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Plavix

Plavix

clopidogrel

Manufacturer:

sanofi-aventis

Distributor:

sanofi-aventis
Concise Prescribing Info
Contents
Clopidogrel bisulfate
Indications/Uses
Secondary prevention of atherothrombotic events in adults w/ history of recent MI, recent stroke, or established peripheral arterial disease; non-ST-segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) including patients who are to be managed medically & w/ percutaneous coronary intervention (w/ or w/o stent) or CABG; ST-segment elevation acute MI; in combination w/ ASA for ST-segment elevation acute MI in patients undergoing percutaneous coronary intervention or medically-treated patients eligible for thrombolytic/fibrinolytic therapy; in combination w/ ASA for moderate to high-risk transient ischemic attack (TIA) (ABCD2 score ≥4) or minor ischemic stroke (IS) (NIHSS ≤3) w/in 24 hr of either the TIA or IS event. Prevention of atherothrombotic & thromboembolic events in adults w/ atrial fibrillation at increased risk of vascular events who can take vit K antagonist (VKA) therapy; those w/ at least 1 risk factor for vascular events & cannot take VKA therapy in combination w/ ASA.
Dosage/Direction for Use
Adult & elderly 75 mg FC tab should be given as single daily dose. Non-ST-segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) Initially, single 300 or 600 mg loading dose. Continue treatment at 75 mg once daily (w/ ASA 75-325 mg daily). Patient <75 yr May consider 600 mg loading dose when percutaneous coronary intervention is intended. ST-segment elevation acute MI Medically treated patients eligible for thrombolytic/fibrinolytic therapy 75 mg as single daily dose, initiated w/ 300 mg loading dose in combination w/ ASA & w/ or w/o thrombolytics. For medical treated patients >75 yr, initiate treatment w/o loading dose. Start combined therapy as early as possible after symptoms start & continue for at least 4 wk. Patient undergoing primary coronary intervention & those undergoing PCI >24 hr of receiving fibrinolytic therapy Initially, 600 mg loading dose. For patients ≥75 yr, administer 600 mg loading dose w/ caution. Start combined therapy as early as possible after symptoms start & continue up to 12 mth, those undergoing PCI w/in 24 hr of receiving fibrinolytic therapy 300 mg loading dose. Start combined therapy as early as possible after symptoms start & continue up to 12 mth. Start combined therapy as early as possible after symptoms start & continue up to 12 mth. Moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) Adult 300 mg loading dose, followed by 75 mg once daily & ASA 75-100 mg daily. Start treatment w/in 24 hr of event & continue for 21 days followed by single antiplatelet therapy. Atrial fibrillation 75 mg as single daily dose. Should be initiated & continued w/ ASA 75-100 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active pathological bleeding eg, peptic ulcer or intracranial hemorrhage.
Special Precautions
History of hypersensitivity to thienopyridines eg, clopidogrel, ticlopidine, prasugrel. Discontinue use if acquired haemophilia is diagnosed. TTP (very rarely). Patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions; who have lesions w/ propensity to bleed (particularly GI & intraocular). Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Discontinue use 7 days prior to elective surgery. Carefully follow patients for any signs of bleeding including occult bleeding especially during 1st wk of treatment &/or after invasive cardiac procedures or surgery. Triple antiplatelet therapy (clopidogrel + ASA + dipyridamole) is not recommended for stroke secondary prevention in patients w/ acute non-cardioembolic ischemic stroke or TIA. Dual antiplatelet therapy (clopidogrel + ASA) is not recommended for recent ischemic stroke in non-minor IS patients (NIHSS >4); patients for whom treatment w/ carotid endarterectomy or intravascular thrombectomy is indicated or those planned for thrombolysis or anticoagulant therapy. Not recommended in concomitant use w/ oral anticoagulants. Concomitant use w/ strong or moderate CYP2C19 inhibitors & strong CYP2C19 inducers are discouraged. Concomitant use w/ ASA, heparin, glycoprotein IIb/IIIa inhibitors, NSAIDs (including COX-2 inhibitors), SSRIs, strong CYP2C19 inducers or drugs associated w/ bleeding risk eg, pentoxifylline; CYP2C8 substrates. Renal impairment. Moderate hepatic disease w/ bleeding diatheses. Not to be used during pregnancy & lactation. Not to be used in childn. 600 mg loading dose: Not recommended in patients w/ non-ST-segment elevation acute coronary syndrome & ≥75 yr. Patients ≥75 years old w/ STEMI PCI.
Adverse Reactions
Haematoma; epistaxis; GI hemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at puncture site.
Drug Interactions
Increased risk of bleeding due to potential additive effect w/ medicinal products associated w/ bleeding risk. May increase intensity of bleeding w/ oral anticoagulants. Concomitant use w/ glycoprotein IIb/IIIa inhibitors; thrombolytics. Possible pharmacodynamic interaction leading to increased risk of bleeding w/ ASA; heparin. Increased occult GI blood loss w/ naproxen. Affected platelet activation & increased risk of bleeding w/ SSRIs. Increased drug levels of active metabolite w/ CYP2C19 inducers eg, rifampicin. Reduced drug levels of active metabolite w/ strong or moderate CYP2C19 inhibitors eg, omeprazole, esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, & efavirenz. Decreased exposure to active metabolite w/ omeprazole, esomeprazole, pantoprazole & lansoprazole. High risk of vascular events w/ boosted anti-retroviral therapy in HIV patients. Risk of increased plasma conc w/ drugs primarily cleared by CYP2C8 metabolism eg, repaglinide, paclitaxel. Potential delayed & reduced absorption w/ opioid agonists. Increased exposure of rosuvastatin.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Plavix FC tab 300 mg
Packing/Price
30's (P5,676.79/pack)
Form
Plavix FC tab 75 mg
Packing/Price
14's (P75.75/film-coated tab, P1,060.5/pack)
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