Sulpirid-ZN (sulpiride) solution for injections 50 mg/ml. 2 ml. ampoules №10

Description

Sulpirid-ZN (sulpiride) solution for injections 50 mg/ml. 2 ml. ampoules №10

Composition

active substance: sulpiride;

1 ml of solution contains 50 mg of sulpiride;

Excipients: sodium chloride, sulfuric acid, water for injections.

Dosage form

Solution for injection.

Main physical and chemical properties: clear, colorless or almost colorless liquid without odor or with a weak specific odor.

Pharmacotherapeutic group

Antipsychotics.
ATX code N05A L01.

Pharmacological properties

Sulpiride affects dopaminergic nerve transmission in the brain as a dopamine mimetic, thus having an activating effect in low doses. At higher doses, sulpiride also has an antireproductive effect.

Indications

Sulpirid-ZN solution 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 solution 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

The drug is administered intramuscularly.

Intended only for adult patients.

The minimum effective dose should always be prescribed. If the patient’s clinical condition allows, treatment should be started at a low dose (100 mg), followed by gradual dose titration.

The dose is from 400 to 800 mg per day for 2 weeks.

After opening the ampoule, the drug should be used immediately.

Children

In this dosage form, the drug is intended only for adult patients.

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.