CoPlavix

CoPlavix

clopidogrel + aspirin

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Clopidogrel 75 mg, ASA 100 mg
Indications/Uses
Secondary prevention of atherothrombotic events in adults already taking both clopidogrel & ASA. For continuation of therapy in non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) including patients undergoing a stent placement following percutaneous coronary intervention; ST segment elevation acute MI in medically treated patients eligible for thrombolytic therapy.
Dosage/Direction for Use
Adult & elderly 75/100 mg as single daily dose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Severe hepatic impairment. Active pathological bleeding eg, peptic ulcer or intracranial haemorrhage. Due to ASA: Hypersensitivity to NSAIDs; syndrome of asthma, rhinitis, & nasal polyps; patients w/ pre-existing mastocytosis. History of GI bleeding or perforation, related to previous NSAIDs therapy; active, or history of recurrent peptic ulcer/haemorrhage. Severe renal impairment (CrCl <30 mL/min). 3rd trimester of pregnancy.
Special Precautions
Risk of bleeding & haematological adverse reactions; GI adverse events including bleeding, ulceration & stomach/intestine perforation. Reports of TTP (very rare); acquired haemophilia. Increased major bleeding in patients w/ recent transient ischaemic attack or stroke. Caution in patients at risk of increased bleeding from trauma, surgery or other pathological conditions & in patients receiving treatment w/ other NSAIDs including COX-2 inhibitors, heparin, glycoprotein IIb/IIIa inhibitors, SSRIs, thrombolytics or other medicinal products associated w/ bleeding risk eg, pentoxifylline; patients who have lesions w/ a propensity to bleed (particularly GI & intraocular); patients w/ history of peptic ulcer or gastroduodenal haemorrhage or minor upper GI symptoms; poor CYP2C19 metabolisers; patients w/ mild to moderate renal impairment; moderate hepatic disease. Long-term administration of NSAIDs has resulted in renal papillary necrosis & other renal injury. Not recommended in patients w/ advanced renal disease. Cross-reactivity among thienopyridines eg, ticlopidine, prasugrel. Concomitant use of strong or moderate CYP2C19 inhibitors or strong CYP2C19 inducers should be discouraged. Caution w/ concomitant CYP2C8 substrates. Not recommended w/ oral anticoagulants. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Contains hydrogenated castor oil. Do not use during the 1st 2 trimesters of pregnancy. Discontinue breastfeeding during treatment. Not recommended in childn & adolescents <18 yr. Due to ASA: Caution in patients w/ history of asthma or allergic disorders; gout; G6PD deficiency; alcohol consumption.
Adverse Reactions
Haematoma; epistaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at the puncture site.
Drug Interactions
Increased risk of bleeding due to potential additive effect w/ oral anticoagulants, glycoprotein IIb/IIIa inhibitors, heparin, thrombolytics, NSAIDs including COX-2 inhibitors, SSRIs. Increased occult GI blood loss w/ concomitant administration of clopidogrel & naproxen. Reduced effect of ASA w/ metamizole. Potential delayed & reduced absorption of clopidogrel w/ opioid agonists. Clopidogrel: Increased levels of the active metabolite w/ strong CYP2C19 inducers (eg, rifampicin). Reduced levels of the active metabolite w/ strong or moderate CYP2C19 inhibitors (eg, omeprazole, esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, efavirenz). Decreased exposure of the active metabolite w/ PPIs eg, omeprazole, esomeprazole. Reduced platelet inhibition in HIV patients treated w/ ritonavir- or cobicistat-boosted anti-retroviral therapy. Increased exposure of CYP2C8 substrates eg, repaglinide & paclitaxel. ASA: May inhibit the effect of uricosurics (eg, benzbromarone, probenecid, sulfinpyrazone). Can inhibit renal clearance of MTX. Increased risk of renal failure w/ tenofovir disoproxil fumarate. Increased serum levels of total & free valproic acid. Risk of Reye's syndrome w/ varicella vaccine. Do not give salicylates for an interval of 6 wk after receiving varicella vaccine. Increased risk of metabolic acidosis w/ acetazolamide. Increased risk of GI ulceration, perforation & haemorrhage w/ nicorandil. Increased risk of GI injury w/ alcohol.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC30 - combinations ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
CoPlavix FC tab
Packing/Price
14's
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