Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7)
STAT RX USA LLC
CLOPIDOGREL BISULFATE
CLOPIDOGREL BISULFATE 75 mg
ORAL
PRESCRIPTION DRUG
PLAVIX (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic events as follows: - Recent MI, Recent Stroke or Established Peripheral Arterial Disease For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, PLAVIX has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. - Acute Coronary Syndrome - For patients with non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, PLAVIX has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI, or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. - For patients with ST-segment elevation acute myocardial infarcti
PLAVIX (clopidogrel bisulfate) 75-mg tablets are available as pink, round, biconvex, film-coated tablets debossed with "75" on one side and "1171" on the other. Tablets are provided as follows: PLAVIX (clopidogrel bisulfate) 300-mg tablets are available as pink, oblong, film-coated tablets debossed with "300" on one side and "1332" on the other. Tablets are provided as follows: NDC 63653-1332-2 unit-dose packages of 30 NDC 63653-1332-3 unit-dose packages of 100 Store at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F) [See USP Controlled Room Temperature]. Distributed by: Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership Bridgewater, NJ 08807 PLAVIX® is a registered trademark. Revised October 2009 Principal Display Panel - 75 mg Carton List No. 1171-30 NDC 63653-1171-3 100 tablets Plavix® (clopidogrel bisulfate) 75 mg Rx only
New Drug Application
PLAVIX - CLOPIDOGREL BISULFATE TABLET, FILM COATED STAT RX USA LLC ---------- DESCRIPTION PLAVIX (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex. Chemically it is methyl (+)-(_S_)-α-(2-chlorophenyl)- 6,7-dihydrothieno[3,2-c]pyridine-5(4_H_)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C H ClNO S•H SO and its molecular weight is 419.9. The structural formula is as follows: Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. PLAVIX for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink, oblong, debossed film-coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains hydrogenated castor oil, hydroxypropylcellulose, mannitol, microcrystalline cellulose and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains ferric oxide, hypromellose 2910, lactose monohydrate, titanium dioxide and triacetin. The tablets are polished with Carnauba wax. CLINICAL PHARMACOLOGYMechanism of Action and Pharmacodynamic Properties Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. A variety of drugs that inhibit platelet function have been shown to decrease morbid events in people with established cardiovascular atherosclerotic disease as evidenced by stroke or transient ischemic attacks, myocardial infarction, unstable angina or the need for vascular bypass or a Přečtěte si celý dokument