Soleron 100 (amisulpride) tablets 100 mg. №30

Description

Soleron 100 (amisulpride) tablets 100 mg. №30

Composition

active substance: amisulpride;

1 tablet contains amisulpride 100 mg or 200 mg;

Excipients: lactose monohydrate; microcrystalline cellulose; hydroxypropylmethylcellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate.

Dosage form

Tablets.

Main physical and chemical properties: round tablets with a biconvex surface, white or almost white, with a dash.

Pharmacotherapeutic group

Antipsychotics.
ATX code N05A L05.

Pharmacological properties

It is an antipsychotic agent. The active substance blocks (selectively) the dopamine D2 and D3 receptors in the brain. It has antipsychotic (neuroleptic) and sedative effects. Reduces the severity of lethargy, productive symptoms.

Indications

Soleron is used:

• with productive mental states (acute psychosis with delirium, paranoid schizophrenia);
• with primary / secondary negative conditions (residual manifestations of psychosis, retardation with mental retardation);
• with a chronic state of depression (dysthymia).

Contraindications

Soleron 100 mg does not apply:

• if you are allergic to amisulpride;
• with intolerance to excipients;
• with pheochromocytoma;
• with prolactinoma of the pituitary gland;
• with breast cancer;
• during pregnancy;
• children under 15 years old.

Soleron 100 mg is prescribed with caution:

• with kidney failure;
• with epilepsy;
• with parkinsonism;
• elderly patients.

Application during pregnancy and lactation

Contraindicated.

Method of administration and dosage

Soleron 100 mg is taken orally.
If the daily dose does not exceed 400 mg, it is taken once a day, and if it does, it is divided into two doses.
The standard dose for productive conditions is 400-800 mg / day, with negative symptoms – 50-300 mg / day, maximum at a time – 300 mg, maximum per day – 1200 mg.
In case of kidney failure (rate of CF less than 30 ml / minute), the dose is reduced to a third of the usual.

Overdose

Symptoms: dizziness, depression of consciousness of varying severity, arterial hypotension, collapse, extrapyramidal disorders.
Therapeutic measures: gastric lavage, the appointment of sorbents, support of the respiratory and cardiovascular systems, control of electrolyte balance, regulation of the acid-base state.

Side effects:

• Neurological disorders: extrapyramidal disorders (hypertension, tremor, rigidity, hypersalivation, hypokinesia, akathisia, dyskinesia), acute dystonia (oculogyric crisis, spastic torticollis, trismus, etc.), drowsiness, tardive dyskinesia (involuntary movements of the tongue, muscles , insomnia, frigidity, anxiety, agitation, neuroleptic malignant syndrome.
• Digestive disorders: dry mouth, nausea, vomiting, constipation.
• Endocrine disorders: hyperprolactinemia (galactorrhea, amenorrhea, gynecomastia, erectile dysfunction, chest pain).
• Metabolic disorders: weight gain, hyperglycemia.
• Laboratory tests: increasing the level of liver enzymes.
• Immune disorders: allergic manifestations.
• Cardiovascular disorders: bradycardia, arterial hypotension, lengthening of the Q-T interval, ventricular arrhythmias (including torsades de pointes, tachycardia, fibrillation, cardiac arrest), sudden coronary death, venous thromboembolism, PE, deep vein thrombosis.
• Hematological disorders: leukopenia, neutropenia, agranulocytosis.
• Dermatological disorders: angioedema, urticaria.