Ticlid

Ticlopidine also is used before open heart surgery and in the treatment of sickle cell disease, certain types of kidney disease (primary glomerulonephritis), and blocked arteries in the legs. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Common side effects of ticlopidine include:

• diarrhea,
• nausea,
• rash,
• stomach upset, and
• vomiting.

Ticlopidine has been associated with a severe reduction in white blood cell count. Ticlopidine also causes a condition called thrombotic thrombocytopenic purpura (TTP). TTP is a serious condition in which blood clots form throughout the body. Blood platelets, which participate in clotting, are consumed, and the result can be bleeding because enough platelets are no longer left to allow blood to clot normally.

Tablets: 250 mg

Ticlopidine should be stored at room temperature, 15 to 30 C (59 to 86 F).

Ticlid is a prescription medication used to reduce the risk of stroke in people who have had a stroke or have had warning signs of a stroke. Ticlid is also used along with aspirin to prevent blood clots from forming in stents placed in the heart. Ticlid belongs to a class of drugs called antiplatelets. These work by preventing platelets (a type of blood cell) from collecting and forming clots.

This medication comes in tablet form and is typically taken 2 times a day, with food.

Common side effects of Ticlid include nausea, diarrhea, upset stomach, rash, and stomach pain.

Ticlid is a prescription medication used to reduce the risk of stroke in people who have had a stroke or have had warning signs of a stroke. Ticlid is also used along with aspirin to prevent blood clots from forming in stents placed in the heart.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ticlid, there are no specific foods that you must exclude from your diet when receiving this medication.

Take Ticlid with food or just after eating in order to minimize gastrointestinal discomfort.

If you take too much Ticlid, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Ticlid can cause life-threatening hematological adverse reactions, including neutropenia/agranulocytosis, thrombotic thrombocytopenic purpura (TTP) and aplastic anemia.

Neutropenia/Agranulocytosis

Among 2048 patients in clinical trials in stroke patients, there were 50 cases (2.4%) of neutropenia (less than 1200 neutrophils/mm3), and the neutrophil count was below 450/mm3 in 17 of these patients (0.8% of the total population).

TTP

One case of thrombotic thrombocytopenic purpura was reported during clinical trials in stroke patients. 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 Ticlid-associated TTP may be as high as one case in every 2000 to 4000 patients exposed.

Aplastic Anemia

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 Ticlid-associated aplastic anemia may be as high as one case in every 4000 to 8000 patients exposed.

Monitoring of Clinical and Hematological Status

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 Ticlid must, therefore, be hematologically and clinically monitored for evidence of neutropenia or TTP. If any such evidence is seen, Ticlid should be immediately discontinued.

Ticlopidine helps to prevent platelets in your blood from sticking together and forming a blood clot. An unwanted blood clot can occur with certain heart or blood vessel conditions.

Ticlopidine is used to prevent blood clots after a recent heart attack or stroke, and in people who have had a stent placed in the arteries that supply blood to the heart.

Ticlopidine may also be used for other purposes not listed in this medication guide.

Drugs Metabolized by Hepatic Microsomal Enzymes

Possible increased plasma half-life of concomitantly administered drugs metabolized by hepatic microsomal enzymes; dosage adjustments may be required when initiating or discontinuing ticlopidine therapy.1 71

Specific Drugs

Storage

Oral

15–30°C1 or 20–25°C.71

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.

Ticlid is indicated:

• to reduce the risk of thrombotic stroke (fatal or nonfatal) in patients who have experienced stroke precursors, and in patients who have had a completed thrombotic stroke. Because Ticlid is associated with a risk of life-threatening blood dyscrasias including thrombotic thrombocytopenic purpura (TTP), neutropenia/agranulocytosis and aplastic anemia (see BOXED WARNING and WARNINGS), Ticlid should be reserved for patients who are intolerant or allergic to aspirin therapy or who have failed aspirin therapy.
• as adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation (see CLINICAL TRIALS).