Plagerine A Tablets (Clopidogrel + Aspirin ).

• Composition :
  Each capsule contains Clopidogrel 75mg + EC Aspirin 75mg/150mg.
• Indications :
  For the prevention of ischemic events, myocardial infarction, stroke and cardiovascular death in patients with acute coronary syndrome (ACS).
• Pharmacodynamics :
  Clopidogrel must be metabolized by CYP450 enzymes to produce the active metabolite. The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. The acetyl group of aspirin binds with a serine residue of cyclooxygenase-1 (COX-1), resulting in irreversible inactivation of the enzyme. Inhibition of COX-1 prevents conversion of arachidonic acid to thromboxane A2 (TXA2), which is a potent agonist of platelet aggregation.
• Dosage and administration :
  One tablet once daily.
• Contraindications :
  Hypersensitivity to clopidogrel, salicylates or any of the excipients or other non-steroidal anti-inflammatory drugs. Severe hepatic and renal impairment, Active pathological bleeding, Active peptic ulceration or past history of ulceration or dyspepsia., Patients who are suffering from gout. Concurrent anticoagulant therapy should be avoided, Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels, Nasal polyps associated with asthma (high risk of severe sensitivity reactions).
• Precautions and warnings :
  Clopidogrel- Increases risk of bleeding, Premature discontinuation increases risk of cardiovascular events, Recent transient ischemic attack or stroke, Thrombotic thrombocytopenic purpura. Aspirin- Increased risk of bleeding., Gastric mucosal irritation and bleeding.
• Use in pregnancy, lactation & pediatrics :
  Clopidogrel/Aspirin should not be used during the first two trimesters of pregnancy unless the clinical condition of the woman requires treatment with clopidogrel /Aspirin. Due to the presence of Aspirin, Clopidogrel/Aspirin is contraindicated during the third trimester of pregnancy. It is not known whether clopidogrel is excreted in human milk, short-term use of the recommended Aspirin dose does not require suspending, long-term use and/or administration of higher doses, breastfeeding should be discontinued. Safety and effectiveness of clopidogrel in the pediatric population have not been established. Aspirin is not recommended for use in adolescents/children under 16 years unless the expected benefits outweigh the risks.
• Drug interactions :
  Clopidogrel- Avoid concomitant use with omeprazole, NSAIDs and Warfarin should be co-administered with caution. Aspirin- Anticoagulant and anti-platelets: increased risk of bleeding, Anticonvulsants: decreased phenytoin concentration and increased serum valproic acid levels, Methotrexate: increased risk of bone marrow toxicity, Nonselective NSAIDs may interfere with Aspirin’s antiplatelet effect. Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia. Salicylics may increase the hypoglycemic effect of sulphonylureas. impairs the renal excretion of digoxin and lithium.
• Adverse reactions :
  Most common adverse reaction for clopidogrel are bleeding, including life-threatening and fatal bleeding and for aspirin are gastrointestinal dyspepsia, hepatic enzyme elevation, hepatitis.
• Therapy Area :
  Anti-Platelets