Solian pills 400mg №30

Dosage form

Pills

Composition

1 pill contains: Amisulprid 400 mg

Auxiliary substances: Lactose monohydrate, sodium carboxymethyl starch (sodium amylopectin glycolate) (type A), microcrystalline cellulose, hypromellose, Magnesium stearate

Packing

30 tablets.

Mechanism of action

Solian is an antipsychotic drug (neuroleptic).

Amisulpride has a high selective affinity for the dopaminergic receptors of the D 2 / D 3 subtypes and does not have an affinity for the D 1, D 4 and D 5 subtypes.

Unlike classical and atypical neuroleptics, amisulpride has no affinity for serotonin receptors, histamine H 1 receptors,? -Adrenoreceptors and cholinergic receptors.

When used in high doses, it blocks postsynaptic D 2 receptors localized in the limbic structures, in contrast to similar striatum receptors. It does not cause catalepsy and does not lead to the development of hypersensitivity of dopamine D 2 -receptors after repeated treatment.

In low doses, it predominantly blocks presynaptic D 2 / D 3 receptors, stimulating the release of dopamine.

Atypical pharmacological profile determines the antipsychotic effect of amisulpride in high doses,resulting from the blockade of postsynaptic dopamine receptors, and its effectiveness in low doses against negative symptoms as a result of the 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 and usage

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

Contraindications

- Concomitant prolactin-dependent tumors (including pituitary prolactinoma, breast cancer).
- Pheochromocytoma.
- Renal failure severe (CC less than 10 ml / min).
- The combined use with a sultoprid.
- Combined use with dopaminergic agonists (including amantadine, apomorphine, Bromocriptine, cabergoline, entacapone, lisuride, pergolid, piribedil, pramipexol, hinagolid, ropinirole, selegilin), except for patients with Parkinson's disease.
- Children's age up to 14 years.
- Lactation period (breastfeeding).
- Hypersensitivity to amisulpride and other components of the drug.

With caution should use the drug for:
- Pregnancy.
- Epilepsy.
- Parkinsonism.
- Renal failure.
- In elderly patients.

Pregnancy and Breastfeeding

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.

Dosage and administration

In 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 maximum daily dose should not exceed 1200 mg.

With 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. Supporting treatment should be set individually at the level of the minimum effective dose.

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

Elderly patients should be prescribed Solian with extreme caution due to the possible development of arterial hypotension or excessive sedation.

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

For convenience of dosing, it is possible to use Solian p.po. 400 mg pack. 30 Sanofi-aventis.

Adverse reactions

From the side of the central nervous system: Often - insomnia, anxiety, agitation; sometimes extrapyramidal symptoms (including tremor, hypertension, hypersalivation, akathisia, hypokinesia), the intensity of which at maintenance doses is usually moderate, the symptoms are partially reversible without discontinuing Solian using anticholinergic antiparkinsonian drugs (the rate of dose-dependent extrapyramidal symptoms remains very low with treatment of patients with a predominance of negative symptoms (doses of 50-300 mg / day); rarely, daytime sleepiness; very rarely - acute dystonia (including spastic torticollis, ocular crises, trismus), which is reversible and corrected with anti-Parkinsonian agents; 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 rare cases - neuroleptic malignant syndrome, convulsive seizures.

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

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

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

Other: In some cases, allergic reactions.

Special notes

Perhaps the development of malignant neuroleptic syndrome, 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 antipsychotic drugs (including Solian) 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 less than 10 ml / min) no kidney function.

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 Solian therapy.

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

In Parkinson's disease, when prescribing antidopaminergic drugs and amisulpride, caution should be exercised due to possible deterioration.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, and, if possible, depending on the clinical condition of the patient, it is recommended to control the factors contributing to the development of arrhythmias: bradycardia (heart rate less than 55 bpm), hypokalemia, congenital lengthening of the QT interval.

In patients who require long-term neuroleptic treatment, an ECG should be performed during the initial status assessment.

In connection with the content in the pills of lactose, the drug is contraindicated in congenital galactosemia, a syndrome of impaired absorption of glucose or galactose, or lactase deficiency.

Application for violations of the liver: When prescribing the drug to patients with impaired liver function, dose reduction is not required.

Application for violations of renal function: Contraindicated use of the drug for severe renal failure (CC less than 10 ml / min).

Impact on the ability to drive vehicles and control mechanisms: Amisulpride affects the reaction rate, with the result that the ability to engage in potentially hazardous activities can be weakened.

Combinations that are contraindicated: With dopaminergic agonists (including amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolid, piribedil, pramipexol, quinagolid, ropinirole, selegilin), with the exception of patients with Parkinson's disease. Dopaminergic agonists and neuroleptics show mutual antagonism. For extrapyramidal syndrome caused by neuroleptics, anticholinergic drugs should be used instead of dopaminergic agonists. With the simultaneous use of Solian with sultoprid increases the risk of ventricular arrhythmias, especially atrial fibrillation.

Combinations that are not recommended: With drugs that can cause pirouette-type arrhythmias: class Ia antiarrhythmic drugs (including quinidine, hydroquinidine, disopyramide) and class III (including Amiodarone, sotalol, dofetilide, ibutilide), some neuroleptics (including thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, Sulpiride, Tiapride, pimozide, Haloperidol, droperidol) and other drugs (including bepridil, cisapride, diphtheria, droperidol) and other drugs (including bepridil, cisapride, diphoridol, droperidol) and other drugs (including bepridil, cisapride, diphoridol, droperidol), mizolastine, vincamine, halofantrine, sparfloxacin, gatiflox ching, moxifloxacin, pentamidine, / in spiramycin). The risk of ventricular arrhythmias increases, especially the development of pirouette-type arrhythmias. If drug combinations cannot be avoided, monitor the QT interval before starting the appointment and start monitoring the ECG. Ethanol enhances the sedative effects of neuroleptics. Consumption of alcohol and the use of drugs containing alcohol should be avoided. One should take into account the mutual antagonism of the action of levodopa and neuroleptics when prescribing these drugs.In patients with Parkinson's disease, it is recommended to use the minimum effective dose of both drugs.

Combinations requiring special care: 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 (cholinesterase inhibitors ( donepezil, rivastigmine, takrin, ambenonium, galantamine, pyridostigmine, neostigmine). With drugs that can cause hypokalemia (including potassium diuretics, laxatives, IV amphotericin B, glucocorticoids, tetracosactides). With the above combinations of drugs, the risk of ventricular arrhythmias remains, especially the development of pirouette-type arrhythmias.

Combinations that should be taken into account: With antihypertensive drugs and beta-blockers in heart failure (including bizoprolol, Carvedilol, metoprolol) has a vasodilating effect, increasing the risk of orthostatic hypotension (additive effect). With morphine derivatives (including analgesics, antitussive drugs), barbiturates, benzodiazepines and other anxiolytics, hypnotic drugs, sedative antidepressants (including Amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), and drugs used in the production of morphine (including amitriptyline, doxepin, mianserin, myrtazapine, trimipramine), and drugs. central action, neuroleptics and other drugs (includingbaclofen, thalidomide, pizothiphene) leads to a pronounced increase in the inhibitory effect on the central nervous system (reduced concentration and a danger to drivers of transport and machine operators).

The drug should be stored in a dry place at a temperature below 25 ° C.

3 years.