The risk of increase of the interval is increased by concomitant treatment with drugs prolong the interval or inhibit the metabolism of sertindole. Using Serdolekta concurrently with such drugs is prohibited. Sertindole is metabolized via the cytochrome nandrolone phenylpropionate profile.
Sertindole concentration in plasma increased by simultaneous reception with drugs that inhibit cytochrome. It may require the appointment of a lower maintenance dose, as well as conducting an examination before and after the change in the dose of these drugs.
In turn, sertindole and its main metabolites have a weak inhibitory effect on cytochrome, which are metabolized via β-blockers, antiarrhythmics, antihypertensives, some, a large number of antipsychotic drugs and antidepressants.
Simultaneous use of sertindole and antibiotics, macrolides (erythromycin) and calcium channel blockers (diltiazem, verapamil) may result in a slight increase in sertindole plasma concentrations.However, the degree of increase may be higher in patients with low activity of cytochrome. As set routinely these patients is quite difficult, the simultaneous application of sertindole and drugs which inhibit the cytochrome is contraindicated, as it may lead to significant increases in the plasma concentration nandrolone phenylpropionate profile of sertindole.
The metabolism of sertindole may be significantly intensified, leading to a decrease in its plasma concentration, under the influence of these drugs – rifampicin, carbamazepine, phenytoin, phenobarbital.Reduced activity antipsychotic sertindole in such cases may require increasing the dose.
Due to the precautionary measures associated with an increase in the interval and monitoring, sertindole should be appointed in cases where there is already a intolerance to at least one other antipsychotic agent.
Danger interval prolongation greater at higher doses interval elongation when receiving a number of drugs can lead to the development of paroxysmal ventricular tachycardia, and sudden death.
Blood pressure monitoring is required during the dose titration period at the beginning and maintenance therapy.
The cardiovascular system
When interval of more than 450 msec in males and 470 msec in females should not be given Serdolekt.
study should be conducted prior to the appointment of the drug, when the equilibrium concentration of about 3 weeks after the start of the reception, or a daily dose of 16 mg, and 3 months after the start treatment. During maintenance therapy an nandrolone phenylpropionate profile study should be carried out every 3 months.
During maintenance therapy study should be conducted before and after increasing the dose of sertindole or accession / increase the dose, which can increase the concentration of sertindole in the blood.
When extending interval over 500 msec sertindole should be canceled.
When the patient symptoms such as palpitations, convulsions, fainting, pointing to the possibility of arrhythmia, your doctor should immediately begin examination of the patient, including .
Perform ECG study, preferably in the morning.
in patients at risk of electrolyte abnormalities should be expressed before treatment Serdolektom measure levels of potassium and magnesium in the blood serum. Hypokalemia and hypomagnesemia should be corrected prior to use of sertindole. We recommend monitoring the concentration of potassium in the blood plasma of patients with diarrhea and vomiting in patients receiving diuretics kaliyvyvodyaschie, as well as other electrolyte disorders.
Antipsychotic drugs may inhibit the effects of dopamine agonists. Serdolekt should be used with caution in patients with Parkinson’s disease.
Reduced liver function
If a minor or moderate impaired liver function requires careful monitoring of the patient. Recommended dosage slower increase and lower maintenance dose.
Serdolekt should be administered with caution in patients with a history of seizures.
Long-term use of antipsychotic drugs, especially in high doses, is associated with the risk of tardive dyskinesia. If in patients receiving sertindole its symptoms appear, it is necessary to reduce the dosage or stop the drug entirely.
Neuroleptic malignant syndrome (NMS)
In the cases of NMS require immediate removal of the drug.
In the abrupt cancellation of antipsychotics can cause nausea, vomiting, sweating, insomnia. It is also possible the return of psychotic symptoms and the emergence of involuntary movement disorders (akathisia, dystonia, dyskinesia). You need gradual withdrawal of the drug.
The tablets contain lactose monohydrate. Patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose absorption disorder and the drug should not be administered.
Pregnancy and lactation
Since Serdolekta safety during pregnancy has not been studied in humans, this drug should not be administered to pregnant women.
The safety of Serdolekta in breastfeeding women has not been studied. In cases where the use of sertindole deemed necessary, should stop breastfeeding.
Children and Youth age (up to 18 years)
The safety and efficacy Serdolekta children and youths has not been studied, so the drug should not be used in childhood and adolescence.
Effects on ability to drive a car or other mechanisms
Although Serdolekt does not have a sedative effect, it is not recommended for patients on the background of his admission to drive a car or other nandrolone phenylpropionate profile arrangements as long as the individual tolerance of the drug is established. cytover t3