Solian, bottle 100mg/ml, 60ml

Composition

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1 ml contains:

amisulpride 100 mg

Pharmacological action

Solian – an antipsychotic drug (neuroleptic), has a neuroleptic, antipsychotic effect. Amisulpride has a high selective affinity for dopaminergic receptors of subtypes D2 /D3 and does not have affinity for subtypes D1, D4 and D5.

Unlike classical and atypical antipsychotics, amisulpride has no affinity for serotonin receptors, histamine H1-receptors, ?- adrenoreceptors and holinoreceptors.

When used in high doses, it blocks postsynaptic D2 receptors localized in limbic structures, in contrast to similar striatum receptors. It does not cause catalepsy and does not lead to the development of hypersensitivity of dopamine D2 receptors after repeated treatment.

At low doses, it predominantly blocks presynaptic D2 /D3 receptors, stimulating dopamine release. An atypical pharmacological profile determines the antipsychotic effect of amisulpride in high doses, which occurs due to blockade of postsynaptic dopamine receptors, and its effectiveness in low doses against negative symptoms resulting from blockade of presynaptic dopamine receptors.

Amisulpride is less likely to cause extrapyramidal side effects, which may be due to its predominant limbic activity.

In patients with schizophrenia with acute attacks, Solian acts on both secondary negative symptoms and affective symptoms (including depressive mood and retardation).

Indications

Acute and chronic schizophrenia, accompanied by pronounced productive (including delusions, hallucinations, thinking disorders) and/or negative (including affective flatness, lack of emotionality, and withdrawal from communication) disorders, including in patients with a predominance of negative symptoms.

Use during pregnancy and lactation

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

Therefore, the use of the drug during pregnancy is not recommended, except in cases where the intended benefit to the mother justifies the potential risk to the fetus.

The use of amisulpride during lactation is contraindicated.

Contraindications

-Concomitant prolactin-dependent tumors (including pituitary prolactinoma, breast cancer). – Pheochromocytoma. – Severe renal insufficiency ( creatinine clearance less than 10 ml / min). – Combined use with sultoprid. – Combined use with dopaminergic agonists (including amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole, selegiline), except in patients with Parkinson’s disease. – Children under 14 years of age. – Lactation period (breastfeeding). – Hypersensitivity to amisulpride and other components of the drug.

The drug should be used with caution during: – Pregnancy. – Epilepsy. – Parkinsonism. – Kidney failure. – In elderly patients.

Side effects

From the central nervous system: Often – insomnia, anxiety, agitation; sometimes – extrapyramidal symptoms (including tremor, hypertension, hypersalivation, akathisia, hypokinesia), the intensity of which is usually moderate at maintenance doses, the symptoms are partially reversible without discontinuation of Solian with anticholinergic antiparkinsonian agents (the frequency of dose – dependent extrapyramidal symptoms remains very low when treating patients with a predominance of negative symptoms at doses of 50-300 mg/kg). spastic torticollis, oculogyric crises, trismus), which is reversible and corrected with antiparkinsonian drugs; with prolonged use – tardive dyskinesia, characterized by rhythmic, involuntary movements mainly of the tongue and/or face (antiparkinsonian drugs are ineffective and can cause worsening of symptoms); in isolated cases – neuroleptic malignant syndrome, which is associated with the use of antiparkinsonian drugs. convulsive seizures.

From the digestive system: Rarely-constipation, nausea, vomiting, dry mouth; in some cases-increased activity of liver enzymes (mainly transaminases).

From the endocrine system: Often-an increase in the level of prolactin in blood plasma (reversible after discontinuation of the drug), which can cause galactorrhea, amenorrhea, gynecomastia, breast swelling, impotence, frigidity, and weight gain.

From the cardiovascular system: Rarely-hypotension, bradycardia, prolongation of the QT interval; very rarely-atrial fibrillation.

Other services: In some cases – allergic reactions.

Interaction

Combinations that are contraindicated: With dopaminergic agonists (including amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole, selegiline), except in patients with Parkinson’s disease. Dopaminergic agonists and antipsychotics exhibit mutual antagonism. In the case of extrapyramidal syndrome caused by neuroleptics, anticholinergic drugs should be used instead of dopaminergic agonists. Concomitant use of Solian with sultoprid increases the risk of ventricular arrhythmias, especially atrial fibrillation.

Combinations that are not recommended: With medications that may cause pirouette-type arrhythmias: Class Ia antiarrhythmic drugs (including quinidine, hydroquinidine, disopyramide ) amiodarone, sotalol, dofetilide, ibutilide), some neuroleptics (including thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, tiapride, pimozide, haloperidol, droperidol ) and other drugs (including bepridil, cisapride, difemanil, intravenous erythromycin, mizolastine, iv vincamine, halofantrine, sparfloxacin, gatifloxacin, moxifloxacin, pentamidine, iv spiramycin). There is an increased risk of ventricular arrhythmias, especially the development of arrhythmias of the “pirouette” type. If the combination of drugs cannot be avoided, before prescribing, monitor the QT interval and start monitoring the ECG. Ethanol enhances the sedative effects of neuroleptics. Alcohol consumption and the use of medicines containing alcohol should be avoided. The mutual antagonism of levodopa and neuroleptics should be taken into account when prescribing these drugs. In patients with Parkinson’s disease, the minimum effective dose of both drugs is recommended.

Combinations requiring special caution: With drugs that cause bradycardia (including beta-blockers /except sotalol/ calcium channel blockers that cause bradycardia – diltiazem and verapamil), clonidine, guanfacine, digitalis preparations, cholinesterase inhibitors (including donepezil, rivastigmine, tacrine, ambenonium, galantamine, pyridostigmine, neostigmine). With drugs that may cause hypokalemia (including potassium-withdrawing diuretics, laxatives, intravenous amphotericin B, glucocorticoids, tetracosactides). With the above-mentioned combinations of drugs, the risk of ventricular arrhythmias remains, especially the development of arrhythmias of the “pirouette”type.

Combinations to be considered: With antihypertensive agents and beta-blockers in heart failure (including bisoprolol, carvedilol, metoprolol ) has a vasodilating effect, increasing the risk of orthostatic hypotension (additive effect). With morphine derivatives (including analgesics, antitussives), barbiturates, benzodiazepines and other anxiolytics, sleeping pills, sedative antidepressants (including amitriptyline, doxepin, mianserin, mirtazapine, trimipramine ), sedative antihistamines, antihypertensive agents of central action, neuroleptics and other drugs (including baclofen, thalidomide, pisotifen ) leads to a pronounced increase in the depressive effect on the central nervous system (concentration of attention decreases and there is a danger for transport drivers and machine operators).

How to take, course of use and dosage

In acute psychotic episodes, the recommended dose is 400 to 800 mg / day. In some cases, if necessary, the dose can be increased to 1200 mg / day. Doses are increased taking into account the individual tolerability of the drug. The maximum daily dose should not exceed 1200 mg.

For mixed negative and productive symptoms, doses should be selected so as to ensure optimal control over productive symptoms: on average, from 400 mg to 800 mg/day, Maintenance treatment should be set individually at the minimum effective dose level.

The recommended daily dose varies from 50 to 300 mg. The selection of doses should be individual.

In elderly patients, Solian should be administered with extreme caution due to the possible development of arterial hypotension or excessive sedation.

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

Overdose

Experience with amisulpride overdose is limited.

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

Treatment: in case of acute overdose, a possible combination with other drugs should be investigated and the necessary measures taken: careful monitoring of vital functions of the body; ECG monitoring (risk of prolongation of the QT interval); in case of serious extrapyramidal symptoms, anticholinergic agents should be prescribed. Hemodialysis is ineffective. There is no specific antidote for amisulpride.

Special instructions

Neuroleptic malignant syndrome may develop, characterized by hyperthermia, muscle rigidity, peripheral nervous system dysfunction, and elevated CPK levels. If hyperthermia develops, especially when used in high doses, all antipsychotic drugs (including Solian) should be discontinued.

Since the elimination of amisulpride is carried out by the kidneys, in case of serious renal impairment, the dose of the drug and the therapy regimen should be adjusted. There is no experience of using the drug in patients with severe renal impairment ( creatinine clearance less than 10 ml/min).

Since the drug is poorly metabolized, no dose reduction is required in patients with impaired liver function.

Due to the possible reduction of the seizure threshold when using amisulpride, patients with a history of epilepsy require constant monitoring during therapy with Solian.

In elderly patients, amisulpride should be used with special precautions due to the possible risk of hypotension or excessive sedation.

In Parkinson’s disease, caution should be exercised when prescribing anti-dopaminergic drugs and amisulpride because of the possible deterioration of the condition. Amisulpride should only be used if antipsychotic therapy cannot be avoided.

Amisulpride causes a dose-dependent prolongation of the QT interval, thereby increasing the risk of developing serious ventricular arrhythmias (such as “pirouette”). Before prescribing the drug, and, if possible, depending on the patient’s clinical condition, it is recommended to monitor factors that contribute to the development of arrhythmia: bradycardia (heart rate less than 55 beats/min), hypokalemia, congenital prolongation of the QT interval.

In patients who require long-term treatment with neuroleptics, an ECG should be performed at the initial assessment of the status.

Due to the content of lactose in tablets, the drug is contraindicated in congenital galactosemia, glucose or galactose absorption disorder syndrome, or in lactase deficiency.

Influence on the ability to drive motor vehicles and manage mechanisms: Amisulpride affects the reaction rate, so that the ability to engage in potentially dangerous activities can be weakened.

Form of production

Solution for oral use

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Amisulpride

Conditions of release from pharmacies

By prescription

Dosage form

oral solution