Clopidogrel (clopidogrel bisulfate)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Clopidogrel bisulfate, a thienopyridine P2Y12 platelet adenosine diphosphate (ADP)-receptor antagonist, is a platelet-aggregation inhibitor.
Clopidogrel bisulfate, a thienopyridine derivative structurally and pharmacologically related to ticlopidine, is a platelet-aggregation inhibitor. Clopidogrel is a prodrug with its platelet-aggregation inhibitory activity dependent on hepatic transformation to an active thiol metabolite.
Biotransformation occurs through a 2-step process where clopidogrel is initially oxidized to a 2-oxo-clopidogrel intermediate metabolite, then subsequently metabolized to the active thiol metabolite. This metabolic pathway has been shown to be mediated by several cytochrome P-450 isoenzymes (e.g., CYP2C19, CYP3A, CYP2B6, CYP1A2). In particular, the CYP2C19 isoenzyme is involved in the formation of both the active metabolite and the 2-oxo-clopidogrel intermediate.
Clopidogrel is an ADP-receptor antagonist; the active metabolite of clopidogrel binds selectively and noncompetitively to a low-affinity, P2Y12 ADP-receptor binding site on the surface of platelets, thereby inhibiting ADP binding to the receptor and subsequent activation of the platelet glycoprotein (GP IIb/IIIa) complex necessary for fibrinogen-platelet binding. Clopidogrel also inhibits ADP-mediated release of platelet dense granule (e.g., ADP, calcium, and serotonin) and alpha granule (e.g., fibrinogen and thrombospondin) contents that augment platelet aggregation. The low-affinity ADP receptor is irreversibly modified by the drug, so platelets exposed to clopidogrel remain affected for the remainder of their lifespan (about 7-10 days).
Unlike aspirin, thienopyridine platelet-aggregation inhibitors such as clopidogrel and ticlopidine do not inactivate platelet cyclooxygenase to prevent synthesis of prostaglandin endoperoxides and thromboxane A.
Clopidogrel is rapidly absorbed after oral administration; at least 50% of an oral dose is absorbed. Peak plasma concentrations of the active metabolite occur approximately 30-60 minutes following an oral dose. When clopidogrel 75 mg is administered daily, inhibition of platelet aggregation is apparent on the first day of therapy, with 40-60% inhibition being achieved at steady state between days 3-7.
Following discontinuance of the drug, platelet aggregation and bleeding time generally return to baseline values within about 5 days.
USES: Clopidogrel is used to prevent heart attacks and strokes in persons with heart disease (recent heart attack), recent stroke, or blood circulation disease (peripheral vascular disease). It is also used with aspirin to treat new/worsening chest pain (new heart attack, unstable angina) and to keep blood vessels open and prevent blood clots after certain procedures (such as cardiac stent). Clopidogrel works by blocking platelets from sticking together and prevents them from forming harmful clots.
It is an antiplatelet drug. It helps keep blood flowing smoothly in your body.
Generic name: clopidogrel bisulfate
Pronunciation: (kloe-PID-oh-grel)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Clopidogrel
Indications
The following indications are listed for Clopidogrel:
- Acute Coronary Syndrome
- Cerebral Thromboembolism Prevention
- Myocardial Reinfarction Prevention
- Peripheral Arterial Thromboembolism Prevention
- Thrombosis Prevention After Percutaneous Coronary Intervention
Also known as: Maintenance Therapy Of Thrombosis Prevention After Pci, Myocardial Reinfarction Prophylaxis, Peripheral Artery Thromboembolism Prophylaxis, Stroke Thromboembolism Prophylaxis, Thrombosis Prophylaxis After Percutaneous Coronary Intervention, Vascular Thrombosis Prevention After Percutaneous Coronary Intervention.
Dosing
Dosage of clopidogrel bisulfate is expressed in terms of clopidogrel.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Active pathological bleeding (e.g., peptic ulcer, intracranial hemorrhage).
*Known hypersensitivity to clopidogrel or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse effect of clopidogrel.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of clopidogrel have not been established in pediatric patients. However, the drug has been used in neonates and infants+ with certain cardiac conditions that predispose them to arterial thrombosis.
Available data from case reports and postmarketing surveillance have not suggested any risks of major birth defects, miscarriage, or adverse fetal outcomes with clopidogrel use in pregnant women. In animal studies, no evidence of fetotoxicity was observed when clopidogrel was administered to pregnant rats and rabbits during organogenesis at doses up to 78 times to recommended daily human dose.
MI and stroke present risks to both the pregnant woman and fetus. Use of clopidogrel during labor or delivery increases the risk of maternal bleeding and hemorrhage. Neuraxial blockade during clopidogrel use should be avoided because of the risk of spinal hematoma. When possible, clopidogrel should be discontinued 5-7 days prior to labor, delivery, or neuraxial blockade.
Clopidogrel is distributed into milk in rats; it is not known whether the drug is distributed into milk in humans. The benefits of breast-feeding should be considered along with the importance of the drug to the mother and any potential adverse effects on the infant from the drug or underlying maternal condition.
No difference in platelet aggregation has been observed in patients 75 years of age or older compared with younger healthy individuals. In the CURE trial, geriatric patients (65 years of age or older) were at greater risk for thrombotic events and major bleeding compared with younger patients. However, in the COMMIT study evaluating patients with ST-segment-elevation MI (STEMI), the efficacy and safety of clopidogrel in preventing ischemic events was independent of age. Dosage adjustment based solely on age does not appear to be necessary in geriatric patients.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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