Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
Clopidogrel hydrogen sulfate
Sanofi-Aventis Australia Pty Ltd
Medicine Registered
PLAVIX ® TABLETS _Clopidogrel_ CONSUMER MEDICINE INFORMATION Please read this leaflet carefully before you start taking Plavix. You may wish to keep it to read again. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Plavix tablets. It does not contain all the available information. Some of the information it contains may not apply to you. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. In deciding to give you Plavix, your doctor has weighed the risks of you taking Plavix against the expected benefits it will have for you. Always follow the instructions that your doctor and pharmacist give you about Plavix tablets. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. WHAT IS PLAVIX USED FOR PLAVIX CONTAINS THE MEDICINE CLOPIDOGREL. PLAVIX BELONGS TO A GROUP OF MEDICINES CALLED ANTI- PLATELET MEDICINES. Platelets are very small blood cells which clump together during blood clotting. By preventing this clumping, anti-platelet medicines reduce the chances of blood clots forming (a process called thrombosis). Plavix is used to prevent blood clots forming in hardened blood vessels (a process known as atherothrombosis) which can lead to events such as stroke, heart attack or death. You may have been prescribed Plavix to help prevent blood clots forming and to reduce the risk of stroke, heart attack and death because: • YOU HAVE PREVIOUSLY SUFFERED A HEART ATTACK, STROKE OR HAVE A CONDITION KNOWN AS PERIPHERAL ARTERIAL DISEASE (LEG PAIN ON WALKING OR AT REST). • YOU HAVE SUFFERED ACUTE CORONARY SYNDROME (EITHER A SEVERE TYPE OF CHEST PAIN CALLED UNSTABLE ANGINA, OR A HEART ATTACK). IN THIS CASE YOU MAY ALSO BE PRESCRIBED ASPIRIN. Your doctor may have prescribed this medicine for another use. If you want more information, ask your doctor. Plavix is only available on a doctor's prescription. BEFORE YOU TAKE PLAVIX _WHEN YOU MUST NOT TAKE IT_ YOU SHOULD NOT TAKE PLAVIX IF: • YOU ARE ALLE Прочитајте комплетан документ
plavix-ccdsv17piv11-31may13 1 PRODUCT INFORMATION PLAVIX NAME OF THE MEDICINE PLAVIX Clopidogrel hydrogen sulfate DESCRIPTION Clopidogrel hydrogen sulfate is designated chemically as methyl (+)-(S)- -(2-chlorophenyl)-6,7- dihydrothieno[3,2-c] pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel hydrogen sulfate is C 16 H 16 ClNO 2 S.H 2 SO 4 and its molecular weight is 419.9. Clopidogrel hydrogen sulfate has the following chemical structure: _ _ C O O S N H Cl ,H 2 SO 4 CH 3 CAS Number: 120202-66-6 (Clopidogrel hydrogen sulfate), 113 665-84-2 (Clopidogrel base). Clopidogrel hydrogen sulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It is freely soluble in methanol, sparingly soluble in methylene chloride and is practically insoluble in ethyl ether. It has a specific optical rotation of about + 56 . Each tablet contains mannitol, macrogol 6000, microcrystalline cellulose, hydrogenated castor oil, hydroxypropylcellulose. The coating contains lactose, hypromellose, titanium dioxide, glycerol triacetate, iron oxide red and carnauba wax. PHARMACOLOGY PHARMACODYNAMICS Clopidogrel is a specific and potent inhibitor of platelet aggregation. Platelets have an established role in the pathophysiology of atherosclerotic disease and thrombotic events. Long term use of anti-platelet drugs has shown consistent benefit in the prevention of ischaemic stroke, myocardial infarction and vascular death in patients at increased risk of such outcomes, including those with established atherosclerosis or a history of atherothrombosis. The active metabolite, a Прочитајте комплетан документ