Clopidogrel

Indications

Clopidogrel tablets are P2Y 12 platelet inhibitor indicated for: ● Acute coronary syndrome – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. – For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. ● Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. Acute Coronary Syndrome (ACS) Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel tablets should be administered in conjunction with aspirin.

Dosage and administration (summary)

● Acute coronary syndrome – Initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. – Initiating clopidogrel tablets without a loading dose will delay establishment of an antiplatelet effect by several days. ● Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily orally without a loading dose. Acute Coronary Syndrome In patients who need an antiplatelet effect within hours, initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiating clopidogrel tablets without a loading dose will delay establishment of an antiplatelet effect by several days .

Contraindications

Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage Hypersensitivity to clopidogrel or any component of the product Active Bleeding Clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Hypersensitivity Clopidogrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product .

Warnings and precautions

CYP2C19 inhibitors: Avoid concomitant use of omeprazole or esomeprazole. Bleeding: Clopidogrel tablets increases risk of bleeding. Discontinuation: Premature discontinuation increases risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding. Thrombotic thrombocytopenic purpura (TTP) has been reported. Cross-reactivity among thienopyridines has been reported. Diminished Antiplatelet Activity in Patients with Impaired CYP2C19 Function Clopidogrel is a prodrug.

Pregnancy

Pregnancy Risk Summary Available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage .There are risks to the pregnant woman and fetus associated with myocardial infarction and stroke .

Storage and supply

Clopidogrel tablets, USP 75mg are available as light pink colored, round, beveled edge, biconvex film coated tablets printed "41" with black ink on one side and plain on the other side. Tablets are provided as follows: Bottles of 30 NDC 43063-371-30 Bottles of 60 NDC 43063-371-60 Bottles of 90 NDC 43063-371-90 Store at 20° to 25° C (68° to 77° F).

Source: Clopidogrel Bisulfate (Clopidogrel Bisulfate) — US FDA prescribing information, 2025-02-27, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.