Neoclopid Special Precautions

Bleeding and hematological disorders: Due to the risk of bleeding and hematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment. As with other antiplatelet 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 ASA, Heparin, Glycoprotein IIb/Illa inhibitors or Non-steroidal anti inflammatory drugs (NSAIDS) including COX-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs), or other medicinal products associated with bleeding risk such as Pentoxifylline. Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery. The concomitant administration of Clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings.
If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable. Clopidogrel should be discontinued 7 days prior to surgery. Patients should inform physicians and dentists that they are taking Clopidogrel before any surgery is scheduled and before any new medicinal product is taken. Clopidogrel prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular). Patients should be told that it might 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 their physician.
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 characterized by thrombocytopenia and microangiopathic hemolytic anemia associated with either neurological findings, renal dysfunction or fever. TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Acquired hemophilia: Acquired hemophilia has been reported following use of Clopidogrel. In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired hemophilia should be considered. Patients with a confirmed diagnosis of acquired hemophilia should be managed and treated by specialists, and Clopidogrel should be discontinued.
Recent ischemic stroke: In view of the lack of data, Clopidogrel cannot be recommended during the first 7 days after acute ischemic stroke.
Cytochrome P4502C19 (CYP2C19): Pharmacogenetics: In patients who are poor CYP2C19 metabolizers, Clopidogrel at recommended doses forms less of the active metabolite of Clopidogrel and has a smaller effect on platelet function. Tests are available to identify a patient's CYP2C19 genotype. Since Clopidogrel is metabolized to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of Clopidogrel. The clinical relevance of this interaction is uncertain. As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged.
CYP2C8 substrates: Caution is required in patients treated concomitantly with Clopidogrel and CYP2C8 substrate medicinal products.
Cross-reactions among thienopyridines: Patients should be evaluated for history of hypersensitivity to thienopyridines (such as Clopidogrel, Ticlopidine, Prasugrel) since cross-reactivity among thienopyridines has been reported. Thienopyridines may cause mild to severe allergic reactions such as rash, angioedema, or hematological cross-reactions such as thrombocytopenia and neutropenia. Patients who had developed a previous allergic reaction and/or hematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine. Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised.
Excipients: Clopidogrel contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product contains hydrogenated castor oil which may cause stomach upset and diarrhea.
Renal impairment: Therapeutic experience with Clopidogrel is limited in patients with renal impairment. Therefore, Clopidogrel should be used with caution in these patients.
Hepatic impairment: Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses. Clopidogrel should therefore be used with caution in this population.