Tiapride
Neuroleptic malignant syndrome
Neuroleptic malignant syndrome is characterized by pallor, hyperthermia, muscle rigidity, dysfunction of the autonomic nervous system, and impaired consciousness. Signs of autonomic nervous system dysfunction, such as increased sweating and lability of blood pressure and pulse, may precede the onset of hyperthermia and therefore represent early warning symptoms. If there is an unexplained increase in body temperature, treatment with tiapride should be discontinued. The cause of the development of neuroleptic malignant syndrome remains unclear. It is assumed that blockade of dopamine receptors in the striatum and hypothalamus plays a role in its mechanism; congenital predisposition (idiosyncrasy) cannot be ruled out. The development of the syndrome can be facilitated by intercurrent infection, disturbances in water and electrolyte balance (in particular, dehydration, hyponatremia), simultaneous administration of lithium, and organic brain damage.
Cases with atypical manifestations of neuroleptic malignant syndrome, for example, without muscle rigidity or hypertension and with less severe hyperthermia, have been observed.
QT prolongation
Tiapride may cause QT prolongation. This effect is known to increase the risk of developing serious ventricular arrhythmias, such as torsade de pointes (see section 4.4).
Before prescribing antipsychotic therapy, if the patient's condition allows, it is necessary to monitor factors predisposing to the development of these severe rhythm disturbances (bradycardia less than 55 beats per minute, hypokalemia, hypomagnesemia, congenital long QT interval, concomitant use of other drugs causing bradycardia less than 55 beats per minute , hypokalemia, hypomagnesemia, slowing of intracardiac conduction or prolongation of the QT interval) (see sections “Contraindications”, “With caution”, “Side effects”).
Patients with the above risk factors predisposing to prolongation of the QT interval should be especially careful when prescribing tiapride. Hypokalemia and hypomagnesemia should be corrected before starting the drug, in addition, medical supervision, monitoring of blood electrolytes and ECG should be provided.
Extrapyramidal syndrome
For extrapyramidal syndrome caused by antipsychotics, anticholinergic drugs (rather than dopamine receptor agonists) should be prescribed (see section "Interaction with other drugs").
Stroke
In randomized clinical trials comparing some atypical antipsychotics with placebo in elderly patients with dementia, a threefold increase in the risk of cerebrovascular events was observed. The mechanism of this risk is unknown. An increase in this risk cannot be ruled out with other antipsychotics or in other patient populations, so tiapride should be used with caution in patients with risk factors for stroke.
Elderly patients with dementia
In elderly patients with psychosis associated with dementia, an increased risk of death was observed when treated with antipsychotic drugs. An analysis of 17 placebo-controlled studies (mean duration greater than 10 weeks) found that most patients taking atypical antipsychotics had a 1.6 to 1.7 times greater risk of death than patients taking placebo. During a 10-week placebo-controlled clinical trial, the death rate was 4.5% in the atypical antipsychotic group and 2.6% in the placebo group. Although causes of death varied in clinical trials with atypical antipsychotics, most causes of death were either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia).
Observational studies have confirmed that, like treatment with atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may also increase mortality. The extent to which the increase in mortality may be due to the antipsychotic drug rather than certain patient characteristics is unclear.
Venous thromboembolic complications
When using antipsychotic drugs, cases of venous thromboembolic complications (VTE), sometimes fatal, have been observed (see section "Side effects"). Therefore, tiapride should be used with caution in patients with risk factors for developing HTO. Since patients taking antipsychotics often have acquired risk factors for developing HTO, any potential risk factors for developing HTO should be identified before and during treatment with Tiapride, and measures aimed at preventing thromboembolic complications should be implemented while taking it.
Mammary cancer
Tiapride may increase plasma prolactin concentrations. Therefore, when using tiapride in patients with a history (including family history) of breast cancer, caution should be exercised (see section "With caution"). Such patients should be closely monitored.
Patients with epilepsy
Due to the fact that tiapride may lower the threshold for seizure activity, when tiapride is used in patients with epilepsy, the latter should be under strict medical supervision.
Patients with Parkinson's disease taking dopamine receptor agonists
Except in exceptional cases, Tiapride should not be used in patients with Parkinson's disease. If there is an urgent need for antipsychotic treatment in patients with Parkinson's disease taking dopamine receptor agonists, a gradual reduction in dosage of the latter should be carried out until complete discontinuation (abrupt withdrawal of dopamine receptor agonists may increase the patient's risk of developing neuroleptic malignant syndrome) (see sections "With caution", "Interaction with other drugs").
Children
The use of tiapride in children has not been studied enough. Therefore, caution should be used when prescribing tiapride to children. Due to the lack of clinical data, caution is recommended when prescribing this drug to children. Moreover, it is recommended to have children's learning abilities tested annually, as the drug may affect cognitive function. It is necessary to regularly adjust the dose depending on the clinical condition of the child.
Hematological disorders
Leukopenia, neutropenia and agranulocytosis have been observed with the use of antipsychotic drugs, including Tiapride. Unexplained infections or fever may be signs of hematological disorders (see section "Side effects") and require immediate hematological evaluation.
Kidney failure
In case of renal failure, the dose of Tiapride should be reduced (due to the possible risk of coma due to impaired excretion of tiapride).
Ethanol
During treatment with Tiaprid, you should not take alcoholic beverages or medications containing ethanol (see section “Interaction with other drugs”).
Tiapridal®
Neuroleptic malignant syndrome
Neuroleptic malignant syndrome is characterized by pallor, hyperthermia, muscle rigidity, dysfunction of the autonomic nervous system, and impaired consciousness. Signs of autonomic nervous system dysfunction, such as increased sweating and lability of blood pressure and pulse, may precede the onset of hyperthermia and therefore represent early warning symptoms. If there is an unexplained increase in body temperature, treatment with tiapride should be discontinued. The cause of the development of neuroleptic malignant syndrome remains unclear. It is assumed that blockade of dopamine receptors in the striatum and hypothalamus plays a role in its mechanism; congenital predisposition (idiosyncrasy) cannot be ruled out. The development of the syndrome can be facilitated by intercurrent infection, disturbances in water and electrolyte balance (in particular, dehydration, hyponatremia), simultaneous administration of lithium, and organic brain damage.
Extending the OT interval
Tiapride may cause QT prolongation. This effect is known to increase the risk of developing serious ventricular arrhythmias, such as torsade de pointes (see section 4.4).
Before prescribing antipsychotic therapy, if the patient's condition allows, it is necessary to exclude the presence of factors predisposing to the development of these severe rhythm disturbances (bradycardia less than 55 beats per minute, hypokalemia, hypomagnesemia, slow intraventricular conduction and congenital long QT interval or prolongation of the QT interval when using other drugs , prolonging the QT interval) (see sections “Contraindications”, “With caution”, “Side effects”).
Patients with the above risk factors,
predisposing to prolongation of the QT interval, if it is necessary to prescribe tiapride, special care must be taken.
Hypokalemia and hypomagnesemia should be corrected before starting the drug, in addition, medical supervision, monitoring of blood electrolytes and ECG should be provided.
Extrapyramidal
y
syndrome
For extrapyramidal syndrome caused by antipsychotics, anticholinergic drugs (rather than dopamine receptor agonists) should be prescribed (see section “Interaction with other drugs”).
Stroke
In randomized clinical trials comparing some atypical antipsychotics with placebo in elderly patients with dementia, a threefold increase in the risk of cerebrovascular events was observed. The mechanism of this risk is unknown. An increase in this risk cannot be ruled out with other antipsychotics or in other patient populations, so tiapride should be used with caution in patients with risk factors for stroke.
Elderly patients with dementia
In elderly patients with dementia-related psychosis, an increased risk of death was observed when treated with antipsychotic drugs. An analysis of 17 placebo-controlled studies (mean duration greater than 10 weeks) found that most patients treated with atypical antipsychotics had a 1.6 to 1.7 times greater risk of death than patients treated with placebo. In a 10-week placebo-controlled study, the incidence of death in these patients was 4.5% with atypical antipsychotics and 2.6% with placebo.
Although the causes of death in clinical studies with atypical antipsychotics varied, most causes of death were either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies have confirmed that, like treatment with atypical antipsychotics, treatment with conventional antipsychotics may also increase mortality. The extent to which the increase in mortality may be due to the antipsychotic drug rather than certain patient characteristics is unclear.
Venous thromboembolic complications
When using antipsychotic drugs, cases of venous thromboembolic complications (VTE), sometimes fatal, have been observed (see section "Side effects"). Therefore, tiapride should be used with caution in patients with risk factors for developing HTO. Since patients taking antipsychotics often have acquired risk factors for developing HTO, any potential risk factors for developing HTO should be identified before and during treatment with Tiapridal, and measures aimed at preventing thromboembolic complications should be implemented while taking it.
Mammary cancer
Tiapride may increase the concentration of prolactin in the blood plasma. Therefore, when using tiapride in patients with a history (including family history) of breast cancer, caution should be exercised (see section "With caution"). Such patients should be closely monitored.
Patients with epilepsy
Due to the fact that tiapride may lower the threshold for seizure activity, when tiapride is prescribed to patients with epilepsy, the latter should be under strict medical supervision.
Patients with Parkinson's disease taking
dopamine receptor agonists
Except in exceptional cases, Tiapridal should not be used in patients with Parkinson's disease.
If there is an urgent need for antipsychotic treatment in patients with Parkinson's disease taking dopamine receptor agonists, a gradual reduction in dosage of the latter should be carried out until complete discontinuation (abrupt withdrawal of dopamine receptor agonists may increase the patient's risk of developing neuroleptic malignant syndrome) (see sections "With
caution", "Interaction with other drugs").
Children
The use of tiapride in children has not been studied enough. Therefore, caution should be used when prescribing tiapride to children. Due to the lack of clinical data, caution is recommended when prescribing this drug to children. Moreover, it is recommended to have children's learning abilities tested annually, as the drug may affect cognitive function. It is necessary to regularly adjust the dose depending on the clinical condition of the child. Hematological disorders
Leukopenia, neutropenia and agranulocytosis have been observed with the use of antipsychotic drugs, including Tiapridal®. Unexplained infections or fever may be signs of hematological disorders (see section "Side effects") and require immediate hematological evaluation.
Ethanol
During treatment with Tiapridal, you should not take alcoholic beverages or medications containing ethanol (see section “Interaction with drugs and other drugs”).
