Clopidogrel (Plavix®) Considerations for Use*

Non-FDA Approved Indication: Stroke Prevention in Atrial Fibrillation when used with aspirin when warfarin therapy is unsuitable due to patient preference or physician’s assessment of the patient’s ability to safely sustain anticoagulation.

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Black Box Warning* Requires activation to an active metabolite by the CYP system, mainly CYP2C19. When treated at recommended doses, poor metabolizer s have higher cardiovascular event rates after acute coronary syn drome or percutaneous coronary intervention than patients with normal CYP 2C19 function. Tests to determine a patient’s CYP2C19 genotype may aid in d etermining therapeutic strategy. Consider alternative treatment or treatme nt strategies in patients identified as CYP2C19 poor metabolizers.

Mechanism of Action

Inhibits platelet aggregation by blocking the effects of adenosine diphosphate at its platelet receptor

Dosing

Adult: 75 mg PO daily

Elderly: No dosage adjustment necessary

Hepatic Impairment: No dosage adjustment necessary

Renal Impairment: No specific recommendations; limi ted experience with severe and moderate renal impairment

Contraindications

Active pathological bleeding

Major Side Effects

Hemorrhagic event, acute liver failure, anaphylaxis, angioedema, aplastic anemia, agranulocytosis, pancreatitis, Stevens-Johnson synd rome, thrombotic thrombocytopenia purpura

Dosage forms and Strengths

PO: 75 mg tablets

Special Notes

Effectiveness is reduced with impaired CYP2C19 func tion; avoid drugs that are strong or moderate CYP2C19 inhibitors (eg, omeprazole, esomeprazole, cimetidine, etravirine, felbamate, fluconazole, fluoxetine, fluvoxamine, ketoconazole, voriconazole).

Discontinue use 5 days before elective surgery, exc ept in 1st year post coronary stent implantation; premature discontinuation incre ases risk of cardiovascular events.

Counseling

Do not discontinue this medication without talking to the healthcare provider who prescribed it.

Consult healthcare professional prior to using new drug (prescription, OTC, herbal).

Report signs and symptoms of bleeding (e.g., unexpected bleeding or bleeding that lasts a long time; red or black, tarry stool; pink or brown urine; unusual bruising; coughing up blood; vomiting blood or vomit that looks like coffee grounds; unexplained pain, swelling, or joint pain; unusual headaches, dizziness, or weakness; recurring nose bleeds)

*Refer to prescribing information for more complete information.
†Dosages given in the table may differ from those recommended by the manufacturers.


Source:

  1. American College of Cardiology (ACC), American Heart Association (AHA), and Heart Rhythm Society (HRS). 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran). Washington, DC: American College of Cardiology Foundation. 2011.
  2. Chest Supplement, Antithrombotic Therapy and Prevention of Thrombosis, 9th edition, American College of Chest Physicians.
  3. Plavix® prescribing information, 5/20/12.