Detailed information
Composition:
Each film coated tablet contains 75 mg clopidogrel base.
Properties:
Clopidogrel is a potent inhibitor of platelet aggregation for use in the prevention of vasculai ischaemic events in patients with established atherosclerotic disease, it is a specific inhibitor of ADP (adenosine diphosphate) receptor and only moderately inhibits collagen-induced aggregation the binding of the active metabolite to the ADP - receptor Impairs the ADP - induced change of the GP JJb-IIIa platelet membrane complex necessary for binding of fibrinogen also'elopidogrel interferes with ADP release from platelets and prolongs bleeding time.
Pharmacokinetics:
Clopidogrel is rapidly but incompletely absorbed after oral administration and is extensively metabolized in the liver following. absorption, mainly to the inactive carboxylic acid derivative, clopidogerl.
and the carboxylic acid derivative are highly protein bound and are excreted about equally in urine and in faeces.
Indications:
clopidogrel is given prophylactically in patients at risk of thrombo-embolic disorders such as myocardial infarction, peripheral arterial disease and stroke .
Contraindications:
Patients with a known hypersensitivity to clopidogrel or to any of the excipients
Patients with haematopoietic disorders such as neutropenia or thrombocytopenia or other haemorrhagic disorders or conditions with an increased risk of bleeding such as gastro-intestinal ulcers or severe liver dysfunction.
SIDE EFFECTS:
Gastrointestinal hemorrhage occurred at rate of 2.0 %. neutropenia, abdominal pain, dyspepsia, constipation, peptic or duodenal ulcers, headache, fatigue, dizziness, diarrhea, pruritis, upper respiratory tract, palpitation, bleeding and clotting disorders.
PRECAUTIONS:
Clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery .
if a patients is to undergo elective surgery and an antiplatelet effect is no desired, Clopidogrel should be discontinued 7 days prior to surgery.
clopidogrel should be used with a caution in patients WHO have lesions with a propensity to bleed and patients with severe hepatic disease.
Clopidogrel should be used during pregnancy only if clearly needed. it is not know whether this drug is excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug . taking into account the importance of the drug to the nursing woman. Safety and effectiveness in the pediatric population have not been establishe.
DRUG INTERACTIONS:
Platelet - Clopidogrel potentiated the effect of aspirin on collagen -induced aggregation.
Concomitant administration of 500mg aspirin twice a day for 1 day did not significantly increase the prolongation of bleeding time induced by Clopidogrel.
The concomitant administration of Aspirin and Clopidogrel has not been established.
Coadministration of heparin had no effect on inhibition of platelet aggregatior induced by Clopidogrel.
Cloidogrel should be coadministered with caution with NSAIDs.
Concomitant administration of Clopidogrel with Warfarin should be undertaken with caution.
DOSAGE AND ADMINISTRATION:
The recommended dose of Clopidogrel is 75mg once daily wither without food no dosage adjustment is necessary for elderly patients or patients with renal disease.
STORAGE:
Store protected from light and moisture below 25°C |
