CoPlavix

CoPlavix

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Clopidogrel 75 mg, acetylsalicylic acid (ASA) 100 mg
Indications/Uses
Secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel & acetylsalicylic acid. For continuation therapy in non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) including patients undergoing 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; pre-existing mastocytosis. Severe renal impairment (CrCl <30 mL/min). History of GI bleeding or perforation related to previous NSAIDs therapy; active or history of recurrent peptic ulcer/haemorrhage. Pregnancy (3rd trimester).
Special Precautions
Risk of bleeding & haematological disorders; GI symptoms; renal papillary necrosis & other renal injury. Cross-reactivity among thienopyrimidines eg, ticlopidine, prasugrel. Thrombotic thrombocytopenic purpura; acquired haemophilia. 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, gylcoprotein IIb/IIIa inhibitors, SSRIs, thrombolytics or other medicinal products associated w/ bleeding risk eg, pentoxifylline. Patients w/ recent transient ischaemic attack or stroke. Patients who are poor CYP2C19 metabolisers. Patients w/ history of peptic ulcer or gastroduodenal haemorrhage or minor upper GI symptoms; impaired renal function, heart failure, liver dysfunction, those taking diuretics & ACE inhibitors, elderly. Not recommended in patients w/ advanced renal disease. Concomitant use w/ strong or moderate CYP2C19 inhibitors or CYP2C8 substrate medicinal products. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Contains hydrogenated castor oil. Patients w/ mild to moderate renal impairment or moderate hepatic disease. Pregnancy (1st & 2nd trimesters). Discontinue breastfeeding during treatment. Not recommended in childn & adolescent <18 yr. Due to ASA: Patients w/ history of asthma or allergic disorders; gout; G6PD deficiency. Increased risk of GI injury w/ alcohol.
Adverse Reactions
Haematoma; epistaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at the puncture site.
Drug Interactions
Increased risk/intensity of bleeding w/ oral anticoagulants, glycoprotein IIb/IIIa inhibitors, heparin, thrombolytics, NSAIDs including Cox-2 inhibitors, SSRIs. Increased occult GI blood loss w/ naproxen. Reduced effect of ASA w/ metamizole. Clopidogrel: Reduced levels of the active metabolite of clopidogrel w/ strong or moderate CYP2C19 inhibitors (eg, omeprazole & esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, efavirenz). Decreased exposure w/ proton pump inhibitors eg, omeprazole, esomeprazole. Increased exposure of CYP2C8 substrate medicinal products eg, repaglinide & paclitaxel. ASA: May inhibit the effect of uricosuric agents (eg, benzbromarone, probenecid, sulfinpyrazone). Can inhibit renal clearance of methotrexate. Increased risk of renal failure w/ tenofovir disoproxil fumarate. Increased serum levels of total & free valproic acid. 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.
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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