Clopidogrel Dosage

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Usual Adult Dose for Ischemic Stroke

75 mg orally once a day with or without food.

Aspirin therapy should be initiated and continued in combination with clopidogrel.

Usual Adult Dose for Myocardial Infarction

75 mg orally once a day with or without food.

Aspirin therapy should be initiated and continued in combination with clopidogrel.

Usual Adult Dose for Acute Coronary Syndrome - Prophylaxis

75 mg orally once a day with or without food.

Aspirin therapy should be initiated and continued in combination with clopidogrel.

Usual Adult Dose for Peripheral Arterial Disease

75 mg orally once a day with or without food.

Aspirin therapy should be initiated and continued in combination with clopidogrel.

Usual Adult Dose for Acute Coronary Syndrome

Unstable angina, non ST segment elevation myocardial infarction (UA/NSTEMI): Initial: 300 mg loading dose, followed by 75 mg once daily for at least 1 month and ideally up to 12 months (in combination with aspirin 75 to 162 mg once daily indefinitely).
ST segment elevation acute myocardial infarction (STEMI): 75 mg once daily (in combination with aspirin 162 to 325 mg initially, followed by 81 to 162 mg/day); Note: The CLARITY TIMI 28 study used a 300 mg loading dose of clopidogrel (with thrombolysis) demonstrating an improvement in the patency rate of the infarct related artery and reduction in ischemic complications. The duration of therapy was less than 28 days (usually until hospital discharge) unless non primary percutaneous coronary intervention (PCI) was performed.

Usual Adult Dose for Percutaneous Coronary Intervention

Percutaneous coronary intervention (PCI) for UA/NSTEMI or STEMI:
Loading dose: 300 to 600 mg (600 mg may be preferred for early invasive strategy with UA/NSTEMI) given as early as possible before or at the time of PCI followed by 75 mg once daily. Note: If an initial loading dose of 300 mg was given prior to PCI, a supplemental loading dose of 300 mg (total loading dose: 600 mg) may be administered. For patients with UA/NSTEMI, it has been recommended that the loading dose be given at least 2 hours (or 24 hours in patients unable to take aspirin) prior to PCI.

Higher vs standard maintenance dosing: May consider a maintenance dose of 150 mg once daily for 6 days, then 75 mg once daily thereafter in patients not at high risk for bleeding; however, in another study, in patients with high on treatment platelet reactivity, the use of 150 mg once daily for 6 months did not demonstrate a difference in 6 month incidence of death from cardiovascular causes, nonfatal MI, or stent thrombosis compared to standard dose therapy (Price, 2011).

Duration of clopidogrel (in combination with aspirin) after stent placement: Premature interruption of therapy may result in stent thrombosis with subsequent fatal and nonfatal MI. With STEMI, clopidogrel for at least 12 months regardless of stent type (either bare metal or drug eluting stent) is recommended. With UA/NSTEMI, at least 12 months of clopidogrel is recommended in patients receiving a drug eluting stent (DES) unless the risk of bleeding outweighs the benefits. For bare metal stent (BMS) placement, at least 1 month and ideally up to 12 months duration is recommended unless the risk of bleeding outweighs the benefits; then, a minimum of 2 weeks is recommended. In either setting, a duration greater than 15 months may be considered in patients with DES placement. For patients without ongoing ACS, clopidogrel should be continued for at least 1 month (for BMS) or at least 12 months (for DES).

Usual Geriatric Dose for Acute Coronary Syndrome

The American College of Chest Physicians recommends:

Patients over 75 years: 75 mg once daily for up to 28 days (with or without thrombolysis)

Usual Pediatric Dose for Platelet Aggregation Inhibition

Note: Safety and efficacy have not been established in pediatric patients; optimal dose is not known; limited dosing information is available; further pediatric studies are needed.

Neonates and Infants up to 2 years: 0.2 mg/kg once daily was found to achieve a mean inhibition of platelet aggregation similar to adults receiving the recommended dose. This dose comes from the PICOLO study which included pediatric patients with a systemic to pulmonary artery shunt, intracardiac or intravascular stent, Kawasaki disease, or arterial graft; 79% of patients received concomitant aspirin; patients less than 2 kg and those born at less than 35 weeks gestational age were excluded.

Children over 2 years of age: Optimal dose is not established; some centers use the following: Initial dose: 1 mg/kg once daily; titrate to response; in general, do not exceed adult dose.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Dosage adjustments do not appear to be required in patients with mild to moderate (Child-Pugh Class A or B) hepatic dysfunction.

There are no data on the pharmacokinetic disposition of clopidogrel in patients with severe liver disease. Because the drug is extensively metabolized in the liver and patients with hepatic disease are predisposed to coagulation disorders, frequent monitoring for adverse effects is recommended.

Note: Inhibition of ADP induced platelet aggregation and mean bleeding time prolongation were similar in patients with severe hepatic impairment compared to healthy subjects after repeated doses of 75 mg once daily for 10 days.

Dose Adjustments

Results of several studies indicate that dosing of clopidogrel may need to be weight adjusted in order to achieve optimal antiplatelet activity. At least one study has shown that a 600 mg loading dose of clopidogrel does not inhibit platelet aggregation in overweight patients (BMI greater than or equal to 25 kg/m2) to the same extent as in normal weight patients (BMI less than 25 kg/m2). However, loading doses greater than 600 mg have not been shown to be significantly more effective. Additional studies are required in order to clearly define/establish a weight adjusted dosing regimen.

Dosing adjustment in patients with CYP450 2C19 poor metabolizer status has not been not established; CYP450 2C19 poor metabolizer status is associated with decreased response to clopidogrel.

Precautions

Clopidogrel is contraindicated in patients with active pathological bleeding, such as peptic ulcer or intracranial hemorrhage and should be used cautiously in patients at increased risk of bleeding.

Caution is advised in patients receiving clopidogrel, particularly those who are also receiving aspirin, who require any type of parenteral access procedure (i.e., venipuncture, lumbar puncture, surgery). These patients are at a higher risk of hemorrhagic complications.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Clopidogrel may be administered with or without food. Although food significantly enhances the bioavailability of clopidogrel, there is no difference in the pharmacodynamics (% inhibition of platelet aggregation) whether administered with or without food.

Many patients begin treatment with clopidogrel before the need for cardiac surgery is established. It has been suggested that in ACS patients requiring coronary bypass graft surgery (CABG), clopidogrel therapy should be discontinued at least 5 days prior to elective CABG surgery, and low-dose aspirin therapy be used perioperatively. Cardiac surgery performed before this time appears to be associated with an increased risk of bleeding complications.

Periodic monitoring of liver function during clopidogrel therapy has been suggested

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