Clinical and pharmacological group: & nbsp

Neuroleptics

Included in the formulation
  • Betamax
    pills inwards 
    GRINDEX, JSC     Latvia
  • BETAMAKS
    pills inwards 
    GRINDEX, JSC     Latvia
  • Prosulfin®
    pills inwards 
    PRO.MED.CS Prague as.     Czech Republic
  • Sulpiride
    pills inwards 
    ORGANICS, JSC     Russia
  • Sulpiride
    solution inwards 
    Rosemont Pharmaceuticals Ltd.     United Kingdom
  • Sulpiride
    solution w / m 
    ORGANICS, JSC     Russia
  • Sulpirid Belupo
    capsules inwards 
  • Eglonil®
    solution w / m 
  • Eglonil®
    pills inwards 
  • Eglonil®
    pills inwards 
  • Eglonil®
    capsules inwards 
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

    N.05.A.L   Benzamides

    Pharmacodynamics:

    Competitive blockade of postsynaptic dopamine D2 receptors in the limbic structures of the brain.

    Pharmacokinetics:

    F 25-35%. It accumulates in the pituitary gland. With breast milk, 0.1% of the daily dose is excreted. Relationship with plasma proteins <40%. Half-life 7 hours. Cl 126 ml / min. Elimination by the kidneys in unchanged form (glomerular filtration 92%).

    Indications:

    As a monotherapy or in combination with other psychotropic drugs:

    - Acute and chronic schizophrenia;

    - acute delirious states;

    - Depression of various etiologies;

    - neurotic disorders;

    - dizziness of various etiologies (vertebro-basilar insufficiency, vestibular neuritis, Meniere's disease, condition after traumatic brain injury, otitis media);

    - auxiliary therapy for peptic ulcer of stomach and duodenal ulcer and irritable bowel syndrome.

    V.F10-F19.F10.4   Mental and behavioral disorders caused by alcohol use - abstinent state with delirium

    V.F20-F29.F20   Schizophrenia

    V.F20-F29.F21   Chrysotile disorder

    V.F20-F29.F22   Chronic delusional disorders

    V.F20-F29.F23   Acute and transient psychotic disorders

    V.F20-F29.F25   Schizoaffective disorder

    V.F20-F29.F29   Inorganic psychosis, unspecified

    V.F30-F39.F31   Bipolar affective disorder

    V.F30-F39.F32   Depressive episode

    V.F30-F39.F33   Recurrent depressive disorder

    V.F40-F48.F41.2   Mixed anxiety and depressive disorder

    V.F40-F48.F48.0   Neurasthenia

    VI.G40-G47.G45.0   Syndrome of vertebrobasilar arterial system

    VIII.H80-H83.H81   Violations of the vestibular function

    VIII.H80-H83.H81.0   Ménière's disease

    VIII.H80-H83.H81.2   Vestibular neuronitis

    XI.K20-K31.K25   Stomach ulcer

    XI.K20-K31.K26   Duodenal ulcer

    XI.K55-K63.K58   Irritable Bowel Syndrome

    XIX.T90-T98.T90   Consequences of head injuries

    Contraindications:

    Hypersensitivity, acute intoxication with alcohol, sleeping pills, narcotic analgesics; manic psychosis, convulsive seizures, Parkinson's disease, pheochromocytoma, prolactin-dependent tumors (including breast cancer), hyperprolactinaemia, affective disorders, aggressive behavior, breastfeeding, children under 6 years of age - for capsules, up to 18 years for other dosage forms . In the presence of lactose in the composition - galactosemia, glucose malabsorption syndrome (galactose) or lactase deficiency.

    Carefully:

    Epilepsy, arterial hypertension, dysmenorrhea, severe heart disease, angina pectoris, renal and / or hepatic insufficiency, a history of malignant neuroleptic syndrome, glaucoma, prostatic hyperplasia, urinary retention, pregnancy, advanced age.

    Pregnancy and lactation:

    Use with caution. In the puerperium sulpiride stimulates lactation without the development of side effects within 4 weeks.

    The category of FDA recommendations is not defined.

    Dosing and Administration:

    The maximum daily intake for adults is 1600 mg of sulpiride.

    Acute and chronic schizophrenia, acute delirious psychosis: initial doses of sulpiride depend on the clinical picture of the disease and make up 600-1200 mg of sulpiride per day, divided into several doses, maintaining doses of 300-800 mg per day.

    Depression: from 150-200 mg to 600 mg per day, divided into several receptions.

    Dizziness: 150-200 mg per day, in severe conditions the dose can be increased to 300-400 mg per day. The duration of treatment should be at least 14 days.

    Auxiliary therapy for peptic ulcer of stomach and duodenum, irritable bowel syndrome: 100-300 mg of sulpiride per day, in one or two doses.

    Doses in patients with impaired renal function: due to the fact that sulpiride is excreted from the body mainly through the kidneys, it is recommended to reduce the dose of sulpiride and / or increase the interval between the administration of individual doses of the drug.

    Doses for the elderly: the initial dose of sulpiride should be 1 / 4-1 / 2 doses for adults.

    Doses for children: the standard dose of sulpiride for children over 14 years is 3-5 mg / kg body weight.

    Side effects:

    On the part of the endocrine system: it is possible to develop reversible hyperprolactinaemia, the most frequent manifestations of which are the galactorrhea,violation of the menstrual cycle, less often - gynecomastia, impotence and frigidity.

    From the gastrointestinal tract: a weakening effect or diarrhea due to the presence of maltitol in the drug, dry mouth, heartburn, nausea, vomiting, increased activity of transaminases and alkaline phosphatase in the blood serum.

    From the side of the nervous system: sedative effect, drowsiness, dizziness, headache, tremor, rarely - extrapyramidal syndrome, early and late dyskinesias, akathisia, oral automatism, aphasia. When used in small doses, there may be psychomotor agitation, anxiety, irritability, sleep disorder, visual acuity. With the development of hyperthermia, the drug should be discarded. an increase in body temperature may indicate the development of neuroleptic malignant syndrome (NZS).

    From the cardiovascular system: tachycardia, it is possible to increase or decrease blood pressure, in rare cases, the development of orthostatic hypotension is possible. Possible: dizziness, tachycardia, prolongation of the QT-interval, rarely, arrhythmia of the "torsade de pointes" type.

    Allergic reactions: skin rash, itching, eczema are possible.

    During treatment with sulpiride, there may be increased sweating, an increase in body weight.

    Overdose:

    Dyskinesia (spasm of chewing musculature, spasmodic torticollis), extrapyramidal disorders. In some cases - pronounced parkinsonism, coma.

    Symptomatic treatment, holinoblokatory central action.

    Interaction:

    Hypotensive drugs - increase their hypotensive effect and increase the risk of developing orthostatic hypotension.

    Levodopa - a decrease in the effectiveness of sulpiride.

    The drugs that oppress the central nervous system (opioid analgesics, hypnotics, tranquilizers, clonidine, antitussive drugs of central action, alcohol), - intensification of their oppressive action.

    Sucralfate, antacids containing magnesium or aluminum, - reduced bioavailability of sulpiride by 20-40%.

    Special instructions:

    Atypical antipsychotic.

    Effective in schizophrenia. In doses up to 800 mg / day causes fewer adverse reactions than typical neuroleptics. The effectiveness of negative symptoms is not well documented. It represents a significantly less costly alternative to new atypical neuroleptics, but no direct comparative studies have been conducted. Sulpiride, amineptin, ritanserin, tricyclic antidepressants, selective serotonin reuptake inhibitors, MAO inhibitors are equal in effectiveness in the treatment of dysthymia, but antidepressants cause more side effects. There is no difference in efficacy between trifluoperazine, chlorpromazine, and sulpiride in the treatment of schizophrenia.

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