Ticlopidine

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Ticlopidine 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. Ticlopidine 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.

Ticlopidine is part of the drug class:

• Platelet aggregation inhibitors excl. heparin

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.

Taking ticlopidine with certain other drugs can increase your risk of bleeding. Tell your doctor about all your current medicines and any you start or stop using, especially:

• any other medicines to treat or prevent blood clots, including heparin or warfarin (Coumadin, Jantoven); or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Tell your doctor about all other medications you use, especially:

• antacids or cimetidine (Tagamet);

• phenytoin; or

• theophylline.

This list is not complete. Other drugs may interact with ticlopidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In the U.S.

• Ticlid

Available Dosage Forms:

• Tablet

Therapeutic Class: Platelet Aggregation Inhibitor

Pharmacologic Class: ADP-Induced Aggregation Inhibitor

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Pinpoint red spots on the skin.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very bad headache.
• Dark urine or yellow skin or eyes.
• Feeling very tired or weak.
• Pale skin.
• Seizures.
• Change in eyesight.
• Not able to pass urine or change in how much urine is passed.
• Very loose stools (diarrhea).
• Very bad belly pain or bloody loose stools.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Ticlopidine hydrochloride is a platelet aggregation inhibitor. Chemically it is 5-[(2-chlorophenyl)methyl]-4,5,6,7-tetrahydrothieno [3,2-c] pyridine hydrochloride. The structural formula is:

Ticlopidine hydrochloride is a white crystalline solid. It is freely soluble in water and self-buffers to a pH of 3.6. It also dissolves freely in methanol, is sparingly soluble in methylene chloride and ethanol, slightly soluble in acetone and insoluble in a buffer solution of pH 6.3. It has a molecular weight of 300.25.

Ticlopidine HCl Tablets, USP for oral administration are provided as white to off-white, oval, unscored, film coated, imprinted tablets containing 250 mg of Ticlopidine Hydrochloride. Each tablet also contains croscarmellose sodium, microcrystalline cellulose and stearic acid as inactive ingredients. The white film coating contains hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide.

The use of Ticlopidine hydrochloride is contraindicated in the following conditions:

• Hypersensitivity to the drug
• Presence of hematopoietic disorders such as neutropenia and thrombocytopenia or a past history of either TTP or aplastic anemia
• Presence of a hemostatic disorder or active pathological bleeding (such as bleeding peptic ulcer or intracranial bleeding)
• Patients with severe liver impairment

• Antiplatelet Agent
• Antiplatelet Agent, Thienopyridine

Platelet aggregation inhibitor that reduces the risk of thrombotic stroke in patients who have had a stroke or stroke precursors (Note: Due to its association with life-threatening hematologic disorders, ticlopidine should be reserved for patients who are intolerant to aspirin, or who have failed aspirin therapy); adjunctive therapy (with aspirin) following successful coronary stent implantation to reduce the incidence of subacute stent thrombosis.

No dosage adjustment provided in manufacturer’s labeling. Use with caution. Use is contraindicated in severe hepatic impairment.

Should be taken with food to reduce stomach upset.

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

Among 2048 patients in clinical trials, 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).

One case of 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 1 case in every 2000 to 4000 patients exposed.

Aplastic anemia was not seen during clinical trials in stroke patients, 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 1 case in every 4000 to 8000 patients exposed.

Severe hematologic 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 treatment.

Hematological adverse reactions cannot be reliably predicted by any identified demographic or clinical characteristics. During the first 3 months of treatment, patients receiving ticlopidine HCl must, therefore, be hematologically and clinically monitored for evidence of neutropenia or TTP. If any such evidence is seen, ticlopidine HCl should be immediately discontinued.

Commonly reported side effects of ticlopidine include: diarrhea. Other side effects include: dyspepsia, nausea, skin rash, and increased serum alkaline phosphatase. See below for a comprehensive list of adverse effects.

Applies to ticlopidine: oral tablet

Along with its needed effects, ticlopidine 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 while taking ticlopidine:

• 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

Check with your doctor as soon as possible if any of the following side effects occur while taking ticlopidine:

• Skin rash

• General feeling of discomfort or illness
• hives or itching of skin
• ringing or buzzing in ears

Some side effects of ticlopidine 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:

• Abdominal or stomach pain (mild)
• diarrhea
• indigestion
• nausea

• Bloating or gas
• dizziness
• vomiting