Plavix

Plavix

clopidogrel

Manufacturer:

Kalventis Sinergi Farma
Concise Prescribing Info
Contents
Clopidogrel
Indications/Uses
Secondary prevention of atherothrombotic events in patients suffering from MI, ischaemic stroke or established peripheral arterial disease; in patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI), including patient undergoing stent placement following percutaneous coronary intervention, in combination w/ ASA; ST segment elevation acute MI, in combination w/ ASA in medically treated patients eligible for thrombolytic therapy. In combination w/ ASA for adult patients w/ moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤2) w/in 24 hr of either TIA or IS event.
Dosage/Direction for Use
Adult & elderly Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q wave MI) Initially 300 mg as single loading dose, then continued at 75 mg once daily w/ ASA 75-325 mg daily. ST segment elevation acute MI 75 mg single daily dose, initiated w/ 300 mg loading dose in combination w/ ASA & w/ or w/o thrombolytics. Elderly >75 yr Initiate w/o a loading dose. Adult patients w/ moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) 300 mg loading dose followed by 75 mg once daily & ASA 75-100 mg once daily. Treatment w/ clopidogrel & ASA should be started w/in 24 hr of the event & continued for 21 days followed by single antiplatelet therapy.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active pathological bleeding eg, peptic ulcer or intracranial hemorrhage. Severe hepatic impairment.
Special Precautions
Consider blood cell count determination. Patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions; in patients receiving treatment w/ ASA, heparin, glycoprotein IIb/IIIa inhibitors or NSAIDs or SSRIs or CYP2C19 strong inducers or other medicine associated w/ bleeding risk eg, pentoxifylline; who had developed a previous allergic &/or haematological reaction to thienopyridine. Concomitant administration w/ oral anticoagulants is not recommended. Discontinue 7 days prior to elective surgery. Lesions w/ a propensity to bleed (particularly GI & intraocular). Not recommended during the first 7 days after acute ischaemic stroke. Discourage concomitant use of strong or moderate CYP2C19 inhibitors. Acquired haemophilia; TTP. Contains hydrogenated castor oil which may cause stomach upset & diarrhoea. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption. Patients w/ moderate hepatic disease who may have bleeding diatheses. Renal impairment. Not to be used during pregnancy & lactation. Childn & adolescent <18 yr.
Adverse Reactions
Haematoma; epistaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at puncture site.
Drug Interactions
Concomitant administration w/ oral anticoagulants, glycoprotein IIb/IIIa inhibitors, ASA, heparin, thrombolytics, SSRIs & NSAIDs may increase intensity of bleeding. Concomitant use of strong CYP2C19 inducers eg, rifampicin increased drug levels of active metabolite. Concomitant use of strong or moderate CYP2C19 inhibitors eg, omeprazole & esomeprazole, fluvoxamine, fluoxetine, moclebemide, voriconazole, fluconazole, ticlopidine, carbamazepine reduced drug levels of clopidogrel active metabolite. Increased exposure of CYP2C8 substrate medicinal products eg, repaglinide, paclitaxel. Reduced inhibition of platelet aggregation w/ PPIs eg, omeprazole & esomeprazole. Co-administration w/ opioid agonist may delay & reduce the absorption of clopidogrel.
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
1 × 10's (Rp351,327/boks)
Form
Plavix FC tab 75 mg
Packing/Price
2 × 14's (Rp1,085,372/boks)
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