Malignant neuroleptic syndrome
Malignant neuroleptic syndrome, which the is potentially a lethal complication, and the occurrence of which is possible with any neuroleptics, is characterized by pallor, hyperthermia, rigidity of muscles, dysfunction of the autonomic nervous system, impaired consciousness. Signs of autonomic nervous system dysfunction, such as increased sweating and lability of blood pressure and pulse, can precede
the onset of hyperthermia and to be early warning signs. In the case of an unexplained increase in body temperature, treatment with sulpiride must be terminated. The cause of malignant neuroleptic syndrome remains unclear. It is assumed that its mechanism is played by the blockade of dopamine receptors in the striatum and the hypothalamus, and congenital predisposition (idiosyncrasy) is also not excluded. The development of the syndrome can contribute to intercurrent infection, dehydration or organic brain damage.
The elongation of the QT interval
Sulpiride can induce prolongation of the QT interval. It is known that this effect increases the risk of developing severe ventricular arrhythmias, such as ventricular pirouette tachycardia (see "Side effect" section).
Before using the drug, 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, retardation of intraventricular conduction and congenital long QT interval, or prolongation of the QT interval with the use of other drugs extending the QT interval) (see the sections "With caution", "Side effect").
Patients with the above risk factors for the need for sulpiride should be observed caution.
Hypokalemia and hypomagnesemia should be adjusted before the drug is started; In addition, medical supervision and regular monitoring of the electrolyte content in the blood and ECG should be provided.
Except in cases of urgent intervention, patients who are required to be treated with antipsychotics are advised to assess the condition and control the ECG.
Extrapyramidal syndrome
For extrapyramidal syndrome caused by neuroleptics, m-cholinoblocking drugs (rather than dopamine receptor agonists) should be prescribed (see section "Interaction with other drugs").
Stroke
In randomized clinical trials, compared with some atypical antipsychotics with placebo performed in elderly patients with dementia, there was a triple increase in the risk of developing cerebrovascular complications. The mechanism of this risk is unknown. It can not be ruled out that this risk increases with other neuroleptics or in other patient populations, so
sulpiride should be used with caution in patients with risk factors for stroke.
Older patients with dementia
In elderly patients with psychoses associated with dementia, in the treatment of antipsychotic drugs, there was an increased risk of death. Analysis of 17 placebo-controlled trials (mean for more than 10 weeks) showed that the majority of patients who received atypical antipsychotics, had a 1.6-1.7 times greater risk of death than patients who received a placebo. During a 10-week placebo-controlled studies of the incidence of fatal outcomes with the use of atypical antipsychotics by such patients was 4.5%, and with placebo - 2.6%. Although the causes of death in clinical studies with atypical antipsychotics varied, most of the causes of death were cardiovascular (for example, cardiac
failure, sudden death), or infectious (eg, pneumonia) by nature.
Observational studies have confirmed that, similar to treatment with atypical antipsychotics, treatment with conventional antipsychotics also can increase
mortality. The extent to which an increase in mortality may be due to an antipsychotic drug, rather than to certain features of patients, is unclear.
Venous thromboembolic complications
When using antipsychotic drugs, cases of venous thromboembolic
complications, sometimes lethal. therefore
sulpiride should be used with caution in patients with risk factors for venous thromboembolic complications (see the sections "With caution", "Side effect").
Mammary cancer
Sulpiride can increase the concentration of prolactin in the blood plasma. Therefore, when using sulpiride in patients who have a history of (including family history) of breast cancer, caution should be used (see "With caution"). Such patients should be carefully monitored.
Patients with epilepsy
Due to the fact that neuroleptics can lower the epileptogenic threshold, when sulpiride is prescribed to patients with epilepsy, the latter should be under strict medical supervision.
Patients with Parkinson's disease who take dopamine receptor agonists
In exceptional cases, the Eglonil® preparation should not be used in patients with Parkinson's disease. If there is an urgent need for treatment with neuroleptics of patients with Parkinson's disease taking dopamine receptor agonists, a gradual reduction in doses of the latter to complete cancellation should be made (the abrupt withdrawal of dopamine receptor agonists may increase the risk of developing a malignant neuroleptic syndrome in the patient)sections "With care", "Interaction with other medicinal products").
Patients with impaired renal function
Use reduced dosages (see section "Method of administration and dose").
Patients with diabetes mellitus or with risk factors for diabetes mellitus
Since it has been reported on the development of hyperglycemia in patients taking atypical antipsychotics, patients with an established diagnosis of diabetes mellitus or with risk factors for its development, who are prescribed treatment with sulpiride, should be monitored
concentration of glucose in the blood.
The use of ethanol
Consumption of alcoholic beverages containing
ethanol, or the use of drugs,
containing
ethanol, during treatment with Eglonil® is strictly prohibited.
Leukopenia, neutropenia and agranulocytosis
Against the background of therapy with neuroleptics, including Eglonil®, leukopenia, neutropenia and agranulocytosis were noted. The development of unexplained infections or fever may be signs of blood disorders, which requires the immediate implementation of hematological studies.
Use in children
In connection with the influence of sulpiride on cognitive processes in children, it is necessary to monitor the ability to learn annually. It is necessary to regularly adjust the dose taking into account the clinical condition of the child.