Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOPIDOGREL BISULPHATE
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
CLOPIDOGREL BISULPHATE
3 x 10tablet Tablets; 9x10 Tablets; 10x10 Tablets
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _____________________________________________________________________________________________________________________________ _ 1 WHAT IS IN THIS LEAFLET 1. What Vitraq is used for 2. How Vitraq works 3. Before you use Vitraq 4. How to use Vitraq 5. While you are using Vitraq 6. Side effects 7. Storage and Disposal of Vitraq 8. Product description 9. Manufactured and Registration Holder 10. Date of Revision WHAT VITRAQ IS USED FOR It is used to prevent the atherothrombotic events where the arteries (blood vessels) become hard and narrow due to the plaque formation and thus restrict the blood flow to the organs. HOW VITRAQ WORKS Clopidogrel prevent the plaque formation under the lining of arteries by inhibits the platelet from being clumped together. BEFORE YOU USE VITRAQ _WHEN YOU MUST NOT TO USE IT _ Do not use this medicine if you: are allergic (hypersensitivity) to the clopidogrel and any other ingredients in this medicine. have severe liver impairment. have ulcer in the stomach or intestine. have bleeding within the skull. _BEFORE YOU START TO USE IT _ Tell your doctor or pharmacist if you: have bleeding or blood disorders. have kidneys and/or liver impairment. recently have stroke. are pregnant or breast-feeding. _TAKING OTHER MEDICINES _ Please tell your doctor or pharmacist if you are taking or having recently taken any other medicines. This includes any medicines which you have bought without a prescription. You should specifically tell your doctor if you take: anticoagulants, medicines used to reduce blood clotting. a non steroidal anti-inflammatory (NSAIDs) medicine, used to treat painful and/or inflammatory conditions of muscle or joints. heparin or any other injectable medicine used to reduce blood clotting. omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach. fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections. flu Baca dokumen lengkap
Important information. Please read carefully. VITRAQ" CLOPIDOGREL 75MG Film-Coated Tablet COMPOSITION Each film-coated tablet contains 75mg Clopidogrel (as Clopidogrel Bisulfate). PHARMACODYNAMICS Clopidogrel is a prodrug that inhibits platelet aggregation after metabolized by the enzyme, CYP 450 to produce the active metabolite. The active metabolite of clopidogrel selectively and irreversibly inhibits the adenosine diphosphate (ADP) from binding to the P2Y 11 platelet receptor, and the subsequent ADP-mediated activation of the glycoprotein GPllb/llla complex, thus inhibits platelet aggregation. Due to the irreversible binding, platelets exposed are affected for the remainder of their lifespan (approximately 7-10 days) and recovery of normal platelet function occurs at rate consistent with platelet turnover. Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP. PHARMACOKINETICS Clopidogrel is rapidly but incompletely absorbed after oral doses, absorption appears to - be at least50%. - It is a prod rug and is extensively metabolized in the liver, mainly to the inactive carboxylic = acid derivatives. Metabolism is mediated by the CYP 450 isoenzymes including CYP 3A4, CYP 266 and to a lesser extent by CYP 1A2, CYP 1A1, and CYP 2C19. The active metabolite appears to be a thiol derivative, which has been identified _in vitro _ but appears to be too unstable to be isolated from plasma. Clopidogrel and the carboxylic acid derivative are highly protein bound. Clopidogrel and its metabolites are excreted in the urine and faeces. About 50% of an oral dose is recovered from the urine and about 46% from the faeces. INDICATIONS For the prevention of atherothrombotic events in: • Peripheral arterial disease, myocardial infarction, ischemic stroke. • Acute coronary syndrome - Non-ST segment elevation (unstable angina or non-Q-wave myocardial infarction) that including patients undergoing a stent placement following percutaneous corona Baca dokumen lengkap