Sulpirid-ZN (sulpiride) tablets 50 mg. №30

Description

Sulpirid-ZN (sulpiride) tablets 50 mg. №30

Composition

active substance: sulpiride;

1 tablet contains sulpiride 50 mg;

Excipients: coelactose 80 (mixture of lactose monohydrate and cellulose powder (75:25)), microcrystalline cellulose, corn starch, colloidal anhydrous silica, talc, magnesium stearate.

Dosage form

Tablets.

Main physical and chemical properties: white or almost white tablets of round cylindrical shape with flat surfaces and chamfers.

Pharmacotherapeutic group

Antipsychotics.
ATX code N05A L01

Pharmacological properties

It is an antipsychotic agent. It has moderate neuroleptic activity, as well as thymoleptic and stimulating effect. It is a selective (selective) antagonist of serotonin and dopamine. In addition, it exhibits antiemetic (antiemetic) action.

Indications

Sulpirid-ZN tablets is used:

• for short-term symptomatic treatment of anxiety conditions in adults in cases where standard therapeutic measures have not worked;
• with serious behavioral disorders (agitation, stereotypy, self-harm) in children from six years of age, especially in patients with autistic syndromes.

Contraindications

Sulpirid-ZN tablets does not apply:

• if you are allergic to sulpiride;
• with intolerance to excipients;
• with pheochromocytoma;
• with acute porphyria;
• with concomitant prolactin-dependent tumors (for example, prolactinoma), breast cancer;
• with concomitant treatment with antiparkinsonian dopamine agonists (rotigotine, cabergoline, kinagolide), levodopa, antiparkinsonian drugs (ropinorol), mechitazine, citalopram, escitalopram.

Application during pregnancy and lactation

Contraindicated.

Method of administration and dosage

For oral use.

The minimum effective dose should always be prescribed.

If the patient’s clinical condition allows, treatment should begin with a low dose, followed by gradual dose titration.

• Adults
  Short-term symptomatic treatment of anxiety in cases where the usual therapeutic measures did not work: the daily dose is 50-150 mg for no more than 4 weeks.
• Children from 6 years old.
  Serious behavioral disorders (agitation, self-harm, stereotype) in children over 6 years of age, especially in patients with autistic syndromes: 5-10 mg / kg body weight per day.

Children

The use of tablets in children under 6 years is contraindicated.

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.