PLAVIX- clopidogrel bisulfate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7)

Available from:

STAT RX USA LLC

INN (International Name):

CLOPIDOGREL BISULFATE

Composition:

CLOPIDOGREL BISULFATE 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Authorization status:

New Drug Application

Summary of Product characteristics

PLAVIX - CLOPIDOGREL BISULFATE TABLET, FILM COATED
STAT RX USA LLC
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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