Solian 400 mg

Trade Name:

Solian

Composition:

Each tablet contains:

Amisulpride 400 mg

Inactive ingredients:

sodium carboxymethyl starch (sodium amylopectin glycolate) (type A), lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate.

Properties:

Antipsychotic (neuroleptic).

Amisulpride has a high selective affinity for dopamine receptors of the D2/D3 subtypes and no affinity for the D1, D4 and D5 subtypes. Unlike classical and atypical antipsychotics, amisulpride has no affinity for serotonin receptors, histamine H1 receptors, α-adrenergic receptors and cholinergic receptors.

Indications:

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

Dosage and administration:

The optimal dosing regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.

For oral administration.

Depending on the indications and the course of the disease, the daily dose varies from 50 mg to 1200 mg. Amisulpride at a dose of more than 400 mg / day is taken in 2 divided doses.

Maintenance treatment is set individually at the level of the minimum effective dose.

Contraindications:

Concomitant prolactin-dependent tumors (incl.pituitary prolactinoma, breast cancer); pheochromocytoma; children’s age up to 15 years; pregnancy; lactation period (breastfeeding); women of childbearing age not using adequate contraception; combinations with the following drugs that may contribute to the development of atrial fibrillation: class IA antiarrhythmic drugs (quinidine, disopyramide, procainamide), class III antiarrhythmic drugs (amiodarone, sotalol); other drugs (bepridil, cisapride, sultopride, thioridazine, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin); combination with levodopa; hypersensitivity to amisulpride.

Warnings and precautions:

Caution should be used in epilepsy, parkinsonism, renal failure; in elderly patients (due to the possible development of arterial hypotension or excessive sedation).

Perhaps the development of NMS, 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 high doses, all antipsychotic drugs (including amisulpride) should be discontinued.

Side effects:

From the nervous system: very often – insomnia, anxiety, agitation; often – drowsiness; possibly – acute dystonia (incl.spastic torticollis, oculogeric crises, trismus), which is reversible and corrected with anticholinergic antiparkinsonian drugs; the incidence 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 with the drug at doses of 50-300 mg / day; with prolonged use – tardive dyskinesia, characterized by rhythmic, involuntary movements, mainly of the tongue and / or face (antiparkinsonian drugs are ineffective and may cause worsening of symptoms); in isolated cases – convulsive seizures, NMS.

From the digestive system: often – constipation, nausea, vomiting, dry mouth; rarely – increased activity of liver enzymes (mainly transaminases).

From the endocrine system: an increase in the level of prolactin in the blood plasma (reversible after discontinuation of the drug), which can cause galactorrhea, amenorrhea, gynecomastia, chest pain, impotence, weight gain.

Storage:

Store at a temperature not exceeding 25°C.

Package:

The carton box contains 30 tablets.