Ticlid (Ticlopidine Hcl)
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Ticlid (Ticlopidine Hcl)

TICLID®
(ticlopidine hydrochloride) Tablets

WARNING

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.

DRUG DESCRIPTION

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:

TICLID®  (ticlopidine hydrochloride)   Structural Formula Illustration

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.

What are the possible side effects of ticlopidine (Ticlid)?

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:

  • nosebleed or other bleeding that will not stop;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on...

Read All Potential Side Effects and See Pictures of Ticlid »

What are the precautions when taking ticlopidine hcl (Ticlid)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other thienopyridines (such as clopidogrel); 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...

Read All Potential Precautions of Ticlid »

Last reviewed on RxList: 6/10/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

TICLID (ticlopidine hcl) is indicated

DOSAGE AND ADMINISTRATION

Stroke: The recommended dose of TICLID (ticlopidine hcl) is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.

Coronary Artery Stenting: The recommended dose of TICLID (ticlopidine hcl) is 250 mg bid taken with food together with antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation.

HOW SUPPLIED

TICLID (ticlopidine hcl) is available in white, oval, film-coated 250-mg tablets, printed in blue with Ticlid (ticlopidine hcl) on one side and 250 on the other. They are provided in unit of use bottles of 30 tablets (NDC 0004-0018-23) and 60 tablets (NDC 0004-0018-22) and 500 tablets (NDC 0004-0018-14).

Store at 15° to 30°C (59°to 86°F)

Distributed by: Roche Pharmaceuticals, Roche Laboratories Inc., 340 Kingsland Street, Nutley, New Jersey 07110-1199. Revised: March 2001. FDA revision date: 4/18/2001

Last reviewed on RxList: 6/10/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Adverse reactions in stroke patients were relatively frequent with over 50% of patients reporting at least one. Most (30% to 40%) involved the gastrointestinal tract. Most adverse effects are mild, but 21% of patients discontinued therapy because of an adverse event, principally diarrhea, rash, nausea, vomiting, GI pain and neutropenia. Most adverse effects occur early in the course of treatment, but a new onset of adverse effects can occur after several months.

The incidence rates of adverse events listed in the following table were derived from multicenter, controlled clinical trials in stroke patients described above comparing TICLID (ticlopidine hcl) , placebo and aspirin over study periods of up to 5.8 years. Adverse events considered by the investigator to be probably drug-related that occurred in at least 1% of patients treated with TICLID (ticlopidine hcl) are shown in the following table:

Percent of Patients With Adverse Events in Controlled Studies (TASS and CATS)

Event TICLID (ticlopidine hcl)
(n = 2048)
Incidence
Aspirin
(n = 1527)
Incidence
Placebo
(n = 536)
Incidence
Any Events 60.0 (20.9) 53.2 (14.5) 34.3 (6.1)
Diarrhea 12.5 (6.3) 5.2 (1.8) 4.5 (1.7)
Nausea 7.0 (2.6) 6.2 (1.9) 1.7 (0.9)
Dyspepsia 7.0 (1.1) 9.0 (2.0) 0.9 (0.2)
Rash 5.1 (3.4) 1.5 (0.8) 0.6 (0.9)
GI Pain 3.7 (1.9) 5.6 (2.7) 1.3 (0.4)
Neutropenia 2.4 (1.3) 0.8 (0.1) 1.1 (0.4)
Purpura 2.2 (0.2) 1.6 (0.1) 0.0 (0.0)
Vomiting 1.9 (1.4) 1.4 (0.9) 0.9 (0.4)
Flatulence 1.5 (0.1) 1.4 (0.3) 0.0 (0.0)
Pruritus 1.3 (0.8) 0.3 (0.1) 0.0 (0.0)
Dizziness 1.1 (0.4) 0.5 (0.4) 0.0 (0.0)
Anorexia 1.0 (0.4) 0.5 (0.3) 0.0 (0.0)
Abnormal Liver Function Test 1.0 (0.7) 0.3 (0.3) 0.0 (0.0)

Incidence of discontinuation, regardless of relationship to therapy, is shown in parentheses.

Hematological: Neutropenia/thrombocytopenia, TTP, aplastic anemia (see BOXED WARNING and WARNINGS), leukemia, agranulocytosis, eosinophilia, pancytopenia, thrombocytosis and bone-marrow depression have been reported.

Gastrointestinal: TICLID (ticlopidine hcl) therapy has been associated with a variety of gastrointestinal complaints including diarrhea and nausea. The majority of cases are mild, but about 13% of patients discontinued therapy because of these. They usually occur within 3 months of initiation of therapy and typically are resolved within 1 to 2 weeks without discontinuation of therapy. If the effect is severe or persistent, therapy should be discontinued. In some cases of severe or bloody diarrhea, colitis was later diagnosed.

Hemorrhagic: TICLID (ticlopidine hcl) has been associated with increased bleeding, spontaneous posttraumatic bleeding and perioperative bleeding including, but not limited to, gastrointestinal bleeding. It has also been associated with a number of bleeding complications such as ecchymosis, epistaxis, hematuria and conjunctival hemorrhage.

Intracerebral bleeding was rare in clinical trials in stroke patients with TICLID (ticlopidine hcl) , with an incidence no greater than that seen with comparator agents (ticlopidine 0.5%, aspirin 0.6%, placebo 0.75%). It has also been reported postmarketing.

Rash: Ticlopidine has been associated with a maculopapular or urticarial rash (often with pruritus). Rash usually occurs within 3 months of initiation of therapy with a mean onset time of 11 days. If drug is discontinued, recovery occurs within several days. Many rashes do not recur on drug rechallenge. There have been rare reports of severe rashes, including Stevens-Johnson syndrome, erythema multiforme and exfoliative dermatitis.

Less Frequent Adverse Reactions (Probably Related): Clinical adverse experiences occurring in 0.5% to 1.0% of stroke patients in controlled trials include: Digestive System: GI fullness

Skin and Appendages: urticaria

Nervous System: headache

Body as a Whole: asthenia, pain

Hemostatic System: epistaxis

Special Senses: tinnitus

In addition, rarer, relatively serious and potentially fatal events associated with the use of TICLID (ticlopidine hcl) have also been reported from postmarketing experience: Hemolytic anemia with reticulocytosis, immune thrombocytopenia, hepatitis, hepatocellular jaundice, cholestatic jaundice, hepatic necrosis, hepatic failure, peptic ulcer, renal failure, nephrotic syndrome, hyponatremia, vasculitis, sepsis, allergic reactions (including angioedema, allergic pneumonitis, and anaphylaxis), systemic lupus (positive ANA), peripheral neuropathy, serum sickness, arthropathy and myositis.

Read the Ticlid (ticlopidine hcl) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Therapeutic doses of TICLID (ticlopidine hcl) caused a 30% increase in the plasma half-life of antipyrine and may cause analogous effects on similarly metabolized drugs. Therefore, the dose of drugs metabolized by hepatic microsomal enzymes with low therapeutic ratios or being given to patients with hepatic impairment may require adjustment to maintain optimal therapeutic blood levels when starting or stopping concomitant therapy with ticlopidine. Studies of specific drug interactions yielded the following results:

Aspirin and Other NSAIDs: Ticlopidine potentiates the effect of aspirin or other NSAIDs on platelet aggregation. The safety of concomitant use of ticlopidine and NSAIDs has not been established. The safety of concomitantuse of ticlopidine and aspirin beyond 30 days has not been established (see Clinical Trials : Stent Patients). Aspirin did not modify the ticlopidine-mediated inhibition of ADP-induced platelet aggregation, but ticlopidine potentiated the effect of aspirin on collagen-induced platelet aggregation. Caution should be exercised in patients who have lesions with a propensity to bleed, such as ulcers. Long-term concomitant use of aspirin and ticlopidine is not recommended (see PRECAUTIONS: GI Bleeding).

Antacids: Administration of TICLID (ticlopidine hcl) after antacids resulted in an 18% decrease in plasma levels of ticlopidine.

Cimetidine: Chronic administration of cimetidine reduced the clearance of a single dose of TICLID (ticlopidine hcl) by 50%.

Digoxin: Coadministration of TICLID (ticlopidine hcl) with digoxin resulted in a slight decrease (approximately 15%) in digoxin plasma levels. Little or no change in therapeutic efficacy of digoxin would be expected.

Theophylline: In normal volunteers, concomitant administration of TICLID (ticlopidine hcl) resulted in a significant increase in the theophylline elimination half-life from 8.6 to 12.2 hours and a comparable reduction in total plasma clearance of theophylline.

Phenobarbital: In 6 normal volunteers, the inhibitory effects of TICLID (ticlopidine hcl) on platelet aggregation were not altered by chronic administration of phenobarbital.

Phenytoin: In vitro studies demonstrated that ticlopidine does not alter the plasma protein binding of phenytoin. However, the protein binding interactions of ticlopidine and its metabolites have not been studied in vivo. Several cases of elevated phenytoin plasma levels with associated somnolence and lethargy have been reported following coadministration with TICLID (ticlopidine hcl) . Caution should be exercised in coadministering this drug with TICLID (ticlopidine hcl) , and it may be useful to remeasure phenytoin blood concentrations.

Propranolol: In vitro studies demonstrated that ticlopidine does not alter the plasma protein binding of propranolol. However, the protein binding interactions of ticlopidine and its metabolites have not been studied in vivo. Caution should be exercised in coadministering this drug with TICLID (ticlopidine hcl) .

Other Concomitant Therapy: Although specific interaction studies were not performed, in clinical studies TICLID (ticlopidine hcl) was used concomitantly with beta blockers, calcium channel blockers and diuretics without evidence of clinically significant adverse interactions (see PRECAUTIONS).

Food Interaction: The oral bioavailability of ticlopidine is increased by 20% when taken after a meal. Administration of TICLID (ticlopidine hcl) with food is recommended to maximize gastrointestinal tolerance. In controlled trials in stroke patients, TICLID (ticlopidine hcl) was taken with meals.

Last reviewed on RxList: 6/10/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Hematological Adverse Reactions: Neutropenia: Neutropenia may occur suddenly. Bone-marrow examination typically shows a reduction in white blood cell precursors. After withdrawal of ticlopidine, the neutrophil count usually rises to !1200/mm³ within 1 to 3 weeks.

Thrombocytopenia: Rarely, thrombocytopenia may occur in isolation or together with neutropenia.

Thrombotic Thrombocytopenic Purpura (TTP): TTP is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragmented RBCs] seen on peripheral smear), neurological findings, renal dysfunction, and fever. The signs and symptoms can occur in any order, in particular, clinical symptoms may precede laboratory findings by hours or days. With prompt treatment (often including plasmapheresis), 70% to 80% of patients will survive with minimal or no sequelae. Because platelet transfusions may accelerate thrombosis in patients with TTP on ticlopidine, they should, if possible, be avoided.

Aplastic Anemia: Aplastic anemia is characterized by anemia, thrombocytopenia and neutropenia together with a bone marrow examination that shows decreases in the precursor cells for red blood cells, white blood cells, and platelets. Patients may present with signs or symptoms suggestive of infection, in association with low white blood cell and platelet counts. Prompt treatment, which may include the use of drugs to stimulate the bone marrow, can minimize the mortality associated with aplastic anemia.

Monitoring for Hematologic Adverse Reactions: Starting just before initiating treatment and continuing through the third month of therapy, patients receiving TICLID (ticlopidine hcl) must be monitored every 2 weeks. Because of discontinue ticlopidine during this 3-month period should continue to be monitored for 2 weeks after discontinuation. More frequent monitoring, and monitoring after the first 3 months of therapy, is necessary only in patients with clinical signs (eg, signs or symptoms suggestive of infection) or laboratory signs (eg, neutrophil count less than 70% of the baseline count, decrease in hematocrit or platelet count) that suggest incipient hematological adverse reactions.

Clinically, fever might suggest neutropenia, TTP, or aplastic anemia; TTP might also be suggested by weakness, pallor, petechiae or purpura, dark urine (due to blood, bile pigments, or hemoglobin) or jaundice, or neurological changes. Patients should be told to discontinue TICLID (ticlopidine hcl) and to contact the physician immediately upon the occurrence of any of these findings.

Laboratory monitoring should include a complete blood count, with special attention to the absolute neutrophil count (WBC x % neutrophils), platelet count, and the appearance of the peripheral smear. Ticlopidine is occasionally associated with thrombocytopenia unrelated to TTP or aplastic anemia. Any acute, unexplained reduction in hemoglobin or platelet count should prompt further investigation for a diagnosis of TTP, and the appearance of schistocytes (fragmented RBCs) on the smear should be treated as presumptive evidence of TTP. A simultaneous decrease in platelet count and WBC count should prompt further investigation for a diagnosis of aplastic anemia. If there are laboratory signs of TTP or aplastic anemia, or if the neutrophil count is confirmed to be < 1200/mm³, then TICLID (ticlopidine hcl) should be discontinued immediately.

Other Hematological Effects: Rare cases of agranulocytosis, pancytopenia, or leukemia have been reported in postmarketing experience, some of which have been fatal. All forms of hematological adverse reactions are potentially fatal.

Cholesterol Elevation: TICLID (ticlopidine hcl) therapy causes increased serum cholesterol and triglycerides. Serum total cholesterol levels are increased 8% to 10% within 1 month of therapy and persist at that level. The ratios of the lipoprotein subfractions are unchanged.

Anticoagulant Drugs: The tolerance and long-term safety of coadministration of TICLID (ticlopidine hcl) with heparin, oral anticoagulants or fibrinolytic agents have not been established. In trials for cardiac stenting, patients received heparin and TICLID (ticlopidine hcl) concomitantly for approximately 12 hours. If a patient is switched from an anticoagulant or fibrinolytic drug to TICLID (ticlopidine hcl) , the former drug should be discontinued prior to TICLID (ticlopidine hcl) administration.

PRECAUTIONS

General: TICLID (ticlopidine hcl) should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or pathological conditions. If it is desired to eliminate the antiplatelet effects of TICLID (ticlopidine hcl) prior to elective surgery, the drug should be discontinued 10 to 14 days prior to surgery. Several controlled clinical studies have found increased surgical blood loss in patients undergoing surgery during treatment with ticlopidine. In TASS and CATS it was recommended that patients have ticlopidine discontinued prior to elective surgery. Several hundred patients underwent surgery during the trials, and no excessive surgical bleeding was reported.

Prolonged bleeding time is normalized within 2 hours after administration of 20 mg methylprednisolone IV. Platelet transfusions may also be used to reverse the effect of TICLID (ticlopidine hcl) on bleeding. Because platelet transfusions may accelerate thrombosis in patients with TTP on ticlopidine, they should, if possible, be avoided.

GI Bleeding: TICLID (ticlopidine hcl) prolongs template bleeding time. The drug should be used with caution in patients who have lesions with a propensity to bleed (such as ulcers). Drugs that might induce such lesions should be used with caution in patients on TICLID (see CONTRAINDICATIONS).

Use in Hepatically Impaired Patients: Since ticlopidine is metabolized by the liver, dosing of TICLID (ticlopidine hcl) or other drugs metabolized in the liver may require adjustment upon starting or stopping concomitant therapy. Because of limited experience in patients with severe hepatic disease, who may have bleeding diatheses, the use of TICLID (ticlopidine hcl) is not recommended in this population (see CLINICAL PHARMACOLOGY and CONTRAINDICATIONS).

Use in Renally Impaired Patients: There is limited experience in patients with renal impairment. Decreased plasma clearance, increased AUC values and prolonged bleeding times can occur in renally impaired patients. In controlled clinical trials no unexpected problems have been encountered in patients having mild renal impairment, and there is no experience with dosage adjustment in patients with greater degrees of renal impairment. Nevertheless, for renally impaired patients, it may be necessary to reduce the dosage of ticlopidine or discontinue it altogether if hemorrhagic or hematopoietic problems are encountered (see CLINICAL PHARMACOLOGY).

Information for the Patient

(See Patient Leaflet) Patients should be told that a decrease in the number of white blood cells (neutropenia) or platelets (thrombocytopenia) can occur with TICLID (ticlopidine hcl) , especially during the first 3 months of treatment and that neutropenia, if it is severe, can result in an increased risk of infection. They should be told it is critically important to obtain the scheduled blood tests to detect neutropenia or thrombocytopenia. Patients should also be reminded to contact their physicians if they experience any indication of infection such as fever, chills, or sore throat, any of which might be a consequence of neutropenia. Thrombocytopenia may be part of a syndrome called TTP. Symptoms and signs of TTP, such as fever, weakness, difficulty speaking, seizures, yellowing of skin or eyes, dark or bloody urine, pallor or petechiae (pinpoint hemorrhagic spots on the skin), should be reported immediately.

All patients should be told that it may take them longer than usual to stop bleeding when they take TICLID (ticlopidine hcl) and that they should report any unusual bleeding to their physician. Patients should tell physicians and dentists that they are taking TICLID (ticlopidine hcl) before any surgery is scheduled and before any new drug is prescribed.

Patients should be told to promptly report side effects of TICLID (ticlopidine hcl) such as severe or persistent diarrhea, skin rashes or subcutaneous bleeding or any signs of cholestasis, such as yellow skin or sclera, dark urine, or light-colored stools.

Patients should be told to take TICLID (ticlopidine hcl) with food or just after eating in order to minimize gastrointestinal discomfort.

Laboratory Tests: Liver Function: TICLID (ticlopidine hcl) therapy has been associated with elevations of alkaline phosphatase, bilirubin, and transaminases, which generally occurred within 1 to 4 months of therapy initiation. In controlled clinical trials in stroke patients, the incidence of elevated alkaline phosphatase (greater than two times upper limit of normal) was 7.6% in ticlopidine patients, 6% in placebo patients and 2.5% in aspirin patients. The incidence of elevated AST (SGOT) (greater than two times upper limit of normal) was 3.1% in ticlopidine patients, 4% in placebo patients and 2.1% in aspirin patients. No progressive increases were observed in closely monitored clinical trials (eg, no transaminase greater than 10 times the upper limit of normal was seen), but most patients with these abnormalities had therapy discontinued. Occasionally patients had developed minor elevations in bilirubin.

Postmarketing experience includes rare individuals with elevations in their transaminases and bilirubin to > 10X above the upper limits of normal. Based on postmarketing and clinical trial experience, liver function testing, including ALT, AST, and GGT, should be considered whenever liver dysfunction is suspected, particularly during the first 4 months of treatment.

Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 2-year oral carcinogenicity study in rats, ticlopidine at daily doses of up to 100 mg/kg (610 mg/m²) was not tumorigenic. For a 70-kg person (1.73 m² body surface area) the dose represents 14 times the recommended clinical dose on a mg/kg basis and two times the clinical dose on body surface area basis. In a 78-week oral carcinogenicity study in mice, ticlopidine at daily doses up to 275 mg/kg (1180 mg/m²) was not tumorigenic. The dose represents 40 times the recommended clinical dose on a mg/kg basis and four times the clinical dose on body surface area basis.

Ticlopidine was not mutagenic in vitro in the Ames test, the rat hepatocyte DNA-repair assay, or the Chinese-hamster fibroblast chromosomal aberration test; or in vivo in the mouse spermatozoid morphology test, the Chinese-hamster micronucleus test, or the Chinese-hamster bone-marrow-cell sister-chromatid exchange test. Ticlopidine was found to have no effect on fertility of male and female rats at oral doses up to 400 mg/kg/day.

Pregnancy:Teratogenic Effects: Pregnancy: Category B. Teratology studies have been conducted in mice (doses up to 200 mg/kg/day), rats (doses up to 400 mg/kg/day) and rabbits (doses up to 200 mg/kg/day). Doses of 400 mg/kg in rats, 200 mg/kg/day in mice and 100 mg/kg in rabbits produced maternal toxicity, as well as fetal toxicity, but there was no evidence of a teratogenic potential of ticlopidine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of a human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: Studies in rats have shown ticlopidine is excreted in the milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ticlopidine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Clearance of ticlopidine is somewhat lower in elderly patients and trough levels are increased. The major clinical trials with TICLID (ticlopidine hcl) in stroke patients were conducted in an elderly population with an average age of 64 years. Of the total number of patients in the therapeutic trials, 45% of patients were over 65 years old and 12% were over 75 years old. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Last reviewed on RxList: 6/10/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

One case of deliberate overdosage with TICLID (ticlopidine hcl) has been reported by a foreign postmarketing surveillance program. A 38-year-old male took a single 6000-mg dose of TICLID (ticlopidine hcl) (equivalent to 24 standard 250-mg tablets). The only abnormalities reported were increased bleeding time and increased SGPT. No special therapy was instituted and the patient recovered without sequelae.

Single oral doses of ticlopidine at 1600 mg/kg and 500 mg/kg were lethal to rats and mice, respectively. Symptoms of acute toxicity were GI hemorrhage, convulsions, hypothermia, dyspnea, loss of equilibrium and abnormal gait.

CONTRAINDICATIONS

The use of TICLID (ticlopidine hcl) is contraindicated in the following conditions:

Last reviewed on RxList: 6/10/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action: When taken orally, ticlopidine hydrochloride causes a time- and dose-dependent inhibition of both platelet aggregation and release of platelet granule constituents, as well as a prolongation of bleeding time. The intact drug has no significant in vitro activity at the concentrations attained in vivo; and, although analysis of urine and plasma indicates at least 20 metabolites, no metabolite which accounts for the activity of ticlopidine has been isolated.

Ticlopidine hydrochloride, after oral ingestion, interferes with platelet membrane function by inhibiting ADP-induced platelet-fibrinogen binding and subsequent platelet-platelet interactions. The effect on platelet function is irreversible for the life of the platelet, as shown both by persistent inhibition of fibrinogen binding after washing platelets ex vivo and by inhibition of platelet aggregation after resuspension of platelets in buffered medium.

Pharmacokinetics and Metabolism: After oral administration of a single 250-mg dose, ticlopidine hydrochloride is rapidly absorbed with peak plasma levels occurring at approximately 2 hours after dosing and is extensively metabolized. Absorption is greater than 80%. Administration after meals results in a 20% increase in the AUC of ticlopidine.

Ticlopidine hydrochloride displays nonlinear pharmacokinetics and clearance decreases markedly on repeated dosing. In older volunteers the apparent half-life of ticlopidine after a single 250-mg dose is about 12.6 hours; with repeat dosing at 250 mg bid, the terminal elimination half-life rises to 4 to 5 days and steady-state levels of ticlopidine hydrochloride in plasma are obtained after approximately 14 to 21 days.

Ticlopidine hydrochloride binds reversibly (98%) to plasma proteins, mainly to serum albumin and lipoproteins. The binding to albumin and lipoproteins is nonsaturable over a wide concentration range. Ticlopidine also binds to alpha-1 acid glycoprotein. At concentrations attained with the recommended dose, only 15% or less ticlopidine in plasma is bound to this protein.

Ticlopidine hydrochloride is metabolized extensively by the liver; only trace amounts of intact drug are detected in the urine. Following an oral dose of radioactive ticlopidine hydrochloride administered in solution, 60% of the radioactivity is recovered in the urine and 23% in the feces. Approximately 1/3 of the dose excreted in the feces is intact ticlopidine hydrochloride, possibly excreted in the bile. Ticlopidine hydrochloride is a minor component in plasma (5%) after a single dose, but at steady-state is the major component (15%). Approximately 40% to 50% of the radioactive metabolites circulating in plasma are covalently bound to plasma proteins, probably by acylation.

Clearance of ticlopidine decreases with age. Steady-state trough values in elderly patients (mean age 70 years) are about twice those in younger volunteer populations.

Hepatically Impaired Patients: The effect of decreased hepatic function on the pharmacokinetics of TICLID (ticlopidine hcl) was studied in 17 patients with advanced cirrhosis. The average plasma concentration of ticlopidine in these subjects was slightly higher than that seen in older subjects in a separate trial (see CONTRAINDICATIONS).

Renally Impaired Patients: Patients with mildly (Ccr 50 to 80 mL/min) or moderately (Ccr 20 to 50 mL/min) impaired renal function were compared to normal subjects (Ccr 80 to 150 mL/min) in a study of the pharmacokinetic and platelet pharmacodynamic effects of TICLID (ticlopidine hcl) (250 mg bid) for 11 days. Concentrations of unchanged TICLID (ticlopidine hcl) were measured after a single 250-mg dose and after the final 250-mg dose on Day 11.

AUC values of ticlopidine increased by 28% and 60% in mild and moderately impaired patients, respectively, and plasma clearance decreased by 37% and 52%, respectively, but there were no statistically significant differences in ADP-induced platelet aggregation. In this small study (26 patients), bleeding times showed significant prolongation only in the moderately impaired patients.

Pharmacodynamics: In healthy volunteers over the age of 50, substantial inhibition (over 50%) of ADP-induced platelet aggregation is detected within 4 days after administration of ticlopidine hydrochloride 250 mg bid, and maximum platelet aggregation inhibition (60% to 70%) is achieved after 8 to 11 days. Lower doses cause less, and more delayed, platelet aggregation inhibition, while doses above 250 mg bid give little additional effect on platelet aggregation but an increased rate of adverse effects. The dose of 250 mg bid is the only dose that has been evaluated in controlled clinical trials.

After discontinuation of ticlopidine hydrochloride, bleeding time and other platelet function tests return to normal within 2 weeks, in the majority of patients.

At the recommended therapeutic dose (250 mg bid), ticlopidine hydrochloride has no known significant pharmacological actions in man other than inhibition of platelet function and prolongation of the bleeding time.

Clinical Trials

Stroke Patients: The effect of ticlopidine on the risk of stroke and cardiovascular events was studied in two multicenter, randomized, double-blind trials.

1. Study in Patients Experiencing Stroke Precursors: In a trial comparing ticlopidine and aspirin (The Ticlopidine Aspirin Stroke Study or TASS), 3069 patients (1987 men, 1082 women) who had experienced such stroke precursors as transient ischemic attack (TIA), transient monocular blindness (amaurosis fugax), reversible ischemic neurological deficit or minor stroke, were randomized to ticlopidine 250 mg bid or aspirin 650 mg bid. The study was designed to follow patients for at least 2 years and up to 5 years.

Over the duration of the study, TICLID (ticlopidine hcl) significantly reduced the risk of fatal and nonfatal stroke by 24% (p = .011) from 18.1 to 13.8 per 100 patients followed for 5 years, compared to aspirin. During the first year, when the risk of stroke is greatest, the reduction in risk of stroke (fatal and nonfatal) compared to aspirin was 48%; the reduction was similar in men and women.

TASS - Fatal or Nonfatal Stroke - Illustration

2. Study in Patients Who Had a Completed Atherothrombotic Stroke: In a trial comparing ticlopidine with placebo (The Canadian American Ticlopidine Study or CATS) 1073 patients who had experienced a previous atherothrombotic stroke were treated with TICLID (ticlopidine hcl) 250 mg bid or placebo for up to 3 years.

TICLID (ticlopidine hcl) significantly reduced the overall risk of stroke by 24% (p = .017) from 24.6 to 18.6 per 100 patients followed for 3 years, compared to placebo. During the first year the reduction in risk of fatal and nonfatal stroke over placebo was 33%.

CATS - Fatal or Nonfatal Stroke - Illustration

Stent Patients: The ability of TICLID (ticlopidine hcl) to reduce the rate of thrombotic events after the placement of coronary artery stents has been studied in five randomized trials, one of substantial size (Stent Anticoagulation Restenosis Study or STARS) described below, and four smaller studies. In these trials, ticlopidine 250 mg bid with ASA (dose range from 100 mg bid to 325 mg qd) was compared to aspirin alone or to anticoagulant therapy plus aspirin. The trials enrolled patients undergoing both planned (elective) and unplanned coronary stent placement. The types of stents used, the use of intravascular ultrasound, and the use of high-pressure stent deployment varied among the trials, although all patients in STARS received a Palmaz-Schatz stent. The primary efficacy endpoints of the trials were similar, and included death, myocardial infarction and the need for repeat coronary angioplasty or CABG. All trials followed patients for at least 30 days.

In STARS, patients were randomized to receive one of three regimens for 4 weeks: aspirin alone, aspirin plus coumadin, or aspirin plus ticlopidine. Therapy was initiated following successful coronary stent placement. The primary endpoint was the incidence of stent thrombosis, defined as death, Q-Wave MI, or angiographic thrombus within the stented vessel demonstrated at the time of documented ischemia requiring emergent revascularization. The incidence rates for the primary endpoint and its components at 30 days are shown in the table below.

STARS TICLID + Aspirin
N=546
Aspirin
N=557
Coumadin +Aspirin
N=550
Odds Ratio
(95% C.I.)*
p-Value*
Primary Endpoint 3
(0.5%)
20
(3.6%)
15
(2.7%)
0.15
(0.03, 0.51)
< 0.001
Deaths 0
(0%)
1
(0.2%)
0
(0%)
- -
Q-Wave MI (Recurrent and Procedure Related) 1
(0.2%)
12
(2.2%)
8
(1.5%)
0.08
(0.002, 0.57)
0.004
Angiographically Evident Thrombosis 3
(0.5%)
16
(2.9%)
15
(2.7%)
0.19
(0.03, 0.66)
0.005
* Comparison of TICLID plus aspirin to aspirin alone.

The use of ticlopidine plus aspirin did not affect the rate of non-Q-wave MIs when compared with aspirin alone or aspirin plus anticoagulants in STARS.

The use of ticlopidine plus aspirin was associated with a lower rate of recurrent cardiovascular events when compared with aspirin alone or aspirin plus anticoagulants in the other four randomized trials.

The rate of serious bleeding complications and neutropenia in STARS are shown in the table below. There were no cases of thrombotic thrombocytopenic purpura (TTP) or aplastic anemia reported in 1346 patients who received ticlopidine plus aspirin in the five randomized trials.

STARS TICLID + Aspirin
N=546
Aspirin
N=557
Coumadin + Aspirin
N=550
Hemorrhagic Complications 30 (5.5%) 10 (1.8%) 34 (6.2%)
Cerebrovascular Accident 0 (0%) 2 (0.4%) 1 (0.2%)
Neutropenia ( ≤ 1200/mm³) 3 (0.5%) 0 (0%) 1 (0.2%)

Last reviewed on RxList: 6/10/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

IMPORTANT INFORMATION ABOUT TICLID (ticlopidine HCl) TABLETS

The information in this leaflet is intended to help you use TICLID (ticlopidine hcl) safely. Please read the leaflet carefully. Although it does not contain all the detailed medical information that is provided to your doctor, it provides facts about TICLID (ticlopidine hcl) that are important for you to know. If you still have questions after reading this leaflet or if you have questions at any time during your treatment with TICLID (ticlopidine hcl) , check with your doctor.

Why TICLID (ticlopidine hcl) was Prescribed by Your Doctor

Stroke Patients: TICLID (ticlopidine hcl) is recommended to help reduce your risk of having a stroke, but only for patients who have had a stroke or early stroke warning symptoms while on aspirin, or for those who have these symptomsbut are intolerant or allergic to aspirin.

Stent Patients: TICLID (ticlopidine hcl) is recommended with aspirin for up to 30 days in patients who have had a stent implanted in their coronary arteries to reduce the risk of blood clots forming inside the stent.

Special Warning for Users of TICLID (ticlopidine hcl) /Necessary Blood Tests: TICLID (ticlopidine hcl) is not prescribed for those who can take aspirin to reduce the risk of stroke because TICLID (ticlopidine hcl) can cause life-threatening blood problems. Getting your blood tests done and reporting symptoms to your doctor as soon as possible can avoid serious complications.

The white cells of the blood that fight infection may drop to dangerous levels (a condition called neutropenia). This occurs in about 2.4% (1 in 40) of people on ticlopidine. You should be on the lookout for signs of infection such as fever, chills or sore throat. If this problem is caught early, it can almost always be reversed, but if undetected it can be fatal.

Another problem that has occurred in some patients taking ticlopidine is a decrease in cells called platelets (a condition called thrombocytopenia). 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.

Things you should watch for as possible early signs of TTP are yellow skin or eye color, pinpoint dots (rash) on the skin, pale color, fever, weakness on a side of the body, or dark urine. If any of these occur, contact your doctor immediately.

Both complications occur most frequently in the first 90 days after TICLID (ticlopidine hcl) is started. To make sure you don't develop have your blood tested before you start taking TICLID (ticlopidine hcl) and then every 2 weeks for the first 3 months you are on TICLID (ticlopidine hcl) . 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 (ticlopidine hcl) 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 (ticlopidine hcl) .

Rarely, decreases in the white blood cells, red blood cells and platelets can occur together. This condition is called aplastic anemia and can be fatal.

Things you should watch for as possible early signs of aplastic anemia are feeling of excessive weakness and tiredness, paleness, bruising, and bleeding from areas such as your nose or gums. You may also develop signs of infection such as fever. If any of these occur, contact your doctor immediately.

Other Warnings and Precautions: A few people may develop jaundice while being treated with TICLID (ticlopidine hcl) . The signs of jaundice are yellowing of the skin or the whites of the eyes or consistent darkening of the urine or lightening in the color of the stools. These symptoms should be reported to your physician promptly.

If any of the symptoms described above for neutropenia, TTP, aplastic anemia or jaundice occur, contact your doctor immediately.

TICLID (ticlopidine hcl) should be used only as directed by your doctor. Do not give TICLID (ticlopidine hcl) to anyone else. Keep TICLID (ticlopidine hcl) out of reach of children!

Some people may have such side effects as diarrhea, skin rash, stomach or intestinal discomfort. If any of these problems are persistent, or if you are concerned about them, bring them to your doctor's

It may take longer than usual to stop bleeding when taking TICLID (ticlopidine hcl) . Tell your doctor if you have any more bleeding or bruising than usual, and, if you have emergency surgery, be sure to let your doctor or dentist know that you are taking TICLID (ticlopidine hcl) . Also, tell your doctor well in advance of any planned surgery (including tooth extraction), because he or she may recommend that you stop taking TICLID (ticlopidine hcl) temporarily.

How TICLID (ticlopidine hcl) Works

Stroke Patients: A stroke occurs when a clot (or thrombus) forms in a blood vessel in the brain or forms in another part of the body and breaks off, then travels to the brain (an embolus). In both cases the blood supply to part of the brain is blocked and that part of the brain is damaged. TICLID (ticlopidine hcl) works by making the blood less likely to clot, although not so much less that it causes you to become likely to bleed, unless you have a bleeding disorder or some injury (such as a bleeding ulcer of the stomach or intestine) that is especially likely to bleed.

Stent Patients: A heart attack or angina (chest pain) can occur when fatty deposits block the arteries that carry oxygen and nutrient-rich blood to your heart. To decrease the chance of fatty deposits building up over time, your doctor may recommend the placement of a coronary stent. TICLID (ticlopidine hcl) may be given to you with aspirin to make blood clots less likely to form inside the stent so that the artery remains open.

Who Should Not Take TICLID (ticlopidine hcl) ?

Contact your doctor immediately and do not take TICLID (ticlopidine hcl) if:

  • you have an allergic reaction to TICLID (ticlopidine hcl)
  • 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 breast-feeding

Last reviewed on RxList: 6/10/2008
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

IMPORTANT INFORMATION ABOUT TICLID (ticlopidine HCl) TABLETS

The information in this leaflet is intended to help you use TICLID (ticlopidine hcl) safely. Please read the leaflet carefully. Although it does not contain all the detailed medical information that is provided to your doctor, it provides facts about TICLID (ticlopidine hcl) that are important for you to know. If you still have questions after reading this leaflet or if you have questions at any time during your treatment with TICLID (ticlopidine hcl) , check with your doctor.

Why TICLID (ticlopidine hcl) was Prescribed by Your Doctor

Stroke Patients: TICLID (ticlopidine hcl) is recommended to help reduce your risk of having a stroke, but only for patients who have had a stroke or early stroke warning symptoms while on aspirin, or for those who have these symptomsbut are intolerant or allergic to aspirin.

Stent Patients: TICLID (ticlopidine hcl) is recommended with aspirin for up to 30 days in patients who have had a stent implanted in their coronary arteries to reduce the risk of blood clots forming inside the stent.

Special Warning for Users of TICLID (ticlopidine hcl) /Necessary Blood Tests: TICLID (ticlopidine hcl) is not prescribed for those who can take aspirin to reduce the risk of stroke because TICLID (ticlopidine hcl) can cause life-threatening blood problems. Getting your blood tests done and reporting symptoms to your doctor as soon as possible can avoid serious complications.

The white cells of the blood that fight infection may drop to dangerous levels (a condition called neutropenia). This occurs in about 2.4% (1 in 40) of people on ticlopidine. You should be on the lookout for signs of infection such as fever, chills or sore throat. If this problem is caught early, it can almost always be reversed, but if undetected it can be fatal.

Another problem that has occurred in some patients taking ticlopidine is a decrease in cells called platelets (a condition called thrombocytopenia). 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.

Things you should watch for as possible early signs of TTP are yellow skin or eye color, pinpoint dots (rash) on the skin, pale color, fever, weakness on a side of the body, or dark urine. If any of these occur, contact your doctor immediately.

Both complications occur most frequently in the first 90 days after TICLID (ticlopidine hcl) is started. To make sure you don't develop have your blood tested before you start taking TICLID (ticlopidine hcl) and then every 2 weeks for the first 3 months you are on TICLID (ticlopidine hcl) . 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 (ticlopidine hcl) 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 (ticlopidine hcl) .

Rarely, decreases in the white blood cells, red blood cells and platelets can occur together. This condition is called aplastic anemia and can be fatal.

Things you should watch for as possible early signs of aplastic anemia are feeling of excessive weakness and tiredness, paleness, bruising, and bleeding from areas such as your nose or gums. You may also develop signs of infection such as fever. If any of these occur, contact your doctor immediately.

Other Warnings and Precautions: A few people may develop jaundice while being treated with TICLID (ticlopidine hcl) . The signs of jaundice are yellowing of the skin or the whites of the eyes or consistent darkening of the urine or lightening in the color of the stools. These symptoms should be reported to your physician promptly.

If any of the symptoms described above for neutropenia, TTP, aplastic anemia or jaundice occur, contact your doctor immediately.

TICLID (ticlopidine hcl) should be used only as directed by your doctor. Do not give TICLID (ticlopidine hcl) to anyone else. Keep TICLID (ticlopidine hcl) out of reach of children!

Some people may have such side effects as diarrhea, skin rash, stomach or intestinal discomfort. If any of these problems are persistent, or if you are concerned about them, bring them to your doctor's

It may take longer than usual to stop bleeding when taking TICLID (ticlopidine hcl) . Tell your doctor if you have any more bleeding or bruising than usual, and, if you have emergency surgery, be sure to let your doctor or dentist know that you are taking TICLID (ticlopidine hcl) . Also, tell your doctor well in advance of any planned surgery (including tooth extraction), because he or she may recommend that you stop taking TICLID (ticlopidine hcl) temporarily.

How TICLID (ticlopidine hcl) Works

Stroke Patients: A stroke occurs when a clot (or thrombus) forms in a blood vessel in the brain or forms in another part of the body and breaks off, then travels to the brain (an embolus). In both cases the blood supply to part of the brain is blocked and that part of the brain is damaged. TICLID (ticlopidine hcl) works by making the blood less likely to clot, although not so much less that it causes you to become likely to bleed, unless you have a bleeding disorder or some injury (such as a bleeding ulcer of the stomach or intestine) that is especially likely to bleed.

Stent Patients: A heart attack or angina (chest pain) can occur when fatty deposits block the arteries that carry oxygen and nutrient-rich blood to your heart. To decrease the chance of fatty deposits building up over time, your doctor may recommend the placement of a coronary stent. TICLID (ticlopidine hcl) may be given to you with aspirin to make blood clots less likely to form inside the stent so that the artery remains open.

Who Should Not Take TICLID (ticlopidine hcl) ?

Contact your doctor immediately and do not take TICLID (ticlopidine hcl) if:

  • you have an allergic reaction to TICLID (ticlopidine hcl)
  • 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 breast-feeding

Last reviewed on RxList: 6/10/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Ticlid Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TICLOPIDINE - ORAL

(tie-KLO-pih-deen)

COMMON BRAND NAME(S): Ticlid

WARNING: Rarely, this medication has caused serious, sometimes life-threatening blood and immune disorders (agranulocytosis, aplastic anemia, neutropenia, thrombotic thrombocytopenic purpura-TTP). Symptoms may appear within the first few days after starting this medication. Seek immediate attention if you notice any of these rare but serious side effects: difficulty speaking, weakness on one side of the body, seizures, red pinpoint-sized bleeding spots on the skin, dark-colored urine, or yellowing of eyes/skin (see also Side Effects section).

Your doctor will be monitoring your blood counts before and regularly during treatment, especially the first 3 months of therapy. It is important that you keep all your medical and laboratory appointments.

USES: This medication is used to prevent strokes in people who cannot take aspirin or for whom aspirin has failed to work. It may also be used in combination with aspirin following certain types of heart procedures (e.g., coronary stent implant).

Ticlopidine is an anti-platelet drug. It works by making your blood less likely to clot.

HOW TO USE: Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

Take this medication with food or just after a meal, usually twice daily, or as directed by your doctor. Do not take this medication two hours before or after taking antacids.

Duration of therapy is based on your medical condition. If you are taking this medication to prevent clots after a stent implant, it is generally taken with aspirin for up to 30 days unless otherwise directed by your doctor. Consult your doctor for more details.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Do not increase your dose or take this more often than prescribed. It is important to continue taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor.

Disclaimer

Ticlid Consumer (continued)

SIDE EFFECTS: See also the Warning section.

Diarrhea, stomach upset/pain, nausea, vomiting, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe/persistent or bloody diarrhea, vomit that looks like coffee grounds, blood in the urine, bleeding from gums or nose, persistent dizziness.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of new infection (e.g., chills, persistent sore throat), unusual weakness/fatigue, easy bruising or bleeding, mental/mood changes, numbness/tingling of arms/legs, persistent nausea/vomiting, severe stomach/abdominal pain, change in the amount of urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Ticlid (ticlopidine hcl) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other thienopyridines (such as clopidogrel); 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, conditions that put you at risk of bleeding (e.g., stomach ulcers), high cholesterol or triglyceride levels.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are taking this medication.

While you are taking this medication, it may take longer than usual for bleeding to stop if you have a cut or injury. Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised, or injured.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Disclaimer

Ticlid Consumer (continued)

DRUG INTERACTIONS: See also the How To Use section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: mifepristone.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting ticlopidine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other antiplatelet drugs (e.g., cilostazol, clopidogrel), cimetidine, digoxin, phenytoin, theophylline, tipranavir, tizanidine.

Other drugs like this medication that affect blood clotting may increase your risk of bleeding. Examples are "blood thinners" (anticoagulants such as enoxaparin, heparin, warfarin). Follow your doctor's instructions carefully and continue your medications as directed. Tell your doctor immediately if you notice unusual bleeding. Consult your doctor or pharmacist for more details.

For certain conditions, you may be instructed by your doctor to take ticlopidine together with aspirin. Follow your doctor's instructions and continue aspirin as directed. If you are not currently taking aspirin, consult your doctor before starting it for any medical condition. Check the labels on all your medicines because they may contain aspirin or aspirin-like NSAIDs (e.g., ibuprofen, naproxen) that can increase the risk of bleeding. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: See also the Warning section.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., complete blood counts, platelet counts, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised October 2011. Copyright(c) 2011 First Databank, Inc.

Ticlid Patient Information Including Side Effects

Brand Names: Ticlid

Generic Name: ticlopidine (oral) (Pronunciation: tye KLOE pi deen)

What is ticlopidine (Ticlid)?

Ticlopidine keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots that 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 with certain disorders of the heart or blood vessels.

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

Ticlid 250 mg

elliptical, white, imprinted with TICLID, 250

Ticlodipine 250 mg-APO

oblong, white, imprinted with APO 027

Ticlopidine 250 mg-TEV

oval, white, imprinted with 93, 154

What are the possible side effects of ticlopidine (Ticlid)?

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:

  • nosebleed or other bleeding that will not stop;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance; or
  • pale skin, easy bruising or bleeding, weakness, fever, and urinating more or less than usual;
  • signs of infection such as fever, chills, sore throat, flu symptoms, mouth sores; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • upset stomach, nausea, or vomiting;
  • ringing in your ears;
  • diarrhea;
  • dizziness; or
  • itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Ticlid (ticlopidine hcl) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about ticlopidine (Ticlid)?

You should not use this medication if you are allergic to ticlopidine, or if you have severe liver disease, any active bleeding such as a stomach ulcer or bleeding in the brain (such as from a head injury), or a blood cell disorder such as anemia (lack of red blood cells) or low levels of platelets (cells that help your blood clot).

Before taking ticlopidine, tell your doctor if you have a bleeding or blood clotting disorder, a history of stroke, including TIA ("mini-stroke"), a stomach ulcer or ulcerative colitis, high cholesterol or triglycerides, liver disease, or kidney disease.

Because ticlopidine keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using ticlopidine.

While you are taking ticlopidine, do not take aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin) without your doctor's advice.

Taking ticlopidine with certain other drugs can increase your risk of bleeding. Before taking ticlopidine, tell your doctor about all other medications you use.

Side Effects Centers

Ticlid Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking ticlopidine (Ticlid)?

You should not use this medication if you are allergic to ticlopidine, or if you have:

  • severe liver disease;
  • any active bleeding such as a stomach ulcer or bleeding in the brain (such as from a head injury); or
  • a blood cell disorder such as anemia (lack of red blood cells) or low levels of platelets (cells that help your blood clot).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take ticlopidine:

  • a bleeding or blood clotting disorder, such as hemophilia;
  • a history of stroke, including TIA ("mini-stroke");
  • a stomach ulcer or ulcerative colitis;
  • high cholesterol or triglycerides;
  • liver disease; or
  • kidney disease.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ticlopidine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take ticlopidine (Ticlid)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medication with a full glass of water.

Take ticlopidine with food.

Because ticlopidine keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using ticlopidine.

Store ticlopidine at room temperature away from moisture and heat.

Side Effects Centers

Ticlid Patient Information including If I Miss a Dose

What happens if I miss a dose (Ticlid)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Ticlid)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include cold feeling, unusual bleeding, trouble breathing, loss of balance or coordination, and seizure (convulsions).

What should I avoid while taking ticlopidine (Ticlid)?

While you are taking ticlopidine, do not take aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) without your doctor's advice. NSAIDs include ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others.

Avoid sports or activities that could result in a bruising or bleeding injury. Use extra caution to avoid cuts when brushing your teeth or shaving.

Avoid drinking alcohol while taking ticlopidine. Alcohol may increase your risk of bleeding in your stomach or intestines.

What other drugs will affect ticlopidine (Ticlid)?

Taking ticlopidine with certain other drugs can increase your risk of bleeding. Before taking ticlopidine, tell your doctor if you also take:

  • aspirin;
  • warfarin (Coumadin);
  • heparin, dalteparin (Fragmin), or enoxaparin (Lovenox);
  • clopidogrel (Plavix);
  • dipyridamole (Persantine); or
  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

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

  • antacids or cimetidine (Tagamet, Tagamet HB);
  • digoxin (Lanoxin, Lanoxicaps);
  • theophylline (Elixophyllin, Theo-24, Uniphyl); or
  • phenytoin (Dilantin).

This list is not complete and there may be other drugs that can interact with ticlopidine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ticlopidine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.03. Revision date: 12/15/2010.

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