Clopifar

Clopifar Special Precautions

clopidogrel

Manufacturer:

Bal Pharma

Distributor:

Conjug8 Corp

Marketer:

Pharmakon
Full Prescribing Info
Special Precautions
Bleeding and haematological disorders: As with other antiplatelet agents, when considering prescribing Clopidogrel bisulphate, physicians should inquire whether the patient has a history of bleeding. Clopidogrel should be used with caution in patients who may be at risk of increased bleeding from recent trauma, surgery or other pathological condition(s). Because of the increased risk of bleeding, the concomitant administration of warfarin with Clopidogrel should be undertaken with caution. Due to the risk of bleeding and haematological undesirable effects, blood cell count determination and/or other appropriate testing should be promptly considered whenever such suspected clinical symptoms arise during the course of treatment.
In patients with recent transient ischaemic attack (TIA) or stroke and who are at high risk of recurrent ischemic events, the combination of ASA and Clopidogrel has not been shown to be more effective than Clopidogrel alone, but the combination has been shown to increase major bleeding.
Platelet transfusion may be used to reverse the pharmacological effects of Clopidogrel when quick reversal is required.
Thrombotic Thrombocytopenic Purpura (TTP) has been reported rarely following the use of Clopidogrel, but it can occur anytime during the first year of exposure. Few cases have been reported after more than one year of exposure. TTP is a potentially fatal condition requiring prompt treatment with plasmapheresis. It is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragmented RBC's] seen on peripheral smear), neurological findings, renal dysfunction, and fever.
Diminished Antiplatelet Activity Due to Impaired CYP2C19 Function: Clopidogrel is a prodrug. Inhibition of platelet aggregation by Clopidogrel is achieved through an active metabolite. The metabolism of Clopidogrel to its active metabolite can be impaired by genetic variations in CYP2C 19 and by concomitant medications that interfere with CYP2C19.
Proton Pump Inhibitor: Avoid concomitant use of Clopidogrel with omeprazole or esomeprazole because both significantly reduce the antiplatelet activity of Clopidogrel.
Use in Children: Safety and effectiveness in pediatric populations have not been established.
Use in Elderly: There is no need of dosage adjustment in geriatric patients.
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