Full Prescribing Info
Clopidogrel bisulfate.
Each film-coated tablet contains: Clopidogrel (as Bisulfate) 75 mg.
Clopidogrel is used to lessen the chances of heart attack or stroke. It is given to people who have already had a heart attack or stroke or to people with other blood circulation problem that could lead to a stroke or heart attack. A heart attack or stroke may occur when a blood vessel in the heart or brain is blocked by a blood clot. Clopidogrel reduces the chance that a harmful blood clot will form by preventing certain cells in the blood from clumping together. This effect of Clopidogrel may also increase the chance of serious bleeding in some people.
Pharmacology: Pharmacokinetics: Clopidogrel is rapidly but incompletely absorbed following oral administration; absorption appears to be about 50%. It is a prodrug and is extensively metabolized in the liver following absorption, mainly to the inactive carboxylic acid derivative. The active metabolites appears to be a thiol derivatives but has not been identified in plasma. Clopidogrel and the carboxylic acid derivatives are highly protein bound. Clopidogrel and its metabolites are excreted about equally in urine and feces.
For the prevention of atherosclerotic events in the peripheral arterial disease, or within 35 days of myocardial infarction or within 6 months of ischemic stroke, or in acute or coronary syndrome without ST-segmental elevation.
Dosage/Direction for Use
The usual dose is 75 mg once daily or as prescribed by the physician.
Special Precautions
Should not be administered to patients with hematopoietic disorders such as neutropenia or thrombocytopenia, haemorrhagic diathetis or other haemorrhagic disorders associated with a prolonged bleeding time, or conditions with an increased risk of bleeding such as gastrointestinal ulcers, acute cerebral hemorrhage or, several liver dysfunctions. Full blood counts should be performed within two weeks during the first 3 months of therapy. If discontinued during the period, a full blood count should be performed within 2 weeks of stopping of treatment. Consideration should be given in stopping the therapy 10-14 days before elective surgery.
Adverse Reactions
Gastrointestinal disturbances and skin rashes are the most commonly reported side-effects associated with Clopidogrel therapy. Blood dyscrasias, including neutropenia and thrombocytopenic purpura, and haemorrhagic disorders have also occurred. There have been reports of hepatitis and cholestatic jaundice. Blood-lipid concentrations may increase during long-term therapy.
Drug Interactions
Should be used with caution in patients receiving other drugs, such as anticoagulants and antiplatelets, which increase the risk of bleeding. May inhibit the metabolism of other drugs that are metabolized in the liver. The clearance of Clopidogrel may be reduced by concomitant cimetidine therapy. Corticosteroids may antagonize the effect of Clopidogrel on bleeding time.
Store at temperatures not exceeding 30°C.
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
FC tab 75 mg x 10's, 30's.
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