Clopivaz

Clopivaz

clopidogrel

Manufacturer:

InnoGen Pharmaceuticals

Distributor:

InnoGen Pharmaceuticals
Full Prescribing Info
Contents
Clopidogrel bisulfate.
Description
Each film coated tablet contains: Clopidogrel (as bisulfate) 75 mg.
Clopidogrel is used to lessen the chance 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 problems 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.
Action
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 derivative 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 in feces.
Indications/Uses
Clopidogrel is a thienopyridine antiplatelet drug used in thromboembolic disorders. It is an analogue of ticlopidine and acts by inhibiting adenosine diphosphate mediated platelet aggregation. It is given prophylactically as an alternative to aspirin in patients with atherosclerosis who are at risk of thromboembolic disorders such as myocardial infarction, peripheral arterial disease, and stroke. Clopidogrel is also used with aspirin in acute coronary syndromes, including acute myocardial infarction and unstable angina, and in coronary stenting. Clopidogrel is given orally as the bisulfate, but doses are expressed in terms of the base; 97.86 mg of clopidogrel bisulfate is equivalent to 75 mg of base. For the prophylaxis of thromboembolic events, the usual dose of clopidogrel is 75 mg once daily. In the management of acute ST-elevation myocardial infarction, clopidogrel is used with aspirin as an adjunct in medically-treated patients. It is given in a dose of 75 mg once daily; patients under 75 years of age may be given a loading dose of 300 mg. Treatment should be continued for at least 4 weeks. In the management of unstable angina and non-Qwave myocardial infarction, clopidogrel is used with aspirin as an adjunct to either medical or interventional treatment, including coronary stenting. A single loading dose of 300 mg is given, followed by 75 mg once daily.
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, haemorrahgic diathesis or other haemorrhagic disorders associated with a prolonged bleeding time, or conditions with an increased risk of bleeding such as gastrointestinal ulcers, acute cerebral haemorrhage, or several liver dysfunction. Full blood counts should be performed before starting treatment and every 2 weeks during the first 3 months of therapy. If discontinued during this period, a full blood count should be performed within 2 weeks of stopping treatment. Consideration should be given at 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 thrombotic 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, that 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.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Clopivaz FC tab 75 mg
Packing/Price
30's (P840/pack)
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