Contraindications
Hypersensitivity to clopidogrel, aspirin, other salicylates, or NSAIDs. Active pathological bleeding, gastrointestinal bleeding, intracranial haemorrhage, haemophilia, or known bleeding disorders; active peptic ulcer or erosive oesophagitis, pre-existing mastocytosis in whom aspirin use may induce severe hypersensitivity reactions; syndrome of asthma with rhinitis and/or nasal polyps. Severe renal and hepatic impairment. Pregnancy (3rd trimester) and lactation.
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Special Precautions
Patient with recent TIA or stroke, lacunar stroke within 180 days; history of peptic ulcer, gastroduodenal haemorrhage, or minor upper gastrointestinal symptoms; G6PD deficiency, gout, history of asthma or allergic disorders; hypersensitivity or haematologic reaction to previous thienopyridine use; who have lesions with a propensity to bleed (e.g. gastrointestinal or intraocular lesions), who are at increased risk of bleeding (e.g. trauma, surgery). For elective surgery, consider temporary discontinuation of therapy 7 days prior to the procedure. CYP2C19 likely intermediate, intermediate, likely poor, and poor metabolisers. Mild to moderate renal and hepatic impairment. Pregnancy (1st-2nd trimester). Monitoring Parameters Obtain blood cell count, Hb, haematocrit, and platelets. Monitor for signs and symptoms of hypersensitivity reaction (particularly in patients with known thienopyridine allergy), gastrointestinal or other bleeding.
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Adverse Reactions
Significant: Increased risk of bleeding, prolonged bleeding time, increased urate concentrations; renal papillary necrosis ad other renal injury (prolonged use), haemolytic anaemia (in patients with G6PD deficiency), hypersensitivity reactions, cross-reactivity among thienopyridine agents (e.g. prasugrel, ticlopidine). Rarely, acquired haemophilia.
Blood and lymphatic system disorders: Leucopenia, eosinophilia, thrombocytopenia. Rarely, neutropenia.
Cardiac disorders: Kounis syndrome.
Ear and labyrinth disorders: Tinnitus, hearing loss. Rarely, vertigo.
Eye disorders: Eye bleeding (retinal, conjunctival, ocular).
Gastrointestinal disorders: Dyspepsia, abdominal pain, diarrhoea, nausea, constipation, flatulence, gastritis, vomiting; gastric, peptic or duodenal ulcer. Rarely, taste disturbances, ageusia.
Hepatobiliary disorders: Acute liver failure, hepatitis.
Immune system disorders: Insulin autoimmune syndrome. Rarely, anaphylactoid reactions, serum sickness.
Metabolism and nutrition disorders: Hypoglycaemia.
Musculoskeletal and connective tissue disorders: Rarely, arthralgia, myalgia, arthritis.
Nervous system disorders: Headache, dizziness, paraesthesia.
Renal and urinary disorders: Haematuria.
Respiratory, thoracic and mediastinal disorders: Epistaxis.
Skin and subcutaneous tissue disorders: Rash, pruritus, skin bleeding (purpura). Rarely, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme.
Vascular disorders: Haematoma. Rarely, vasculitis, hypotension.
Potentially Fatal: Serious gastrointestinal bleeding, ulceration, and perforation. Rarely, thrombotic thrombocytopenic purpura. |
Drug Interactions
Increased risk of bleeding with other antiplatelet agents (e.g. ticlopidine, tirofiban), anticoagulants (e.g. heparin, warfarin), NSAIDs including cyclooxygenase 2 (COX-2) inhibitors, thrombolytics, SSRIs, and pentoxifylline. May increase the risk of renal impairment with ACE inhibitors, thiazide diuretics, and NSAIDs including COX-2 inhibitors.
Clopidogrel: Serum concentrations of the active metabolite of clopidogrel may be decreased by strong or moderate CYP2C19 inhibitors (e.g. esomeprazole, omeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, efavirenz). Strong CYP2C19 inducers (e.g. rifampicin) may increase the serum concentration of the clopidogrel active metabolite and may increase the risk of bleeding. Antiplatelet effect may be diminished with ritonavir. May increase the plasma concentrations of rosuvastatin, and agents metabolised by CYP2C8 (e.g. repaglinide, paclitaxel).
Aspirin: Metamizole may decrease the effect of aspirin on platelet aggregation. May increase the risk of gastrointestinal ulceration and bleeding with corticosteroids. May inhibit the effects of uricosuric agents (e.g. probenecid, sulfinpyrazone). May result in bone marrow toxicity with methotrexate (doses higher than 20 mg/week). May cause reduced valproic acid protein binding and inhibition of valproic acid metabolism, resulting in increased serum levels of total and free valproic acid. May increase the risk of Reye's syndrome with varicella vaccines. Increased risk of metabolic acidosis with acetazolamide. May increase the risk of severe complications (e.g. gastrointestinal ulceration, perforation or haemorrhage) of nicorandil. Absorption may be reduced and delayed by opioid agonists (e.g. morphine). May enhance the effects of oral hypoglycaemic agents.
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ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
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