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See related Plavix film-coated tab information |
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Manufacturer |
sanofi-aventis |
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Distributor |
DKSH |
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Contents |
Clopidogrel hydrogen sulfate 97.875 mg (molar equiv of clopidogrel base 75 mg) |
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Indications |
Prevention of atherothrombotic events in patients suffering from MI (from a few days until <35 days), ischemic stroke (from 7 days until <6 mth), established peripheral arterial disease; non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) including patients undergoing a stent placement following percutaneous coronary intervention, in combination w/ acetylsalicylic acid (ASA); ST segment elevation acute MI in combination w/ ASA in patients eligible for thrombolytic therapy.
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Dosage |
Adult & elderly 75 mg once daily. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) Initially 300 mg then 75 mg once daily (w/ ASA 75-325 mg daily). ST segment elevation acute MI Initially 75 mg as a single dose w/ or w/o loading dose (w/ ASA & w/ or w/o thrombolytics). Patient >75 yr Initiate w/o a loading dose.
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Overdosage |
View Plavix overdosage for action to be taken in the event of an overdose. |
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Administration |
May be taken with or without food |
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Contraindications |
Severe liver impairment. Peptic ulcer & intracranial haemorrhage. Lactation.
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Special Precautions |
Genetic polymorphisms that reduce CYP2C19 function. Combination w/ ASA in previous transient ischemic attack/stroke patients. Patients at risk of increased bleeding from trauma, surgery or other pathological conditions. Patients who have lesions w/ a propensity to bleed (particularly GI & intraocular). Patients w/ moderate hepatic disease who may have bleeding diatheses. Patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Renal impairment. Pregnancy. Childn <18 yr.
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Adverse Drug Reactions |
Intracranial, GI, retroperitoneal, skin, musculoskeletal, eye, resp tract bleeding; haematuria & haemorrhage of operative wound; diarrhoea, abdominal pain, dyspepsia.
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Drug Interactions |
Proton-pump inhibitors. Concomitant use w/ warfarin, ASA, heparin, gylcoprotein IIb/IIIa inhibitors, thrombolytics or NSAIDs including COX-2 inhibitors, strong or moderate CYP2C19 inhibitors.
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Pregnancy Category (US FDA) |
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters). |
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Storage |
View Plavix storage conditions for details to ensure optimal shelf-life. |
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Description |
View Plavix description for details of the chemical structure and excipients (inactive components). |
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Mechanism of Action |
View Plavix mechanism of action for pharmacodynamics and pharmacokinetics details. |
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