Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Clopidogrel bisulfate 97.875mg equivalent to 75 mg clopidogrel;
Sandoz New Zealand Limited
Clopidogrel bisulfate 97.875 mg (equivalent to 75 mg clopidogrel)
75 mg
Film coated tablet
Active: Clopidogrel bisulfate 97.875mg equivalent to 75 mg clopidogrel Excipient: Hydrogenated vegetable oil Hyprolose Mannitol Microcrystalline cellulose Opacode black S-1-17823 Opadry Pink Purified water
Blister pack, Al/Al, 28 tablets
Prescription
Prescription
Dr Reddy's Laboratories Limited
Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease.
Package - Contents - Shelf Life: Blister pack, Al/Al - 28 tablets - 2 years from date of manufacture stored at or below 25°C
2010-05-07
NEW ZEALAND DATASHEET CLOPIDOGREL SANDOZ _®_ _CLOPIDOGREL FILM-COATED TABLETS 75MG _ NAME OF THE MEDICINE Generic name: Clopidogrel hydrogen sulfate Chemical name: Methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c] pyridine-5(4H)-acetate sulfate (1:1) CAS: 120202-66-6 (Clopidogrel hydrogen sulfate) 113 665-84-2 (Clopidogrel base) Empirical formula: C 16 H 16 ClNO 2 S.H 2 SO 4 MW: 419.9 DESCRIPTION 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, microcrystalline cellulose, hydroxypropylcellulose, hydrogenated vegetable oil, Opadry Pink 03B54942 and Opacode S-1-17823 Black. 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 receptors, P2Y12, thus inhibiting platelet aggregation. Clopidogrel also inhibits platelet aggregation induced by other agoni Leggi il documento completo