Ticlopidine hydrochloride can cause life-threatening hematological adverse reactions, including neutropenia/agranulocytosis, thrombotic thrombocytopenic purpura (TTP) and aplastic anemia.
Among 2,048 patients in clinical trials, there were 50 cases (2.4%) of neutropenia (less than 1,200 neutrophils/mm(3)), and the neutrophil count was below 450/mm(3) in 17 of these patients (0.8% of the total population).
One case of thrombotic thrombocytopenic purpura (TTP) was reported during clinical trials. Based on postmarketing data, US physicians reported about 100 cases between 1992 and 1997. Based on an estimated patient exposure of 2 million to 4 million, and assuming an event reporting rate of 10% (the true rate is not known), the incidence of ticlopidine-associated TTP may be as high as one case in every 2,000 to 4,000 patients exposed.
Aplastic anemia was not seen during clinical trials, but US physicians reported about 50 cases between 1992 and 1998. Based on an estimated patient exposure of 2 million to 4 million, and assuming an event reporting rate of 10% (the true rate is not known), the incidence of ticlopidine-associated aplastic anemia may be as high as one case in every 4,000 to 8,000 patients exposed.
Severe hematological adverse reactions may occur within a few days of the start of therapy. The incidence of TTP peaks after about 3 to 4 weeks of therapy and neutropenia peaks at approximately 4 to 6 weeks. The incidence of aplastic anemia peaks after about 4 to 8 weeks of therapy. The incidence of the hematologic adverse reactions declines thereafter. Only a few cases of neutropenia, TTP, or aplastic anemia have arisen after more than 3 months of therapy.
Hematological adverse reactions cannot be reliably predicted by any identified demographic or clinical characteristics. During the first 3 months of treatment, patients receiving ticlopidine hydrochloride must, therefore, be hematologically and clinically monitored for evidence of neutropenia or TTP. If any such evidence is seen, ticlopidine hydrochloride should be immediately discontinued .
Can cause life-threatening hematological adverse reactions, including neutropenia/agranulocytosis, thrombotic thrombocytopenic purpura (TTP) and aplastic anemia. Hematological adverse reactions cannot be reliably predicted by any identified demographic or clinical characteristics. During the first 3 months of treatment, patients receiving ticlopidine must, therefore, be hematologically and clinically monitored for evidence of neutropenia or TTP. If any such evidence is seen, ticlopidine should be immediately discontinued .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Platelet Aggregation Inhibitor
Pharmacologic Class: ADP-Induced Aggregation Inhibitor
Ticlopidine 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.
ticlopidine is available only with a doctor's prescription.
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:
Tell your doctor if you have ever had any unusual or allergic reaction to ticlopidine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
There is no specific information comparing use of ticlopidine in children with use in other age groups.
ticlopidine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using ticlopidine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using ticlopidine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of ticlopidine. Make sure you tell your doctor if you have any other medical problems, especially:
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 ticlopidine 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.
The dose of ticlopidine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ticlopidine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of ticlopidine, 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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
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 ticlopidine. 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 ticlopidine (for example, sports that can cause injuries). Also, check with your doctor immediately if you are injured while being treated with ticlopidine.
Check with your doctor immediately if you notice any of the following side effects:
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
Check with your doctor as soon as possible if any of the following side effects occur:More common
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.