- Approval Id
- 2ed4f71108334eb2
- Drug Name
- CLOPISWIFT FILM-COATED TABLET 75MG
- Product Name
- CLOPISWIFT FILM-COATED TABLET 75MG
- Approval Number
- SIN17130P
- Approval Date
- 2024-10-30
- Registrant
- SEA PHARMA CONSULTANCY PTE LTD
- Licence Holder
- SEA PHARMA CONSULTANCY PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE & METHOD OF ADMINISTRATION:</strong><br>
<strong>Posology</strong></p>
<ul>
<li><p>Adults and elderly<br>
Clopidogrel should be given as a single daily dose of 75 mg.</p>
<p>In patients suffering from acute coronary syndrome:</p>
<ul class="dash">
<li>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 600mg loading dose. A 600 mg loading dose may be considered in patients <75 years of age when percutaneous coronary intervention is intended. 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</li>
<li>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 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.</li>
</ul>
<p>Adult patients with moderate to high-risk TIA or minor IS:<br>
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.</p>
<p>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.</p>
<p>Pharmacogenetics<br>
CYP2C19 poor metaboliser status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolisers increases antiplatelet response an appropriate dose regimen for this patient population has not been established.</p>
<p>If a dose is missed:</p>
<ul class="dash">
<li>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.</li>
<li>For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.</li>
</ul>
</li>
<li>Paediatric population<br>
Clopidogrel should not be used in children because of efficacy concerns.</li>
<li>Renal impairment<br>
Therapeutic experience is limited in patients with renal impairment.</li>
<li>Hepatic impairment<br>
Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.</li>
</ul>
<p><u>Method of administration</u><br>
Oral use.<br>
It may be given with or without food.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS & USAGE:</strong><br>
<em>Secondary prevention of atherothrombotic events</em><br>
Clopidogrel is indicated in:</p>
<ul>
<li>Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.</li>
<li>Adult patients suffering from acute coronary syndrome:
<ul class="dash">
<li>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).</li>
<li>ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.</li>
</ul>
</li>
</ul>
<p><em>In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)</em><br>
Clopidogrel in combination with ASA is indicated in:</p>
<ul class="dash">
<li>Adult patients with moderate to high-risk TIA (ABCD2<sup>1</sup> score ≥4) or minor IS (NIHSS<sup>2</sup> ≤3) within 24 hours of either the TIA or IS event.</li>
</ul>
<p><em>Prevention of atherothrombotic and thromboembolic events in atrial fibrillation</em><br>
In adult patients with atrial fibrillation 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.<br>
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.</p>
<p>For further information please refer to section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.<br>
<sup>1</sup> Age, Blood pressure, Clinical features, Duration, and Diabetes mellitus diagnosis<br>
<sup>2</sup> National Institutes of Health Stroke Scale</p>
- Contraindications
- <p><strong>CONTRAINDICATION:</strong></p>
<ul>
<li>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Severe hepatic impairment.</li>
<li>Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.</li>
</ul>
- Atc Code
- B01AC04
- Pharma Manufacturer Name
- SEA PHARMA CONSULTANCY PTE. LTD.
- Company Detail Path
- /organization/sea-pharma-consultancy-pte-ltd
