Clopidogrel

What is Clopidogrel?

Clopidogrel (Plavix) is a P2Y12 platelet inhibitor, used to treat people who have any of the following:

• chest pain due to heart problems
• poor circulation in their legs (peripheral arterial disease)
• a heart attack
• a stroke

• Clopidogrel tablets are used alone or with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clot that can lead to death.

Clopidogrel structure

Clopidogrel activation

Clopidogrel skeletal formula

Clopidogrel 3D

What are the uses of this medicine?

• Clopidogrel (Plavix) is used 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 (Plavix) is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically.
• Clopidogrel tablets are used alone or with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clot that can lead to death.
• Clopidogrel is also used to prevent serious or life-threatening problems with the heart and blood vessels in people who have peripheral arterial disease.

• Platelets are blood cells that help your blood clot normally. Clopidogrel tablets help to prevent platelets from sticking together and forming a clot that can block an artery.

How does this medicine work?

• Clopidogrel (kloe pid' oh grel) is an inhibitor of adenosine diphosphate (ADP)-induced platelet aggregation and is used widely to decrease the risk of myocardial infarction and stoke in patients who have documented coronary or cerebrovascular disease or previous heart attack or stroke.
• Activated platelets release ADP which binds to platelet receptors, causing activation of intracellular glycoprotein IIb/IIIA complex which triggers platelet adherence and aggregation.
• The aggregation of platelets plays an important role in the growth of atheromatous plaques, which can lead to coronary, cerebral and peripheral arterial occlusions.
• In large clinical trials, clopidogrel therapy has been shown to decrease the frequency of recurrence of myocardial infarction and stroke.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• currently have a condition that causes bleeding, such as a stomach ulcer.
• are allergic to clopidogrel or other ingredients in clopidogrel tablets.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• [[]]aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), and naproxen (Aleve, Naprosyn)
• cilostazol
• esomeprazole (Nexium)
• etravirine (Intelence)
• omeprazole (Prilosec, Prilosec OTC, Zegerid)
• certain opiate medications for cough such as codeine (in Triacin-C, in Tuzistra XR, others) or hydrocodone (Hycodan, Tussicaps) or for pain such as codeine (in Fioricet, in Trezix), fentanyl (Actiq, Duragesic, Subsys, others), hydrocodone (Hysingla, Zohydro, in Anexsia, in Norco), meperidine (Demerol), morphine (Duramorph, Kadian), or oxycodone (in Percocet, in Roxicet, others)
• repaglinide (Prandin, in Prandimet)
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft);
• selective serotonin/norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), sibutramine (no longer available in the U.S.; Meridia), and venlafaxine (Effexor)

Is this medicine FDA approved?

• Clopidogrel was approved for use in the United States in 1997 and is widely used, with more than 1.5 million prescriptions filled yearly.

How should this medicine be used?

Recommended dosage:

For Acute coronary syndrome:

• In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300-mg oral loading dose and then continue at 75 mg once daily.

For Recent MI, Recent Stroke, or Established Peripheral Arterial Disease:

• 75 mg once daily orally without a loading dose.

Administration:

• Clopidogrel comes as a tablet to take by mouth.
• Take clopidogrel tablets exactly as your doctor tells you.
• Do not change your dose or stop taking clopidogrel tablets without talking to your doctor first. Stopping clopidogrel tablets may increase your risk of heart attack or stroke.
• Take clopidogrel tablets with aspirin as instructed by your doctor.
• If you miss a dose, take clopidogrel tablets as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take the next dose at your regular time. Do not take 2 doses of clopidogrel tablets at the same time unless your doctor tells you to.
• If you take too much clopidogrel tablets, call your doctor or go to the nearest emergency room right away.
• Talk with your doctor about stopping your clopidogrel tablets before you have surgery. Your doctor may tell you to stop taking clopidogrel tablets at least 5 days before you have surgery to avoid excessive bleeding during surgery.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 75 mg, 300 mg

This medicine is available in fallowing brand namesː

• Plavix

What side effects can this medication cause?

The most common side effects of this medicine include:

• purplish spots (called purpura) on the skin or in the mouth (mucous membranes) due to bleeding under the skin
• your skin or the whites of your eyes are yellow (jaundice)
• you feel tired or weak
• your skin looks very pale
• fever
• fast heart rate or feeling short of breath
• headache
• speech changes
• confusion
• low amount of urine, or urine that is pink or has blood in it
• stomach area (abdominal) pain
• nausea, vomiting, or diarrhea
• vision changes

Clopidogrel tablets can cause serious side effects including:

• bleeding which can be serious and can sometimes lead to death
• Thrombotic Thrombocytopenic Purpura (TTP)
• coma
• stroke
• seizure

What special precautions should I follow?

• Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by genetic variations in CYP2C19. Avoid concomitant use of clopidogrel with omeprazole or esomeprazole because both significantly reduce the antiplatelet activity of clopidogrel.
• Thienopyridines, including clopidogrel, increase the risk of bleeding.
• Advise patients that they:
• will bruise and bleed more easily
• will take longer than usual to stop bleeding.
• must report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine.
• Discontinuation of clopidogrel increases the risk of cardiovascular events. If clopidogrel must be temporarily discontinued (e.g., to treat bleeding or for surgery with a major risk of bleeding), restart it as soon as possible. When possible, interrupt therapy with clopidogrel for five days prior to such surgery. Resume clopidogrel as soon as hemostasis is achieved.
• Thrombotic thrombocytopenic purpura (TTP) has been reported. Instruct patients to get prompt medical attention if they experience symptoms of TTP that cannot otherwise be explained.
• Advise patients to inform physicians and dentists that they are taking clopdiogrel before any surgery or dental procedure
• Advise patients not to take omeprazole or esomeprazole while taking clopidogrel. Dexlansoprazole, lansoprazole and pantoprazole had less pronounced effects on the antiplatelet activity of clopidogrel than did omeprazole or esomeprazole
• Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving clopidogrel, including patients with a history of hypersensitivity or hematologic reaction to other thienopyridines.
• It is not known if clopidogrel passes into your breast milk. A decision should be made with your healthcare provider to avoid or discontinue breastfeeding when continuing clopidogrel is needed.
• Clopidogrel has been linked to rare instances of idiosyncratic, clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Platelet inhibition by clopidogrel is irreversible and will last for the life of the platelet. Overdose following clopidogrel administration may result in bleeding complications.
• Symptoms of acute toxicity were vomiting, prostration, difficult breathing, and gastrointestinal hemorrhage.

Management of overdosage:

• Based on biological plausibility, platelet transfusion may restore clotting ability.

Can this medicine be used in pregnancy?

• It is not known if clopidogrel tablets will harm your unborn baby.
• 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.

Can this medicine be used in children?

• Safety and effectiveness in pediatric populations have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• clopidogrel bisulfate, USP

Inactive ingredients:

• Tablet: microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil.
• Film coating: Hypromellose, titanium dioxide, polyethylene glycol and red iron oxide.

Who manufactures and distributes this medicine?

Manufactured for:

• Vensun Pharmaceuticals, Inc.
• Yardley, PA

Manufactured by:

• ScieGen Pharmaceuticals, Inc.
• Hauppauge, NY USA

What should I know about storage and disposal of this medication?

• Store clopidogrel tablets at 59°F to 86°F (15°C to 30°C).

• Dailymed label info on Clopidogrel
• FDA Clopidogrel

Clopidogrel Resources
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