⚠️ Warnings
Pregnancy
Pregnancy:
Except where formally indicated, Ticlopidine should not be prescribed during pregnancy.
Breast-feeding
Breast-feeding:
Except where formally indicated, Ticlopidine should not be prescribed during breast-feeding.
Renal impairment
Renal impairment:
Dose reduction may be necessary; discontinue therapy if haemorrhagic complications arise.
Haematological monitoring
Haematological parameters (including platelets) must be determined before starting treatment, every two weeks during the first three months of treatment with Ticlopidine, and during the 15 days following discontinuation if this occurs within the first three months.
If neutropenia (<1500 neutrophils/mm³), thrombocytopenia (<100,000 platelets/mm³), or a decrease in haematocrit occurs, treatment should be discontinued. A complete blood count should be performed, including platelets and blood film elements (schistocytes), and serum creatinine, with monitoring maintained until normal values are restored.
Clinical monitoring
All patients should be carefully monitored to detect any signs and symptoms related to adverse reactions, particularly during the first three months of treatment.
Signs and symptoms that may be related to neutropenia (fever, tonsillitis, or oral ulceration), thrombocytopenia and/or haemostatic abnormalities (unusual or prolonged bleeding, bruising, purpura, and melaena), or jaundice (including dark urine and pale stools) should be explained to the patient.
All patients should be advised to discontinue medication and consult their physician immediately if any of the above symptoms occur.
The decision to resume treatment should be based on clinical and laboratory findings.
The clinical diagnosis of Thrombotic Thrombocytopenic Purpura (TTP) is characterised by the presence of thrombocytopenia, haemolytic anaemia, neurological symptoms, renal dysfunction, and fever.
Onset may be sudden.
Most cases were reported in the first eight weeks after initiation of therapy.
Due to the risk of a fatal outcome, if thrombotic thrombocytopenic purpura is suspected, a specialist medical team should be contacted.
Plasma exchange treatment has been reported to improve prognosis.
Haemostasis
Ticlopidine should be used with caution in patients susceptible to haemorrhage.
The drug should not be administered concomitantly with heparins, oral anticoagulants, or antiplatelet agents; however, in exceptional cases of concomitant administration, careful clinical and laboratory monitoring must be ensured.
In patients undergoing elective surgery, treatment should, whenever possible, be discontinued at least 10 days before surgery.
In an emergency surgical situation, in an attempt to minimise the haemorrhagic risk as well as the prolongation of bleeding time, three measures may be used, alone or in combination:
− administration of 0.5 to 1 mg/kg of methylprednisolone I.V., which may be repeated.
− desmopressin 0.2 to 0.4 μg/kg.
− platelet transfusion.
As Ticlopidine is extensively metabolised by the liver, the drug should be used with caution in patients with hepatic impairment, and treatment should be discontinued if hepatitis or jaundice develops.
In cases of hepatitis or jaundice, investigation should be initiated to clarify the situation.
In such cases, re-exposure to ticlopidine should be avoided.