Clorel is a preparation of Clopidogrel which is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.
Clorel is indicated for prevention of atherosclerotic events in patients with history of symptomatic atherosclerotic disease (ischaemic stroke, myocardial infarction or, established peripheral arterial disease).
Clorel is indicated-
• To reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS (patients who are to be managed medically and those who are to be managed with coronary revascularization).
• To reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (who are to be managed medically).
• To reduce the rate of MI and stroke in patients with established peripheral arterial disease or with a history Of recent myocardial infarction (MI) or recent stroke.
Clorel should be administered in conjunction with aspirin.
Route of administration: Clorel should be administered in oral route.
Acute coronary syndrome: Initiate Clorel with a single 300 mg oral loading dose and then continue at 75 mg once daily.
Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily without a loading dose.
Pregnancy: There are no adequate and well-controlled studies in pregnant women with clopidogrel.
Lactation: There are no data on the presence of clopidogrel in human milk or the effects on milk production.
Use in children and adolescents
Safety and effectiveness in children and adolescents have not been established.
The metabolism of clopidogrel can be impaired by genetic variations in CYP2C19. P2Y12 inhibitors including clopidogrel increase the risk of bleeding. Discontinuation of administration increases the risk of cardiovascular events. If it must be temporarily discontinued, restart it as soon as possible. There's risk of thrombotic thrombocytopenic purpura (TTP) following administration.
The most common side effects are bleeding, including life-threatening and fatal bleeding.
It is contraindicated in patients with history of known hypersensitivity to dopidogrel or any other components of this product. It is also contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
Drug interaction with medication: Avoid concomitant use with strong CYP2C19 inducers, omeprazole or esomeprazole. Consider the use of a parenteral antiplatelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists. Concomitant use with NSAIDs, SSRIs, SNRls and other antiplatelet agents increases the risk of gastrointestinal bleeding. Dose adjustment is necessary in concomitant use with repaglinide.
Drug interaction with food and others: Not applicable.
In case of overdose, bleeding complications may occur. Treatment should be symptomatic and supportive measures instituted as required.
No Data
Store in cool and dry place protected from light. keep away from the reach of children.
Clorel 75 mg Tablet: Each coated tablet contains Clopidogrel 75 mg as Bisulfate USP.
Storage
Store below 30°C in a dry place, protected from light. Keep away from the reach of children.
Packing
Clorel 75 mg Tablet: Carton of 50 tablets in blister pack.