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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 (PCI); ST segment elevation acute MI in patients undergoing PCI (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic 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, in whom use of ASA may induce severe hypersensitivity reactions. History of GI bleeding or perforation, related to previous NSAID 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; serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines. Reports of TTP (very rare); acquired haemophilia; DRESS. Increased major bleeding in patients w/ recent transient ischaemic attack or stroke who are at high risk of recurrent ischaemic events. Caution in patients who may be 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, strong CYP2C19 inducers, 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. Concomitant administration w/ oral anticoagulants is not recommended. Concomitant use w/ strong or moderate CYP2C19 inhibitors or strong CYP2C19 inducers should be discouraged. Caution w/ concomitant CYP2C8 substrates. Cross-reactivity among thienopyridines (eg, ticlopidine, prasugrel). Should not be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Contains hydrogenated castor oil, which may cause stomach upset & diarrhoea. Long-term administration of NSAIDs has resulted in renal papillary necrosis & other renal injury. Not recommended in patients w/ advanced renal disease. Caution in patients w/ mild to moderate renal impairment; moderate hepatic disease who may have bleeding diatheses. Should not be used during the 1st 2 trimesters of pregnancy unless clinical condition of the woman requires treatment. Breastfeeding should be discontinued 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. Possible association between ASA & Reye's syndrome in childn <18 yr. Caution w/ alcohol consumption, especially if chronic or heavy.
Adverse Reactions
Haematoma; epistaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at the puncture site.
Drug Interactions
Increased risk of bleeding w/ medicinal products associated w/ bleeding risk; oral anticoagulants; glycoprotein IIb/IIIa inhibitors; heparin; thrombolytics; NSAIDs including COX-2 inhibitors; SSRIs. Clopidogrel: Increased occult GI blood loss w/ naproxen. 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); rosuvastatin. Potentially delayed & reduced absorption w/ opioid agonists. ASA: Reduced effect on platelet aggregation w/ metamizole. Inhibited effect of uricosurics (eg, benzbromarone, probenecid, sulfinpyrazone). Inhibited 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; patients should not be given 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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