Clopidogrel dosage and administration

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Clopidogrel
PLAVIX® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Clopidogrel
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]

Dosage and Administration

2.1 Acute Coronary Syndrome

Plavix can be administered with or without food [see Clinical Pharmacology (12.3)]. For patients with non-ST-elevation ACS (UA/NSTEMI), initiate Plavix with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75–325 mg once daily) and continue in combination with Plavix [see Clinical Studies (14.1)].

For patients with STEMI, the recommended dose of Plavix is 75 mg once daily orally, administered in combination with aspirin (75–325 mg once daily), with or without thrombolytics.

Plavix may be initiated with or without a loading dose [see Clinical Studies (14.1)].


2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

The recommended daily dose of Plavix is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].


2.3 CYP2C19 Poor Metabolizers

CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.


2.4 Use with Proton Pump Inhibitors (PPI)

Avoid using omeprazole or esomeprazole with Plavix. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of Plavix. When concomitant administration of a PPI is required, consider using another acid-reducing agent with minimal or no CYP2C19 inhibitory effect on the formation of clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].[1]

References

  1. "PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB/SANOFI PHARMACEUTICALS PARTNERSHIP]".

Adapted from the FDA Package Insert.