Clopidogrel is a prodrug; requires activation by CYP enzyme system (principally by CYP2C19) to produce its pharmacologically active metabolite.
Genetic variations of CYP2C19 can result in impaired metabolism and reduced effectiveness of clopidogrel. (See Reduced Efficacy Associated with Impaired CYP2C19 Function under Cautions.) Higher rates of major adverse cardiovascular events (e.g., death, MI, stroke) have been reported in poor metabolizers of CYP2C19 receiving clopidogrel at recommended dosages following acute coronary syndrome or PCI compared with those who have normal CYP2C19 function.
Genetic tests are available to determine a patient's CYP2C19 genotype; results of such tests may be used to guide treatment decisions.
Consider use of other antiplatelet agents or alternative dosing strategies for clopidogrel in patients with variant CYP2C19 genotypes.
REMS:
FDA approved a REMS for clopidogrel to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
CLOPIDOGREL (kloh PID oh grel) helps to prevent blood clots. This medicine is used to prevent heart attack, stroke, or other vascular events in people who are at high risk.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of the following conditions:
Take this medicine by mouth with a drink of water. Follow the directions on the prescription label. You may take this medicine with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular check ups. Do not stop taking your medicine unless your doctor tells you to.
If you are going to have surgery or dental work, tell your doctor or health care professional that you are taking this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature of 59 to 86 degrees F (15 to 30 degrees C). Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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