Ticlid

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.

• Eon Labs, Inc.

Serious side effects have been reported with Ticlid. See "Ticlid Precautions” section.

Common side effects of Ticlid include the following:

• nausea
• diarrhea
• upset stomach
• rash
• stomach pain
• purple-colored spots and patches that form on the skin
• vomiting
• gas
• itching
• loss of weight due to loss of appetite
• dizziness

This is not a complete list of Ticlid side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Aspirin and other NSAIDs
• Antacids
• Tagamet (cimetidine)
• Digoxin
• Theophylline
• Phenobarbital
• Phenytoin
• Propranolol

This is not a complete list of Ticlid drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Ticlid including the following: 

• Decrease in white blood cells (neutropenia). This can happen especially during the first 3 months of treatment. If white blood cells get very low, this can result in an increased risk for infection. Your doctor will monitor your blood cell counts. Tell your healthcare provider immediately if you have fever, chills, sore throat, or other signs of infection.
• Decrease in platelets (thrombocytopenia). This can happen especially during the first 3 months of treatment. Your doctor will monitor your blood cell counts. This may occur as part of a syndrome that includes injury to red blood cells, causing anemia, kidney abnormalities, neurologic changes and fever. This condition is called TTP and can be fatal. Tell your healthcare provider immediately if you notice yellow skin or eye color, pinpoint dots (rash) on the skin, pale color, fever, weakness on a side of the body, or dark urine.
  • To make sure you don't develop either of these problems, your doctor will arrange for you to have your blood tested before you start taking Ticlid and then every 2 weeks for the first 3 months you are on Ticlid. If detected, neutropenia and thrombocytopenia can almost always be reversed. It is essential that you keep your appointments for the blood tests and that you call your doctor immediately if you have any indication that you may have TTP or neutropenia. If you stop taking Ticlid for any reason within the first 3 months, you will still need to have your blood tested for an additional 2 weeks after you have stopped taking Ticlid.
• Unusual bleeding or bruising. Tell your healthcare provider if you have unusual bleeding or bruising. Tell your healthcare providers including dentists you are taking Ticlid before any surgery is scheduled. Your doctor may tell you to stop taking Ticlild 10 to 14 days before your procedure.
• Jaundice. Tell your healthcare provider if you notice yellow skin or sclera, dark urine, or light-colored stools.

Report side effects of Ticlid such as severe or persistent diarrhea, skin rashes or subcutaneous bleeding. 

Do not take Ticlid if:

• you have an allergic reaction to ticlopidine
• you have a blood disorder or a serious bleeding problem, such as a bleeding stomach ulcer
• you have previously been told you had TTP or aplastic anemia
• you have severe liver disease or other liver problems
• you are pregnant or you are planning to become pregnant
• you are breastfeeding

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.

Before taking Ticlild, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to ticlopidine or to any of its ingredients
• have or have ever had liver disease, bleeding disorders, bleeding ulcers, low blood cell counts (neutropenia, thrombocytopenia, anemia, TTP), kidney disease, high blood cholesterol, or high blood fats (triglycerides).
• having surgery, including dental surgery, tell the doctor or dentist that you are taking Ticlild. Your doctor may tell you to stop taking Ticlild 10 to 14 days before your procedure. 
• you are pregnant or you are planning to become pregnant
• you are breastfeeding

Talk to your doctor about the risks and benefits of taking Ticlild if you are 65 years of age or older. Older adults should not usually take Ticlild because it is not as safe or effective as other medications that can be used to treat the same condition.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ticlid falls into category B. There are no well-done studies that have been done in humans with Ticlid. In animal studies, pregnant animals were given this medication, and there was no evidence of a teratogenic potential of Ticlid. Because animal reproduction studies are not always predictive of a human response, this drug should be used during pregnancy only if clearly needed

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Ticlid crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Ticlid.

Take Ticlid exactly as prescribed.

Ticlid comes in a tablet form and is taken twice a day.

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

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends will be based on the condition being treated

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

• Store Ticlid at room temperature.
• Keep this and all medicines out of the reach of children.

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.