In the U.S.—

In Canada—

• Antithrombotic
• platelet aggregation inhibitor

Ticlopidine (tye-KLOE-pi-deen ) is used to lessen the chance of having a stroke. It is given to people who have already had a stroke and to people with certain medical problems that may lead to a stroke. Because ticlopidine can cause serious side effects, especially during the first 3 months of treatment, it is used mostly for people who cannot take aspirin to prevent strokes.

A stroke may occur when blood flow to the brain is interrupted by a blood clot. Ticlopidine reduces the chance that a harmful blood clot will form, by preventing certain cells in the blood from clumping together. This effect of ticlopidine may also increase the chance of serious bleeding in some people.

This medicine is available only with a doctor's prescription in the following dosage form:

Oral
• Tablets (U.S. and Canada)

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 ticlopidine, the following should be considered:

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

Pregnancy—Studies with ticlopidine have not been done in pregnant women. This medicine did not cause birth defects in animal studies. However, it caused other unwanted effects in animal studies when it was given in amounts that were large enough to cause harmful effects in the mother.

Breast-feeding—It is not known whether ticlopidine passes into the breast milk.

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

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger 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 ticlopidine, it is especially important that your health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners) or
• Aspirin or
• Carbenicillin by injection (e.g., Geopen) or
• Clopidogrel (e.g., Plavix) or
• Dipyridamole (e.g., Persantine) or
• Divalproex (e.g., Depakote) or
• Heparin (e.g., Hepalean, Liquaemin) or
• Inflammation or pain medicine, except narcotics or
• Low molecular weight heparin (ardeparin [e.g., Normiflo], dalteparin [e.g., Fragmin], enoxaparin [e.g., Lovenox], nadroparin [e.g., Fraxiparine]) or
• Pentoxifylline (e.g., Trental) or
• Plicamycin (e.g., Mithracin) or
• Sulfinpyrazone (e.g., Anturane) or
• Ticarcillin (e.g., Ticar) or
• Valproic acid (e.g., Depakene)—The chance of serious bleeding may be increased

• Phenytoin (e.g., Dilantin)—Ticlopidine may increase the amount of phenytoin in the blood and increase the chance of side effects from phenytoin
• Xanthines such as theophylline (e.g. Theo-Dur)—Ticlopidine may slow the elimination of theophylline and increase the chance of side effects from theophylline

• Blood clotting problems, such as hemophilia and von Willebrand's disease, or
• Liver disease (severe) or
• Stomach ulcers—The chance of serious bleeding may be increased

• Blood disease—The chance of serious side effects may be increased

• Kidney disease (severe)—Ticlopidine is removed from the body more slowly when the kidneys are not working properly. This may increase the chance of side effects

Also, tell your doctor if you have ever had a problem called thrombotic thrombocytopenic purpura (TTP). This problem could reoccur if you take ticlopidine.

Ticlopidine should be taken with food. This increases the amount of medicine that is absorbed into the body. It may also lessen the chance of stomach upset.

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

Dosing—

Follow your doctor's orders or the directions on the label. The following dose was used, and found effective, in studies. However, some people may need a different dose. 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 strokes:
    • Adults—1 tablet (250 mg) two times a day, with food.
    • Children—It is not likely that ticlopidine would be used to help prevent strokes in children. If a child needs this medicine, however, the dose would have to be determined by the doctor.
  • For prevention of strokes or heart attack following heart stent procedure:
    • Adults—1 tablet (250 mg) two times a day, with food together with your doctor's recommended dose of aspirin for up to 30 days following the procedure
    • Children—It is not likely that ticlopidine would be used to help prevent strokes or heart attack 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 your 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.

It is very important that blood tests be done before treatment is started with ticlopidine, and repeated every 2 weeks for the first 3 months of treatment with ticlopidine. The tests are needed to find out whether certain side effects are occurring. Finding these side effects early helps to prevent them from becoming serious. Your doctor will arrange for the blood tests to be done. Be sure that you do not miss any appointments for these tests. You will probably not need to have your blood tested so often after the first 3 months of treatment, because the side effects are less likely to occur after that time.

Tell all medical doctors, dentists, nurses, and pharmacists you go to that you are taking this medicine. Ticlopidine may increase the risk of serious bleeding during an operation or some kinds of dental work. Therefore, treatment may have to be stopped about 10 days to 2 weeks before the operation or dental work is done.

Ticlopidine may cause serious bleeding, especially after an injury. Sometimes, bleeding inside the body can occur without your knowing about it. Ask your doctor whether there are certain activities you should avoid while taking this medicine (for example, sports that can cause injuries). Also, check with your doctor immediately if you are injured while being treated with this medicine.

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

• Bruising or bleeding, especially bleeding that is hard to stop. Bleeding inside the body sometimes appears as bloody or black, tarry stools, or faintness. Also, bleeding may occur from the gums when brushing or flossing teeth.
• Any sign of infection, such as fever, chills, or sore throat.
• Sores, ulcers, or white spots in the mouth.
• Dark or bloody urine, difficulty in speaking, fever, pale color of skin, pinpoint red spots on skin, convulsions (seizures), weakness, or yellow eyes or skin.

After you stop taking ticlopidine, the chance of bleeding may continue for 1 or 2 weeks. During this period of time, continue to follow the same precautions that you followed while you were taking the 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:

• Less common or rare
  • Abdominal or stomach pain (severe) or swelling;  back pain;  blistering, peeling, or loosening of the skin or lips or mucous membranes (moist lining of many body cavities, including the mouth, lips, inside of nose, anus, and vagina);  blood in eyes;  bloody or black tarry stools;  bruising or purple areas on skin;  change in mental status;  convulsions (seizures);  coughing up blood;  dark or bloody urine;  decreased alertness;  dizziness;  fever, chills, or sore throat ;  headache (severe or continuing);  joint pain or swelling;  nosebleeds;  pale color of skin;  paralysis or problems with coordination;  pinpoint red spots on skin;  red lesions on the skin, often with a purple center;  red, thickened, or scaly skin;  sores, ulcers, or white spots in mouth;  stammering or other difficulty in speaking;  unusually heavy bleeding or oozing from cuts or wounds;  unusual tiredness ;  unusually heavy or unexpected menstrual bleeding ;  vomiting of blood or material that looks like coffee grounds;  weakness;  yellow eyes or skin 
  
  

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

• More common
  • Skin rash 
  
  

• Less common or rare
  • General feeling of discomfort or illness;  hives or itching of skin;  ringing or buzzing in ears  
  
  

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);  diarrhea ;  indigestion;  nausea 
  
  

• Less common
  • Bloating or gas;  dizziness;  vomiting 
  
  

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