Clopidogrel Bisulfate Uses

How do you administer this medicine?
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What is Clopidogrel Bisulfate?

Clopidogrel Bisulfate is used alone or together with aspirin to lessen the chance of a heart attack or stroke. It is given to patients who have already had a heart attack, severe chest pain, or a stroke, or to patients with other circulation problems that could cause a stroke or heart attack.

A heart attack or stroke may occur when a blood vessel is blocked by a blood clot. Clopidogrel Bisulfate is a platelet inhibitor. It reduces the chance that a harmful blood clot will form by preventing platelets from clumping together in the blood. Clopidogrel Bisulfate may also increase the chance of serious bleeding in some people.

Clopidogrel Bisulfate is available only with your doctor's prescription.

Clopidogrel Bisulfate indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Acute Coronary Syndrome (ACS)

For 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 Bisulfate has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
For patients with ST-elevation myocardial infarction (STEMI), Clopidogrel Bisulfate has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown.

The optimal duration of Clopidogrel Bisulfate therapy in ACS is unknown.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, Clopidogrel Bisulfate has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.

How should I use Clopidogrel Bisulfate?

Use Clopidogrel Bisulfate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Clopidogrel Bisulfate.

Uses of Clopidogrel Bisulfate in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Acute coronary syndrome:

ST-segment elevation myocardial infarction: To reduce the rate of myocardial infarction (MI) and stroke in conjunction with aspirin in patients with acute ST-elevation MI who are to be managed medically.

Non-ST-segment elevation acute coronary syndromes: To decrease the rate of MI and stroke in conjunction with aspirin in patients with non-ST-segment elevation acute coronary syndromes (unstable angina/non-ST-elevation MI), including patients who are to be managed medically and those who are to be managed with coronary revascularization.

Myocardial infarction, ischemic stroke, or peripheral atherosclerotic disease: To reduce the rate of MI and stroke in patients with a history of recent MI, recent stroke, or established peripheral atherosclerotic disease.

Off Label Uses

Carotid artery atherosclerosis, symptomatic

Based on the American College of Chest Physicians guidelines for antithrombotic therapy in peripheral artery disease, Clopidogrel Bisulfate is effective and recommended for patients with symptomatic carotid artery atherosclerosis.

Carotid artery stenting

A randomized, controlled trial with blinded end point adjudication evaluated carotid artery stenting versus carotid endarterectomy in patients with carotid artery stenosis. In this trial, aspirin in combination with Clopidogrel Bisulfate was used for patients who underwent carotid artery stenting, which suggests that this antiplatelet combination is effective.

Clopidogrel Bisulfate description

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Clopidogrel Bisulfate, an antiplatelet agent structurally and pharmacologically similar to ticlopidine, is used to inhibit blood clots in a variety of conditions such as peripheral vascular disease, coronary artery disease, and cerebrovascular disease. Clopidogrel Bisulfate is sold under the name Plavix by Sanofi and Bristol-Myers Squibb. The drug is an irreversible inhibitor of the P2Y12 adenosine diphosphate receptor found on the membranes of platelet cells. Clopidogrel Bisulfate use is associated with several serious adverse drug reactions such as severe neutropenia, various forms of hemorrhage, and cardiovascular edema.

Clopidogrel Bisulfate dosage

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet,

Oral:

Plavix: 75 mg, 300 mg [DSC]

Generic: 75 mg, 300 mg

Dosing: Adult

Acute coronary syndrome:

Note: Routine platelet-function testing or genetic testing for CYP2C19 polymorphisms is not recommended (ACC/AHA [Levine 2016]; Scott 2013; Sibbing 2019).

ST-segment elevation myocardial infarction: Note: Regardless of the reperfusion strategy, administer Clopidogrel Bisulfate in combination with a parenteral anticoagulant and aspirin (ACCF/AHA [O'Gara 2013]).

If using fibrinolytic therapy for reperfusion:

Age ≤75 years:

Oral: Initial loading dose: 300 mg once at the time of diagnosis; followed by 75 mg once daily (ACCF/AHA [O'Gara 2013]; Sabatine 2005a).

Age >75 years:

Oral: 75 mg once daily (ACCF/AHA [O'Gara 2013]).

Patient requires percutaneous coronary intervention following fibrinolytic therapy:

Fibrinolytic administered with a loading dose of Clopidogrel Bisulfate:

Oral: Continue 75 mg once daily (do not administer an additional loading dose) (ACCF/AHA [O'Gara 2013]).

Fibrinolytic administered ≤24 hours ago without a loading dose of Clopidogrel Bisulfate:

Oral: Initial: 300 mg once prior to percutaneous coronary intervention (PCI); followed by 75 mg once daily after PCI (ACCF/AHA [O'Gara 2013]).

Fibrinolytic administered >24 hours ago without a loading dose of Clopidogrel Bisulfate:

Oral: Initial: 600 mg once prior to PCI; followed by 75 mg once daily after PCI (ACCF/AHA [O'Gara 2013]).

If using percutaneous coronary intervention for reperfusion (alternative agent) (off-label use): Note: Some experts prefer ticagrelor or prasugrel over Clopidogrel Bisulfate unless there is high risk for bleeding (Lincoff 2019; Wallentin 2009; Wiviott 2007).

Oral: Initial: 600 mg once as early as possible before PCI; followed by 75 mg once daily after PCI (ACCF/AHA [O'Gara 2013]; Dangas 2009; Mehta 2010).

If no planned reperfusion strategy (alternative agent): Note: Some experts prefer ticagrelor over Clopidogrel Bisulfate (Lincoff 2019).

Oral: Initial: 300 mg once at the time of diagnosis; followed by 75 mg once daily (Lincoff 2019).

Duration of therapy: Clopidogrel Bisulfate plus aspirin (dual antiplatelet therapy [DAPT]) should be continued for ≥12 months unless bleeding is a concern. If there have been no major bleeding complications after 12 months, continuation of DAPT may be considered. Reevaluate the need for DAPT at regular intervals based on bleeding and thrombotic risks. When DAPT is complete, discontinue Clopidogrel Bisulfate and continue aspirin indefinitely (ACC/AHA [Levine 2016]; ACCF/AHA [O'Gara 2013]; Lincoff 2019; Mauri 2014).

Non-ST-segment elevation acute coronary syndromes: Note: Regardless of the management strategy, administer Clopidogrel Bisulfate in combination with a parenteral anticoagulant and aspirin (ACC/AHA [Amsterdam 2014]).

If using an ischemia-guided approach (medical management) (alternative agent): Note: Some experts prefer ticagrelor over Clopidogrel Bisulfate (Cutlip 2019a).

Oral: Initial: 300 or 600 mg once at the time of diagnosis; followed by 75 mg once daily (ACC/AHA [Amsterdam 2014]). Some experts prefer an initial dose of 600 mg unless there is high risk for bleeding, in which case, an initial dose of 300 mg is also appropriate (Cutlip 2019a).

If using an invasive approach (reperfusion using percutaneous coronary intervention) (alternative agent): Note: Some experts prefer ticagrelor or prasugrel over Clopidogrel Bisulfate unless there is high risk for bleeding (Cutlip 2019a; Wallentin 2009; Wiviott 2007).

Oral: Initial: 600 mg once as early as possible before PCI; followed by 75 mg once daily after PCI (ACC/AHA [Amsterdam 2014]).

Duration of therapy: Clopidogrel Bisulfate plus aspirin (DAPT) should be continued for ≥12 months unless bleeding is a concern. If there have been no major bleeding complications after 12 months, continuation of DAPT may be considered. Reevaluate the need for DAPT at regular intervals based on bleeding and thrombotic risks. When DAPT is complete, discontinue Clopidogrel Bisulfate and continue aspirin indefinitely (ACC/AHA [Amsterdam 2014]; ACC/AHA [Levine 2016]; Cutlip 2019a; Mauri 2014; Mehta 2001; Yusuf 2001).

Percutaneous coronary intervention for stable ischemic heart disease (off-label use): Note: Administer Clopidogrel Bisulfate in combination with a parenteral anticoagulant and aspirin for patients who undergo PCI with stenting (ACCF/AHA/SCAI [Levine 2011]).

Oral: Initial: 600 mg once, administered ≥2 hours before PCI, ideally ≥24 hours before PCI; followed by 75 mg once daily (ACCF/AHA/SCAI [Levine 2011]; Cutlip 2020).

Duration of therapy: Upon completion of the recommended duration of DAPT (Clopidogrel Bisulfate plus aspirin), discontinue Clopidogrel Bisulfate and continue aspirin indefinitely (ACC/AHA [Levine 2016]; Cutlip 2019c):

• Bare metal stent implantation: DAPT for a minimum of 1 month (ACC/AHA [Levine 2016]). Some experts recommend at least 6 months and up to 12 months; in patients at high bleeding risk, shorter duration may be considered. After 6 to 12 months, assess bleeding and ischemic risks to determine if patient should receive longer therapy (eg, for an additional 18 to 24 months) (Cutlip 2019c).

• Drug eluting stent implantation: DAPT for at least 6 months and up to 12 months; if bleeding occurs or patient is at high risk of bleeding, may stop after 3 months (ACC/AHA [Levine 2016]). After 6 to 12 months, assess bleeding and ischemic risks to determine if patient should receive longer therapy (eg, for an additional 18 to 24 months) (Cutlip 2019c).

Carotid artery atherosclerosis, symptomatic (alternative agent) (off-label use): Note: For patients who are intolerant of aspirin.

Oral: 75 mg once daily (ACCP [Alonso-Coello 2012]; Cucchiara 2019).

Carotid artery stenting (off-label use):

Initial:

Initiation ≥48 hours before procedure:

Oral: 75 mg

twice daily in combination with aspirin (Brott 2010; Fairman 2019).

Initiation <48 hours of procedure:

Oral: 450 mg once ≥4 hours before procedure in combination with aspirin (Brott 2010; Fairman 2019).

Maintenance:

Oral: 75 mg

once daily in combination with aspirin for ≥6 weeks; after 6 weeks of DAPT with Clopidogrel Bisulfate and aspirin, assess bleeding and ischemic risks to determine total duration of therapy; upon completion of DAPT, discontinue Clopidogrel Bisulfate and continue aspirin indefinitely. In patients with history of neck irradiation, some experts recommend continuing Clopidogrel Bisulfate plus aspirin indefinitely (Brott 2010; Fairman 2019).

Coronary artery bypass graft surgery (off-label use):

Aspirin-allergic or aspirin-intolerant patients:

Oral: 75 mg once daily; continue indefinitely (AHA [Kulik 2015]).

Following off-pump coronary artery bypass graft surgery:

Oral: 75 mg once daily in combination with aspirin for 1 year, then discontinue Clopidogrel Bisulfate and continue aspirin indefinitely (AHA [Kulik 2015]; Deo 2013; Mannacio 2012).

Patients with acute coronary syndrome followed by coronary artery bypass graft surgery:

Oral: 75 mg once daily in combination with aspirin for 1 year, then discontinue Clopidogrel Bisulfate and continue aspirin indefinitely (AHA [Kulik 2015]). Some experts do not use Clopidogrel Bisulfate postoperatively in these patients (Aranki 2020).

Peripheral atherosclerotic disease (upper or lower extremity; with or without revascularization):

Oral: 75 mg once daily (ACCP [Alonso-Coello 2012]; AHA/ACC [Gerhard-Herman 2017]; CAPRIE 1996).

Stable ischemic heart disease (alternative agent) (off-label use): Note: Aspirin is preferred; Clopidogrel Bisulfate is an alternative for patients who have a history of GI bleeding or are allergic to aspirin (ACCF/AHA [Fihn 2012]).

Oral: 75 mg once daily (ACCF/AHA [Fihn 2012]; ACCP [Vandvik 2012]; CAPRIE 1996).

Stroke/Transient ischemic attack:

Intracranial atherosclerosis (50% to 99% stenosis of a major intracranial artery), secondary prevention: Note: Aspirin is recommended for all patients; may consider Clopidogrel Bisulfate (in combination with aspirin) for short-term use in patients with recent stroke or transient ischemic attack (within 30 days) (AHA/ASA [Kernan 2014]; Ehtisham 2019). For long-term stroke prevention, indefinite use of Clopidogrel Bisulfate monotherapy is an alternative to aspirin (AHA/ASA [Kernan 2014]).

Oral: 75 mg once daily in combination with aspirin; duration of Clopidogrel Bisulfate depends on degree of stenosis.

Stenosis of 50% to 69%: Clopidogrel Bisulfate may be added to aspirin for 21 days; after 21 days, discontinue Clopidogrel Bisulfate and continue aspirin indefinitely (Ehtisham 2019).

Stenosis of 70% to 99%: Clopidogrel Bisulfate may be added to aspirin for 90 days; after 90 days, discontinue Clopidogrel Bisulfate and continue aspirin indefinitely (AHA/ASA [Kernan 2014]; Derdeyn 2014; Ehtisham 2019).

Ischemic stroke or transient ischemic attack, noncardioembolic, secondary prevention:

Oral: 75 mg once daily.

Minor ischemic stroke (NIHSS score ≤3) or high-risk transient ischemic attack (ABCD score ≥4): Note: Short-term use of Clopidogrel Bisulfate in combination with aspirin may be considered for initiation as soon as possible and within 24 hours of stroke onset. If an IV thrombolytic was administered, delay starting antiplatelet therapy for ≥24 hours but administer as soon as possible thereafter (AHA/ASA [Kernan 2014]; AHA/ASA [Powers 2018]; Johnston 2018; Wang 2013).

Oral: Initial: 300 to 600 mg in combination with aspirin; followed by 75 mg once daily for 21 days; after 21 days, discontinue Clopidogrel Bisulfate and continue aspirin indefinitely (AHA/ASA [Kernan 2014]; AHA/ASA [Powers 2018]; Johnston 2018; Wang 2013).

Transcatheter aortic valve replacement (thromboprophylaxis) (off-label use):

Oral: 300 mg once prior to valve implantation in combination with aspirin; followed by 75 mg once daily for 3 to 6 months depending on the type of valve implanted; after completion of Clopidogrel Bisulfate, continue aspirin indefinitely (ACC [Otto 2017]; AHA/ACC [Nishimura 2014], AHA/ACC [Nishimura 2017]; Kalich 2018). To minimize risk of bleeding complications, may give aspirin or Clopidogrel Bisulfate alone and reserve dual antiplatelet therapy during the first 3 to 6 months for patients at high risk of a thrombotic event; for either strategy, continue aspirin indefinitely (Kuno 2019).

Transitioning between P2Y inhibitor to Clopidogrel Bisulfate:

Transitioning from prasugrel:

Patient received prasugrel for ≤5 days: Give a Clopidogrel Bisulfate 300 mg loading dose 24 hours after the last dose of prasugrel, followed by 75 mg once daily; some experts do not administer a loading dose (Lincoff 2019).

Patient received prasugrel for >5 days: Give Clopidogrel Bisulfate 75 mg once daily, starting 24 hours after the last dose of prasugrel (Kerneis 2013; Lincoff 2019).

Transitioning from ticagrelor: Give a Clopidogrel Bisulfate 600 mg loading dose 12 hours after the last dose of ticagrelor, followed by 75 mg once daily (Franchi 2018).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Antiplatelet effect: Limited data available:

Infants and Children ≤24 months: In the PICOLO trial, a dose of 0.2 mg/kg/dose once daily was found to achieve a mean inhibition of platelet aggregation similar to adults receiving the recommended dose; Note: This study 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 (Li 2008).

Children >2 years and Adolescents: Initial dose: 1 mg/kg once daily; titrate to response; in general, do not exceed adult dose (Finkelstein 2005; Soman 2006).

CYP2C19 poor metabolizers (ie, CYP2C19*2 or *3 carriers): Specific pediatric recommendations are lacking; based on experience in adult patients, routine genetic testing is not recommended in patients treated with Clopidogrel Bisulfate undergoing PCI, testing may be considered to identify poor metabolizers who would be at risk for poor outcomes while receiving Clopidogrel Bisulfate; if identified, these patients may be considered for an alternative P2Y12 inhibitor (Levine 2011).

Clopidogrel Bisulfate interactions

See also:
What other drugs will affect Clopidogrel Bisulfate?

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Acalabrutinib: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Monitor therapy

Alpelisib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Alpelisib. Management: Avoid coadministration of BCRP/ABCG2 inhibitors and alpelisib due to the potential for increased alpelisib concentrations and toxicities. If coadministration cannot be avoided, closely monitor for increased alpelisib adverse reactions. Consider therapy modification

Amiodarone: May decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Monitor therapy

Amodiaquine: CYP2C8 Inhibitors (Moderate) may increase the serum concentration of Amodiaquine. Avoid combination

Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Exceptions: Bemiparin; Enoxaparin; Heparin. Monitor therapy

Apixaban: Antiplatelet Agents (P2Y12 Inhibitors) may enhance the adverse/toxic effect of Apixaban. Specifically, the risk for bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Consider therapy modification

Bemiparin: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Bemiparin. Management: Avoid concomitant use of bemiparin with antiplatelet agents. If concomitant use is unavoidable, monitor closely for signs and symptoms of bleeding. Consider therapy modification

BuPROPion: CYP2B6 Inhibitors (Weak) may increase the serum concentration of BuPROPion. Monitor therapy

Calcium Channel Blockers: May diminish the therapeutic effect of Clopidogrel Bisulfate. Exceptions: Clevidipine. Monitor therapy

Cangrelor: May diminish the antiplatelet effect of Clopidogrel Bisulfate. More specifically, while the use of Cangrelor is expected to increase total platelet inhibition in patients who have previously received Clopidogrel Bisulfate, Cangrelor is expected to decrease binding of Clopidogrel Bisulfate metabolites to P2Y12 receptors and thus reduce the extent of irreversible platelet inhibition. Management: Avoid administration of Clopidogrel Bisulfate until cangrelor infusion is discontinued. Consider therapy modification

Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Monitor therapy

Cladribine: BCRP/ABCG2 Inhibitors may increase the serum concentration of Cladribine. Management: Avoid concomitant use of BCRP inhibitors during the 4 to 5 day oral cladribine treatment cycles whenever possible. If combined, consider dose reduction of the BCRP inhibitor and separation in the timing of administration. Consider therapy modification

Collagenase (Systemic): Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Monitor therapy

CYP2C19 Inducers (Strong): May increase serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Monitor therapy

CYP2C19 Inhibitors (Moderate): May decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Management: Due to a risk for impaired Clopidogrel Bisulfate effectiveness with such a combination, carefully consider the need for a moderate CYP2C19 inhibitor in patients receiving Clopidogrel Bisulfate. Monitor patients closely for evidence of a diminished response to Clopidogrel Bisulfate. Consider therapy modification

CYP2C19 Inhibitors (Strong): May decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Management: Due to a risk for impaired Clopidogrel Bisulfate effectiveness with such a combination, carefully consider the need for a strong CYP2C19 inhibitor in patients receiving Clopidogrel Bisulfate. Monitor patients closely for evidence of a diminished response to Clopidogrel Bisulfate. Consider therapy modification

Dabigatran Etexilate: Antiplatelet Agents (P2Y12 Inhibitors) may enhance the adverse/toxic effect of Dabigatran Etexilate. Specifically, the risk of bleeding may be increased. Antiplatelet Agents (P2Y12 Inhibitors) may increase the serum concentration of Dabigatran Etexilate. Specifically, Clopidogrel Bisulfate may increase dabigatran serum concentrations. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Consider therapy modification

Dabrafenib: CYP2C8 Inhibitors (Moderate) may increase the serum concentration of Dabrafenib. Monitor therapy

Dasabuvir: CYP2C8 Inhibitors (Moderate) may increase the serum concentration of Dasabuvir. Monitor therapy

Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy

Deoxycholic Acid: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy

Desloratadine: CYP2C8 Inhibitors (Moderate) may increase the serum concentration of Desloratadine. Monitor therapy

Edoxaban: Antiplatelet Agents (P2Y12 Inhibitors) may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Management: Carefully consider the anticipated risks and benefits of this combination. If combined, increased monitoring for bleeding is recommended. Consider therapy modification

Enoxaparin: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Enoxaparin. Management: Discontinue antiplatelet agents prior to initiating enoxaparin whenever possible. If concomitant administration is unavoidable, monitor closely for signs and symptoms of bleeding. Consider therapy modification

Enzalutamide: CYP2C8 Inhibitors (Moderate) may increase the serum concentration of Enzalutamide. Monitor therapy

Erythromycin (Systemic): May diminish the antiplatelet effect of Clopidogrel Bisulfate. Monitor therapy

Esomeprazole: May diminish the antiplatelet effect of Clopidogrel Bisulfate. Esomeprazole may decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Management: Clopidogrel Bisulfate prescribing information recommends avoiding concurrent use with esomeprazole. Rabeprazole or pantoprazole may be lower-risk alternatives to esomeprazole. Consider therapy modification

Etravirine: May decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Management: Consider alternatives to Clopidogrel Bisulfate in patients treated with etravirine. If combined, monitor for reduced Clopidogrel Bisulfate effectiveness. Consider therapy modification

Fat Emulsion (Fish Oil Based): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Monitor therapy

FentaNYL: May diminish the antiplatelet effect of Antiplatelet Agents (P2Y12 Inhibitors). FentaNYL may decrease the serum concentration of Antiplatelet Agents (P2Y12 Inhibitors). Monitor therapy

FluvoxaMINE: May enhance the adverse/toxic effect of Clopidogrel Bisulfate. Specifically, the risk for bleeding may be increased. FluvoxaMINE may decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Monitor therapy

Glucosamine: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Grapefruit Juice: May decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Management: Advise patients receiving Clopidogrel Bisulfate to minimize consumption of grapefruit and grapefruit juice. Consumption of three 200 mL glasses of grapefruit juice a day may substantially reduce Clopidogrel Bisulfate antiplatelet effects. Consider therapy modification

Heparin: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Heparin. Management: Decrease the dose of heparin or agents with antiplatelet properties if coadministration is required. Consider therapy modification

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Management: Avoid combination when possible. If used, monitor more closely for evidence of bleeding. Discontinue herbal products with anticoagulant or antiplatelet actions 2 weeks prior to surgical, dental, or invasive procedures. Consider therapy modification

Ibritumomab Tiuxetan: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Monitor therapy

Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Monitor therapy

Inotersen: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Lansoprazole: May decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Monitor therapy

Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Morphine (Systemic): May diminish the antiplatelet effect of Antiplatelet Agents (P2Y12 Inhibitors). Morphine (Systemic) may decrease the serum concentration of Antiplatelet Agents (P2Y12 Inhibitors). Management: Consider alternative anti-ischemic/analgesic therapies (eg, beta-blockers, nitroglycerin) in patients with acute coronary syndromes treated with a P2Y12 inhibitor when possible. The risks associated with other opioids are unknown. Consider therapy modification

Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Obinutuzumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased. Monitor therapy

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: CYP2C8 Inhibitors (Moderate) may increase the serum concentration of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir. Specifically, the concentrations of the dasabuvir component may be increased. Monitor therapy

Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Omeprazole: May diminish the antiplatelet effect of Clopidogrel Bisulfate. Omeprazole may decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Management: Clopidogrel Bisulfate labeling recommends avoiding concurrent omeprazole due to a possible decrease in Clopidogrel Bisulfate effectiveness. Rabeprazole or pantoprazole may be lower-risk alternatives to omeprazole. Consider therapy modification

Ozanimod: BCRP/ABCG2 Inhibitors may increase serum concentrations of the active metabolite(s) of Ozanimod. Avoid combination

PACLitaxel (Conventional): CYP2C8 Inhibitors (Moderate) may increase the serum concentration of PACLitaxel (Conventional). Monitor therapy

PACLitaxel (Protein Bound): CYP2C8 Inhibitors (Moderate) may increase the serum concentration of PACLitaxel (Protein Bound). Monitor therapy

Pantoprazole: May decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Management: Due to the possible risk for impaired Clopidogrel Bisulfate effectiveness, clinicians should carefully consider the need for proton pump inhibitor therapy in patients receiving Clopidogrel Bisulfate. Other acid-lowering therapies do not appear to share this interaction. Monitor therapy

PAZOPanib: BCRP/ABCG2 Inhibitors may increase the serum concentration of PAZOPanib. Avoid combination

Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Monitor therapy

Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Pioglitazone: CYP2C8 Inhibitors (Moderate) may increase the serum concentration of Pioglitazone. Monitor therapy

Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Repaglinide: Clopidogrel Bisulfate may increase the serum concentration of Repaglinide. Management: Avoid use of Clopidogrel Bisulfate and repaglinide if possible; if the combination must be used, limit total repaglinide daily dose to no more than 4 mg. This is contraindicated in some non-US labeling. Consider therapy modification

Rimegepant: BCRP/ABCG2 Inhibitors may increase the serum concentration of Rimegepant. Avoid combination

Ritonavir: May diminish the antiplatelet effect of Clopidogrel Bisulfate. Ritonavir may decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Monitor therapy

Rivaroxaban: Antiplatelet Agents (P2Y12 Inhibitors) may enhance the adverse/toxic effect of Rivaroxaban. Specifically, the risk of bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Consider therapy modification

Rosuvastatin: Clopidogrel Bisulfate may increase the serum concentration of Rosuvastatin. Monitor therapy

Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Monitor therapy

Selexipag: CYP2C8 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Selexipag. Management: Reduce the selexipag dose to once daily when combined with moderate CYP2C8 inhibitors. Revert back to twice daily selexipag dosing upon stopping the moderate CYP2C8 inhibitor. Consider therapy modification

Sibutramine: CYP2B6 Inhibitors (Weak) may increase serum concentrations of the active metabolite(s) of Sibutramine. CYP2B6 Inhibitors (Weak) may increase the serum concentration of Sibutramine. Monitor therapy

Sodium Zirconium Cyclosilicate: May decrease serum concentrations of the active metabolite(s) of Clopidogrel Bisulfate. Management: Separate the administration of sodium zirconium cyclosilicate and Clopidogrel Bisulfate by at least 2 hours. Consider therapy modification

Talazoparib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Talazoparib. Monitor therapy

Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Monitor therapy

Tipranavir: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Topotecan: BCRP/ABCG2 Inhibitors may increase the serum concentration of Topotecan. Avoid combination

Treprostinil: CYP2C8 Inhibitors (Moderate) may increase the serum concentration of Treprostinil. Monitor therapy

Ubrogepant: BCRP/ABCG2 Inhibitors may increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (if needed) of 50 mg when used with a BCRP inhibitor. Consider therapy modification

Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Avoid combination

Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Warfarin: Clopidogrel Bisulfate may enhance the anticoagulant effect of Warfarin. Monitor therapy

Zanubrutinib: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Clopidogrel Bisulfate side effects

See also:
What are the possible side effects of Clopidogrel Bisulfate?

The following serious adverse reactions are discussed below and elsewhere in the labeling:

Bleeding
Thrombotic thrombocytopenic purpura

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions and durations of follow up, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clopidogrel Bisulfate has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for 1 year or more. The clinically important adverse reactions observed in trials comparing Clopidogrel Bisulfate plus aspirin to placebo plus aspirin and trials comparing Clopidogrel Bisulfate alone to aspirin alone are discussed below.

Bleeding

CURE

In CURE, Clopidogrel Bisulfate use with aspirin was associated with an increase in major bleeding (primarily gastrointestinal and at puncture sites) compared to placebo with aspirin. The incidence of intracranial hemorrhage (0.1%) and fatal bleeding (0.2%) were the same in both groups. Other bleeding events that were reported more frequently in the Clopidogrel Bisulfate group were epistaxis, hematuria, and bruise.

The overall incidence of bleeding is described in Table 1.

Table 1: CURE Incidence of Bleeding Complications (% Patients)
*
Other standard therapies were used as appropriate.
Life-threatening and other major bleeding.
Major bleeding event rate for Clopidogrel Bisulfate + aspirin was dose-dependent on aspirin: < 100mg = 2.6%; 100 mg to 200 mg = 3.5%; >200 mg = 4.9%

Major bleeding event rates for Clopidogrel Bisulfate + aspirin by age were: <65 years = 2.5%,≥ 65 to <75 years = 4.1%, ≥75 years = 5.9%

§
Major bleeding event rate for placebo + aspirin was dose-dependent on aspirin: <100 mg = 2.0%; 100 mg to 200 mg = 2.3%; >200 mg = 4.0%

Major bleeding event rates for placebo + aspirin by age were: <65 years = 2.1%, ≥65 to <75 years = 3.1%, ≥75 years = 3.6%

Led to interruption of study medication

Event

Clopidogrel Bisulfate

(+ aspirin)*

(n=6259)

Placebo

(+ aspirin)*

(n=6303)

Major Bleeding†

3.7‡

2.7§

Life-threatening bleeding

2.2

1.8

Fatal

0.2

0.2

5 g/dL hemoglobin drop

0.9

0.9

Requiring surgical intervention

0.7

0.7

Hemorrhagic strokes

0.1

0.1

Requiring inotropes

0.5

0.5

Requiring transfusion (≥4 units)

1.2

1.0

Other major bleeding

1.6

1.0

Significantly disabling

0.4

0.3

Intraocular bleeding with significant loss of vision

0.05

0.03

Requiring 2-3 units of blood

1.3

0.9

Minor bleeding¶

5.1

2.4

Ninety-two percent (92%) of the patients in the CURE study received heparin or low molecular weight heparin (LMWH), and the rate of bleeding in these patients was similar to the overall results.

COMMIT

In COMMIT, similar rates of major bleeding were observed in the Clopidogrel Bisulfate and placebo groups, both of which also received aspirin.

Table 2: Incidence of Bleeding Events in COMMIT (% Patients)

Type of bleeding

Clopidogrel Bisulfate

(+ aspirin)

(n=22,961)

Placebo

(+ aspirin)

(n=22,891)

p-value

Major* noncerebral or cerebral bleeding**

0.6

0.5

0.59

Major noncerebral

0.4

0.3

0.48

Fatal

0.2

0.2

0.90

Hemorrhagic stroke

0.2

0.2

0.91

Fatal

0.2

0.2

0.81

Other noncerebral bleeding (non-major)

3.6

3.1

0.005

Any noncerebral bleeding

3.9

3.4

0.004

* Major bleeds were cerebral bleeds or non-cerebral bleeds thought to have caused death or that required transfusion.

** The relative rate of major noncerebral or cerebral bleeding was independent of age. Event rates for Clopidogrel Bisulfate + aspirin by age were: <60 years = 0.3%, ≥60 to <70 years = 0.7%,≥ 70 years = 0.8%. Event rates for placebo + aspirin by age were: <60 years = 0.4%, ≥60 to <70 years = 0.6%, ≥70 years = 0.7%.

CAPRIE (Clopidogrel Bisulfate vs. Aspirin)

In CAPRIE, gastrointestinal hemorrhage occurred at a rate of 2.0% in those taking Clopidogrel Bisulfate vs. 2.7% in those taking aspirin; bleeding requiring hospitalization occurred in 0.7% and 1.1%, respectively. The incidence of intracranial hemorrhage was 0.4% for Clopidogrel Bisulfate compared to 0.5% for aspirin.

Other bleeding events that were reported more frequently in the Clopidogrel Bisulfate group were epistaxis and hematoma.

Other Adverse Events

In CURE and CHARISMA, which compared Clopidogrel Bisulfate plus aspirin to aspirin alone, there was no difference in the rate of adverse events (other than bleeding) between Clopidogrel Bisulfate and placebo.

In CAPRIE, which compared Clopidogrel Bisulfate to aspirin, pruritus was more frequently reported in those taking Clopidogrel Bisulfate. No other difference in the rate of adverse events (other than bleeding) was reported.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Clopidogrel Bisulfate. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura (TTP), acquired hemophilia A
Eye disorders: Eye (conjunctival, ocular, retinal) bleeding
Gastrointestinal disorders: Gastrointestinal and retroperitoneal hemorrhage with fatal outcome, colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea
General disorders and administration site condition: Fever, hemorrhage of operative wound
Hepato-biliary disorders: Acute liver failure, hepatitis (non-infectious), abnormal liver function test
Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness
Musculoskeletal, connective tissue and bone disorders: Musculoskeletal bleeding, myalgia, arthralgia, arthritis
Nervous system disorders: Taste disorders, fatal intracranial bleeding, headache
Psychiatric disorders: Confusion, hallucinations
Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, respiratory tract bleeding, eosinophilic pneumonia
Renal and urinary disorders: Increased creatinine levels
Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome,acute generalized exanthematous pustulosis (AGEP), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), erythema multiforme, skin bleeding, lichen planus, generalized pruritus
Vascular disorders: Vasculitis, hypotension

Clopidogrel Bisulfate contraindications

See also:
What is the most important information I should know about Clopidogrel Bisulfate?

Active Bleeding

Clopidogrel Bisulfate is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Hypersensitivity

Clopidogrel Bisulfate is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to Clopidogrel Bisulfate or any component of the product.

Active ingredient matches for Clopidogrel Bisulfate:

Clopidogrel Bisulfate


Unit description / dosage (Manufacturer)Price, USD
100 tablet in 1 blister pack
1000 tablet in 1 bottle
30 tablet in 1 bottle
90 tablet in 1 bottle
Clopidogrel Bisulfate tablet, film coated 300 mg/1 (Dr.Reddy's Laboratories Limited (US))
Clopidogrel Bisulfate tablet 75 mg/1 (REMEDYREPACK INC. (US))
Clopidogrel Bisulfate tablet, film coated 75 mg/1 (Carilion Materials Management (US))

List of Clopidogrel Bisulfate substitutes (brand and generic names):

Amnigrel 75 mg x 2 Blister x 10 Tablet
Bio-Clopi 75 mg x 1 Blister x 10 Tablet
Clomex 75 mg x 100's
Tablet; Oral; Clopidogrel Bisulfate 75 mg (Bristol myers squibb)
Tablet; Oral; Clopidogrel 75 mg (Bristol myers squibb)
Plavix 300 mg tablet (Bristol myers squibb)$ 24.86
Plavix 75 mg tablet (Bristol myers squibb)$ 9.23
Clopidogrel / C.Y.H 75 mg x 1000's (Bristol myers squibb)
Clopidogrel / Winthrop 75 mg x 1000's (Bristol myers squibb)
CLOPIDOGREL 75MG TABLET 1 strip / 10 tablets each (Bristol myers squibb)$ 0.62
Clopidogrel tablet 75 mg (Bristol myers squibb)
Clopidogrel tablet, film coated 75 mg/1 (Bristol myers squibb)
Clopidogrel tablet, film coated 300 mg/1 (Bristol myers squibb)
Clopidogrel tablet 75 mg/1 (Bristol myers squibb)
Clopidogrel tablet 300 mg/1 (Bristol myers squibb)
Clopidogrel TV Pharm 75 mg x 3 Blister x 10 Tablet
Cloptaz 75 mg x 1 Blister x 10 Tablet
Dinclop FC tab 75 mg 100's (Interphil)
Fladox 75 mg x 3 Blister x 10 Tablet
Nasiflu-GW 75 mg x 2 Blister x 10 Tablet
Neoclopid FC tab 75 mg 100's (GXI)$ 0.27
Noclot 75 75 mg x 2 Blister x 10 Tablet
Pedolip FC tab 75 mg 3 x 10's (Healthcare Pharma)
Pidolap 75 mg x 3 Blister x 10 Tablet
Plavix film-coated tab 75 mg 14's (sanofi-aventis)
Progrel 75 mg x 1000's
PROGREL 75 MG TABLET 1 strip / 10 tablets each (Apostle Remedies)$ 0.41
Progrel 75mg Tablet (Apostle Remedies)$ 0.04
RiteMED Clopidogrel FC tab 75 mg 50's (RiteMED)
Syclopid 75 mg x 100's
Tevoral 75 mg x 3 Blister x 10 Tablet
Wintofen 75 mg x 3 Blister x 10 Tablet

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