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Pharmacological properties

Sulpiride affects the dopaminergic nerve transmission in the brain as a dopaminomimetic, due to which it has an activating effect. at higher doses, Sulpiride also reduces the severity of productive symptoms.

Pharmacokinetics

Suction. After oral administration of one tablet 200 mg Cmax plasma Sulpiride (0.73 mg / l) is reached after 3-6 hours.

Distribution. The bioavailability of oral dosage forms is 25–35% with wide individual fluctuations; Sulpiride has a linear pharmacokinetic profile after administration in doses of 50-300 mg.

Sulpiride is rapidly distributed in the tissues of the body: the apparent volume of distribution in a stationary state is 0.94 l / kg. Binding to blood plasma proteins - 40%.

Sulpiride in small quantities is determined in breast milk and can penetrate the placental barrier.

Biotransformation. Sulpiride is practically not metabolized in the human body.

Sulpiride is excreted mainly through the kidneys by glomerular filtration. The renal clearance is 126 ml / min. T½ from blood plasma is 7 hours.

Indications

Betamax 50 and 100 mg:

  • short-term symptomatic treatment of anxiety conditions in adults in the case when the usual therapeutic measures have failed;
  • serious behavioral disorders (agitation, self-harm, stereotype) in children over the age of 6 years, especially in patients with autistic syndromes.

Betamax 200 mg:

  • acute mental disorders;
  • chronic mental disorders (schizophrenia, chronic non-schizophrenic disorders: paranoid states, chronic hallucinatory psychosis).

Application

For oral use. the minimum effective dose should always be given. if the clinical condition of the patient allows, treatment should begin with a low dose, after which its gradual titration is possible.

Betamax 50 and 100 mg

Adults Short-term symptomatic treatment of anxiety conditions in the case when the usual therapeutic measures have not yielded results: the daily dose is 50-150 mg for no more than 4 weeks.

Children from the age of 6 years. Serious behavioral disorders (agitation, self-harm, stereotype) in children over the age of 6 years, especially in patients with autistic syndromes: 5 mg / kg body weight per day (if necessary, the dose can be increased to 10 mg / kg body weight per day).

Children. Since the effectiveness and safety of the use of Sulpiride in children has not been fully studied, it should be used with caution (see APPLICATION). Due to the effect that the drug has on cognitive abilities, it is recommended that a clinical examination be conducted annually to assess learning ability. It is necessary to periodically adjust the dose of the drug based on the clinical status of the child.

The use of tablets in children under the age of 6 years is contraindicated, as this can lead to airway obstruction.

Betamax 200 mg. In this dosage form, the drug is intended for adult patients.

The daily dose is 200-1000 mg.

Children. The drug in this dosage form is for adult patients.

Contraindications

Hypersensitivity to Sulpiride or any of the excipients of the drug. prolactin-dependent tumors (e.g., prolactin-secreting pituitary adenoma (prolactinoma) and breast cancer). known or suspected diagnosis of pheochromocytoma. acute porphyria. combinations with nonantiparkinsonian dopamine agonists (cabergoline, rotigotine and kinagolid), combinations with levodopa or antiparkinsonian drugs (including ropinorol), combinations with mechitazine, citalopram and escitalopram (see interactions).

Side effects

Adverse reactions associated with the use of the drug and observed during clinical trials are given below for the classes of organs and systems in descending order of frequency of occurrence.

Nervous Disorders. Early dyskinesia (spastic torticollis, oculogyric crises, trismus). The severity of symptoms decreases with the use of anticholinergic anti-Parkinsonian drugs.

Extrapyramidal symptoms and related disorders:

  • parkinsonism and related symptoms: tremor, hypertonicity, hypokinesia, hypersalivation;
  • akinetic symptoms, accompanied or not accompanied by hypertonicity, which are partially reduced with the use of anticholinergic antiparkinsonian agents;
  • hyperkinetic-hypertonic, exciting motor activity;
  • akathisia.

With late dyskinesia, which is characterized by involuntary rhythmic movements, in particular of the tongue and / or face, and which can be observed during long courses of treatment with all antipsychotics, anticholinergic antiparkinsonian drugs are ineffective and can worsen clinical manifestations.

Soothing effect or drowsiness.

Insomnia and anxiety have been reported.

Convulsions (see SPECIAL INSTRUCTIONS).

Potentially fatal malignant antipsychotic syndrome (see SPECIAL INSTRUCTIONS).

General violations. Weight gain.

Immune system disorders. Anaphylactic reactions, shortness of breath and anaphylactic shock.

Endocrine Disorders Short-term hyperprolactinemia can lead to amenorrhea, galactorrhea, gynecomastia, impotence, frigidity, enlargement of the mammary glands and pain in the mammary glands. Disappears after discontinuation of treatment.

Cardiological disorders. Elongation of the Q – T interval, ventricular arrhythmias, in particular paroxysmal ventricular tachycardia such as pirouette (torsades de pointes) and ventricular tachycardia, which can lead to ventricular fibrillation or cardiac arrest, sudden death (see SPECIAL INSTRUCTIONS).

Vascular disorders Orthostatic arterial hypotension, increased blood pressure.

When using antipsychotic drugs, cases of venous thromboembolism have been reported, including sometimes fatal cases with pulmonary embolism and deep vein thrombosis, the frequency of cases has not been established.

On the part of the blood system and lymphatic system. Leukopenia, neutropenia, agranulocytosis - the frequency of occurrence is unknown.

From the hepatobiliary system. Increased activity of liver enzymes.

Pathology of the skin and subcutaneous tissue. Maculopapular rash, urticaria.

General disorders. Hypersensitivity reactions.

Pregnancy, postpartum and perinatal conditions. Cancellation syndrome in newborns - the frequency of occurrence is unknown.

special instructions

In patients with diabetes mellitus or risk factors for developing diabetes mellitus, proper monitoring of blood glucose levels should be performed at the beginning of Sulpiride therapy.

Except in special cases, this drug should not be prescribed to patients with Parkinsons disease.

For patients with renal failure, reduced doses and enhanced monitoring are recommended; in case of severe renal failure, intermittent courses of treatment are advisable.

During treatment with Sulpiride, more careful observation is necessary for patients with epilepsy, since Sulpiride can lower the seizure threshold (there have been reports of cases of seizures in patients treated with Sulpiride (see ADVERSE EFFECTS)), elderly patients who are susceptible to the development of postural hypotension, sedative effects and extrapyramidal effects of the drug.

In patients with aggressive behavior or agitation with impulsivity, Sulpiride should be prescribed along with sedatives.

It was reported that against the background of the use of antipsychotics, including Sulpiride, leukopenia, neutropenia and agranulocytosis occurred. Infections of an unknown etiology or an increase in body temperature of an unknown etiology can be signs of leukopenia (see ADVERSE EFFECTS): in such cases, a blood test should be performed immediately.

Potentially fatal malignant antipsychotic syndrome. In the event of an increase in body temperature of an unknown etiology, treatment should be stopped immediately, since this may be one of the symptoms of a malignant syndrome that can develop with antipsychotics (pallor, hyperthermia, autonomic disorders, impaired consciousness, muscle stiffness).

Signs of autonomic nervous system dysfunction, such as increased sweating and changes in blood pressure, can develop before the onset of hyperthermia, and therefore they should be considered as early alarming symptoms.

Although this antipsychotic effect may have an idiosyncratic nature, risk factors such as dehydration and organic brain damage may be noted.

Extension of the Q – T interval. Sulpiride may lead to a dose-dependent lengthening of the Q – T interval. This effect, which is known to increase the risk of developing serious ventricular arrhythmias, in particular bidirectional spindle-shaped ventricular tachycardia, is more often observed in patients with bradycardia, hypokalemia, and congenital or acquired prolongation of the Q – T interval (when Sulpiride is taken simultaneously with the drug, which leads to lengthening the Q – T interval), see ADVERSE EFFECTS.

Given this, before the introduction of the drug and if the clinical situation allows, one should check the presence of risk factors in patients that can cause the development of this type of arrhythmia. Risk factors: bradycardia 55 beats / min, hypokalemia, congenital lengthening of the Q – T interval, use of a drug that can cause severe bradycardia (55 beats / min), hypokalemia, slowing of intracardiac conduction, or lengthening of the Q – T interval (see CONTRAINDICATIONS and INTERACTIONS).

Except in urgent cases, it is recommended to conduct an ECG study during the initial examination of patients who should receive treatment with an antipsychotic drug.

Stroke. During randomized, placebo-controlled clinical trials, elderly patients with dementia treated with some atypical antipsychotics showed an increased risk of stroke compared with those receiving placebo. The mechanism for this increased risk is unknown. An increased risk cannot be excluded with the use of other antipsychotic agents or in other patient populations. For patients with risk factors for stroke, this drug is prescribed with caution.

Elderly patients with dementia. The risk of death is increased in elderly patients with psychosis caused by dementia, and receiving treatment with antipsychotic drugs.

An analysis of these studies involving patients who generally took atypical antipsychotic drugs showed that the risk of death was 1.6–1.7 times higher among patients taking these drugs compared with placebo.

After the average treatment period of 10 weeks was completed, the risk of death was 4.5% in the group of patients receiving treatment, compared with 2.6% in the placebo group.

Although the causes of death during clinical trials using atypical antipsychotics were varied, most deaths occurred as a result of cardiovascular (such as heart failure, sudden death) or infectious diseases (such as pneumonia).

Epidemiological studies suggest that treatment with standard antipsychotic drugs can increase the likelihood of death, just as with atypical antipsychotic drugs.

The appropriate role of antipsychotic drugs and patient characteristics in increasing mortality in epidemiological studies remains uncertain.

Venous thromboembolism. When using antipsychotic drugs, rare lethal cases have been reported with venous thromboembolism. Since patients taking antipsychotic drugs often have acquired risk factors for venous thromboembolism, it is necessary to identify all potential risk factors for the development of this pathology and take preventative measures before and during treatment (see ADVERSE EFFECTS).

It is not recommended to take this drug simultaneously with alcohol, levodopa, dopamine receptor agonists, antiparasitic drugs that can cause paroxysmal ventricular tachycardia such as pirouette (torsades de pointes), with methadone, other antipsychotics and drugs that can cause paroxysmal ventricular tachycardia such as pirouette ( torsades de pointes), see ADVERSE EFFECTS.

In the case of the use of the drug, even in low doses, the risk of developing tardive dyskinesia, in particular among the elderly, should be taken into account.

Sulpiride has an anticholinergic effect, so it should be used with caution in patients with glaucoma, intestinal obstruction, congenital gastrointestinal stenosis, urinary retention, and a history of prostatic hyperplasia.

Sulpiride should be used with caution in patients with a tendency to hypertension, especially the elderly, because of the risk of hypertensive crisis.

Warning of excipients. Betamax tablets contain lactose. This drug is not recommended for patients with rare congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Use during pregnancy or lactation

Pregnancy. In animals, there was a decrease in fertility associated with the pharmacological properties of the drug (prolactin-mediated effect).

Animal studies do not indicate a direct or indirect harmful effect on the course of pregnancy, development of the embryo / fetus and / or postpartum development.

Clinical data on the use during pregnancy is very limited, so the use is not recommended.

For people, a very limited amount of data is available on the effects on pregnancy. In almost all cases of impaired development of the fetus or newborns, which were reported in the context of the use of Sulpiride during pregnancy, alternative explanations are allowed, which seem more likely. Thus, due to the limited experience with Sulpiride during pregnancy, its use is not recommended. Newborns whose mothers received antipsychotics in the third trimester of pregnancy after birth are at risk of side effects, including extrapyramidal symptoms and / or withdrawal symptoms, with varying degrees of severity and duration. The following adverse reactions have been reported: agitation, hypertonicity, hypotension, tremor, drowsiness, respiratory distress, and nutritional problems. In this regard, the condition of newborns must be carefully monitored.

Lactation. Since Sulpiride passes into breast milk, breastfeeding during treatment is not recommended.

The ability to influence the reaction rate when driving vehicles or other mechanisms. Sulpiride acts on the central nervous system and can cause drowsiness, dizziness, visual impairment and slow psychomotor reactions (see ADVERSE EFFECTS).During the use of the drug, it is contraindicated to drive vehicles and work with mechanisms.

Interactions

Sedatives. it should be remembered that many drugs can exhibit an additive inhibitory effect on the central nervous system and lead to a decrease in mental activity. these agents include morphine derivatives (analgesics, cough suppressants and substitution therapy), antipsychotics, barbiturates, benzodiazepines, nonbenzodiazepine anxiolytics (such as meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, miansperin, sedative, myrtle antihistamines, antihypertensive drugs with a central effect, baclofen and thalidomide.

Drugs that can cause the development of paroxysmal ventricular tachycardia (torsades de pointes). A number of drugs that have or do not have antiarrhythmic activity can lead to this serious heart rhythm disturbance. Provoking factors are hypokalemia (see Potassium-sparing drugs) and bradycardia (see Drugs that cause bradycardia) or the presence of a congenital or acquired prolongation of the Q – T interval.

Such drugs include, in particular, antiarrhythmic drugs of classes la and III and some antipsychotics.

This interaction enters dolasetron, erythromycin, spiramycin and vincamine only in dosage forms for iv administration.

The simultaneous administration of two “torsadogenic” (causing torsades de pointes) drugs is contraindicated in most cases. However, the exception is methadone and some other substances:

  • antiparasitic drugs (halofantrine, lumefantrine, pentamidine) are undesirable to combine with other drugs that can cause paroxysmal ventricular tachycardia such as pirouette (torsades de pointes);
  • antipsychotics that can cause paroxysmal ventricular tachycardia such as pirouette (torsades de pointes) are also not recommended, but are not contraindicated for use in combination with other drugs that can cause paroxysmal ventricular tachycardia such as pirouette (torsades de pointes).

Contraindicated combinations (see CONTRAINDICATIONS)

Citalopram, escitalopram. Increased risk of developing ventricular arrhythmias, especially polymorphic ventricular tachycardia.

Agonists of dopamine receptors not intended for the treatment of Parkinsons disease (cabergoline, quinagolid, rotigotine). Mutual antagonism exists between dopamine agonists and antipsychotics.

Levodopa and antiparkinsonian drugs (including ropinorol). Between levodopa, antiparkinsonian drugs (amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, pyribedil, pramipexole, ropinolol, razagilin, selegiline) and antipsychotics there is mutual antagonism.

Dopamine agonists can cause or exacerbate mental disorders. If patients with Parkinsons disease receiving treatment with dopamine agonists need to be prescribed antipsychotics, the doses of dopamine agonists should be gradually reduced (abrupt cancellation puts the patient at risk of malignant antipsychotic syndrome), since the simultaneous use of drugs is contraindicated.

Mechitazine. Increased risk of developing ventricular arrhythmias, especially polymorphic ventricular tachycardia.

Undesirable combinations (see SPECIAL INSTRUCTIONS)

With antiparasitic drugs that can cause the development of paroxysmal ventricular tachycardia (torsades de pointes) (halofantrine, lumefantrine, pentamidine). Increased risk of ventricular arrhythmias, in particular paroxysmal ventricular tachycardia such as pirouette (torsades de pointes). If possible, treatment with antifungal azoles should be discontinued.

If simultaneous treatment cannot be avoided, before starting it, the Q – T interval should be checked and ECG indices should be monitored during its treatment.

With anti-Parkinsonian dopamine agonists (amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, pyribedil, pramipexole, ropinorol, razagilin, selegiline). Mutual antagonism exists between dopamine agonists and antipsychotics.

Dopamine agonists can cause or exacerbate mental disorders. If patients with Parkinsons disease receiving treatment with dopamine agonists need to be prescribed antipsychotics, the doses of dopamine agonists should be gradually reduced (abrupt cancellation puts the patient at risk of malignant antipsychotic syndrome).

With other drugs that can cause paroxysmal ventricular tachycardia such as pirouette (torsades de pointes) (class Ia antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide) and class III (amiodarone, dronedarone, sotalol, dofetilide, ibutilide) and other drugs such as bepridil , cisapride, difemanil, dolasetron, erythromycin for iv administration, levofloxacin, misolastine, prucaloprid, vincamine for iv administration, moxifloxacin, spiramycin for iv administration and toramifen). High risk of ventricular arrhythmias, in particular paroxysmal ventricular tachycardia such as pirouette (torsades de pointes).

With other antipsychotics that can cause the development of paroxysmal ventricular tachycardia such as pirouette (torsades de pointes) (amisulpride, chlorpromazine, cyamemazine, droperidol, flupentixol, flufenazine, haloperidol, levomepromazine, pimozide, pipotoliprizidepidezidepidezidepidezidepidezidepidezidepidezidepidezidepidezidepidezidepidezidepidezidepidezidepidezidezide A high risk of ventricular arrhythmias, in particular paroxysmal ventricular tachycardia such as pirouette (torsades de pointes).

With alcohol. Potentiation of sedative effects of antipsychotics. Patients should avoid drinking alcohol or taking medications containing alcohol.

With methadone. Increased risk of ventricular arrhythmias, in particular paroxysmal ventricular tachycardia such as pirouette (torsades de pointes).

Combinations that require caution

Azithromycin Increased risk of developing ventricular arrhythmias, especially polymorphic ventricular tachycardia. During the period of simultaneous use, it is necessary to perform an ECG and carry out clinical monitoring.

With β-adrenoreceptor blockers, which are used for heart failure (bisoprolol, carvedilol, metoprolol, nebivolol). Increased risk of ventricular arrhythmias, in particular paroxysmal ventricular tachycardia such as pirouette (torsades de pointes). Clinical monitoring and ECG monitoring is required.

Bradycardia agents (such as class Ia antiarrhythmic drugs, β-adrenoreceptor blockers, some class III antiarrhythmic drugs, some calcium channel blockers (diltiazem, verapamil, clonidine, guanfacine), digitalis glycosides, pilocarpine, anticholinesterase drugs). Increased risk of ventricular arrhythmias, in particular paroxysmal ventricular tachycardia such as pirouette (torsades de pointes). Clinical monitoring and ECG monitoring is required.

Clarithromycin Increased risk of developing ventricular arrhythmias, especially polymorphic ventricular tachycardia. During the period of simultaneous use, it is necessary to perform an ECG and carry out clinical monitoring.

Potassium-sparing drugs (potassium-sparing diuretics, alone or in combination, stimulant laxatives, GCS, tetracosactide and amphotericin B for iv use). Increased risk of ventricular arrhythmias, in particular paroxysmal ventricular tachycardia such as pirouette (torsades de pointes). Before the introduction, it is necessary to correct the existing hypokalemia, carry out clinical monitoring, control electrolytes and ECG.

Lithium preparations. The risk of neuropsychiatric signs indicating malignant antipsychotic syndrome or lithium poisoning.

It is necessary to regularly monitor the clinical picture and the results of laboratory tests, especially at the beginning of simultaneous use.

The use of lithium increases the risk of extrapyramidal adverse reactions.

Roxithromycin. Increased risk of developing ventricular arrhythmias, especially polymorphic ventricular tachycardia. During the period of simultaneous use, it is necessary to perform an ECG and carry out clinical monitoring.

With sucralfate. Decreased absorption of Sulpiride in the digestive tract.

Between the introduction of sucralfate and Sulpiride should be a certain time interval (more than 2 hours, if possible).

With gastrointestinal topical agents, antacids and activated charcoal. Decreased absorption of Sulpiride in the digestive tract.

Between the introduction of these agents and Sulpiride should be a certain time interval (more than 2 hours, if possible).

Combinations to consider

Other sedatives. More pronounced depression of the central nervous system. Due to the reduced ability to concentrate, driving and operating machinery can be dangerous.

Antihypertensive agents. Increased risk of arterial hypotension, especially orthostatic.

With β-adrenergic receptor blockers (except for esmolol, sotalol and β-adrenergic receptor blockers used in heart failure). Vasodilating effect and risk of hypotension, in particular postural (additive effect).

With nitrates, nitrites and related drugs. Increased risk of hypotension, in particular postural. Sulpiride may decrease the effectiveness of ropinorol.

Overdose

Symptoms experience with Sulpiride is limited. dyskinetic manifestations with spasmodic torticollis, protrusion of the tongue and trismus may be observed. some patients may develop manifestations of parkinsonism, which pose a threat to life, or coma.

Treatment. Sulpiride is partially excreted during hemodialysis. There is no specific antidote. Treatment should be symptomatic, resuscitation with careful monitoring of cardiac activity and respiratory function (risk of prolongation of the Q – T interval and ventricular arrhythmias), which should be continued until the patient is fully recovered. In the case of severe extrapyramidal syndrome, anticholinergic drugs must be administered.

Storage conditions

It does not require special storage conditions.