Peripheral vascular disease (PVD) refers to diseases of the blood vessels (arteries and veins) located outside the heart and brain. While there are many causes of peripheral vascular disease, doctors commonly use the term peripheral vascular disease to refer to peripheral artery disease (peripheral arterial disease, PAD), a condition that develops when the arteries that supply blood to the internal organs, arms, and legs become completely or partially blocked as a result of atherosclerosis.
Atherosclerosis is a gradual process whereby hard cholesterol substances (plaques) are deposited in the walls of the arteries. Cholesterol plaques cause hardening of the artery walls and narrowing of the inner channel (lumen) of the artery. The atherosclerosis process begins early in life (as early as teens in some people). When atherosclerosis is mild an...
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TICLID®
(ticlopidine hydrochloride) Tablets
TICLID (ticlopidine hcl) 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 ticlopidine-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 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 one case in every 4000 to 8000 patients exposed.
Monitoring of Clinical and Hematologic 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 (ticlopidine hcl) must, therefore, be hematologically and clinically monitored for evidence of neutropenia or TTP. If any such evidence is seen, TICLID (ticlopidine hcl) should be immediately discontinued.
The detection and treatment of ticlopidine-associated hematological adverse reactions are further described under WARNINGS.
TICLID (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:
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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.
TICLID (ticlopidine hcl) tablets for oral administration are provided as white, oval, film-coated, blue-imprinted tablets containing 250 mg of ticlopidine hydrochloride. Each tablet also contains citric acid, magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid as inactive ingredients. The white film-coating contains hydroxypropylmethyl cellulose, polyethylene glycol and titanium dioxide. Each tablet is printed with blue ink, which includes FD&C Blue #1 aluminum lake as the colorant. The tablets are identified with Ticlid (ticlopidine hcl) on one side and 250 on the reverse side.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using ticlopidine and call your doctor at once if you have a serious side effect such as:
Read All Potential Side Effects and See Pictures of Ticlid »
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood or immune disorders (thrombotic thrombocytopenic purpura, aplastic anemia, agranulocytosis, neutropenia), serious/active bleeding (e.g., bleeding stomach ulcers), severe liver disease.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver or kidney problems, bleeding/blood clotting disorders,...
Last reviewed on RxList: 6/10/2008
This monograph has been modified to include the generic and brand name in many instances.
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