מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
clopidogrel besilate
Amneal Pharma Australia Pty Ltd
clopidogrel besilate
Registered
Clopidogrel AMNEAL CMI v7.0 1 CLOPIDOGREL AMNEAL TABLETS _clopidogrel (as besilate) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CLOPIDOGREL AMNEAL. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking CLOPIDOGREL AMNEAL against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT CLOPIDOGREL AMNEAL IS USED FOR CLOPIDOGREL AMNEAL 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). CLOPIDOGREL AMNEAL 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 CLOPIDOGREL AMNEAL 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. CLOPIDOGREL AMNEAL is only available on a doctor's prescription. BEFORE YOU TAKE CLOPIDOGREL AMNEAL _WHEN YOU MUST NOT TAKE IT _ YOU SHOULD NOT TAKE CLOPIDOGREL AMNEAL IF: • YOU ARE ALLERGIC TO CLOPIDOGREL OR ANY OF THE INGREDIENTS LISTED UNDER 'PRODUCT DESCRIPTION' AT THE END OF THIS LEAFLET. • YOU קרא את המסמך השלם
CLOPIDOGREL AMNEAL TABLETS PRODUCT INFORMATION Clopidogrel AMNEAL PI v0.1 1 NAME OF THE MEDICINE The drug substance is clopidogrel besilate. Clopidogrel besilate has the following chemical structure: CAS Number: 744256-69-7 Molecular Formula: C 16 H 16 CINO 2 S.C 6 H 6 O 3 S Molecular Mass: 479.99 Chemical Names: (+)-(S)-α-(2-chlorophenyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine-5- yl-acetic acid methyl ester benzene sulfonate DESCRIPTION Clopidogrel besilate is a white to almost white powder. It is practically insoluble in water. It is very soluble in methanol, acetonitrile and dichloromethane. CLOPIDOGREL AMNEAL is available as clopidogrel 75 mg film-coated tablets. Each tablet contains lactose anhydrous, microcrystalline cellulose, crospovidone, glyceryl behenate and talc. The coating contains purified talc, polyvinyl alcohol, titanium dioxide, macrogol 3350, lecithin and iron oxide red. 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. Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor, and the subsequent ADP-mediated activation of the GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Biotransformation of clopidogrel is necessary to produce inhibition of platelet aggregation. The active metabolite, a thiol derivative, is formed by oxidation of clopidogrel to 2-oxoclopidogrel and subsequent hydrolysis. The active thiol metabolite, which has been isolated _in vitro_ , binds rapidly and irreversibly to platelet ADP CLOPIDOGREL AMNEAL PRODUCT INFORMATION Clopidogrel AMNEAL PI v2 2 receptors, P2Y12, thus inhibiting platelet קרא את המסמך השלם