Solian, 100 mg/ml, oral solution, 60 ml, 1 pc.

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Manufacturers: Sanofi-Aventis

Active ingredients

• Amisulpride

Disease class

• Schizophrenia

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Neuroleptic
• Antipsychotic

Pharmacological group

• Neuroleptics

Pharmacological properties of the drug Solian

Pharmacodynamics. Amisulpride is an antipsychotic drug belonging to the class of substituted benzamides. Amisulpride binds selectively and with high affinity to subtypes D2/D3 of opaminergic receptors. Amisulpride has no affinity for serotonin, histamine, adrenergic and cholinergic receptors. When used in high doses, it blocks predominantly dopaminergic neurons localized in the mesolimbic structures, and not in the striatal system. This specific affinity explains the predominantly antipsychotic effect of amisulpride. At low doses, it preferentially blocks presynaptic D2/D3 receptors, which explains its effect on the negative symptoms of schizophrenia. In a controlled (with haloperidol), double-blind clinical trial involving 191 patients with acute schizophrenia, Solian significantly reduced the severity of secondary negative symptoms of the disease to a significantly greater extent than haloperidol. Pharmacokinetics. After oral administration of amisulpride, two absorption peaks are observed: one is achieved quickly, one hour after administration, and the second - between 3 and 4 hours after administration. The concentration in blood plasma is 39±3 and 54±4 ng/ml, respectively, after taking a dose of 50 mg. The volume of distribution is 5.8 l/kg. Since plasma protein binding is low (16%), interaction with other drugs is unlikely. Absolute bioavailability is 48%. Amisulpride is poorly metabolized in the body; Two of its inactive metabolites have been identified, constituting approximately 4% of the administered dose. There is no accumulation of amisulpride; its pharmacokinetics remains unchanged after repeated doses. The half-life of amisulpride after oral administration is approximately 12 hours. Amisulpride is excreted unchanged in the urine. After IV administration, 50% of the dose is excreted in the urine, with 90% of this amount excreted within the first 24 hours. Renal clearance is approximately 20 l/hour, or 330 ml/min. A carbohydrate-rich meal (containing 68% liquid) significantly reduces AUC, reduces the maximum concentration of amisulpride in the blood and reduces the time to reach it; No changes were noted after eating fatty foods. Due to the fact that the drug is poorly metabolized, there is no need to reduce its dose in patients with impaired liver function. The half-life in patients with renal failure does not change, but systemic clearance decreases by 2.5–3 times. The AUC of amisulpride in mildly severe renal failure increases twice, and in moderately severe renal failure almost tenfold. Practical experience, however, is limited, and there are no results using the drug in doses exceeding 50 mg. Amisulpride is poorly dialyzable. Limited pharmacokinetic data in elderly patients (over 65 years of age) indicate that after a single 50 mg oral dose, an increase in maximum blood concentration, half-life and AUC is observed by 10-30%. There are no data on the effect of repeated doses.

Solian oral solution

Instructions for medical use of the drug

Indications for use

Treatment of acute and chronic schizophrenia with productive symptoms (delusions, hallucinations, thought disorders) and/or negative symptoms (flattening of affect, loss of emotional and social connections), including patients with a predominance of negative symptoms.

Release form

oral solution 100 mg/ml; bottle (bottle) 60 ml with dosing syringe cardboard pack 1.

Pharmacodynamics

Amisulpride is an antipsychotic drug from the group of substituted benzamides. The pharmacodynamic profile of amisulpride is due to its selective and preferential affinity for the D2- and D3-dopaminergic receptor subtypes of the limbic system. Amisulpride has no affinity for serotonin and other neuroreceptors, such as histamine, cholinergic and adrenergic receptors. Animal studies have shown that, when used in high doses, amisulpride blocks dopaminergic neurons in the mesolimbic system to a greater extent than dopaminergic neurons in the striatum. This specific affinity appears to explain the predominance of the antipsychotic effects of amisulpride over its extrapyramidal effects. When used in low doses, amisulpride preferentially blocks presynaptic D2 and D3 dopaminergic receptors, which may explain its positive effect on negative symptoms.

Pharmacokinetics

Amisulpride has two absorption peaks: one is achieved quickly, after an hour, and the second - between 3 and 4 hours after taking the drug. After taking the drug at a dose of 50 mg, the Cmax corresponding to these peaks is (39 ± 3) and (54 ± 4) ng/ml. The volume of distribution is 5.8 l/kg. Due to low plasma protein binding (16%), amisulpride is not expected to interact with other drugs at the protein binding level. Absolute bioavailability is 48%. Amisulpride is slightly metabolized in the liver (about 4%), 2 inactive metabolites have been identified. During a course of treatment, accumulation of amisulpride does not occur, and its pharmacokinetics do not change. When taken orally, T1/2 of amisulpride is approximately 12 hours. Amisulpride is excreted unchanged in the urine. Renal Cl is approximately 330 ml/min. A carbohydrate-rich meal significantly reduces the AUC, Tmax and Cmax of amisulpride, while a fat-rich meal does not cause changes in the above pharmacokinetic parameters. However, the significance of these observations in daily clinical practice is unknown. Kidney failure. T1/2 in patients with renal failure does not change, but systemic clearance decreases by a factor of 2.5 to 3. The AUC of amisulpride in mild renal failure doubles, and in moderate renal failure - almost tenfold (see "Method of administration" and doses"). Experience with the drug in renal failure is limited, and there are no data on amisulpride at doses greater than 50 mg. Amisulpride is practically not excreted by hemodialysis. Liver failure. Due to the fact that amisulpride is slightly metabolized in the liver, drug accumulation is not expected in case of liver failure and a dose reduction is not required. Elderly patients. When comparing the pharmacokinetic parameters of patients over 65 years of age with those of younger patients, it was found that after a single oral dose of amisulpride in a dose of 50 mg, the values ​​of Cmax, T1/2 and AUC were 10–30% higher. There are no data on pharmacokinetics in elderly patients during a course of taking amisulpride.

Use during pregnancy

The safety of taking amisulpride during pregnancy has not been established. Therefore, the use of the drug during pregnancy is not recommended, except in cases where the expected benefit to the mother justifies the potential risk to the fetus. Although there are no reported cases of side effects in newborns, theoretically, amisulpride, when used at the end of pregnancy and in high doses, can cause side effects in newborns (atropine-like effects: tachycardia, hyperreflexia, abdominal bloating, delayed passage of meconium; extrapyramidal symptoms: hypertonicity, tremor ; sedation), for which they may require appropriate monitoring. It is unknown whether amisulpride passes into breast milk, so breastfeeding while taking it is contraindicated.

Contraindications for use

hypersensitivity to amisulpride or other components of the drug; concomitant prolactin-dependent tumors (for example, pituitary prolactinoma and breast cancer); pheochromocytoma (diagnosed or suspected); children and adolescents under 15 years of age (lack of clinical experience); breastfeeding period; severe renal failure with creatinine Cl less than 10 ml/min (lack of clinical experience); concomitant therapy with dopaminergic agonists (cabergoline, quinagolide) when used not for the treatment of Parkinson's disease (see “Interaction”). concomitant therapy with levodopa, amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, ropinirole, selegiline) (see “Interactions”); concomitant therapy with drugs that can prolong the QT interval and cause the development of rhythm disturbances, including potentially life-threatening polymorphic ventricular tachycardia of the “torsade de pointes” type (see “Interaction”): - class IA antiarrhythmics (quinidine, disopyramide) and Class III (amiodarone, sotalol, dofetilide, ibutilide); - other drugs (bepridil, cisapride, methadone, sultopride, thioridazine, difemanil methyl sulfate, IV erythromycin, IV spiramycin, mizolastine, IV vincamine, halofantrine, lumefantrine, sparfloxacin, moxifloxacin, pentamidine); congenital galactosemia, glucose or galactose malabsorption syndrome, or lactase deficiency. With caution: in patients with predisposing factors for the development of severe ventricular arrhythmias, including potentially life-threatening polymorphic ventricular tachycardia of the “pirouette” type (torsade de pointes), namely, in patients with congenital long QT interval, acquired prolongation of the QT interval (when combined with drugs , increasing the duration of the QTc interval, with the exception of those indicated in the “Contraindications” section (see “Interactions”), bradycardia less than 55 beats/min, electrolyte disorders, including hypokalemia, in patients receiving concomitant therapy with drugs that can cause severe hypokalemia bradycardia less than 55 beats/min, slow down intracardiac conduction (since amisulpride can dose-dependently prolong the QT interval and increase the risk of developing severe ventricular arrhythmias, including polymorphic ventricular tachycardia of the torsade de pointes type (see “Side effects” , “Interaction”); in patients with renal failure, because there is a risk of accumulation of the drug, and experience with its use in renal failure is limited (see “Pharmacokinetics” and “Dosage and Administration”, “Special Instructions”); in elderly patients, because they have an increased predisposition to the development of arterial hypotension and excessive sedation; in elderly patients with dementia (see “Special Instructions”); in patients with risk factors for stroke (see “Special Instructions”); in patients with epilepsy, because amisulpride may lower the seizure threshold; in patients with risk factors for the development of thromboembolism (see “Side effects”, “Special instructions”); in patients with Parkinson's disease, because amisulpride, like other antidopaminergic drugs, may enhance the manifestations of Parkinson's disease (see "Special Instructions"); in patients with diabetes mellitus and patients with risk factors for developing diabetes mellitus (because some atypical antipsychotics, including amisulpride, may cause an increase in blood glucose concentrations.

Side effects

Side effects are presented in accordance with the following gradations of their frequency of occurrence: very often (> 10%), often (> 1%, 0.1%, 0.01%, The following are side effects observed in controlled clinical trials and post-marketing use drug. It should be noted that in some cases it is very difficult to differentiate side effects from the symptoms of the underlying disease. From the nervous system: very often - extrapyramidal symptoms (tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia). These symptoms are usually moderate in taken in optimal doses and partially reversible with the addition of anticholinergic antiparkinsonian drugs without stopping treatment with amisulpride.The incidence of extrapyramidal symptoms is dose dependent.Therefore, in patients with predominantly negative symptoms taking amisulpride at a dose of 50-300 mg, the incidence of extrapyramidal disorders is very low; often - acute dystonia (spasmodic torticollis, oculogyric crises, trismus), reversible with the addition of anticholinergic antiparkinsonian drugs without stopping treatment with amisulpride; daytime sleepiness; uncommon - tardive dyskinesia, characterized by rhythmic, involuntary movements mainly of the tongue and/or facial muscles, usually occurring after long-term use of the drug. Anticholinergic antiparkinsonian drugs are ineffective in these cases or may increase symptoms; seizures; unknown frequency - neuroleptic malignant syndrome (see "Special Instructions"). From the gastrointestinal tract: often - constipation, nausea, vomiting, dry mouth. From the endocrine system: often - amisulpride causes an increase in plasma concentrations of prolactin, which is reversible after discontinuation of the drug. This can lead to galactorrhea, amenorrhea, gynecomastia, breast pain and erectile dysfunction. Metabolic disorders: often - increase in body weight; infrequently - hyperglycemia (see "Contraindications", "With caution" and "Special instructions"). Cardiovascular system disorders: often - arterial hypotension; infrequently - bradycardia; unknown frequency - QT interval prolongation; ventricular rhythm disturbances, such as polymorphic ventricular tachycardia of the “pirouette” type (torsade de pointes), which can develop into ventricular fibrillation and lead to cardiac arrest and sudden death (see “Special Instructions”); thromboembolism, including pulmonary embolism, sometimes fatal, and deep vein thrombosis (see “Special Instructions”). From laboratory parameters: infrequently - an increase in the levels of liver enzymes, mainly transaminases. From the immune system: infrequently - allergic reactions. Other: often - insomnia, anxiety, agitation, orgasm disorders, frigidity.

Directions for use and doses

Inside. Usually, if the daily dose does not exceed 400 mg, it can be taken once a day, but if the daily dose exceeds 400 mg, then it should be divided into two doses. With a predominance of negative episodes. For patients with a predominance of negative symptoms, it is recommended to prescribe amisulpride at a dose of 50 to 300 mg/day (on average, at a dose of 100 mg/day). Dose selection should be done individually. If the dose is less than 200 mg, 100 or 200 mg tablets should be used. With mixed episodes with productive and negative symptoms. For patients with mixed negative and productive symptoms, doses should be adjusted to provide optimal control of productive symptoms, averaging 400 to 800 mg. Maintenance treatment should be individualized at the minimum effective dose level (depending on the patient's response). Acute psychotic episodes Beginning of treatment: - it is possible to begin treatment by intramuscular administration of the drug for several days at a maximum dose of 400 mg/day, followed by switching to oral administration of the drug; — for oral administration doses from 400 to 800 mg are used. The maximum dose should never exceed 1200 mg/day. Maintenance therapy. Subsequently, the selected dose is maintained or adjusted depending on the patient's response. In all cases, maintenance doses should be set individually at the level of the minimum effective dose. In patients with renal failure. Clinical experience with the drug in patients with impaired renal function is limited. Amisulpride is eliminated through the kidneys. In case of renal failure, the dose for patients with creatinine Cl 30-60 ml/min should be reduced by half, and for patients with creatinine Cl 10 to 30 ml/min - by 3 times. There are no data on amisulpride at doses greater than 50 mg. Due to the lack of data on the use of the drug in patients with creatinine Cl less than 10 ml/min, the use of amisulpride in this group of patients is contraindicated (see “Contraindications”). In patients with liver failure. Due to the fact that the drug is poorly metabolized in the liver, a dose reduction is not required in case of liver failure. In elderly patients. When prescribing the drug to elderly patients, special care should be taken (see “Special Instructions”).

Overdose

Symptoms: Experience with amisulpride overdose is very limited. A significant increase in the known pharmacological effects of the drug has been reported, namely the development of drowsiness, sedation, coma, arterial hypotension and extrapyramidal symptoms. It should be borne in mind that overdose phenomena can occur in cases of erroneous administration of additional doses of the drug or simultaneous use of other drugs. Treatment: There is no specific antidote for amisulpride. In case of overdose, the basic vital functions of the body should be monitored and maintained until the patient completely recovers from the overdose. In case of overdose, ECG monitoring is mandatory, because There is a risk of prolongation of the QT interval and the development of life-threatening disorders. If severe extrapyramidal symptoms occur, anticholinergic drugs should be used. Because Since the elimination of amisulpride by hemodialysis is insignificant, the use of hemodialysis for its removal in case of overdose is inappropriate.

Interactions with other drugs

Contraindicated combinations With drugs that can prolong the QT interval and cause paroxysmal tachycardia, including potentially lethal torsades de pointes (see “Contraindications”): with class IA (quinidine, disopyramide) and class III antiarrhythmics (amiodarone, sotalol, dofetilide, ibutilide); with bepridil, cisapride, methadone, sultopride, thioridazine, difemanil methyl sulfate, erythromycin (iv), spiramshchin (iv), mizolastine, vincamine (iv), halofantrine, lumefantrine, sparfloxacin, gatifloxacin, moxifloxacin, pentamidine. With dopaminergic agonists (cabergoline, quinagolide) when used not for the treatment of Parkinson's disease - mutual antagonism of the effects of dopaminergic receptor agonists and antipsychotics. Dopaminergic agonists may cause or worsen psychotic symptoms. Amisulpride may increase symptoms of Parkinson's disease (see "Special Instructions"); With levodopa (see “Contraindications”) - reciprocal antagonism of the effects of levodopa and antipsychotics. Not recommended combinations With drugs that increase the risk of potentially fatal polymorphic ventricular tachycardia of the “torsade de pointes” type (“torsade de pointes”) - drugs that cause bradycardia (beta-blockers, verapamil, diltiazem, clonidine, guanfacine, digitalis preparations, donepezil, rivastigmine, tacrine , ambenonium chloride, galantamine, pyridostigmine bromide, neostigmine bromide). With drugs that cause hypokalemia (hypokalemia-causing diuretics, laxatives that simulate intestinal motility, intravenously administered amphotericin B, corticosteroids, tetracosactide) - when using them, it is imperative to restore potassium losses and maintain a normal level of potassium in the blood. With some antipsychotics (haloperidol, pimozide, pipothiazine, sertindole, chlorpromazine, levomepromazine, cyamemazine, sultopride, sulpiride, tiapride, veraliprid, droperidol), imipramine antidepressants, lithium drugs, azole antifungals, the risk of developing ventricular arrhythmias, in particular ventricular tachycardia type “pirouette” (“torsade de pointes”): With alcohol - amisulpride enhances the central effects of alcohol. Alcohol enhances the sedative effect of neuroleptics; With dopaminergic agonists (amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, ropinirole, selegiline) (see “Contraindications” and “Special Instructions”) - mutual antagonism of the effects of dopaminergic receptor agonists and antipsychotics. Dopaminergic agonists may cause or worsen psychotic symptoms. Amisulpride may increase symptoms of Parkinson's disease. Combinations that should be taken into account With CNS depressants - morphine derivatives (analgesics, antitussives); barbiturates; benzodiazepines; non-benzodiazepine anxiolytics; sleeping pills; antidepressants with a sedative effect (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine); blockers of H1-histamine receptors with a sedative effect; centrally acting antihypertensive drugs (clonidine); neuroleptics; baclofen; thalidomide, pizotifen - a pronounced increase in the inhibitory effect on the central nervous system. An additional decrease in concentration, which creates a greater danger for vehicle drivers and people working with machinery; With antihypertensive drugs, including beta-blockers (bisoprolol, carvedilol, metoprolol) - the risk of developing arterial hypotension, in particular orthostatic hypotension (additive effect). For beta-blockers, see additionally "Interactions, combinations not recommended."

Special instructions for use

According to a controlled, double-blind study comparing amisulpride and haloperidol in patients with acute schizophrenia (191 patients), a significantly greater reduction in secondary negative symptoms was observed with amisulpride. According to clinical studies, a significantly lower incidence of extrapyramidal symptoms was observed with the use of amisulpride than with the use of haloperidol. As with the use of other antipsychotics, when using amisulpride (especially high doses), neuroleptic malignant syndrome may develop, characterized by hyperthermia, muscle rigidity, autonomic disorders, and increased levels of creatine phosphokinase. If hyperthermia develops, especially during the use of high doses of antipsychotics, all antipsychotic drugs, including amisulpride, should be discontinued. Caution should be exercised when prescribing antidopaminergic drugs, and in particular amisulpride, for Parkinson's disease, because when prescribed, the course of this disease may worsen. In patients with Parkinson's disease, amisulpride should only be used if its use cannot be avoided. If treatment with amisulpride is necessary in a patient with Parkinson's disease receiving dopaminergic agonists, dopaminergic agonists should be discontinued gradually (by gradually reducing the dose until they are completely discontinued) because Abrupt withdrawal may lead to the development of neuroleptic malignant syndrome. To correct extrapyramidal symptoms that occur during treatment with amisulpride, anticholinergic antiparkinsonian drugs (rather than dopaminergic agonists) should be used. Due to the fact that amisulpride causes a dose-dependent increase in the duration of the QT interval, its use increases the risk of developing paroxysmal tachycardias, including potentially life-threatening polymorphic ventricular tachycardia of the torsades de pointes type. Therefore, if the patient’s condition allows, before prescribing amisulpride, it is recommended to take an ECG and examine the electrolyte composition of the blood, identify and, if possible, correct factors that may contribute to the occurrence of dangerous rhythm disturbances (bradycardia less than 55 beats/min, hypokalemia, hypomagnesemia, congenital or acquired prolonged QT interval, simultaneous use of drugs that can cause severe bradycardia (less than 55 beats/min), hypokalemia, slowing of intracardiac conduction, increase in the duration of the QT interval) (see “Interaction”). During treatment with amisulpride, you should not take alcohol or drugs containing alcohol. Due to the drug's ability to lower the seizure threshold, when taking amisulpride in patients with epilepsy, they should undergo careful clinical and, if possible, EEG monitoring. Some atypical antipsychotics, including amisulpride, may cause increases in blood glucose levels. In patients with diabetes mellitus and patients with risk factors for developing diabetes mellitus, blood glucose concentrations should be regularly monitored when amisulpride is prescribed. In elderly patients, amisulpride, like other antipsychotics, should be used with extreme caution due to the possible risk of hypotension or excessive sedation. In randomized clinical trials conducted in a group of elderly patients with dementia treated with certain atypical antipsychotic drugs, compared with placebo, a threefold increase in the risk of cerebrovascular events (acute cerebrovascular accidents) was observed. The mechanism for this increased risk is unknown. An increase in this risk cannot be excluded with the use of other antipsychotic drugs or in other patient groups. Amisulpride should be used with caution in patients with risk factors for stroke. In elderly patients with dementia-related psychosis, an increased risk of death was observed when treated with antipsychotic drugs. An analysis of 17 placebo-controlled studies (mean duration greater than 10 weeks) found that most patients treated with atypical antipsychotics had a 1.6 to 1.7 times greater risk of death than patients treated with placebo. Although the causes of death in clinical studies with atypical antipsychotics varied, most causes of death were either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies have confirmed that, like treatment with atypical antipsychotics, treatment with conventional antipsychotics may also increase mortality. The extent to which the increase in mortality may be due to the antipsychotic drug rather than certain patient characteristics is unclear. Cases of venous thromboembolism, sometimes fatal, have been observed with the use of antipsychotic drugs. Therefore, amisulpride should be used with caution in patients with risk factors for thromboembolism (see "Side effects"). Amisulpride is eliminated by the kidneys. If renal function is impaired, the dose of the drug should be reduced (see “Dosage and Administration”). Impact on the ability to drive vehicles or other machinery. Patients, especially those who are drivers of vehicles or people who operate machinery, should be informed about the possibility of drowsiness and decreased psychomotor reactions while taking amisulpride, especially at the beginning of treatment, because this can be dangerous when driving vehicles or operating machinery.

Storage conditions

In a dry place, at a temperature not exceeding 25 °C.

Best before date

36 months

ATX classification:

N Nervous system

N05 Psycholeptics

N05A Antipsychotic drugs

N05AL Benzamides

N05AL05 Amisulpride

Use of the drug Solian

At a dose exceeding 400 mg/day, Solian should be administered in 2 doses; at a dose of up to 400 mg/day, the drug is taken in one dose. For patients with predominantly negative symptoms, it is recommended to prescribe the drug at a dose of 50–300 mg/day. Dose selection should be individual. The optimal dose is about 100 mg per day. For patients with mixed negative and positive symptoms, the dose should be adjusted to provide maximum control of positive symptoms (400–800 mg/day). Maintenance treatment is carried out in the minimum effective dose, which is set individually. For acute psychotic episodes, oral dosage of 400–800 mg/day is recommended; the maximum daily dose is no more than 1200 mg. Maintenance treatment is carried out at the minimum effective dose, which is set individually. Since amisulpride is eliminated by the kidneys, in case of renal failure, the daily dose of the drug in patients with a creatinine clearance of 30-60 ml/min should be reduced by half, and in patients with a creatinine clearance of 10-30 ml/min - by 2/3. Since the drug is poorly metabolized in the body, a dose reduction is not required if liver function is impaired.

Solian®

Neuroleptic malignant syndrome

As with the use of other antipsychotics, when using amisulpride (especially high doses), neuroleptic malignant syndrome, a potentially fatal complication characterized by hyperthermia, muscle rigidity, autonomic disorders, and increased concentrations of creatine phosphokinase, may develop.

If hyperthermia develops, especially during the use of high doses of antipsychotics, all antipsychotic drugs, including amisulpride, should be discontinued.

Patients with Parkinson's disease taking dopamine receptor agonists

Caution should be exercised when using dopamine receptor blockers and, in particular, amisulpride in Parkinson's disease, since its use may worsen the course of this disease.

In patients with Parkinson's disease, amisulpride should only be used if its use cannot be avoided. If treatment with amisulpride is necessary in a patient with Parkinson's disease taking dopamine receptor agonists, dopamine receptor agonists should be discontinued gradually (by gradually reducing the dose until they are completely discontinued), since abrupt withdrawal may lead to the development of neuroleptic malignant syndrome.

Extrapyramidal syndrome

To correct extrapyramidal symptoms that arise during treatment with amisulpride, centrally acting m-anticholinergic blockers (and not dopamine receptor agonists) should be used. Due to the fact that amisulpride causes a dose-dependent increase in the duration of the QT interval, its use increases the risk of developing paroxysmal tachycardias, including potentially life-threatening torsade de pointes (TdP). Therefore, if the patient’s condition allows, before using amisulpride, it is recommended to do an ECG and determine the concentration of electrolytes in the blood, identify and, if possible, correct factors that may contribute to the occurrence of these dangerous rhythm disturbances (such as bradycardia less than 55 beats per minute, hypokalemia, hypomagnesemia , congenital or acquired prolongation of the QT interval, simultaneous use of drugs that can cause severe bradycardia (less than 55 beats per minute), hypokalemia, slowing of intracardiac conduction, increase the duration of the QT interval) (see section “Interaction with other drugs”).

Ethanol consumption

During treatment with amisulpride, you should not take ethanol or medications containing ethanol.

Patients with epilepsy

Due to the drug's ability to lower the seizure threshold, when taking amisulpride in patients with epilepsy, they should undergo careful clinical and, if possible, electroencephalographic monitoring.

Patients with diabetes mellitus or with risk factors for developing diabetes mellitus

Some atypical antipsychotics, including amisulpride, may cause increases in blood glucose levels. In patients with diabetes mellitus and patients with risk factors for developing diabetes mellitus, blood glucose concentrations should be regularly monitored when using amisulpride.

Stroke

In randomized clinical trials conducted in a group of elderly patients with dementia treated with certain atypical antipsychotic drugs, there was a threefold increase in the risk of developing cerebrovascular events (acute cerebrovascular accidents) compared with placebo. The mechanism for this increased risk is unknown. An increase in this risk cannot be excluded with the use of other antipsychotic drugs or in other patient groups.

Amisulpride should be used with caution in patients with risk factors for stroke.

Elderly patients

In elderly patients, amisulpride, like other antipsychotics, should be used with extreme caution due to the possible risk of low blood pressure or excessive sedation.

Elderly patients with dementia

In elderly patients with dementia-related psychosis, an increased risk of death was observed when treated with antipsychotic drugs.

An analysis of 17 placebo-controlled studies (average duration of more than 10 weeks), conducted mainly in patients receiving atypical antipsychotic drugs, showed that they had a 1.6-1.7 times greater risk of death than patients receiving placebo. In a typical 10-week study, the death rate in patients receiving these drugs was 4.5%, compared with 2.6% in the placebo group.

Although causes of death varied in clinical studies with atypical antipsychotics, most causes of death were cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia).

Observational studies have confirmed that, like treatment with atypical antipsychotics, treatment with conventional antipsychotics may also increase mortality. The extent to which the increase in mortality may be due to the antipsychotic drug rather than certain patient characteristics is unclear.

Syndrome "OoC with caution"). Such patients should be closely monitored.

Benign pituitary

Amisulpride may increase plasma prolactin concentrations. Cases of the development of benign pituitary tumors, such as prolactinoma, have been reported with the use of amisulpride. If there are high plasma prolactin concentrations or clinical signs and symptoms of a pituitary tumor (such as visual field defects and headache), an x-ray examination (eg, magnetic resonance imaging) of the pituitary gland should be performed. If the diagnosis of a pituitary tumor is confirmed, treatment with amisulpride should be discontinued.

Patients with impaired renal function

Amisulpride is eliminated by the kidneys. If renal function is impaired, the dose of the drug should be reduced (see section “Method of administration and dosage”).

Leukopenia, neutropenia and agranulocytosis

Leukopenia, neutropenia and agranulocytosis have been observed with the use of antipsychotic drugs, including Solian®. Unexplained infections or fever may be associated with hematological disorders (see section "Side effects") and require immediate hematological evaluation.

Contraindications to the use of the drug Solian

Hypersensitivity to amisulpride or other components of the drug, diagnosed or suspected pheochromocytoma, age under 15 years (due to lack of clinical data), pregnancy and lactation, diagnosed or suspected prolactin-dependent tumors (for example, pituitary prolactinoma and breast cancer), severe renal failure (creatinine clearance ≤10 ml/min), simultaneous use of dopaminergic receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole, selegiline), with the exception of patients with Parkinson's disease (see. INTERACTIONS), congenital galactosemia, glucose or galactose malabsorption syndrome, lactase deficiency (due to the lactose content of the drug).

Side effects of the drug Solian

From the central nervous system Often - insomnia, anxiety, agitation, extrapyramidal symptoms (tremor, hypertension (arterial hypertension), hypersalivation, akathisia, hypokinesia). The severity of these symptoms is usually moderate, they are partially reversible without discontinuation of Solian when anticholinergic antiparkinsonian therapy is prescribed. The incidence of extrapyramidal symptoms depends on the dose of the drug and is very low in patients taking the drug at a dose of 50-30 mg/day for treatment of predominantly negative symptoms. Clinical studies have found that the incidence of extrapyramidal symptoms is lower in patients taking Solian than in patients taking haloperidol. Rarely - daytime sleepiness. Very rarely - acute dystonia (spasmodic torticollis, oculogyric crisis, trismus), which does not require discontinuation of Solian and resolves with the use of anticholinergic antiparkinsonian drugs; tardive dyskinesia, characterized by involuntary movements mainly of the tongue and/or facial muscles, usually develops with long-term use of the drug (anticholinergic antiparkinsonian drugs are ineffective for it, they can cause worsening of the condition); convulsions; neuroleptic malignant syndrome (see SPECIAL INSTRUCTIONS). From the side of metabolism Often - a reversible increase in the level of prolactin in the blood serum (passing after discontinuation of the drug), which can cause galactorrhea, amenorrhea, gynecomastia, swelling of the mammary glands, impotence and frigidity; increase in body weight. From the gastrointestinal tract Rarely - constipation, nausea, vomiting, dry mouth. From the cardiovascular system Very rarely - arterial hypotension and bradycardia, increased QT on the ECG. In isolated cases - ventricular tachyarrhythmia of the flutter-flicker type (see SPECIAL INSTRUCTIONS). From the hepatobiliary system Very rarely - increased activity of liver enzymes, especially transaminases. From the immune system Very rarely - allergic reactions.

Special instructions for the use of the drug Solian

As with the use of other antipsychotics, when treated with Solian, the development of neuroleptic malignant syndrome, characterized by hyperthermia, muscle rigidity, dysfunction of the peripheral nervous system, and increased levels of CPK in the blood serum, is possible. If hyperthermia develops, especially when used in high doses, all antipsychotic drugs, including Solian, should be discontinued. Amisulpride may cause a dose-dependent increase in the QT on the ECG, which increases the risk of dangerous ventricular tachyarrhythmias such as ventricular fibrillation-flutter. The risk of developing dangerous ventricular arrhythmias increases with bradycardia, hypokalemia, and in the case of congenital or acquired long QT (combination with drugs that prolong the QT ). If the clinical situation allows, then before using the drug it is recommended to make sure that there are no factors that may contribute to the development of this rhythm disorder: bradycardia less than 55 beats/min, hypokalemia, congenital prolonged QT , simultaneous use of drugs that can cause severe bradycardia (≤ 55 beats/min), hypokalemia, slowing of intracardiac conduction or prolongation of the QT . For patients who require long-term treatment with antipsychotics, it is recommended to conduct an ECG study before prescribing them. Solian may lower the seizure threshold. Therefore, medical supervision is necessary for patients taking Solian with a history of seizures. In elderly patients, Solian, like other antipsychotics, should be used with extreme caution due to the possible risk of arterial hypotension or sedation. In Parkinson's disease, caution should be exercised when prescribing Solian. Solian should only be used if antipsychotic therapy cannot be avoided. The drug may cause drowsiness, which may impair the ability to drive vehicles or operate dangerous machinery. The safety of Solian during pregnancy has not been established, therefore the use of the drug is not recommended. It is unknown whether Solian passes into breast milk, so breastfeeding while taking Solian is contraindicated.

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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Solian, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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Interactions of the drug Solian

Contraindicated combinations Dopaminergic receptor agonists (except levodopa) - amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole, selegiline, except when used in patients with Parkinson's disease. Dopaminergic receptor agonists and antipsychotics are mutual antagonists. For extrapyramidal syndrome caused by antipsychotics, the use of anticholinergic drugs is recommended instead of dopaminergic receptor agonists. Sultopride (benzamide antipsychotic) - increases the risk of developing ventricular arrhythmias, especially tachyarrhythmias of the ventricular fibrillation-flutter type. Not recommended combinations Medicines that can cause tachyarrhythmia of the ventricular fibrillation-flutter type: class la (quinidine, hydroquinidine, disopyramide) and class III antiarrhythmic drugs (amiodarone, sotalol, dofetilide, ibutilide), some neuroleptics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, tiapride, pimozide, haloperidol, droperidol) and other drugs such as bepridil, cisapride, difemanil, erythromycin (iv), mizolastine, vincamine (iv), halofantrine, sparfloxacin, gatifloxacin, moxifloxacin, pentamidine, spiramycin (iv) - increased risk of developing ventricular arrhythmias, especially tachyarrhythmias of the ventricular fibrillation-flutter type. If possible, such drugs should be discontinued; if such a combination of drugs cannot be avoided, before starting treatment it is necessary to determine the duration of the QT on an ECG, and treatment should be carried out under ECG monitoring. Alcohol increases the sedative effect of antipsychotics and decreases vigilance. It is necessary to avoid drinking alcohol and using medications containing ethanol during treatment with Solian. Levodopa is a mutual antagonism of the action of levodopa and antipsychotics. For the treatment of patients with Parkinson's disease, both drugs are recommended to be used in minimal effective doses. Dopaminergic receptor agonists, except levodopa (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole, selegiline) for use in parkinsonism are mutual antagonists with antipsychotics. Dopaminergic receptor agonists may cause or worsen psychotic disorders. If treatment with antipsychotics is necessary in a patient with Parkinson's disease taking a dopaminergic drug, the dose should be gradually reduced until completely discontinued (abrupt withdrawal may lead to the development of neuroleptic malignant syndrome). Combinations requiring caution in use Drugs that cause bradycardia (calcium channel blockers: diltiazem, verapamil; β-receptor blockers, except sotalol; clonidine, guanfacine; mefloquine; digitalis preparations, cholinesterase inhibitors: donezpepzil, rivastigmine, tacrine, ambemonium, galaitamine, pyridostigmine, neostigmine) - increases the risk of ventricular arrhythmias, especially torsades de pointes tachyarrhythmia. Clinical and ECG monitoring is required. Drugs that can cause hypokalemia: potassium-sparing diuretics, stimulant laxatives, intravenous amphotericin B, glucocorticoids, tetracosactide - increase the risk of ventricular arrhythmias, especially torsades de pointes tachyarrhythmias. Hypokalemia must be corrected before starting the drug. It is necessary to monitor electrolyte balance, ECG, and the patient’s condition. Combinations to consider Antihypertensive drugs (all) - additive effects, increasing the risk of postural hypotension. Other drugs that have a depressant effect on the central nervous system (morphine derivatives, barbiturates, benzodiazepines and other anxiolytics, hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), H1 receptor blockers with sedative action, centrally acting antihypertensives , antipsychotics, baclofen, thalidomide, pizotifen) - increased depressive effect, decreased reaction speed. β-adrenergic receptor blockers (bisoprolol, carvedilol, metoprolol) for heart failure - vasodilatory effect, risk of arterial hypotension, especially orthostatic (additive effect).

Instructions for use SOLIAN

Combinations are contraindicated

Dopamine receptor agonists (including amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole, selegiline) and antipsychotics exhibit mutual antagonism. Dopamine receptor agonists may cause or worsen psychotic disorders. Combinations are contraindicated except in patients with Parkinson's disease.

For extrapyramidal syndrome caused by antipsychotics, anticholinergic drugs should be used instead of dopamine receptor agonists.

When Solian is used simultaneously with sultopride, the risk of developing ventricular arrhythmias, especially atrial fibrillation, increases.

Combinations are not recommended

The risk of developing ventricular arrhythmias, especially arrhythmias, increases with simultaneous use of amisulpride with drugs that can cause arrhythmias:

• antiarrhythmic drugs of class I A (including quinidine, hydroquinidine, disopyramide) and class III (including amiodarone, sotalol, dofetilide, ibutilide), some antipsychotics (including thioridazine, chlorpromazine, levomepromazine, trifluoperazine , cyamemazine, sulpiride, tiapride, pimozide, haloperidol, droperidol) and other drugs (including bepridil, cisapride, difemanil, IV erythromycin, mizolastine, IV vincamine, halofantrine, sparfloxacin, gatifloxacin, moxifloxacin, pentamidine, iv spiramycin). If a combination of drugs cannot be avoided, then before prescribing, monitor the QT interval and begin ECG monitoring.

Ethanol enhances the sedative effect of neuroleptics. During the treatment period, medications containing ethanol should not be prescribed.

The mutual antagonism of the effects of levodopa and antipsychotics should be taken into account when prescribing these drugs. In patients with Parkinson's disease, it is recommended to use the minimum effective doses of both drugs.

If antipsychotic treatment is necessary for a patient with Parkinson's disease receiving a dopamine receptor agonist (including amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole, selegiline), then the dose of the latter should be gradually reduced up to cancellation (abrupt withdrawal can lead to the development of NMS).

Combinations that require caution when using

When used simultaneously 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) increases the risk of developing ventricular arrhythmias, especially arrhythmias (with these combinations, monitoring of the clinical condition and ECG is required).

When used simultaneously with drugs that can cause hypokalemia (including potassium-sparing diuretics, laxatives, intravenous amphotericin B, corticosteroids, tetracosactide), the risk of developing ventricular arrhythmias, especially arrhythmias, increases (with these combinations, monitoring of the clinical condition is required, electrolyte balance and ECG).

Combinations to Consider

When used simultaneously with antihypertensive drugs, an additive effect is observed and the risk of developing orthostatic hypotension increases.

When used simultaneously with other drugs that have a depressant effect on the central nervous system, including morphine derivatives (including opioid analgesics, antitussives), barbiturates, benzodiazepines and other anxiolytics, hypnotics, antidepressants with a sedative effect (including amitriptyline , doxepin, mianserin, mirtazapine, trimipramine), blockers of histamine H1 receptors with a sedative effect, centrally acting antihypertensives, antipsychotics and other drugs (including baclofen, thalidomide, pizotifen) leads to an increased central depressive effect (decreases concentration and there is a danger for vehicle drivers and machine operators).

When Solian is used in patients with heart failure receiving beta-blockers (including bisoprolol, carvedilol, metoprolol), a vasodilatory effect is observed and the risk of developing arterial hypotension, especially orthostatic, increases (additive effect).

Solian overdose, symptoms and treatment

There is little data on Solian overdose. An increase in the known pharmacological effects of the drug has been reported. Drowsiness, sedation, coma, arterial hypotension and extrapyramidal symptoms are possible. In case of acute overdose, the possibility of interaction between several drugs should be considered. There is no specific antidote. Maintenance therapy, monitoring of vital body functions, especially ECG monitoring, are indicated until the patient’s condition is completely normalized. When severe extrapyramidal symptoms appear, anticholinergics are prescribed. Since Solian is poorly dialyzable, hemodialysis is ineffective.