). For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1– Dosage Forms, Strengths, Composition and Packaging Each oval, white, biconvex, film–coated tablet, engraved “250” on one side and plain on the other side, contains ticlopidine hydrochloride 250 mg.
Available in bottles of 100 tablets. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. 3 Less Common Clinical Trial Adverse Reactions). Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral tablet 250 mg carnauba wax, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide.
3 Less Common Clinical Trial Adverse Reactions). Gastrointestinal Conditions associated with active bleeding, such as bleeding ulcers, constitute contraindications for ticlopidine hydrochloride (see 2 CONTRAINDICATIONS). Clinical judgement and monitoring of stool for occult blood and for bloody vomit (hematemesis) are required for patients with a history of ulcerative lesions.
2 Clinical Trial Adverse Reactions). The majority of cases are mild and transient in nature and occur within 3 months of initiation of therapy. Typically, events are resolved within 1 - 2 weeks without discontinuation of therapy. If the effect is severe or persistent, therapy should be discontinued.
Hematologic Hematological Complications:
All forms of hematological adverse reactions are potentially fatal. Rarely, cases of pancytopenia, aplastic anemia or thrombocytopenia have been reported (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX). Thrombotic thrombocytopenic purpura (TTP) is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragmented RBCs] seen on peripheral smear), neurological findings (mental changes, confusion, trouble speaking, paralysis , seizures, dizziness, weakness, tingling or numbness and pain in the hands and feet and paralysis), 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. The median time to occurrence was 3-4 weeks from the start of therapy, but a few cases occurred as soon as the day of therapy, or more than 12 weeks after drug administration.
Treatment consists of discontinuation of ticlopidine and plasmapheresis. 5 Post-Market Adverse Reactions). Severe neutropenia has been observed in clinical trials and occurred during the first 3-12 weeks of therapy. It may develop quickly over a few days.
The bone marrow shows a reduction in myeloid precursors. The condition may be life-threatening. 2 Clinical Trial Adverse Reactions). 3 Less Common Clinical Trial Adverse Reactions). Thrombocytopenia occurs during the first 3-12 weeks of therapy, and recovery usually occurs after drug discontinuation.
All patients should have a white blood cell count with a differential and platelet count performed every week starting at baseline, before treatment is initiated, to the end of the third month of therapy with ticlopidine. When the neutrophil count shows a declining trend or the neutrophil numbers have fallen below 30% of the baseline, the values should be confirmed.
8 x 1011 cells/L) are confirmed, the drug PrTICLOPIDINE ticlopidine hydrochloride tablets Page 8 of 33 should be discontinued and CBC with white cell differential and platelet count should be monitored until they return to normal. Because of the long plasma half-life of ticlopidine, it is recommended that any patient who discontinues ticlopidine for any reason within the first 90 days have an additional CBC with white cell differential count obtained two weeks after discontinuation of therapy.
Hemorrhagic Complications:
Prolongation of bleeding time occurs in subjects treated with ticlopidine hydrochloride. 5 Post-Market Adverse Reactions). Patients must be instructed to watch for signs of bleeding disorders and to report any abnormality to their physician immediately (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX).
Ticlopidine hydrochloride therapy has to be stopped by the patient if a physician is not immediately available for consultation. Ticlopidine hydrochloride should be discontinued temporarily until the danger of abnormal bleeding is eliminated.
3 Less Common Clinical Trial Adverse Reactions). The extent to which ticlopidine may have contributed to the severity of the bleeding is unknown. 2 Pharmacodynamics). Ticlopidine hydrochloride is contraindicated in patients with severe liver dysfunction or hepatitis, cholestatic jaundice, colitis, hepatic necrosis, […]