Rhea Clopidogrel Bisulfate Special Precautions

Bleeding and haemotological disorders: 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 (see Adverse Reactions). Because of the increased risk of bleeding, the concomitant administration of warfarin with clopidogrel should be undertaken with caution.
As with other anti-platelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions, and in patients receiving treatment with acetylsalicylic acid, heparin, glycoprotein IIb/IIIa inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), or selective serotonin reuptake inhibitors (SSRIs).
If a patient is to undergo elective surgery and an antiplatelet effect is not desired, clopidogrel should be discontinued 5 to 7 days prior to surgery. Clopidogrel prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular). Drugs that might induce gastrointestinal lesions (such as acetylsalicylic acid and Non-Steroidal Anti-Inflammatory Drugs) should be used with caution in patients taking clopidogrel. Patients should be told that it may take longer than usual to stop bleeding when they take clopidogrel alone or in combination with ASA, and that they should report any unusual bleeding (site or duration) to the physician. Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new drug is taken.
Recent ischemic stroke: In patients with recent transient ischaemic attack or stroke who are at high risk of recurrent ischaemic events, the combination of ASA and clopidogrel has been shown to increase major bleeding. Therefore, such addition should be undertaken with caution outside of clinical situations where the combination has proven to be beneficial.
Thrombotic Thrombocytopenic Purpura (TTP): Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure. It is characterised by thrombocytopenia and microangiopathic haemolytic anemia associated with either neurological findings, renal dysfunction or fever. TTP is a potentially fatal condition requiring prompt treatment, including plasmapheresis (plasma exchange).
Acquired haemophilia: Acquired haemophilia has been reported following use of clopidogrel. In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered. Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and clopidogrel should be discontinued.
Cytochrome P450 2C19 (CYP2C19): Pharmacogenetics: In patients who are CYP2C19 poor metabolisers clopidogrel at recommended doses forms less of the active metabolite of clopidogrel and has a smaller effect on platelet function. Poor metabolisers with acute coronary syndrome or undergoing percutaneous coronary intervention treated with clopidogrel at recommended doses may exhibit higher cardiovascular event rates than do patients with normal CYP2C19 function. Tests are available to identify a patient's CYP2C19 genotype; these tests can be used as an aid in determining therapeutic strategy. Consider the use of higher clopidogrel doses in patients who are known CYP2C19 poor metabolisers.
Cross-reactivity among thienopyridines: Patients should be evaluated for history of hypersensitivity to another thienopyridine (such as ticlopidine, prasurgel) since allergic cross-reactivity among thienopyridines has been reported (see Adverse Reactions). Thienopyridines may cause mild to severe allergic reactions such as rash, angioedema, or haematological reactions such as thrombocytopaenia and neutropaenia (see Advere Reactions). Patients who had developed a previous allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine. Monitoring for cross-reactivity is advised.
Renal impairment: Experience with clopidogrel is limited in patients with severe renal impairment. Therefore, clopidogrel should be used with caution in this population.
Hepatic impairment: Experience is limited in patients with severe hepatic disease who may have bleeding diatheses. Clopidogrel should therefore be used with caution in this population.
Excipients: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Driving a Vehicle or Performing Other Hazardous Tasks: No impairment of driving or psychometric performance was observed following clopidogrel administration.