Sulpiride intramuscular 50 mg/ml 2 ml – [10 ampoules]

Atypical antipsychotic (neuroleptic), also has stimulant, antidepressant and antiemetic effect. The neuroleptic effect is associated with antidopaminergic action. In the central nervous system, sulpiride blocks mainly dopaminergic receptors of the limbic system, it has little effect on the neostriatal system, it has antipsychotic effect. Peripheral action of sulpiride is based on inhibition of presynaptic receptors. An increase in dopamine in central nervous system (hereinafter referred to as CNS) is associated with improvement of mood, a decrease – with the development of depression symptoms.

Antipsychotic effect of sulpiride is manifested in doses over 600 mg per day, in doses up to 600 mg per day, stimulant and antidepressant effects predominate. Sulpiride has no significant effect on adrenergic, cholinergic, serotonin, histamine and gamma-aminobutyric acid receptors.

Sulpiride stimulates prolactin secretion and has a central antiemetic effect (inhibition of the vomiting center) due to blockade of dopamine D2-receptors of the trigger zone of the vomiting center.

Anxiety disorders in adults (short-term symptomatic treatment if conventional therapy is ineffective).

Severe behavioral disorders (agitation, self-harm, stereotypy) in children over 6 years of age, especially with autism syndrome.

– Children under 18 years of age (for 200 mg tablets)

– Children under 6 years of age (50 mg tablets)

– Hypersensitivity to sulpiride and/or excipients of the drug

– Known or suspected pheochromocytoma

– Prolactin-dependent tumors (pituitary prolactinomas and breast cancer);

– hyperprolactinemia;

– acute porphyria

– acute intoxication with ethanol, hypnotics, narcotic analgesics

– concomitant use with levodopa (see section “Interaction with other medicinal products”)

– concomitant therapy with dopamine receptor agonists (rotigotine, cabergoline, ropinirole, quinagolide) (see section “Interaction with other medicinal products”)

– concomitant use with mechitazin, citalopram, escitalopram

– Breast-feeding period

– galactosemia, glucose/galactose malabsorption syndrome or lactase deficiency (due to the presence of lactose in the drug).

• The preparation in form of solution for intramuscular injection is intended for use in adults only.
• In all cases, the lowest effective doses of the drug should be used. If the clinical condition of the patient allows, treatment should be started with a low dose. The minimum effective dose is selected by gradually increasing the dose until the desired effect is achieved.
• Daily dose is from 400 to 800 mg for 2 weeks.
• Doses for the elderly: The starting dose of sulpiride should be 1/4 to 1/2 of the adult dose.
• Doses in patients with impaired renal function: due to the fact that sulpiride is eliminated from the body mainly through the kidneys, it is recommended to reduce the dose and/or increase the interval between injections of individual doses of the drug, depending on creatinine clearance values: in creatinine clearance of 30 – 60 ml/min, the dose of sulpiride should be reduced by 30%, and the interval between doses should be increased by 1.5 times; in creatinine clearance of 10 – 30 ml/min, the dose of sulpiride should be reduced by 2 times, and the interval between doses of the drug – increased by 2 times; in creatinine clearance less than 10 ml/min, the dose of sulpiride should be reduced by 70%, and the interval between drug doses – increased by 3 times.