CLOPIDOGREL SANDOZ FILM COATED TABLET 75MG [SIN13746P]

Product Info

CLOPIDOGREL SANDOZ FILM COATED TABLET 75MG

[SIN13746P]

Indication

4.1 Therapeutic indications

Secondary prevention of atherothrombotic events
Clopidogrel is indicated in:

• Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

• Adult patients suffering from acute coronary syndrome:

  • Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).

  • ST segment elevation acute myocardial infarction, in combination with ASA in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy.

In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)
Clopidogrel in combination with ASA is indicated in:

• Adult patients with moderate to high-risk TIA (ABCD2¹ score ≥4) or minor IS (NIHSS² ≤3) within 24 hours of either the TIA or IS event.

¹ Age, Blood pressure, Clinical features, Duration, and Diabetes mellitus diagnosis
² National Institutes of Health Stroke Scale

Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
In adult patients with atrial fibrillation (AF) who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

In patients with AF at increased risk of vascular events who can take VKA therapy, VKA has been shown to result in better clinical benefit than ASA alone or the combination of clopidogrel and ASA for reductions of stroke.

For further information please refer to section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Dosing

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 or 600 mg loading dose. A 600 mg loading dose may be considered in patients <75 years of age when percutaneous coronary intervention is intended (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Clopidogrel treatment should be continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg–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: For medically treated patients eligible for thrombolytic/fibrinolytic therapy, 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 medically treated 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).
○ In adult patients <75 years of age, when percutaneous coronary intervention (PCI) is intended:

• Clopidogrel should be initiated at a loading dose of 600 mg in patients undergoing primary PCI and in patients undergoing PCI more than 24 hours of receiving fibrinolytic therapy.

• Clopidogrel 300 mg loading dose should be given in patients undergoing PCI within 24 hours of receiving fibrinolytic therapy.
  Clopidogrel treatment should be continued at 75 mg once a day with ASA 75 mg – 100 mg daily. Combined therapy should be started as early as possible after symptoms start and continued up to 12 months (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).

Special populations
• Elderly patients
Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction):

• A 600 mg loading dose may be considered in patients <75 years of age when percutaneous coronary intervention is intended (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

ST segment elevation acute myocardial infarction:

• For medically treated patients eligible for thrombolytic/fibrinolytic therapy: in patients over 75 years of age clopidogrel should be initiated without a loading dose.

For patients undergoing primary PCI:

• There is no data to recommend the use of a loading dose in patients aged ≥ 75 years.

• 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 may have 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.

Contraindications

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients.

• Severe liver impairment.

• Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.