Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Prophylaxis of thromboembolic disorders For patients with recent MI/ischaemic stroke or established peripheral arterial disease: 75 mg once daily. For patients with atrial fibrillation who have at least 1 risk factor for vascular events, are not suitable for vitamin K antagonist treatment, and have low bleeding risk: In combination with aspirin: 75 mg once daily. Acute coronary syndrome Acute ST-elevation MI: In combination with aspirin (with or without thrombolytics): ≤75 years 300 mg loading dose, followed by 75 mg once daily. Initiate combined treatment as early as possible after symptoms start and continue for at least 4 weeks. Non-ST-elevation MI or unstable angina, including those undergoing stent placement after PCI: In combination with aspirin: 300 mg loading dose, followed by 75 mg once daily.
Clopidogrel: May be taken with or without food.
Active pathological bleeding (e.g. peptic ulcer or intracranial haemorrhage). Severe hepatic impairment.
Special Precautions
Patients with platelet disorders, bleeding disorders, or at increased risk for bleeding (e.g. recent trauma or surgery); lesions with a propensity to bleed (e.g. gastrointestinal, intraocular), acute lower gastrointestinal bleeding, coronary artery stents; previous hypersensitivity or haematologic reactions to thienopyridine use (e.g. ticlopidine, prasugrel). CYP2C19 intermediate and poor metabolisers. Patients undergoing CABG or other elective surgical procedures. Temporarily discontinue 5-7 days before elective surgery if antiplatelet effect is not desirable. Renal and moderate hepatic impairment. Elderly. Pregnancy and lactation. Monitoring Parameters Monitor Hb and haematocrit periodically; signs of bleeding including occult bleeding, particularly during the 1st weeks of treatment and following invasive cardiac procedures or surgery.
Adverse Reactions
Significant: Cross-reactive drug hypersensitivity (e.g. rash, angioedema, haematologic reaction) among thienopyridines; prolonged bleeding time. Rarely, acquired haemophilia. Blood and lymphatic system disorders: Thrombocytopenia, leucopenia, eosinophilia, neutropenia. Gastrointestinal disorders: Diarrhoea, abdominal pain, dyspepsia, gastric ulcer, duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence. General disorders and administration site conditions: Puncture site bleeding. Investigations: Decreased neutrophil and platelet counts. Nervous system disorders: Headache, paraesthesia, dizziness. Renal and urinary disorders: Haematuria. Respiratory, thoracic and mediastinal disorders: Epistaxis. Skin and subcutaneous tissue disorders: Bruising, pruritis. Vascular disorders: Haematoma.
Potentially Fatal: Rarely, thrombotic thrombocytopenic purpura, intracranial bleeding, gastrointestinal and retroperitoneal haemorrhage.
Drug Interactions
Increased risk of bleeding with aspirin, anticoagulants, antiplatelets, NSAIDs including cyclooxygenase 2 (COX-2) inhibitors, thrombolytics, glycoprotein IIb/IIIa inhibitors, SSRIs, serotonin norepinephrine reuptake inhibitors. Antiplatelet effect may be reduced when given with moderate or strong CYP2C19 inhibitors (e.g. esomeprazole, omeprazole, fluvoxamine, moclobemide, voriconazole, ticlopidine, carbamazepine, efavirenz). May increase the plasma concentrations of CYP2C8 substrates (e.g. repaglinide, paclitaxel). Absorption may be delayed and reduced by opioid agonists (e.g. morphine).
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Disclaimer: This information is independently developed by CIMS based on clopidogrel from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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