Composition
1 tablet contains:
Active ingredient:
sulpiride 200 mg
. excipients:
microcrystalline granulated cellulose,
lactose monohydrate,
granulated lactose,
sodium carboxymethylaminopectin,
corn starch,
magnesium stearate,
povidone 90.
Pharmacological action
Prosulpin (Sulpiride) is an atypical antipsychotic from the group of substituted benzamides.
It has moderate neuroleptic activity in combination with stimulating and thymoanaleptic (antidepressant) effects.
The neuroleptic effect is associated with an anti-dopaminergic effect. It blocks dopaminergic D2 and D3 receptors, has little effect on the neostriary system, and has an antipsychotic effect.
The antipsychotic effect of sulpiride is manifested in doses of more than 600 mg per day, in doses up to 600 mg per day, the stimulating and antidepressant effects predominate.
Sulpiride has no significant effects on noradrenergic, acetylcholine, serotonin, histamine and GABA receptors.
In small doses, sulpiride can be used as an auxiliary agent in the treatment of psychosomatic diseases, in particular, peptic ulcer of the stomach and duodenum.
With irritable bowel syndrome, it reduces the intensity of abdominal pain.
Low doses of sulpiride (50-300 mg per day) are effective for dizziness. It stimulates prolactin secretion and has a central antiemetic effect (inhibition of the emetic center).
Indications
-Psychosomatic diseases, including peptic ulcer of the stomach and duodenum, stress ulcers of the gastrointestinal tract, drug-induced ulcers, symptomatic ulcers, ulcerative colitis and irritable bowel syndrome.
– Dysphoric disorders.
– Depression of various etiologies, including reactive (nosogenic).
– Neuroses.
– Acute and chronic psychotic disorders of various etiologies (including schizophrenia).
– Migraines.
– Dizziness of various etiologies (vertebrobasilar insufficiency, vestibular neuritis, Meniere’s disease, condition after traumatic brain injury, otitis media).
– Children have psychoses, behavioral disorders.
Use during pregnancy and lactation
During pregnancy and lactation, it should be used with caution and at the lowest effective doses, in cases where the intended benefit to the mother exceeds the potential risk to the fetus.
It is necessary to carefully monitor the condition of the mother, fetus, and newborn.
Extrapyramidal disorders may develop in newborns whose mothers have used sulpiride for a long time.
Contraindications
-Acute poisoning with alcohol, sleeping pills, analgesics. – Hypersensitivity to sulpiride. – Hypertension stage 2-3. – Pheochromocytoma. – Psychomotor agitation.
With caution:
– Pregnancy. – Lactation period. – The newborn period. – Old age. – Cardiovascular diseases. – Kidney failure. – Parkinsonism. – Epilepsy.
Side effects
From the central nervous system: sedation, drowsiness, dizziness, tremor, early dyskinesia (spastic torticollis, oculogyric crises, trismus), which passes with the appointment of central m-holinoblockers; rarely — extrapyramidal syndrome and related disorders: akinesia, sometimes combined with muscle hypertonicity and partially eliminated with the appointment of central m-holinoblockers, hyperkinesia-hypertonicity, motor arousal, akathisia.
There have been cases of tardive dyskinesia, characterized by involuntary rhythmic movements, mainly of the tongue and / or face, during long courses of treatment, which can be observed during courses of treatment with all neuroleptics: the use of Antiparkinsonian drugs is ineffective or may cause worsening of symptoms.
If hyperthermia develops, the drug should be discontinued, since an increase in body temperature may indicate the development of neuroleptic malignant syndrome.
From the endocrine system: reversible hyperprolactinemia may develop, the most common manifestations of which are galactorrhea, amenorrhea, dysmenorrhea; less often-impotence and frigidity.
During treatment with sulpiride, increased sweating and weight gain may occur.
From the digestive system: increased activity of liver enzymes.
From the cardiovascular system: tachycardia, possible increase or decrease in blood pressure; in rare cases, orthostatic hypotension may develop, prolongation of the QT interval; very rare cases of torsade des pointes syndrome.
From the circulatory and lymphatic systems: hemolytic anemia, aplastic anemia, leukocytosis, thrombocytopenic purpura, granulocytosis.
Allergic reactions: possible skin rash.
Interaction
Contraindicated combinations
Dopamine receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole), except for patients with Parkinson’s disease
There is a mutual antagonism between dopamine receptor agonists and neuroleptics. In neuroleptic-induced extrapyramidal syndrome, dopamine receptor agonists are not used; in such cases, anticholinergic agents are used.
Sultopride
The risk of ventricular arrhythmias, particularly atrial fibrillation, increases.
Not recommended combinations
Drugs that can induce ventricular arrhythmia type “torsade des pointes”: antiarrhythmic agents class Ia (quinidine, gedragingen, disopyramide) and class III (amiodarone, sotalol, dofetilide, ibutilide), some antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, tiapride, haloperidol, droperidol, pimozide) and other drugs such as bepridil, cisapride, was diphemanil, I/erythromycin, mizolastine, I/vincamine has, etc.
Alcohol
Alcohol increases the sedative effect of neuroleptics. Impaired attention creates a danger for driving vehicles and working with mechanisms that require increased attention. The consumption of alcoholic beverages and the use of medicines containing alcohol should be avoided.
Levodopa
Mutual antagonism between levodopa and neuroleptics. Patients with Parkinson’s disease should be prescribed the minimum effective dose of both drugs.
Dopamine receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole) in patients with Parkinson’s disease
There is a mutual antagonism between dopamine receptor agonists and neuroleptics. The above medications may cause or increase psychosis. If treatment with a neuroleptic agent is necessary for a patient with Parkinson’s disease who is receiving a dopamine receptor antagonist, the dose of the latter should be gradually reduced until withdrawal (abrupt withdrawal of dopamine receptor agonists may lead to the development of neuroleptic malignant syndrome).
Halofantrine, pentamidine, sparfloxacin, moxifloxacin
The risk of ventricular arrhythmias increases, in particular, “torsade des pointes”. If possible, the antimicrobial drug that causes ventricular arrhythmia should be discontinued. If the combination cannot be avoided, the QT interval should be checked beforehand and the ECG monitored.
Combinations that require caution
Drugs that cause bradycardia (BCC with bradycardic action: diltiazem, verapamil, beta-blockers, clonidine, guanfacine, cardiac glycosides; cholinesterase inhibitors: donepezil, rivastigmine, tacrine, ambenonium chloride, galantamine, pyridostigmine bromide, neomycin methyl sulfate
The risk of ventricular arrhythmias increases, in particular, “torsade des pointes”. Clinical and cardiographic monitoring is recommended.
Drugs that reduce the concentration of potassium in the blood (potassium-removing diuretics, laxatives of a stimulating nature, amphotericin B (iv), CORTICOSTEROIDS, tetracosactide
The risk of ventricular arrhythmias increases, in particular, “torsade des pointes”. Before prescribing the drug, hypokalemia should be eliminated, clinical and cardiographic monitoring should be established, as well as monitoring of electrolyte concentrations.
Combinations to take into account
Antihypertensive medications
Increased hypotensive effect and increased possibility of postural hypotension (additive effect).
Other CNS depressants: morphine derivatives (narcotic analgesics, antitussives and substitution therapy), barbiturates, benzodiazepines and other anxiolytics, sleeping pills, sedatives, antidepressants, sedative blockersof H1-histamine receptors, antihypertensive agents of central action, baclofen, thalidomide
CNS depression. Impaired attention creates a danger for driving vehicles and working with mechanisms that require increased attention.
Sucralfate, antacids containing Mg2+ and/or A%^%13+, reduce the bioavailability of oral dosage forms by 20-40%. Sulpiride should be prescribed 2 hours before taking them.
How to take it, course of administration and dosage
It is not recommended to take the drug in the afternoon (after 16 hours) due to an increase in the level of wakefulness.
– Psychosomatic disorders, including peptic ulcer of the stomach and duodenum, stress ulcers of the gastrointestinal tract, drug-induced ulcers, symptomatic ulcers, ulcerative colitis, irritable bowel syndrome 100-300 mg per day in one or two doses, for 4-6 weeks.
– Neuroses 100-400 mg per day in 2-3 doses.
– Depression From 150-300 mg per day, divided into several doses. The maximum dose is 600 mg per day.
– Acute and chronic psychoses (including schizophrenia): Depending on the clinical picture of t
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