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Plavix (clopidogrel bisulfate)

BOXED WARNING

Effectiveness is dependent on activation to an active metabolite via CYP2C19. Poor metabolizers of CYP2C19 with acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention treated with clopidogrel at recommended doses exhibit higher cardiovascular (CV) event rates than 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. Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers.

THERAPEUTIC CLASS

Platelet aggregation inhibitor

DEA CLASS

RX

INDICATIONS

To decrease the rate of combined endpoint of CV death, myocardial infarction (MI), stroke, or refractory ischemia in patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation MI [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. To reduce the rate of death from any cause and the rate of combined endpoint of death, reinfarction, or stroke in patients with ST-elevation MI (STEMI). To reduce the rate of combined endpoint of new ischemic stroke, new MI, and other vascular death in patients with history of recent MI, recent stroke, or established peripheral arterial disease.

ADULT DOSAGE

Acute Coronary Syndrome

Unstable Angina/Non-ST-Elevation MI:
LD: 300mg
Maint: 75mg qd. Initiate ASA (75-325mg qd) and continue in combination w/ clopidogrel

ST-Elevation MI:
75mg qd w/ ASA (75-325mg qd), w/ or w/o thrombolytics
May initiate w/ or w/o a LD

Recent Myocardial Infarction/Recent Stroke/Peripheral Arterial Disease

75mg qd

ADMINISTRATION

Oral route

May be administered w/ or w/o food

HOW SUPPLIED

Tab: 75mg, 300mg

CONTRAINDICATIONS

Active pathological bleeding (eg, peptic ulcer, intracranial hemorrhage).

WARNINGS/PRECAUTIONS

Increases the risk of bleeding; d/c 5 days prior to surgery if an antiplatelet effect is not desired. Avoid lapses in therapy; if therapy must be temporarily discontinued, restart as soon as possible. Premature discontinuation may increase risk of CV events. TTP reported. Hypersensitivity (eg, rash, angioedema, hematologic reaction) reported, including in patients with a history of hypersensitivity or hematologic reaction to other thienopyridines.

ADVERSE REACTIONS

Bleeding.

DRUG INTERACTIONS

Reduced antiplatelet activity with omeprazole or esomeprazole; avoid concomitant use, or consider using another acid-reducing agent with minimal or no CYP2C19 inhibitory effect on the formation of clopidogrel active metabolite when coadministration of a proton pump inhibitor is required. Certain CYP2C19 inhibitors may reduce platelet inhibition. NSAIDs, warfarin, SSRIs, SNRIs, and ASA may increase risk of bleeding.

PREGNANCY AND LACTATION

Category B, not for use in nursing.

MECHANISM OF ACTION

Platelet activation and aggregation inhibitor; irreversibly and selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex.

PHARMACOKINETICS

Absorption: Rapid. Tmax=30-60 min (active thiol metabolite). Metabolism: Extensive via esterases (leading to hydrolysis) and via multiple CYP450 enzymes; active thiol metabolite (principally by CYP2C19). Elimination: Urine (50%), feces (46%); T1/2=6 hrs, 30 min (active thiol metabolite).

ASSESSMENT

Assess for active pathological bleeding, hypersensitivity to drug or another thienopyridine, CYP2C19 genotype, pregnancy/nursing status, and possible drug interactions. Assess use in patients at risk for increased bleeding (eg, undergoing surgery).

MONITORING

Monitor for bleeding, TTP, hypersensitivity, and other adverse reactions.

PATIENT COUNSELING

Inform about the benefits and risks of treatment. Instruct to take exactly as prescribed and not to d/c without consulting the prescribing physician. Inform that they will bruise and bleed more easily and that bleeding will take longer than usual to stop. Advise to report any unanticipated, prolonged, or excessive bleeding, or blood in stool or urine. Instruct to seek prompt medical attention if unexplained fever, weakness, extreme skin paleness, purple skin patches, yellowing of the skin or eyes, or neurological changes occur. Instruct to notify physician or dentist about therapy before scheduling any invasive procedure. Advise to inform physician of all medications they are taking or planning to take.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F).

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