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Ticlopidine (ticlopidine hydrochloride)

BOXED WARNING

May cause life-threatening hematological adverse reactions, including neutropenia/agranulocytosis, thrombotic thrombocytopenic purpura (TTP), and aplastic anemia. Monitor hematologically and clinically for evidence of neutropenia or TTP during the first 3 months of treatment; d/c immediately if any such evidence is seen.

OTHER BRAND NAMES

Ticlid (Discontinued)

THERAPEUTIC CLASS

Platelet aggregation inhibitor

DEA CLASS

RX

INDICATIONS

To reduce the risk of thrombotic stroke (fatal or nonfatal) in patients who have experienced stroke precursors and in patients who have had a completed thrombotic stroke who are intolerant or allergic to aspirin (ASA) therapy or who have failed ASA therapy. Adjunctive therapy with ASA to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation.

ADULT DOSAGE

Stroke

To reduce risk of thrombotic stroke in patients who have experienced stroke precursors and in patients who have had a completed thrombotic stroke; reserve for patients who are intolerant or allergic to aspirin therapy or who have failed aspirin therapy

250mg bid

Coronary Artery Stenting

Adjunctive therapy w/ aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation

250mg bid w/ antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation

ADMINISTRATION

Oral route

Take w/ food

HOW SUPPLIED

Tab: 250mg

CONTRAINDICATIONS

Hematopoietic disorders (eg, neutropenia, thrombocytopenia) or history of TTP or aplastic anemia, hemostatic disorder or active pathological bleeding (eg, bleeding peptic ulcer, intracranial bleeding), severe liver impairment.

WARNINGS/PRECAUTIONS

Platelet transfusions may accelerate thrombosis in patients with TTP; avoid if possible. Monitor for hematologic adverse reactions every 2 weeks during the first 3 months of therapy, and for 2 weeks after discontinuation in patients who d/c therapy during this 3-month period. Monitor more frequently and after the first 3 months of therapy in patients with clinical or laboratory signs that suggest incipient hematological adverse reactions. May increase serum cholesterol and TG levels. Caution with risk of increased bleeding from trauma, surgery, or pathological conditions. D/C use 10-14 days prior to elective surgery if desire to eliminate antiplatelet effects of drug prior to surgery. Prolongs template bleeding time; use with caution in patients who have lesions with a propensity to bleed (eg, ulcers), or with drugs that might induce such lesions. May require dose adjustment in patients with hepatic impairment. May need to reduce dose or d/c if hemorrhagic/hematopoietic problems are encountered in renally impaired patients. May elevate alkaline phosphatase, bilirubin, and transaminases; consider obtaining LFTs whenever liver dysfunction is suspected, particularly during the first 4 months of treatment.

ADVERSE REACTIONS

Diarrhea, rash, nausea, GI pain, dyspepsia, neutropenia, agranulocytosis, TTP, aplastic anemia.

DRUG INTERACTIONS

D/C anticoagulant or fibrinolytic drugs prior to treatment. Caused an increase in antipyrine T1/2 and may cause analogous effects on similarly metabolized drugs; dose of drugs metabolized by hepatic microsomal enzymes with low therapeutic ratios may require adjustment when starting or stopping concomitant therapy. Potentiates the effect of ASA or other NSAIDs on platelet aggregation; long-term use with ASA not recommended. Decreased levels with antacids. Reduced clearance with cimetidine. May decrease digoxin levels. May increase T1/2 and reduce clearance of theophylline. Elevated phenytoin levels with associated somnolence and lethargy reported following coadministration; use caution when coadministering, and remeasure phenytoin concentrations. Caution with propranolol.

PREGNANCY AND LACTATION

Category B, not for use in nursing.

MECHANISM OF ACTION

Platelet aggregation inhibitor; interferes with platelet membrane function by inhibiting adenosine diphosphate-induced platelet fibrinogen binding and subsequent platelet-platelet interactions.

PHARMACOKINETICS

Absorption: Rapid. Tmax=2 hrs. Distribution: Plasma protein binding (98%). Metabolism: Liver (extensive). Elimination: Urine (60%), feces (23%); T1/2=12.6 hrs (single dose), 4-5 days (multiple doses).

ASSESSMENT

Assess for hematopoietic disorders, history of TTP or aplastic anemia, hemostatic disorder, active pathological bleeding, risk of increased bleeding, lesions with a propensity to bleed, hepatic/renal impairment, pregnancy/nursing status, and possible drug interactions. Obtain baseline CBC, including absolute neutrophil count (ANC), platelet count, and peripheral smear.

MONITORING

Monitor for signs/symptoms of neutropenia, agranulocytosis, TTP, aplastic anemia, bleeding, and other adverse reactions. During first 3 months of therapy, monitor CBC including ANC, platelet count, and peripheral smear every 2 weeks. If therapy is discontinued before 3 months, monitor for 2 weeks following discontinuation. If liver dysfunction suspected, obtain LFTs (eg, ALT, AST, GGT). Monitor serum cholesterol and TG levels.

PATIENT COUNSELING

Inform that a decrease in the number of WBC or platelets may occur, especially during the first 3 months of treatment, and that severe neutropenia may result in an increased risk of infection; advise to follow scheduled blood tests, and to contact physician if experiencing any indication of infection (eg, fever, chills, sore throat) or signs/symptoms of TTP (eg, fever, weakness, difficulty speaking, seizures, yellowing of skin or eyes, dark or bloody urine, pallor, or petechiae). Instruct to inform that it may take longer than usual to stop bleeding when taking the medication; advise to report to physician any unusual bleeding. Instruct to inform physicians and dentists if patient is taking ticlopidine before any surgery is scheduled and before any new drug is prescribed. Instruct to promptly report side effects (eg, severe/persistent diarrhea, skin rashes, SQ bleeding), or any signs of cholestasis (eg, yellow skin or sclera, dark urine, light-colored stools).

STORAGE

20-25°C (68-77°F).

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