Clavix 75

Clavix 75

clopidogrel

Manufacturer:

Intas

Distributor:

Accord Healthcare
Concise Prescribing Info
Contents
Clopidogrel
Indications/Uses
Adult patients suffering from MI (few days until <35 days), ischaemic stroke (7 days until <6 mth) or established peripheral arterial disease; non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) ie, patients undergoing stent placement following percutaneous coronary intervention; ST segment elevation acute MI, in combination w/ acetylsalicylic acid (ASA) in medically treated patients eligible for thrombolytic therapy. In combination w/ ASA for the prevention of atherothrombotic & thromboembolic events ie, stroke.
Dosage/Direction for Use
Adult & elderly 75 mg single daily dose. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) Single 300-mg loading dose then continued at 75 mg once daily w/ ASA 75-325 mg daily. ST segment elevation acute MI 75 mg single daily dose initiated w/ 300-mg loading dose in combination w/ ASA w/ or w/o thrombolytics. Atrial fibrillation 75 mg single daily dose in combination w/ ASA 75-100 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Severe hepatic impairment, active pathological bleeding eg, peptic ulcer or intracranial haemorrhage.
Special Precautions
Patients at increased risk of bleeding from trauma, surgery or other pathological conditions & receiving concomitant ASA, heparin, glycoprotein IIb/IIIa inhibitors or NSAIDs including COX-2 inhibitors. Avoid concomitant use w/ oral anticoagulants. Discontinue 7 days prior to surgery. Lesions w/ propensity to bleed (particularly GI & intraocular). Thrombotic thrombocytopenic purpura (TTP). Not recommended during 1st 7 days after acute ischaemic stroke. Avoid concomitant use w/ CYP2C19 inhibitors omeprazole & esomeprazole. Patients undergoing percutaneous coronary intervention. Avoid lapses in therapy. Nasogastric administration in critically ill patients after cardiopulmonary resuscitation. Renal impairment. Moderate hepatic impairment w/ bleeding diatheses. Pregnancy & lactation. Not to be used in childn.
Adverse Reactions
Thrombocytopenia, leucopenia, eosinophilia, neutropenia ie, severe neutropenia, TTP, aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia; serum sickness, anaphylactoid reactions; hallucinations, confusion; intracranial bleeding, headache, paraesthesia, dizziness, taste disturbances; conjunctival, ocular, retinal bleeding; vertigo; haematoma, serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension; epistaxis, resp tract bleeding, bronchospasm, interstitial pneumonitis; acute liver failure, hepatitis, abnormal liver function test; GI, skin & subcutaneous tissue, musculoskeletal, connective tissue & bone disorders; renal & urinary disorders; fever; prolonged bleeding time, decreased neutrophil & platelet count.
Drug Interactions
Increased risk of bleeding w/ anticoagulants, other antiplatelets, NSAIDs. Reduced drug levels by CYP2C19 inhibitors eg, proton-pump inhibitors. Ineffective inhibition of platelet aggregation w/ amiodarone. Decreased antiplatelet effect & increased risk of thrombotic events w/ amlodipine, diltiazem, felodipine, nicardipine, nimodipine, verapamil. Reduced clinical efficacy w/ chloramphenicol, cimetidine, fluconazole, fluoxetine, ketoconazole, omeprazole, ticlopidine, voriconazole. Contradictory effects of clinical efficacy reduction by fluvoxamine. Increased risk for thrombosis w/ esomeprazole, omeprazole, rabeprazole. Increased risk of tamoxifen toxicity.
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Clavix 75 FC tab 75 mg
Packing/Price
10 × 10's
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