Prosulpin (in gastroenterology)
Prosulpin ®
(
Prosulpin ®
) is a neuroleptic, antipsychotic, antiemetic drug. It is also a prokinetic agent and as such is used in gastroenterology.
Dosage forms and composition of Prosulpin
Prosulpin on the Russian market is presented in tablets of 50 and 200 mg, which contain, respectively, 50 and 200 mg of the active substance - sulpiride. In addition, Prosulpin tablets contain excipients: potato starch, magnesium stearate, talc, lactose monohydrate, colloidal silicon dioxide, hypromellose.
Indications for use of Prosulpin
In psychiatry and neurology (both types of tablets):
- all forms of schizophrenia and psychosis
- acute delirious states
- depression and neuroses
- dizziness and migraines
In psychiatry and neurology (50 mg tablets):
- adults: neuroses and anxiety when other treatment methods are ineffective
- children over 6 years of age: severe behavioral disorders
In gastroenterology (only as an additional remedy):
- stress ulcers of the stomach and duodenum
- drug-induced ulcers of the stomach and duodenum
- symptomatic ulcers of the stomach and duodenum
- nonspecific ulcerative colitis
- irritable bowel syndrome
Prosulpin belongs to the regulators of the motor function of the gastrointestinal tract (GIT).
It improves not only motor skills, but also blood supply to the gastrointestinal tract, and gives an antiemetic effect. The antidepressant, anti-anxiety and activating (antiasthenic) effects of Prosulpin are favorable for the patient. Taking this into account, Propulsin can be used as a prokinetic agent, as an additional agent in the treatment of GERD (Trukhan D.I., Tarasova L.V.). The use of prosulpin as part of complex therapy for erosive lesions of the gastroduodenal region has a pronounced therapeutic effect. Along with the positive dynamics of clinical symptoms and indicators of the functional state of the stomach, favorable changes are observed in the aggressive-protective balance of the mucous membrane (Belova E.V., Belov I.V.).
The use of prosulpin in addition to standard therapy in patients with GERD with vegetative-vascular therapy syndrome reduces the severity of vegetative manifestations, improves well-being, improves mood and quality of life indicators of patients (Alyavia F.A., Khamrabaeva F.I.).
A drug that is advisable to use in the complex therapy of GERD or peptic ulcer in the treatment of patients who, along with dyspeptic symptoms considered characteristic of these diseases, also have acute and mental psychoses, is prosulpin. It has an antipsychotic effect through blockade of dopamine receptors. In small doses, prosulpin, acting at the level of central dopaminergic receptors, has a disinhibiting effect. In doses above 600 mg/day it reduces productive symptoms (Vasiliev Yu.V.).
Method of administration of Prosulpin and dose
Propulsin is taken orally, 1 to 3 times a day, with a small amount of liquid, regardless of meals.
It is not recommended to take Prosulpin after 16 hours. In the treatment of gastroenterological diseases, Prosulpin is used strictly as part of complex therapy prescribed by a doctor, as an adjuvant.
Professional medical publications concerning the use of Prosulpin in gastroenterology
- Belova E.V., Belov I.V. Evaluation of the therapeutic effectiveness of prosulpin for erosive lesions of the gastroduodenal region (GDO). VIII International Slavic-Baltic Scientific Forum “St. Petersburg - Gastro-2006”. S. M14.
- Vasiliev Yu.V. “Internal runny nose” and GERD: etiopathogenesis, diagnosis, treatment of patients // Experimental and clinical gastroenterology. -2011. - No. 8. pp. 80-85.
On the website gastroscan.ru in the literature catalog there is a section “Prokinetics”, containing medical articles concerning the treatment of diseases of the gastrointestinal tract with various prokinetics.
general information
According to the pharmacological index, Prosulpin belongs to the Neuroleptics group.
According to ATC, Prosulpin is included in the group “N05A Antipsychotic drugs” and has the code “N05AL01 Sulpiride”. Prosulpin is available from pharmacies with a prescription.
The manufacturer of Prosulpina is PRO.MED.CS Prague as. (PRO.MED.CS Praha as), Czech Republic.
Other drugs containing the active ingredient sulpiride
The following drugs with the active substance sulpiride are (have been) registered in Russia: Betamax, Vero-Sulpiride, Sulpiride, Sulpiride Belupo, Eglek, Eglonil.
In the USA, Canada and Australia, sulpiride is not approved for use. In many countries of the European Union, Latin America and Southeast Asia it is sold under the trade name Dogmatil. In the UK - Dolmatil, Sulpiride and Sulpor. In Japan - Abilit, Betamac T, Dogmatyl, Keityl, Margenol, Miradol, Pyrikappl, Skanozen, Sulpiride Choseido, Sulpiride Kyowa Yakuhin, Sulpiride Taisho, Sulpiride Taiyo, Sulpiride Towa Yakuhin, Youmathyle, as well as under many other trade names in various countries around the world .
Prosulpin has contraindications, side effects and application features; consultation with a specialist is necessary.
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Prosulpin, 50 mg, tablets, 30 pcs.
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 mutual antagonism between dopamine receptor agonists and antipsychotics. For extrapyramidal syndrome induced by antipsychotics, dopamine receptor agonists are not used; in such cases, anticholinergic drugs are used.
Sultopride
The risk of ventricular arrhythmias, in particular atrial fibrillation, increases.
Not recommended combinations
Drugs that can cause ventricular arrhythmias
: antiarrhythmic drugs class Ia (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, sotalol, dofetilide, ibutilide), some antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, tiapride, haloperidol, droperidol, pimozide) and others drugs such as bepridil, cisapride, difemanil, IV erythromycin, mizolastine, IV vincamine, etc.
Alcohol
Alcohol enhances 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 medications containing alcohol should be avoided.
Levodopa
Mutual antagonism between levodopa and antipsychotics. 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 mutual antagonism between dopamine receptor agonists and antipsychotics. The above drugs may cause or worsen psychosis. If treatment with a neuroleptic is necessary for a patient with Parkinson's disease and receiving a dopamine receptor antagonist, the dose of the latter should be gradually reduced until discontinuation (abrupt withdrawal of dopamine receptor agonists can 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 causing ventricular arrhythmia should be discontinued. If the combination cannot be avoided, the QT interval should first be checked and ECG monitoring should be ensured.
Combinations requiring caution
Drugs that cause bradycardia (CBCs 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 cardiac monitoring is recommended.
Drugs that reduce the concentration of potassium in the blood (potassium-sparing diuretics, stimulant laxatives, 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 cardiac monitoring should be established, as well as monitoring of electrolyte concentrations.
Combinations to Consider
Antihypertensive drugs
Strengthening the hypotensive effect and increasing the possibility of postural hypotension (additive effect).
Other CNS depressants: morphine derivatives (narcotic analgesics, antitussives and replacement therapy), barbiturates, benzodiazepines and other anxiolytics, hypnotics, sedatives, antidepressants, sedating H1-blockers, centrally acting antihypertensives, 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 A13+, reduce the bioavailability of oral dosage forms by 20–40%. Sulpiride should be prescribed 2 hours before taking them.
Prosulpin®
Neuroleptic malignant syndrome
Neuroleptic malignant syndrome is characterized by pallor, hyperthermia, muscle rigidity, dysfunction of the autonomic nervous system, and impaired consciousness. Signs of dysfunction of the autonomic nervous system, such as increased sweating, lability of blood pressure and pulse, may precede the onset of hyperthermia and, therefore, are early warning symptoms. In case of unexplained increase in body temperature, treatment with sulpiride should be discontinued. The genesis of the development of NMS remains unclear: it is assumed that blockade of dopamine receptors in the striatum and hypothalamus plays a role in its mechanism, and congenital predisposition (idiosyncrasy) cannot be ruled out. The development of the syndrome may be facilitated by intercurrent infection, dehydration, or organic brain damage.
QT prolongation
Sulpiride may cause a dose-dependent prolongation of the QT interval. This effect increases the risk of developing severe ventricular arrhythmias, such as torsades de pointes.
Before starting antipsychotic therapy, it is necessary to ensure that there are no risk factors predisposing to the development of severe heart rhythm disturbances, such as: bradycardia with a heart rate less than 55 beats/min; slowing of intracardiac conduction, congenital prolongation of the QT interval, or prolongation of the QT interval associated with the simultaneous use of other drugs that prolong the QT interval; disturbance of electrolyte metabolism: hypomagnesemia, and especially hypokalemia - must be corrected; in addition, such patients need to be provided with constant monitoring of the content of electrolytes in the blood, ECG monitoring and constant medical supervision.
Patients with the above risk factors should be careful when prescribing sulpiride (see sections “With caution”, “Side effects”).
Extrapyramidal syndrome
For extrapyramidal syndrome caused by antipsychotics, anticholinergic drugs should be prescribed rather than dopaminergic agonists (see section “Interaction with other drugs”).
Stroke
In randomized clinical trials comparing the effects of certain atypical antipsychotics with placebo in elderly patients with dementia, a threefold increase in the risk of cerebrovascular events was observed. The mechanism of this risk is not known. An increase in this risk cannot be ruled out with other antipsychotics or in other patient populations, so sulpiride should be used with caution in patients with risk factors for stroke.
Elderly patients with dementia
In elderly patients with psychosis associated with dementia, when treated with antipsychotic drugs, there was an increase (1.6-1.7 times) in the risk of death, in most cases associated with cardiovascular (heart failure, sudden death) or infectious diseases (pneumonia). An analysis of 17 placebo-controlled studies showed that the risk of death in elderly patients with dementia treated with atypical antipsychotic drugs was 4.5%, and 2.6% with placebo. Comparative studies have confirmed that treatment with both atypical and typical antipsychotic drugs may increase mortality. The extent to which the increase in mortality may be due to the antipsychotic drug rather than to certain patient characteristics is unclear.
Venous thromboembolic complications
Cases of venous thromboembolic complications, including pulmonary embolism, sometimes fatal, have been observed with the use of antipsychotic drugs; deep vein thrombosis. Therefore, all possible risk factors for venous thromboembolic complications must be identified before and during drug therapy; It is also necessary to take appropriate preventive measures (see section "With caution").
Patients with epilepsy
Due to the fact that antipsychotics can lower the epileptogenic threshold, strict medical supervision should be provided when prescribing sulpiride to patients with epilepsy.
Patients with Parkinson's disease receiving dopaminergic agonists
Except in exceptional cases, sulpiride should not be prescribed to patients suffering from Parkinson's disease. If there is an urgent need for antipsychotic treatment in patients with Parkinson's disease receiving dopaminergic agonists, a gradual reduction in dosage of the latter should be carried out until complete withdrawal. Abrupt withdrawal of dopaminergic drugs may increase the patient's risk of developing NMS (see sections "With caution", "Interaction with other drugs").
Leukopenia, neutropenia, agranulocytosis
With long-term use of antipsychotics, it is recommended to regularly monitor the composition of peripheral blood, especially in the event of fever or the addition of an infection of unknown etiology (the possibility of developing leukopenia and agranulocytosis). If significant hematological changes in the composition of the peripheral blood are detected, treatment with sulpiride should be discontinued.
Patients with impaired renal function
In patients with impaired renal function, reduced doses of sulpiride should be used (see section "Dosage and Administration").
Patients with diabetes mellitus or with risk factors for developing diabetes mellitus
Since there is evidence of the development of hyperglycemia in patients taking atypical antipsychotic drugs, patients with an established diagnosis of diabetes mellitus or with risk factors for its development who are prescribed treatment with sulpiride should monitor their blood sugar levels.
Drinking alcohol or using medications containing alcohol during treatment with sulpiride is strictly prohibited.
It should be borne in mind that sulpiride, when used simultaneously with general stimulants (for example, anorectics, some anti-asthmatic drugs), can cause anxiety, neurosis, excitability and insomnia.
Special precautions should be taken when prescribing sulpiride to young women with an unsteady menstrual cycle.
It is recommended to carry out constant medical monitoring of the condition of newborns who have been exposed to sulpiride in utero. Neonates may be at risk of developing adverse reactions, including extrapyramidal symptoms and/or withdrawal symptoms.
Attention deficit disorder with (or without) hyperactivity disorder
It should be taken into account that due to the influence of sulpiride on cognitive processes in children, it is necessary to annually monitor the child’s learning ability. It is necessary to regularly adjust the dose of the drug taking into account the clinical condition of the child.
The drug contains lactose. For patients with rare hereditary disorders, including galactose intolerance, lactase deficiency or glucose-galactose malabsorption, this drug is not recommended.
