Solian
Solian: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. For violations of liver function
- 12. In case of impaired renal function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Reviews
- 18. Price in pharmacies
Latin name: Solian
ATX code: N05AL05
Active ingredient: amisulpride (amisulpride)
Producer: Sanofi-Winthrop Industrie (France)
Description and photo update: 2019-13-08
Prices in pharmacies: from 3579 rubles.
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Solian is a neuroleptic, antipsychotic drug.
Release form and composition
Dosage forms:
- tablets: almost white or white, round flat, engraved with "AMI 100" or "AMI 200" on one side and a dividing line on the other (10 pcs. in a blister, 3 blisters in a cardboard box);
- film-coated tablets: biconvex oblong, white, with a dividing line between the engraving "AMI" and "400" on one side (10 pcs. in a blister, 3 blisters in a cardboard box);
- oral solution: clear liquid with a caramel smell from brownish-yellow to yellow (60 ml each in dark glass vials, 1 bottle in a cardboard box).
1 tablet contains:
- active substance: amisulpride - 0.1 g or 0.2 g;
- auxiliary components: lactose monohydrate, hypromellose, magnesium stearate, sodium carboxymethyl starch (sodium amylopectin glycolate) (type A), microcrystalline cellulose.
1 film-coated tablet contains:
- active substance: amisulpride - 0.4 g;
- auxiliary components: microcrystalline cellulose, sodium carboxymethyl starch (sodium amylopectin glycolate) (type A), magnesium stearate, lactose monohydrate, hypromellose;
- shell composition: macrogol stearate, microcrystalline cellulose, hypromellose, titanium dioxide (E171).
1 ml of solution contains:
- active substance: amisulpride - 0.1 g;
- auxiliary components: Gesvit (sodium gluconate, sodium saccharinate, glucurolactone), potassium sorbate, 3 M hydrochloric acid solution, methyl parahydroxybenzoate, caramel flavor, propyl parahydroxybenzoate, water.
Pharmacological properties
Pharmacodynamics
Amisulpride is an antipsychotic drug from the group of substituted benzamides with selective and predominant affinity for the D2 and D3 dopamine receptor subtypes of the limbic system. This substance has no affinity for serotonin and other neuroreceptors (histamine, cholinergic, adrenergic).
Animal studies have led to the conclusion that when taken in high doses, amisulpride blocks dopaminergic neurons of the mesolimbic system to a greater extent than analogous neurons in the striatum system. This specific affinity seems to explain the predominance of the antipsychotic effects of amisulpride over the extrapyramidal ones.
When used at low doses, amisulpride is able to block predominantly presynaptic D2 and D3 dopamine receptors, which may explain its positive effect on negative symptoms.
Pharmacokinetics
Amisulpride has two absorption peaks: the first is reached after 1 hour, the second - between 3 and 4 hours after administration. When Solian is used at a dose of 50 mg, the corresponding plasma concentrations of amisulpride are 39 ± 3 ng / ml and 54 ± 4 ng / ml.
The volume of distribution of the substance is 5.8 l / kg, the absolute bioavailability is 48%. Amisulpride binds poorly to plasma proteins (16%), so the interaction of Solian with other drugs at the level of protein binding is not expected.
Liver metabolism is insignificant (approximately 4%), two inactive metabolites are found.
Course reception does not lead to the accumulation of amisulpride and a change in its pharmacokinetics. The half-life of amisulpride when taken orally is approximately 12 hours. The substance is excreted unchanged in the urine. Renal clearance is approximately 330 ml / min.
Food rich in carbohydrates causes a significant decrease in AUC, T max and C max of amisulpride, while food rich in fat does not change the above pharmacokinetic parameters. The relevance of these observations for daily clinical practice is unknown.
In patients with renal insufficiency, the following changes in the pharmacokinetic parameters of amisulpride take place:
- decrease in systemic clearance by 2.5-3 times;
- 2-fold increase in AUC with mild renal failure;
- an increase in AUC by almost 10 times with moderate renal failure.
Experience with amisulpride in renal failure is limited. There are no data on the intake of a substance in a dose of more than 50 mg.
Amisulpride is practically not excreted during hemodialysis.
The metabolism of amisulpride in the liver is insignificant, therefore, in hepatic insufficiency, a decrease in the dose of Solian is not required
Comparison of pharmacokinetic parameters in patients over 65 years of age and younger patients found that with a single ingestion of amisulpride at a dose of 50 mg, the values of C max, T 1/2 and AUC in the elderly are 10–30% higher. There are no data on the pharmacokinetics of amisulpride with a course of administration in this category of patients.
Indications for use
According to the instructions, Solian is indicated for the treatment of chronic and acute forms of schizophrenia, accompanied by productive (hallucinations, delusions, thought disorder) and / or negative (affective flattening, loss of emotional and social connections) symptoms, including patients with predominantly negative symptoms.
Contraindications
- pheochromocytoma, including if it is suspected;
- concomitant breast cancer, pituitary prolactinoma and other prolactin-dependent tumors;
- severe renal failure [creatinine clearance (CC) less than 10 ml / min];
- concomitant therapy with dopamine receptor agonists (cabergoline, quinagolide and others), except for patients with Parkinson's disease;
- simultaneous use of levodopa, amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, ropinirole, selegiline;
- combination with drugs that prolong the QT interval and can cause the development of cardiac arrhythmias, including pirouette-type ventricular tachycardia: class IA antiarrhythmics (disopyramide, quinidine) and class III (sotalol, amiodarone, ibutilide, dofetilide), diphemanil methyl sulfate, bepridil, methadone sultopride, thioridazine, halofantrine, mizolastine, cisapride, lumefantrine, moxifloxacin, sparfloxacin, pentamidine, intravenous erythromycin, spiramycin, or vincamine;
- age up to 18 years;
- period of breastfeeding;
- hypersensitivity to the components of the drug.
It is recommended to prescribe Solian with caution in the presence of risk factors predisposing the development of severe ventricular arrhythmias (including potentially life-threatening patient with ventricular tachycardia of the pirouette type), congenital lengthening of the QT interval, acquired lengthening of the QT interval against the background of combination therapy with drugs that increase the duration of the QT interval (not indicated in contraindications), with bradycardia (less than 55 beats per minute), electrolyte disorders, including hypokalemia, renal failure, concomitant drug therapy that can cause a slowdown in intracardiac conduction, hypokalemia and / or severe bradycardia, with epilepsy, the presence of risk factors stroke and / or thromboembolism, with Parkinson's disease, since amisulpride can exacerbate its symptoms,diabetes mellitus or risk factors for its development, in elderly patients due to an increased risk of lowering blood pressure (BP) and the development of excessive sedation, in elderly patients with dementia.
It is not recommended to use Solian during pregnancy, except in cases of urgent need, when the expected effect of therapy for the mother justifies the potential threat to the fetus.
Instructions for the use of Solian: method and dosage
Solian tablets and solution are intended for oral administration.
The solution is taken using a syringe for taking the prescribed dose, 1 ml contains 0.1 g of the drug.
The dose should be adjusted individually.
The frequency of taking Solian depends on the daily dose, if it does not exceed 0.4 g, the drug is taken once, the dose above 0.4 g is divided into 2 doses.
Recommended daily dosage:
- schizophrenic disorders with a predominance of negative symptoms: 0.05–0.3 g, usually 0.1 g; at a dose less than 0.2 g, tablets of 0.1 g or 0.2 g should be prescribed;
- mixed episodes with productive and negative symptoms: 0.4–0.8 g, the dose should provide optimal control of productive symptoms. Supportive therapy is carried out in the minimum effective dose, established taking into account the patient's response to the drug;
- acute psychotic episodes: at the beginning of treatment - 0.4–0.8 g, maintenance therapy is carried out in an individually selected minimum effective dose. The maximum daily dose is 1.2 g.
Correction of dosage of Soliana for patients with renal insufficiency:
- CC 30-60 ml / min: 1/2 of the usual dose;
- CC 10-30 ml / min: 1/3 of the usual dose.
In hepatic impairment, dose adjustment is not required.
With extreme caution, the dose of Solian should be selected for elderly patients.
Side effects
- on the part of the nervous system: very often - extrapyramidal symptoms (rigidity, hypersalivation, tremor, hypokinesia, dyskinesia, akathisia), which are dose-dependent, at optimal doses are usually moderately expressed and partially reversible with the simultaneous administration of anticholinergic antiparkinsonian drugs; often - daytime sleepiness, anxiety, insomnia, orgasm disturbance, agitation, reversible acute dystonia (oculogyric crises, trismus, spastic torticollis); infrequently - seizures, tardive dyskinesias (rhythmic involuntary movements of facial muscles and / or tongue during prolonged therapy); frequency unknown - neuroleptic malignant syndrome with a high risk of death;
- on the part of the cardiovascular system: often - lowering blood pressure; infrequently - bradycardia; frequency unknown - prolongation of the QT interval, ventricular arrhythmias (including polymorphic ventricular tachycardia of the pirouette type, which can be complicated by ventricular fibrillation, cardiac arrest and sudden death), deep vein thrombosis, venous thromboembolic complications (including pulmonary embolism, sometimes fatal outcome);
- from the digestive system: often - dry mouth, nausea, vomiting, constipation; infrequently - an increase in the activity of liver enzymes (mainly transaminases);
- from the immune system: infrequently - allergic reactions, urticaria, angioedema;
- from the endocrine system: often - an increase in body weight, an increase in the blood plasma concentration of prolactin (galactorrhea, gynecomastia, amenorrhea, pain in the mammary glands, erectile dysfunction); infrequently - hyperglycemia; frequency unknown - hypercholesterolemia, hypertriglyceridemia;
- from the hematopoietic system: the frequency is unknown - agranulocytosis, leukopenia, neutropenia;
- pregnancy, postpartum and perinatal conditions: frequency unknown - withdrawal syndrome in newborns whose mothers took the drug during pregnancy.
Overdose
In case of an overdose of Solian, a significant increase in the known pharmacological effects of amisulpride can be observed: the development of drowsiness, sedation, a decrease in blood pressure, the development of extrapyramidal symptoms and coma. There are also reports of deaths from overdose (mainly when taken simultaneously with other psychotropic drugs). It must be borne in mind that the cause of an overdose may be the simultaneous administration of several drugs.
There is no specific antidote for amisulpride. In case of an overdose, it is necessary to ensure control and support of the basic vital functions of the body until the patient is completely overdose. Due to the risk of lengthening the QT interval and the development of life-threatening rhythm disturbances, ECG monitoring is mandatory.
With the development of severe extrapyramidal symptoms, the use of m-anticholinergics of central action (for example, trihexyphenidil) is recommended.
The use of hemodialysis for the elimination of amisulpride in case of an overdose of Solian is inappropriate.
special instructions
In acute schizophrenia, the use of Solian causes fewer secondary negative symptoms than haloperidol. In addition, clinical studies have confirmed the development of a significantly lower frequency of extrapyramidal symptoms while taking amisulpride compared with haloperidol.
Like other antipsychotics, Solian, especially when high doses are administered, can cause the development of neuroleptic malignant syndrome. Typical signs of a potentially fatal complication are hyperthermia, autonomic disorders, muscle stiffness, and increased concentration of creatine phosphokinase (CPK). When a patient develops hyperthermia, amisulpride and all antipsychotics should be discontinued immediately.
Since amisulpride can aggravate the course of this disease in patients with Parkinson's disease, Solian should be prescribed in this category of patients with great care and only as a last resort, if its use cannot be avoided. In this case, dopamine receptor agonists (in the presence of concomitant therapy) should be gradually canceled. Abrupt withdrawal of dopamine receptor agonists can contribute to the onset of neuroleptic malignant syndrome.
If extrapyramidal symptoms occur, the patient should be prescribed M-anticholinergics of central action.
To reduce the risk of developing paroxysmal tachycardia, before prescribing the drug, the patient is recommended to conduct a study of the electrolyte composition of the blood, electrocardiography (ECG). This will determine the presence of violations and, if possible, adjust the therapy.
During the period of treatment, alcohol and ethanol-containing drugs should not be consumed.
Solian is able to lower the seizure threshold, so patients with epilepsy should be provided with careful clinical and electroencephalographic observation.
Patients with risk factors and patients with diabetes mellitus should regularly monitor blood glucose levels.
Elderly patients with dementia have an increased risk of death, which in most cases is caused by cardiovascular (heart failure, sudden death) or infectious (pneumonia) pathologies.
Cancellation of amisulpride is recommended to be carried out, gradually reducing the dose in order to prevent the development of the withdrawal syndrome - the occurrence of involuntary movement disorders (akathisia, dyskinesia, impaired muscle tone).
When a patient develops an unexplained infection or fever, an immediate examination is required for blood disorders, since the drug can contribute to the development of leukopenia, neutropenia and agranulocytosis.
Due to the possible appearance in patients during the use of Solian, especially at the beginning of treatment, drowsiness, a decrease in the speed of psychomotor reactions, caution should be exercised when driving vehicles and mechanisms.
Application during pregnancy and lactation
There is no data on the safety of using amisulpride for the treatment of pregnant women, therefore, Solian can be used only in cases where the potential benefit to the mother outweighs the possible risk to the child.
In newborns exposed during the third trimester of pregnancy to intrauterine exposure to antipsychotic drugs (including Solian), there is a possibility of developing adverse reactions in the postnatal period, including extrapyramidal symptoms or withdrawal symptoms, which can vary in duration and severity. There is evidence of the development of respiratory disorders, muscle hypotension, tremor, muscle hypertonia, agitation, drowsiness, or difficulty in breastfeeding. Newborns from this category should be under constant medical supervision.
There are no data on the excretion of amisulpride in breast milk, therefore, it is not recommended to use Solian during breastfeeding.
Pediatric use
The safety and efficacy of using amisulpride in the treatment of children under 15 years of age have not been established, therefore the use of Solian in patients of this category is prohibited. Since there are limited data on the use of amisulpride in adolescents with schizophrenia, it is not recommended to prescribe the drug to patients with this disease aged 15–18 years.
For violations of liver function
No dose adjustment of Soliana is required for patients with hepatic impairment.
With impaired renal function
In renal failure with a creatinine clearance of 30-60 ml / min, the dose of Solian should be reduced by 2 times, with a creatinine clearance of 10-30 ml / min - 3 times. It is forbidden to use the drug with creatinine clearance less than 10 ml / min.
Use in the elderly
When prescribing Solian to elderly patients, special care must be taken because of the possible excessive sedation or the risk of developing arterial hypotension.
Drug interactions
The risk of polymorphic ventricular tachycardia of the pirouette type, potentially life-threatening for the patient, increases with the simultaneous use of Solian with the following drugs:
- drugs that contribute to the development of hypokalemia: diuretics (causing hypokalemia), laxatives (stimulating intestinal motility), intravenous administration of amphotericin B, glucocorticosteroids, tetracosactides (this combination requires constant restoration and maintenance of normal blood potassium levels);
- agents causing bradycardia: clonidine, verapamil, beta-blockers, diltiazem, donepezil, guanfacine, digitalis preparations, rivastigmine, tacrine, galantamine, ambenonium chloride, neostigmine bromide, pyridostigmine bromide;
- antipsychotics: pimozide, haloperidol, chlorpromazine, pipothiazine, droperidol, sertindole, cyamemazine, levomepromazine, sultopride, tiapride, sulpiride, veraliprid;
- imipramine antidepressants, azole antifungals, lithium preparations.
Ethanol-containing drugs enhance the sedative effect of amisulpride, which, in turn, increases the central effects of ethanol.
Caution should be exercised with concomitant therapy with drugs that depress the central nervous system (CNS): barbiturates, morphine derivatives (antitussives, analgesics), benzodiazepines, hypnotics, non-benzodiazepine anxiolytics, blockers of H 1 -histamine receptors with a sedative effect, antidepressants with a sedative effect (antidepressants), amitriptyline, mianserin, trimipramine, mirtazapine), centrally acting antihypertensive drugs, antipsychotics, thalidomide, baclofen, pizotifen. With a combination of these funds with amisulpride, a pronounced increase in the inhibitory effect on the central nervous system, a decrease in concentration of attention is possible.
The likelihood of arterial hypotension (including orthostatic hypotension) increases when combined with beta-blockers (carvedilol, bisoprolol, metoprolol) and other antihypertensive agents.
Solian's analogs
The analogue of Solian is Limipranil.
Terms and conditions of storage
Keep out of the reach of children.
Store in a dry place at temperatures up to 25 ° C.
The shelf life is 3 years.
Reviews about Solian
Reviews of Solian indicate the high effectiveness of this drug, but many users note the development of side effects (for example, weight gain, apathy).
Solian price in pharmacies
The price for Solian is: 30 tablets of 200 mg each - about 3600 rubles, 60 ml of solution for oral administration - about 4013 rubles.
Solian: prices in online pharmacies
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Drug name Price Pharmacy |
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Solian 100 mg / ml oral solution 60 ml 1 pc. 3579 RUB Buy |
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Solian 200 mg tablets 30 pcs. 3792 RUB Buy |
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Solian solution for internal approx. 100mg / ml 60ml 3994 RUB Buy |
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Solian 400 mg film-coated tablets 30 pcs. RUB 6087 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!
