral dose of clopidogrel at 1500 or 2000 mg/kg was lethal to mice and rats, and at 3000 mg/kg to baboons.
Treatment:
No antidote to the pharmacological activity of clopidogrel has been found. Platelet transfusion may be used to reverse the pharmacological effects of RBX-CLOPIDOGREL when quick reversal is required. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/ Composition Non-medicinal Ingredients Oral Tablets, 75 mg Hydrogenated castor oil, hypromellose, iron oxide red, lactose monohydrate, low substituted- hydroxypropylcellulose, microcrystalline cellulose, polyethylene glycol 6000, polyethylene glycol 400, and titanium dioxide Dosage Forms RBX-CLOPIDOGREL 75 mg is available as pink coloured, round, film-coated tablets with “75” debossed on one side and plain on the other side.
9 mg of clopidogrel bisulfate USP which is the molar equivalent of 75 mg of clopidogrel base. Non-medicinal ingredients: hydrogenated castor oil, lactose monohydrate, low substituted-hydroxypropylcellulose, microcrystalline cellulose, and polyethylene glycol 6000.
The pink film coating contains hypromellose, iron oxide red, polyethylene glycol 400 and titanium dioxide. Packaging RBX-CLOPIDOGREL 75 mg is available in bottles containing 100 and 500 tablets. 7 WARNINGS AND PRECAUTIONS Driving and Operating Machinery PrRBX-CLOPIDOGREL (Clopidogrel Tablets USP) Page 7 of 55 No impairment of driving or psychometric performance was observed following clopidogrel administration.
Endocrine and Metabolism Cytochrome P450 2C19 (CYP2C19) Clopidogrel bisulfate is a pro-drug, which requires metabolism by the hepatic cytochrome CYP2C19 to form the active thiol metabolite. The function of this enzyme can be compromised, either through direct drug inhibition or dysfunctional genetic variants that lower enzyme activity, thus the effectiveness of clopidogrel bisulfate could diminish correspondingly.
Use of drugs that induce the activity of CYP2C19 would be expected to result in increased drug levels of the active metabolite of clopidogrel and might potentiate the bleeding risk. As a precaution, concomitant use of strong CYP2C19 inducers should be avoided (see 9 DRUG INTERACTIONS).
Pharmacogenetics - CYP2C19 Poor Metabolisers In patients who are CYP2C19 poor metabolisers, clopidogrel bisulfate at recommended doses forms less of the active metabolite of clopidogrel and has a smaller effect on platelet function.
Poor metabolisers with acute coronary syndrome or undergoing percutaneous coronary intervention treated with Clopidogrel bisulfate at recommended doses may exhibit higher cardiovascular event rates than do patients with normal CYP2C19 function.
Consider alternative treatment or treatment strategies in patients […]