LYMIPRANIL 400MG PILLS

Indications

- acute and chronic schizophrenia, accompanied by pronounced productive (including delusions, hallucinations, mental disorders) and / or negative (including affective flattening, lack of emotionality and avoiding communication) disorders, including in patients with a predominance of negative symptoms.

Dosage and administration

The drug is taken orally.

At acute psychotic episodes The recommended dose is 400 to 800 mg / day. In some cases, if necessary, the dose may be increased to 1200 mg / day. Doses increase, taking into account the individual tolerance of the drug.

The safety of the drug in doses of more than 1200 mg / day has not been studied sufficiently, so this dose should not be exceeded.

At mixed negative and productive symptoms The dose should be taken individually and in such a way as to ensure optimal control over the productive symptoms. Maintenance treatment should be set individually at the level of the minimum effective dose.

At prevalence of negative symptoms The recommended daily dose ranges from 50 to 300 mg. Selection of doses should be individual.

In doses exceeding 400 mg / day, Lymipranil should be administered in 2 doses.

Elderly patients Lymipranil should be prescribed with extreme caution because of the possible development of arterial hypotension or excessive sedation.

At renal failure dose for patients with QC from 30 to 60 ml / min should be reduced to 1/2, with QC from 10 to 30 ml / min - up to 1/3.

Adverse effects

From the side of the central nervous system: 5-10% - insomnia, anxiety, agitation; 0.1-5% - drowsiness; perhaps - acute dystonia (including spastic torticollis, oculograptic crises, trismism), which is reversible and corrected with anticholinergic anti-parkinsonian agents; the frequency of dose-dependent extrapyramidal symptoms (tremor, increased blood pressure, hypersalivation, akathisia, hypokinesia) remains very low in the treatment of patients with a predominance of negative symptoms of the drug in doses of 50-300 mg / day; with prolonged use - tardive dyskinesia, characterized by rhythmic, involuntary movements, mainly of the tongue and / or face (anti-Parkinsonian drugs are ineffective and can cause worsening of symptoms); in isolated cases - convulsive seizures, ZNS.

Gastrointestinal: 0.1-5% - constipation, nausea, vomiting, dry mouth; rarely - increased activity of liver enzymes (mainly transaminases).

On the part of the endocrine system: increased levels of prolactin in blood plasma (reversible after discontinuation of the drug), which can cause galactorrhea, amenorrhea, gynecomastia, chest pain, impotence, weight gain.

Cardiovascular: rarely, arterial hypotension, bradycardia, prolongation of the QT interval; very rarely - atrial fibrillation.

Other: rarely - allergic reactions.

Contraindications

- concomitant prolactin-dependent tumors (including pituitary prolactinoma, breast cancer);

- pheochromocytoma;

- children's age up to 15 years;

- pregnancy;

- lactation period (breastfeeding);

- women of childbearing age who do not use adequate contraception;

- combinations with the following drugs that can contribute to the development of atrial fibrillation: antiarrhythmic drugs of class A A (quinidine, disopyramide, procainamide), class III antiarrhythmic drugs (amiodarone, sotalol); other drugs (bepridil, cisapride, sultoprid, thioridazine, Erythromycin in / in, vincamine, halofantrine, pentamidine, sparfloxacin);

- combination with levodopa;

- hypersensitivity to the drug.

WITH caution the drug should be used for epilepsy, parkinsonism, renal failure, in elderly patients.

Use during pregnancy and lactation

The drug is contraindicated in pregnancy and lactation (breastfeeding).

The safety of using amisulpride during pregnancy has not been established.

It is not known whether amisulpride will be excreted in breast milk.

Application for violations of kidney function

WITH caution should use the drug for renal failure.

Use in children

Contraindicated in children and adolescents up to 15 years.

Use in elderly patients

WITH caution the drug should be used in elderly patients.

Special notes

It is possible to develop NNS, characterized by hyperthermia, muscle rigidity, dysfunction of the peripheral nervous system, elevated levels of CPK. With the development of hyperthermia, especially against the background of the use in high doses, all antipsychotics (including Limipranil) should be canceled.

Since the removal of amisulpride is carried out by the kidneys, in case of serious impaired renal function, the dose of the drug and the treatment regimen should be adjusted. Experience with the use of the drug in patients with severe disorders (CC <10 ml / min) no kidney function, therefore, in such cases, special care is required.

Since the drug is poorly metabolized, with abnormal liver function, a dose reduction is not required.

In connection with a possible decrease in the convulsive threshold in the application of amisulpride to patients with epilepsy in history, constant monitoring is required during Lymipranil therapy.

In elderly patients, Lymipranil, like other antipsychotics, should be used with extreme caution because of the possible risk of arterial hypotension or excessive sedation.

In Parkinson's disease, when prescribing antidopaminergic drugs and Lymipranil, caution is necessary because of possible deterioration of the condition. Lymipranil should only be used if antipsychotic therapy cannot be avoided.

Lymipranil causes a dose-dependent lengthening of the QT interval, thereby increasing the risk of developing serious pirouette ventricular arrhythmias. Prior to the appointment of the drug and during the treatment period, depending on the clinical condition of the patient, it is recommended to control the factors contributing to the development of arrhythmias such as "pirouette": bradycardia (HR <55 beats / min); hypokalemia; congenital prolongation of the QT interval; simultaneous use of drugs that can cause severe bradycardia (<55 beats / min), hypokalemia, decreased conduction or prolonged QT interval.

Influence on ability to drive motor transport and control mechanisms

Amisulpride affects the reaction rate, with the result that the ability to engage in potentially hazardous activities can be impaired.

Overdosage

The experience associated with overdose of amisulpride is limited.

Symptoms: enhancing the known pharmacological effects of the drug (including drowsiness, sedation, hypotension, extrapyramidal symptoms, coma).

Treatment: in acute overdose, the possibility of the interaction of several drugs should be assumed. There is no specific antidote for amisulpride. Strict control of the vital functions of the body is recommended; continuous monitoring of the heart condition (risk of prolongation of the QT interval) until the patient’s condition is restored. If serious extrapyramidal symptoms appear, anticholinergics should be prescribed.Hemodialysis is ineffective.

Drug interaction

Combinations are contraindicated with drugs that can cause ventricular pirouette arrhythmia: class I antiarrhythmic drugs (quinidine, disopyramide, procainamide), class III antiarrhythmic drugs (amiodarone, sotalol); other drugs (bepridil, cisapride, sultoprid, thioridazine, i.v. erythromycin, i.v. vincamine, halofantrine, pentamidine, sparfloxacin);

There is mutual antagonism of the action of levodopa and neuroleptics.

Combination not recommended with alcohol, because Amisulpride enhances the inhibitory effect of ethanol on the central nervous system.

Combinations requiring special care: with drugs that cause bradycardia (including beta-blockers, Calcium channel blockers, causing bradycardia - diltiazem and verapamil), clonidine, guanfacine, and digitalis preparations.

With drugs that can cause hypokalemia - potassium and diuretics, laxatives, amphotericin B, GCS, tetrakozaktidy (hypokalemia should be corrected).

With neuroleptics such as pimozide, Haloperidol ; tricyclic antidepressants (imipramine); with lithium preparations.

Combinations to be taken into account: combination with drugs that inhibit the function of the central nervous system, including narcotic analgesics, antipsychotics (neuroleptics), antihistamines with a sedative effect, barbiturates, benzodiazepines and other anxiolytic drugs leads to a pronounced increase in the inhibitory effect; with antihypertensive drugs - increased antihypertensive action.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 30 ° C.