Plavix (Clopidogrel Bisulfate) Drug Overview and Uses for Patients and Caregivers at RxList

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May 27, 2012

Plavix

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Heart attack facts

A heart attack results when a blood clot completely obstructs a coronary artery supplying blood to the heart muscle and heart muscle dies.
The blood clot that causes the heart attack usually forms at the site of rupture of an atherosclerotic, cholesterol plaque on the inner wall of a coronary artery.
The most common symptom of heart attack is chest pain.
The most common complications of a heart attack are heart failure and ventricular fibrillation.
The risk factors for atherosclerosis and heart attack include elevated cholesterol levels, increased blood pressure, tobacco use, diabetes, male gender, and a family history of heart attacks at an early age.
Heart attacks are diagnosed with electrocardiograms and measurement of cardiac enzymes in blood.
Early reopening of blocked coronary arteries reduces the amount of damage to the heart and im...

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Plavix

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PLAVIX
(clopidogrel bisulfate)

WARNING

DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS

The effectiveness of Plavix is dependent on its activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 [see WARNINGS AND PRECAUTIONS]. Plavix at recommended doses forms less of that metabolite and has a smaller effect on platelet function in patients who are CYP2C19 poor metabolizers. Poor metabolizers with acute coronary syndrome or undergoing percutaneous coronary intervention treated with Plavix at recommended doses exhibit higher cardiovascular event rates than do patients with normal CYP2C19 function. Tests are available to identify a patient's CYP2C19 genotype; these tests can be used as an aid in determining therapeutic strategy [see CLINICAL PHARMACOLOGY]. Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers [see DOSAGE AND ADMINISTRATION].

DRUG DESCRIPTION

Plavix (clopidogrel bisulfate) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C₁₆H₁₆ClNO₂S•H₂SO₄ and its molecular weight is 419.9.

The structural formula is as follows:

PLAVIX (clopidogrel bisulfate) Structural Formula Illustration

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.

Last reviewed on RxList: 1/12/2012
This monograph has been modified to include the generic and brand name in many instances.