Drug monograph for the active ingredient in Plavix

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

CLOPIDOGREL (Systemic)

Some commonly used brand names are:

In the U.S.—

• Plavix

Category

• Antithrombotic
• platelet aggregation inhibitor

Description

Clopidogrel (kloh-PID-oh-grel) is used to lessen the chance of heart attack or stroke. It is given to people who have already had a heart attack or stroke or to people with other blood circulation problems that could lead to a stroke or heart attack.

A heart attack or stroke may occur when a blood vessel in the heart or brain is blocked by a blood clot. Clopidogrel reduces the chance that a harmful blood clot will form by preventing certain cells in the blood from clumping together. This effect of clopidogrel may also increase the chance of serious bleeding in some people.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For clopidogrel, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to clopidogrel. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies with clopidogrel have not been done in pregnant women. This medicine did not cause birth defects in animal studies. However, discuss with your doctor whether or not you should take this medicine if you are pregnant.

Breast-feeding—It is not known whether clopidogrel passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—There is no specific information comparing use of clopidogrel in children with use in other age groups.

Older adults—Although blood levels of clopidogrel may be higher in elderly patients than in younger adults, it is not expected to cause different side effects or problems in older people than it does in other adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking clopidogrel, it is especially important that your health care professional know if you are taking any of the following:

• Inflammation or pain medicine, except narcotics—The chance of serious bleeding may be increased

Other medical problems—The presence of other medical problems may affect the use of clopidogrel. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Liver disease (severe) or
• Stomach ulcers—The chance of serious bleeding may be increased

Proper Use of This Medicine

Take this medicine only as directed by your doctor. Clopidogrel will not work properly if you take less of it than directed. Taking more clopidogrel than directed may increase the chance of serious side effects without increasing the helpful effects.

Dosing—The dose of clopidogrel may be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average dose of clopidogrel. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For prevention of heart attacks or strokes:
    • Adults—1 tablet (75 milligrams [mg]) once a day.
    • Children—It is not likely that clopidogrel would be used to help prevent heart attacks or strokes in children. If a child needs this medicine, however, the dose would have to be determined by the doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Tell all medical doctors, dentists, nurses, and pharmacists you go to that you are taking this medicine. Clopidogrel may increase the risk of serious bleeding during an operation or some kinds of dental work. Therefore, treatment may have to be stopped about 7 days before the operation or dental work is done.

Check with your doctor immediately if you notice bruising or bleeding, especially bleeding that is hard to stop. Bleeding inside the body sometimes appears as bloody or black, tarry stools, or faintness.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Red or purple spots on skin, varying in size from pinpoint to large bruises

Less common

Nosebleed; vomiting of blood or material that looks like coffee grounds

Rare

Black, tarry stools; blistering, flaking, or peeling of skin; blood in urine or stools; fever, chills, or sore throat; headache (sudden, severe); stomach pain (severe); ulcers, sores, or white spots in mouth; unusual bleeding or bruising; weakness (sudden)

Also, check with your doctor as soon as possible if any of the following side effects occur:

More common

Chest pain; cough; generalized pain; runny nose; sneezing

Less common

Fainting; frequent urination; irregular heartbeat; joint pain; painful or difficult urination; shortness of breath; swelling of feet or lower legs

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Abdominal or stomach pain (mild); aching muscles; back pain; dizziness; general feeling of discomfort or illness; headache; heartburn

Less common

Anxiety; constipation; diarrhea; itching; leg cramps; mental depression; numbness or tingling; nausea; skin rash; trouble in sleeping; unusual tiredness; vomiting; weakness

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 05/22/1998

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