12 August

Serdolekt - instruction , application reviews

Contents:

1. active substance

2. Product form

3. Composition

4. Indications

5. Contraindications

6. dosage and Administration

7. Side effects

8. Cautions

9. Terms and Conditions of storage

Serdolekt - antipsychotic (neuroleptic).

active substance

Sertindole (Sertindole).

Product form

Serdolekt is available in tablet form.The preparation is realized in a blister 10 and 14 pcs., Are placed into cardboard boxes.

Composition

Tablets

Table 1.

Sertindole

4 mg

12 mg

16 mg

20 mg

Excipients: lactose monohydrate, corn starch, giproloza, MCC, croscarmellose sodium, magnesium stearate.

shell composition: titanium dioxide (E171), hypromellose, iron oxide yellow (E172), macrogol 400.

Indications

indications for the drug is schizophrenia.

Contraindications Contraindications to receiving the drug:

  • Congestive heart failure.
  • Severe cardiovascular disease (including history).
  • bradycardia (less than 50 beats / min).
  • Arrhythmias.
  • myocardial hypertrophy.
  • Uncorrected hypokalemia or hypomagnesemia.
  • acquired prolongation of the interval QT (470 msec in females and more than 450 msec in males).
  • syndrome Congenital prolongation of the interval QT (including family history).
  • Severe hepatic insufficiency.
  • Simultaneous use of medicines, prolonging the interval the QT, including some antipsychotic drugs (thioridazine), macrolide antibiotics (erythromycin), quinolone antibiotics (gatifloxacin), antihistamines (astemizole, terfenadine), class IA antiarrhythmics and III (amiodarone, sotalol, dofetilide,quinidine), as well as drugs lithium cisapride.
  • Concomitant use of drugs that inhibit CYP3A isozymes, including some macrolide antibiotics (clarithromycin, erythromycin), antifungals (ketoconazole, itraconazole), cimetidine, calcium channel blocker (diltiazem, verapamil), HIV protease inhibitors (indinavir).
  • Pregnancy and breast-feeding (lactation).
  • Children and teens under 18 years of age (efficacy and safety have not been established).
  • Increased individual sensitivity to the ingredients of the drug.

Dosage and Administration

Serdolekt taken orally 1 time / day, regardless of meals.

The recommended starting dose is 4 mg / day.Every 4-5 days the daily dose increased to 4 mg until the optimal dose range from 12 mg / day to 20 mg / day.The maximum dose of 24 mg / day of the drug is used in exceptional cases (with increasing doses there is a risk of QT interval prolongation).

elderly patients before prescribing the drug is required to conduct a thorough diagnosis of the cardiovascular system.Increasing the dose of the drug should be carried out slowly, taking a lower dose.

In patients with moderate or mild hepatic impairment need to increase the dose more slowly.In general, the drug for this patient is assigned at lower doses.

In patients with renal insufficiency, the dosage regimen is not necessary to adjust.Hemodialysis pharmacokinetics Serdolekta not affected.

If the re-appointment of the drug after discontinuation passed less than a week, then gradually increase the dose is not necessary (you can assign Serdolekta at the same dose).In all other cases, increase the dose to the optimum must be gradually titrated (before titration, patients should undergo an electrocardiogram-research).

When switching from another oral antipsychotic therapy Serdolektom can start with gradual dose escalation, together with the abolition of the previous drug.

Side effects

use of the drug may cause the following side effects:

  • Cardiovascular system: lengthening the interval QT, peripheral edema, postural hypotension (occurs early in treatment and is transient);rarely - paroxysmal ventricular tachycardia (including arrhythmia for "pirouette" type).
  • Central nervous system: paresthesia, dizziness;rare - movement disorders (including tardive dyskinesia), seizures, syncope;in some cases - neuroleptic malignant syndrome (NMS).Extrapyramidal symptoms on the background use of sertindole appear with the same frequency as that during the placebo treatment.
  • urinary system: rarely - hematuria, leucocyturia.
  • Respiratory system: shortness of breath, difficulty in nasal breathing, rhinitis.
  • Other : sometimes - a decrease in ejaculate volume, weight gain, dry mouth;rarely - hyperglycemia.

Symptoms of overdose: transient elongation QT interval, slurred speech, drowsiness, decreased blood pressure, tachycardia.Perhaps the appearance of paroxysmal ventricular tachycardia (arrhythmia type "pirouette") at complex application of sertindole with drugs that cause this type of side effect.

Cautions

In connection with the safety precautions associated with ECG monitoring and an increase in the QT interval, the drug should be taken only if the patient has already been marked intolerance to at least one antipsychotic.

Serdolekta When taken in high doses (20-24 mg / day) increases the risk of QT interval prolongation.This phenomenon may lead to the development of ventricular paroxysmal tachycardia and sudden death.

At the beginning of the maintenance treatment and during dose adjustment is necessary to monitor blood pressure.

Prior to the appointment of the drug to the patient is required to perform an ECG study.

During maintenance treatment, ECG study should be carried out every 3 months.This should be done before and after the increase in dose or after joining Serdolekta either increasing doses of the drug, which can increase the concentration of sertindole in the blood.

The drug should be discontinued at lengthening the QT interval of more than 500 ms.

When the patient symptoms such as syncope, convulsions, palpitations indicating the possible presence of arrhythmias, the physician must examine the patient as quickly as possible, including the conduct of ECG.This study is desirable to prescribe the morning.

Patients at risk of electrolyte abnormalities before starting drug treatment should measure the magnesium and potassium levels in the blood serum.Hypomagnesemia and hypokalemia must be corrected prior to use Serdolekta.Makers kaliyvyvodyaschie diuretics, patients with diarrhea and vomiting, and other electrolyte disorders is recommended to control the level of potassium in the blood plasma.

Antipsychotic medications (including Serdolekt) can inhibit the action of dopamine agonists.The drug should be administered with caution to patients with Parkinson's disease.

In moderate or minor degree of functional disorders of the liver requires careful monitoring of the patient.It is also recommended that the slower increase in the dosage of the drug and a lower maintenance dose.

Serdolekt should be used with caution in patients with a history of seizures.

Due to the prolonged use of antipsychotic drugs, especially in high doses, there is the risk of dyskinesia.If background use Serdolekta appear its symptoms, the dose should be reduced or completely stop the drug.

In cases of neuroleptic malignant syndrome requires immediate withdrawal of the drug.

With a sharp lifting of the drug may experience insomnia, increased sweating, nausea, vomiting.It is also possible the development of involuntary movement disorders (dystonia, akathisia, dyskinesia) and the return of psychotic symptoms.In this case, a gradual withdrawal of the drug.

Since the safety of the drug during pregnancy has not been studied, it should not be administered to pregnant women.In cases where the use of Serdolekta deemed necessary, it is necessary to stop breastfeeding.

patients with lactase deficiency, hereditary galactose intolerance or impaired absorption of glucose and galactose Serdolekt appointed should not.

Although the drug has no sedation, patients are not recommended on the background of his admission to drive a car or operate other machinery.This limitation is valid as long as there is no set individual tolerability Serdolekta.

Conditions and terms

Keep out of direct sunlight at a temperature not exceeding +25 ° C.

Keep away from children.

Shelf life - 5 years.

Attention!

Product description posted on this page is a supplement and a simplified version of the official version of the annotations to the drug.The information is provided for informational purposes only and is not a guide to self-medication.Before using the product you should consult with a specialist and to get acquainted with the instructions approved by the manufacturer.

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