Generic Name

Clopidogrel Bisulfate

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Classification

FDA Approved Indications

• Prevention of stroke, myocardial infarction, and vascular death in patients at risk; Treatment of acute coronary syndrome (ACS) including unstable angina and myocardial infarction

Mechanism of Action

Clopidogrel is an irreversible antagonist of the P2Y12 ADP receptor on platelets, inhibiting platelet aggregation and preventing thrombus formation.

Dosage and Administration

Adult: Typically 75 mg once daily, with or without food; for acute coronary syndrome, initial dosing may be 300 mg loading dose followed by 75 mg daily.

Pediatric: Not established; only approved for certain pediatric conditions under specific circumstances.

Geriatric: Use with caution due to increased bleeding risk; no specific dose adjustment but monitor closely.

Renal Impairment: Careful use; no specific dose adjustment, but bleeding risk increases.

Hepatic Impairment: Use with caution; no specific dose adjustment.

Pharmacokinetics

Absorption: Well absorbed orally.

Distribution: Extensively bound to plasma proteins (~98%).

Metabolism: Prodrug activated primarily by CYP2C19; also involves CYP1A2, CYP2B6, and others.

Excretion: Metabolites excreted mainly in urine.

Half Life: Approximately 6 hours for the active metabolites; platelet inhibition lasts for the lifespan of the platelet (~7-10 days).

Contraindications

• Active pathological bleeding (e.g., peptic ulcer, intracranial hemorrhage)

Precautions

• History of bleeding disorders, hepatic impairment, recent surgery or trauma

Adverse Reactions - Common

• Bleeding, including subdural hematoma (Common)
• Bruising, bleeding at injection site (Common)

Adverse Reactions - Serious

• Thrombotic thrombocytopenic purpura (TTP) (Rare but serious)
• Major bleeding events (Serious)

Drug-Drug Interactions

• Proton pump inhibitors, especially omeprazole and esomeprazole, as they may reduce effectiveness by inhibiting CYP2C19.
• Other anticoagulants and antiplatelet agents increase bleeding risk.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Report any unusual bleeding or bruising.
• Use caution with activities that could cause injury.
• Inform about the importance of adherence to therapy.

Special Considerations

Black Box Warnings:

• Increased risk of significant bleeding.
• Thrombotic thrombocytopenic purpura (TTP)—a rare but serious condition that can occur within 2 weeks of starting therapy.

Genetic Factors: CYP2C19 genetic polymorphisms can affect drug metabolism and response.

Lab Test Interference: Can prolong bleeding time tests.

Overdose Management

Signs/Symptoms: Excessive bleeding, bruising, hematomas.

Treatment: Discontinue drug; supportive care; platelet transfusions in severe cases.

Storage and Handling

Storage: Store at room temperature, away from moisture and light.

Stability: Stable until the expiration date on the packaging.