Serdolect - Instructions For Use, Reviews, Price, Analogs Of Tablets

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Serdolect

Serdolect: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Serdolect

ATX code: N05AE03

Active ingredient: sertindole (sertindole)

Manufacturer: H. Lundbeck, A / S (Denmark)

Description and photo update: 2019-26-08

Prices in pharmacies: from 2089 rubles.

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Serdolect is an antipsychotic drug (neuroleptic).

Release form and composition

Dosage form of Serdolect - coated tablets: oval, biconvex:

• 4 mg - pale yellow, with the symbol "S4" on one side (10 pcs. In blisters, in a cardboard box 2 or 3 blisters);
• 12 mg - pale yellow-brown color, with the symbol "S12" on one side (14 pcs. In blisters, in a cardboard box 1, 2 or 4 blisters);
• 16 mg - brownish-pink color, with the symbol "S16" on one side (14 pcs. In blisters, in a cardboard box 1, 2 or 4 blisters);
• 20 mg - pale pink, with the "S20" symbol on one side (14 pcs. In blisters, in a cardboard box 1, 2 or 4 blisters).

Active ingredient: sertindole, in 1 tablet - 4, 12, 16 or 20 mg.

Auxiliary components: microcrystalline cellulose, lactose monohydrate, hyprolose, croscarmellose sodium, magnesium stearate, corn starch.

Shell composition: macrogol 400, hypromellose, titanium dioxide (E171), as well as dyes: in tablets 4 mg - iron oxide yellow (E172), 12 mg - iron oxide yellow (E172) and iron oxide red (E172), 16 mg - iron oxide red (E172), 20 mg - iron oxide red (E172), iron oxide yellow (E172) and iron oxide black (E172).

Pharmacological properties

Pharmacodynamics

Sertindole is an atypical neuroleptic that belongs to the group of phenylindole derivatives. The neuropharmacological profile of this substance, which has antipsychotic properties, is associated with the selective blockade of mesolimbic dopaminergic neurons. Sertindole also has a balanced inhibitory effect on serotonin 5HT ₂ -receptors and central dopamine D ₂ -receptors, as well as on α ₁ -adrenergic receptors.

Antipsychotic drugs usually increase serum prolactin levels due to blockade of dopamine receptors. In patients who took Serdolect both during a short course of treatment and as a means of long-term therapy (up to 1 year), the prolactin concentration did not significantly deviate from the normative values.

Sertindole does not affect histamine and muscarinic H ₁ receptors, as evidenced by the absence of sedative and anticholinergic effects due to the effect on these receptors.

Pharmacokinetics

The degree of absorption of sertindole from the intestine is quite high. The maximum concentration of the substance is recorded approximately 10 hours after ingestion. Taking Serdolect with meals does not alter the extent and rate of its absorption.

After repeated use, the apparent volume of distribution of sertindole is approximately 20 l / kg. The degree of binding to blood plasma proteins reaches 99.5%. Sertindole crosses the blood-brain and placental barriers.

The active substance is metabolized in the liver with the participation of cytochrome P450 isoenzymes CYP2D6 and CYP3A. The resulting metabolites have no neuroleptic activity. The half-life is approximately 3 days. Sertindole and its metabolites are excreted primarily through the intestines and partly through the kidneys.

Indications for use

According to the instructions, Serdolect is a drug for the treatment of schizophrenia (with the exception of emergency situations when it is necessary to stop acute psychotic disorders).

Contraindications

• bradycardia (heart rate less than 50 beats / minute);
• arrhythmias;
• severe cardiovascular diseases (including history);
• myocardial hypertrophy;
• congenital (including in family history) or acquired prolonged QT interval (more than 470 msec in women and 450 msec in men);
• congestive heart failure;
• uncorrectable hypokalemia or hypomagnesemia;
• severe liver failure;
• hereditary galactose intolerance, lactase deficiency, impaired absorption of glucose and galactose;
• age up to 18 years;
• the period of pregnancy and breastfeeding;
• the simultaneous use of drugs that can prolong the QT interval, including cisapride, some antipsychotics (for example, thioridazine), lithium drugs, antiarrhythmics of class IA and III (sotalol, dofetilide, amiodarone, quinidine), some quinolone antibiotics (for example, gatifloxacin), some macrolide antibiotics (for example, erythromycin), some antihistamines (for example, terfenadine and astemizole);
• concomitant use of drugs that inhibit CYP3A isoenzymes, including cimetidine, HIV protease inhibitors (for example, indinavir), antifungal agents from the azole group (such as itraconazole and ketoconazole), some calcium channel blockers (for example, verapamil and diltiazem), some antibiotics from the group of macrolides (for example, erythromycin or clarithromycin);
• hypersensitivity to the components of Serdolect tablets.

Carefully:

• Parkinson's disease;
• a history of seizures;
• minor to moderate liver dysfunction.

Instructions for the use of Serdolekt: method and dosage

Serdolect tablets should be taken orally 1 time per day. Food intake does not affect the effectiveness of the neuroleptic.

Treatment begins with a daily dose of 4 mg. Then it is gradually increased by 4 mg every 4-5 days until the optimal therapeutic dose (12-20 mg / day) is reached. In exceptional cases, it is possible to increase the daily dose to 24 mg.

Before the appointment of Serdolekt, elderly people undergo a thorough examination of the cardiovascular system, use lower doses of the drug, and increase the dose more slowly. A similar dosage of the neuroleptic is recommended for patients with mild to moderate hepatic impairment.

In the event of a break in treatment, if it does not exceed 7 days, a gradual increase in the dose is not necessary, that is, Serdolect can be used in the same dose. In all other cases, the dose is increased gradually, by titration, before which an electrocardiographic study is required.

When transferring a patient to Serdolect from another oral antipsychotic, it is recommended to gradually increase the dose while canceling the previous drug. In the case of previous treatment with neuroleptics in the depot form, the first intake of Serdolect should be on the day when the next injection of the depot form should be (instead of it).

Side effects

• from the central nervous system: paresthesia, dizziness; in rare cases - movement disorders (including tardive dyskinesia), syncope, convulsions; in some cases - neuroleptic malignant syndrome;
• on the part of the cardiovascular system: prolongation of the QT interval, peripheral edema, postural hypotension (usually occurs at the beginning of therapy and is transient); in rare cases - paroxysmal ventricular tachycardia (including pirouette-type arrhythmia);
• from the respiratory system: difficulty in nasal breathing, rhinitis, shortness of breath;
• from the urinary system: infrequently - hematuria, leukocyturia;
• others: infrequently - an increase in body weight, dry mouth, a decrease in ejaculate volume; rarely, hyperglycemia.

Overdose

Symptoms of an overdose of Serdolekt are a decrease in blood pressure, a transient increase in the QT interval, tachycardia, slurred speech, drowsiness. In some cases, the development of paroxysms of ventricular tachycardia (of the "torsade de pointes" type) is observed, especially when sertindole is combined with drugs that can provoke this type of side effect.

When treating patients with a diagnosed overdose, it is necessary to immediately cancel Serdolect and take measures to ensure normal airway patency and adequate oxygenation.

It is recommended to immediately start monitoring the most important somatic parameters and ECG. With an increase in the QT interval, ECG monitoring is carried out until this parameter is normalized, and the half-life of sertindole, which varies from 2 to 4 days, should be taken into account. Treatment also includes gastric lavage, laxatives and activated charcoal, and intravenous catheter placement.

There is no specific antidote to sertindole, and the substance cannot be excreted by dialysis, therefore, the appointment of supportive therapy is vital. A sharp decrease in blood pressure and manifestations of vascular collapse require correction, which is carried out using solutions for intravenous administration. When prescribing sympathomimetics, dopamine or adrenaline must be used with caution, since stimulation of β-adrenergic receptors, combined with the antagonistic effect on α ₁ -adrenergic receptors characteristic of sertindole, can contribute to a pronounced decrease in blood pressure.

When using antiarrhythmic drugs, it is necessary to take into account that procainamide, disopyramide, quinidine can potentially prolong the QT interval.

In the event of severe extrapyramidal disorders, anticholinergic drugs may be prescribed. The patient should remain under constant medical supervision until the negative symptoms disappear completely.

special instructions

During the selection of the optimal dose of Serdolekt and at the beginning of maintenance therapy, it is necessary to control blood pressure.

The monitoring of the electrocardiogram (ECG) is shown before the appointment of Serdolekt and in the process of its use: upon reaching a daily dose of 16 mg or an equilibrium state (about 3 weeks after the start of treatment), then 3 weeks after the start of therapy. During maintenance therapy, an ECG is recommended every 3 months. In addition, an ECG should be performed before and after increasing the dose of the drug, as well as in the case of concomitant administration or increasing the dose of another drug that can increase the concentration of sertindole in the blood.

When taking Serdolect in high doses (20-24 mg / day), the risk of prolongation of the QT interval increases. Prolongation of the QT interval, resulting from the concomitant use of certain drugs, can lead to the development of paroxysmal ventricular tachycardia and even sudden death.

If the QT interval is prolonged above 500 msec, Serdolect should be canceled. If a patient develops fainting, palpitations, seizures, or other symptoms that may indicate the development of arrhythmia, it is necessary to immediately examine the patient, including an electrocardiographic study (preferably in the morning).

Patients with risk factors for the development of electrolyte disturbances before the appointment of Serdolect need to determine the concentration of magnesium and potassium in the blood serum. If hypomagnesemia and / or hypokalemia is identified, these conditions should be corrected before starting treatment.

In patients with diarrhea and vomiting or electrolyte disturbances, as well as with the concomitant use of potassium-excreting diuretics during treatment, it is necessary to regularly monitor the concentration of potassium in the blood serum.

Sertindole can inhibit the effects of dopamine agonists and should therefore be used with caution in patients with Parkinson's disease.

Patients with mild and moderate liver dysfunction should be under constant supervision. A slower dose increase and a lower maintenance dose are recommended.

With prolonged use of antipsychotics, especially in high doses, the risk of developing tardive dyskinesia increases. If symptoms appear that indicate the development of this disorder, the dose of Serdolect should be reduced or canceled altogether.

With the development of a neuroleptic malignant syndrome, it is necessary to immediately cancel Serdolect.

In case of abrupt discontinuation of treatment, insomnia, increased sweating, nausea and vomiting may occur. In addition, a resumption of psychotic symptoms, the appearance of involuntary movement disorders (dystonia, akathisia, dyskinesia) is possible. For this reason, Serdolect should be phased out.

Influence on the ability to drive vehicles and complex mechanisms

At the beginning of treatment, it is recommended to refrain from driving and performing potentially hazardous activities. Further, the degree of restriction is determined individually.

Application during pregnancy and lactation

During pregnancy and while breastfeeding, taking Serdolect is prohibited.

Pediatric use

Serdolect is not prescribed for children and adolescents under the age of 18.

For violations of liver function

Patients with mild to moderate hepatic impairment should take the drug with caution. For such patients, Serdolect is first prescribed in low doses, and then gradually increased.

Patients with severe hepatic insufficiency are contraindicated to take the drug.

Use in the elderly

Serdolect is used with caution in elderly patients.

Drug interactions

With the concomitant use of drugs that prolong the QT interval or inhibit the metabolism of sertindole, the risk of prolongation of the QT interval increases, therefore such combinations are contraindicated.

Due to the risk of a significant increase in the concentration of sertindole in the blood plasma, the simultaneous use of calcium channel blockers and antibiotics from the macrolide group is contraindicated.

Medicines that inhibit the isoenzyme CYP2D6 (for example, paroxetine, fluoxetine, quinidine) may increase the concentration of sertindole in the blood plasma, and therefore may require a reduction in the dose of Serdolect, as well as an ECG study before and after changing doses of drugs.

Sertindole may have a weak inhibitory effect on the CYP2D6 isoenzyme involved in the metabolism of antidepressants, antiarrhythmics, beta-blockers, many antipsychotics and some antihypertensive drugs.

In the case of the simultaneous use of phenytoin, carbamazepine, rifampicin and phenobarbital can significantly increase the metabolism of sertindole, as a result of which a significant decrease in its concentration in blood plasma is possible. In such cases, an increase in the dose of Serdolekt is required.

Analogs

Serdolect's analogs are: Zeldox, Sertindol, Risperidone, Zipsila, Sulpiride, Rileptid, etc.

Terms and conditions of storage

Keep out of the reach of children, protected from light at temperatures up to 25 ° C.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Serdolekt

According to reviews, Serdolect is often used to treat patients suffering from panic attacks and schizophrenia. Moreover, in all cases it is reported that the treatment was long and continuous (2 years or more). Almost all patients mention the side effects of the drug, which most often include decreased libido, dullness of emotional perception, weight gain, increased appetite, nasal congestion, drowsiness, lethargy, mood swings, depending on weather conditions, headache. If the severity of side effects was significant, specialists predominantly canceled Serdolect and prescribed another neuroleptic.

However, most patients respond positively to the drug, noting an improvement in intelligence and quality of life compared to taking conventional antipsychotics, no confusion and disappearance of symptoms of the disease, as well as progress in socialization. The advantage of Serdolect is the lack of suppression of cognitive functions, which it even stimulates.

Price for Serdolect in pharmacies

On average, the price for Serdolect with a dosage of 4 mg is 21192420 rubles (the package contains 30 tablets). You can buy a drug with a dosage of 12 mg for about 4823-5784 rubles, and with a dosage of 16 mg for 5300-6980 rubles (each pack contains 28 tablets). Serdolect with a dosage of 20 mg is sold at a price of 9,000 rubles per pack of 28 tablets.

Serdolect: prices in online pharmacies

Drug name Price Pharmacy

Serdolect 4 mg film-coated tablets 30 pcs. 2089 RUB Buy

Serdolect 12 mg film-coated tablets 28 pcs. RUB 5069 Buy

Serdolect 16 mg film-coated tablets 28 pcs. RUB 5,999 Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!