Betamax tab. 50 mg per blister. in pack No. 10x3 (sulpiride)

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Atypical antipsychotic . It has antidepressant, stimulating and antiemetic effects. Does not cause a hypnotic effect in the usual dosage. The antipsychotic effect is explained by the blockade of dopamine D2 receptors and manifests itself at a dose of more than 600 mg/day, antidepressant effect - at a dose of up to 600 mg/day.

The antiemetic effect is associated with blockade of dopamine D2 receptors of the vomiting center. In case of peptic ulcer , it suppresses the excitation of the sympathetic nervous system, increases the secretion of mucus in the stomach, improves its blood supply, accelerates the regeneration of the mucous membrane and the healing of ulcerative defects.

Stimulates the secretion of prolactin . It has no effect on cholinergic, adrenergic, serotonin and histamine receptors.

Pharmacokinetics

When taken orally, maximum concentrations are determined after 2–3 hours. Bioavailability is about 27%. Less than 40% binds to blood proteins. Not metabolized. Excreted unchanged by the kidneys. In severe renal failure, the half-life is 20–26 hours. It is excreted in breast milk.

Betamax tablets 50 mg No. 10x3

Name

Description

Tablets 50 mg and 100 mg: round, flat-cylindrical tablets of white or almost white color with a bevel. Tablets 200 mg: round, flat-cylindrical tablets of white or almost white color with a chamfer and a score on one side. The tablet can be divided into equal doses.

Main active ingredient

Sulpiride

Release form

Film-coated tablets. 10 tablets in a blister made of aluminum foil and polyvinyl chloride film. 3 blisters along with instructions for medical use of the drug in a cardboard pack.

Dosage

50 mg

special instructions

pharmachologic effect

Pharmacodynamics

In low doses, sulpiride prevents dopaminergic nervous transmission in brain tissue and has an activating effect, simulating a dopaminomimetic effect. In high doses, sulpiride also has an antiproductive effect. Sulpiride is an atypical antipsychotic from the group of substituted benzamides. Sulpiride has moderate neuroleptic activity in combination with stimulating and thymoanaleptic (antidepressive) effects. The neuroleptic effect is associated with an antidopaminergic effect. In the central nervous system, sulpiride predominantly blocks dopaminergic receptors of the limbic system, and has a slight effect on the neostriatal system; it has an antipsychotic effect. The peripheral effect of sulpiride is based on inhibition of presynaptic receptors. An increase in the amount of dopamine in the central nervous system (hereinafter referred to as the CNS) is associated with an improvement in mood, and a decrease is associated with the development of symptoms of depression. 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 effect predominates. Sulpiride does not have a significant effect on adrenergic, cholinergic, serotonin, histamine and GABA receptors.

Pharmacokinetics

With intramuscular administration of 100 mg of sulpiride, the maximum concentration in blood plasma is reached after 30 minutes and is 2.2 mg/l. When administered orally, the maximum concentration of sulpiride in plasma is reached after 3-6 hours and is 0.73 mg/l when taking one tablet containing 200 mg, and 0.25 mg/ml for one capsule containing 50 mg. The bioavailability of dosage forms intended for oral administration is 25-35% and is characterized by significant individual variability. Sulpiride has linear kinetics after doses ranging from 50 to 300 mg. Sulpiride quickly diffuses into body tissues: the apparent volume of distribution at steady state is 0.94 l/kg. Plasma protein binding is approximately 40%. Small amounts of sulpiride appear in breast milk and cross the placental barrier. In the human body, sulpiride is metabolized only to a small extent: 92% of the intramuscularly administered dose is excreted unchanged in the urine. Sulpiride is excreted from the body mainly through the kidneys, by glomerular filtration. The total clearance is 126 ml/min. The half-life of the drug is 7 hours.

Indications for use

Tablets 100 mg, 200 mg: • Acute psychotic disorders. • Chronic psychotic disorders (schizophrenia, chronic non-schizophrenic delusional states: paranoid delusions, chronic hallucinatory psychosis). Tablets 50 mg: • Anxiety conditions in adults (short-term symptomatic treatment when conventional treatment methods are ineffective). • Severe behavioral disorders (agitation, self-harm, stereotypy) in children over 6 years of age, especially in combination with autism syndrome.

Directions for use and doses

The minimum effective dose should always be used. If the patient's clinical condition allows, treatment should begin with low doses, which can then be gradually increased. The drug is taken 1-3 times a day with a sufficient amount of water, regardless of meals. Tablets 100 mg, 200 mg For adults only. The daily dose ranges from 200 to 1000 mg, divided into several doses. Tablets 50 mg Adults The daily dose is from 50 to 150 mg for no more than 4 weeks. Children over 6 years of age The daily dose is from 5 to 10 mg/kg body weight. For children, dosing in the form of an oral solution is more acceptable. Doses for the elderly The initial dose of sulpiride should be ¼-½ the dose for adults. Doses for patients with impaired renal function Due to the fact that sulpiride is excreted from the body primarily through the kidneys, it is recommended to reduce the dose and/or increase the interval between doses depending on the creatinine clearance: with a clearance of 30-60 ml/min, the dose should be reduce by 30%, and the intervals between doses of the drug should be increased by 1.5 times; with a clearance of 10-30 ml/min, the dose should be reduced by 2 times, and the intervals between doses of the drug should be increased by 2 times; with clearance less than 10 ml/min, the dose should be reduced by 70%, and the intervals between doses should be increased by 3 times.

Use during pregnancy and lactation

Pregnancy Experiments on animals did not reveal teratogenic effects. Human clinical data on the use of sulpiride during pregnancy are very limited. Therefore, given the limited experience, the use of sulpiride during pregnancy is not recommended. Neonates who were exposed in utero to antipsychotic drugs, including sulpiride, during the 3rd trimester of pregnancy are at risk of developing side effects after birth, including extrapyramidal symptoms or withdrawal syndrome, which may vary in severity and duration (see section "Adverse Effects" "). Agitation, increased or decreased muscle tone, tremor, drowsiness, respiratory distress or eating disorders have been reported. Therefore, newborns must be under constant medical supervision. Breastfeeding period Sulpiride passes into human breast milk. Therefore, breastfeeding during treatment with sulpiride is not recommended.

Precautionary measures

Special warnings and precautions for use Neuroleptic malignant syndrome In case of an increase in body temperature of unknown etiology, treatment with sulpiride should be stopped immediately, since this may be one of the symptoms of a malignant syndrome that can develop when taking neuroleptics (pallor, hyperthermia, autonomic disorders, impaired consciousness, muscle stiffness). Signs of autonomic nervous system dysfunction, such as excessive sweating and changes in blood pressure, may develop before the onset of hyperthermia and should therefore be considered early warning signs. Although this antipsychotic effect may be idiosyncratic in nature, risk factors such as dehydration and organic brain damage may be present. QT interval prolongation Sulpiride may cause QT interval prolongation in a dose-dependent manner. It is known that this effect may increase the risk of developing severe ventricular arrhythmias, such as torsades de pointes, which is more often observed in patients with bradycardia, hypokalemia and congenital or acquired QT prolongation (when sulpiride is taken concomitantly with a drug that causes QT prolongation ). Before using the drug, if the patient’s condition allows, it is necessary to exclude the presence of factors predisposing to the development of these severe rhythm disturbances, for example: - bradycardia (

Interaction with other drugs

Contraindicated combinations • With levodopa Mutual antagonism of the effects of levodopa and antipsychotics. • With dopamine receptor agonists (cabergoline, quinagolide, ropinirole, rotigotine) Mutual antagonism between dopamine receptor agonists and antipsychotics (see sections “Contraindications” and “Precautions”). Not recommended combinations • With ethanol Ethanol enhances the sedative effect of neuroleptics. Alcoholic beverages and medications containing ethanol should be avoided. • With drugs that can prolong the QT interval or cause the development of ventricular tachycardia of the “pirouette” type: - drugs that cause bradycardia: beta-blockers; blockers of “slow” calcium channels that reduce heart rate (verapamil, diltiazem); clonidine, guanfacine, cardiac glycosides; - drugs that cause hypokalemia: diuretics that reduce the concentration of potassium in the blood; laxatives that stimulate intestinal motility; amphotericin B for intravenous use, glycocorticosteroids; tetracosactide (hypokalemia must be corrected before using sulpiride); - class IA antiarrhythmic drugs, such as quinidine, disopyramide; - class III antiarrhythmic drugs, such as amiodarone, sotalol, dofetelide, ibutilide; - other drugs, such as pimozide; amisulpride; sultopride; tiapride; haloperidol; thioridazine; methadone; chlorpromazine; droperidol; cyamemazine; Pipothiazine; sertindole; levomepromazine; antidepressants, imipramine derivatives; lithium preparations; bepridil; cisapride; intravenously administered erythromycin; intravenous vincamine; spiramycin administered intravenously; moxifloxacin; levofloxacin; mizolastine; diphemanil; halofantrine; pentamidine; lumefantrine; sparfloxacin, azithromycin, clarithromycin, roxithromycin; - selective serotonin reuptake inhibitors (citalopram, escitalopram). If the simultaneous administration of these drugs with sulpiride cannot be avoided in patients, then patients should undergo careful clinical, laboratory (monitoring of blood electrolyte composition) and electrocardiographic monitoring. Interactions that should be taken into account • With antihypertensive drugs, nitrates and nitrate derivatives Additive hypotensive effect, increased risk of orthostatic hypotension. • With drugs that depress the function of the central nervous system: morphine derivatives (analgesics, antitussives); blockers of H1-histamine receptors with a sedative effect; barbiturates; benzodiazepines and other anxiolytics; sleeping pills; antidepressants with sedative effects (amitriptyline, doxepin, mianserin, trimipratin); centrally acting antihypertensives (clonidine and other centrally acting antihypertensives); baclofen; thalidomide. A pronounced increase in the inhibitory effect of the central nervous system and a decrease in psychomotor reaction are possible. • With antacids and sucralfate. When used simultaneously, the absorption of sulpiride is reduced. Therefore, when using sulpiride and antacids or sucralfate simultaneously, at least a two-hour break is required between their doses. • With lithium preparations the risk of extrapyramidal adverse reactions increases. Both drugs should be discontinued at the first sign of neurotoxicity.

Contraindications

— Hypersensitivity to sulpiride and/or excipients of the drug; - acute poisoning with alcohol, sleeping pills, narcotic analgesics; - prolactin-dependent tumors (pituitary prolactinomas and breast cancer); - hyperprolactinemia; - known or suspected pheochromocytoma; - acute porphyria; - congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (due to the presence of lactose in the drug); - simultaneous use with levodopa, cabergoline, kinagolide and rotigotine; - simultaneous use with mechitazine, citalopram and escitalopram; - period of breastfeeding; - children under 6 years of age.

Compound

One tablet contains: active substance – 50 mg, 100 mg or 200 mg of sulpiride; excipients: lactose monohydrate; methylcellulose; potato starch; potato starch, dried; colloidal silicon dioxide, anhydrous; magnesium stearate; talc.

Overdose

Symptoms Experience with overdose of sulpiride is limited. There are no specific symptoms, but the following may be observed: dyskinesia with spasmodic torticollis, tongue protrusion and trismus. Some patients experience life-threatening parkinsonism and coma. Sulpiride is partially eliminated by hemodialysis. Treatment Due to the lack of a specific antidote, symptomatic and supportive therapy should be used, with careful monitoring of respiratory function and constant monitoring of cardiac activity (risk of prolongation of the QT interval and the development of ventricular arrhythmias), which should continue until the patient recovers completely. With the development of severe extrapyramidal syndrome, m-anticholinergic drugs are prescribed.

Side effect

Classification of adverse reactions (HP) by frequency of development according to the recommendations of the World Health Organization: very often (≥10%), often (≥1% and

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Buy Betamax tab. 50 mg per bl. in pack No. 10x3 in the pharmacy

Price for Betamax tablet. 50 mg per bl. in pack №10x3

Instructions for use for Betamax tab. 50 mg per bl. in pack №10x3

Indications for use

• delirious state;
• schizophrenia (acute and chronic);
• depression, accompanied by lethargy, decreased motor and speech activity;
• neuroses and neurotic disorders;
• dizziness of various origins (with vestibular neuritis, traumatic brain injury, otitis media , vertebrobasilar insufficiency , Meniere's disease );
• peptic ulcer , irritable bowel syndrome (as an auxiliary therapy).

Contraindications

Betamax is not prescribed for:

• manic psychosis;
• affective disorders , aggression;
• poisoning with alcohol, opioids and sleeping pills;
• convulsive seizures;
• prolactin-dependent tumors;
• pheochromocytoma;
• hyperprolactinemia;
• Parkinson's disease;
• severe arterial hypertension ;
• breastfeeding;
• under 18 years of age;
• hypersensitivity.

It is prescribed with caution for increased convulsive readiness and epilepsy , parkinsonism , dysmenorrhea and menstrual irregularities, angina pectoris , liver failure , impaired renal function, prostatic hyperplasia , glaucoma .

Side effects

Betamax may cause:

• drowsiness, dizziness, excessive sedation, rarely - agitation, sleep disorder, extrapyramidal syndrome , aphasia ;
• increased blood pressure and orthostatic hypotension (rare);
• dry mouth, vomiting, heartburn, constipation;
• hyperprolactinemia, menstrual irregularities;
• skin rash, itching;
• increased temperature, increased sweating;
• swelling, weight gain.

Betamax, instructions for use (Method and dosage)

The tablets are taken orally, regardless of meals. It is advisable to take it before 16.00, given the stimulating effect. The dose of the drug depends on the disease and the degree of clinical manifestations. Recommended doses are given below.

Schizophrenia , acute delirious psychosis - 600-1200 mg/day. The maximum daily dose is 1600 mg.

Depressive disorders - 150-200 mg in several doses. The maximum daily dose is 600 mg.

Neuroses - 400-600 mg/day.

Dizziness of various origins - 150-200 mg/day, if necessary up to 400 mg. Course duration is up to 14 days.

Migraine - 100-300 mg/day.

Elderly persons are prescribed 1/2 the adult dose. If it is necessary to use the drug during pregnancy, it is prescribed in low doses and not for a long time.

The instructions for use of Betamax contain a warning that alcohol should not be consumed during treatment and should not be used by vehicle drivers. If hyperthermia occurs, the drug is discontinued.

* Attention! Product packaging may differ from that shown in the photo.

Product description

Pharmacological action
Antipsychotic drug, atypical antipsychotic from the group of substituted benzamides. Betamax has a moderate antipsychotic effect in combination with a stimulating and thymoanaleptic (antidepressive) effect. The mechanism of antipsychotic action is associated with antidopaminergic activity. In the central nervous system, sulpiride predominantly blocks dopamine receptors of the limbic system, and has a slight effect on the neostriatal system. The peripheral effect of sulpiride is due to inhibition of presynaptic receptors. An increase in the amount of dopamine in the central nervous system is associated with an improvement in mood, and a decrease is associated with the development of symptoms of depression. The antipsychotic effect of sulpiride is manifested in doses of more than 600 mg/day; in doses of up to 600 mg/day, the stimulating and antidepressant effect predominates. Betamax does not have a significant effect on noradrenergic, acetylcholine, serotonin, histamine and GABA receptors. In small doses, sulpiride can be used as an adjuvant in the treatment of psychosomatic diseases, in particular, the drug is effective in relieving the negative mental symptoms of gastric and duodenal ulcers. In irritable bowel syndrome, sulpiride reduces the intensity of abdominal pain and leads to an improvement in the patient's clinical condition. Betamax in low doses (50-300 mg/day) is effective for dizziness, regardless of etiology. The drug stimulates the secretion of prolactin and has a central antiemetic effect (suppression of the vomiting center).

Pharmacokinetics

Absorption After oral administration, Cmax in plasma is reached within 1.5-3 hours. Bioavailability of sulpiride is 27%. Distribution The binding of sulpiride to plasma proteins is less than 40%. The concentration of sulpiride in the central nervous system is 2-5% of the plasma concentration. Sulpiride is excreted in breast milk. Metabolism Sulpiride is not metabolized in the human body. Excretion Excreted by the kidneys almost unchanged. Pharmacokinetics in special clinical cases T1/2 is significantly increased in patients with moderate and severe renal failure (up to 20-26 hours after IV administration). Such patients should reduce the dose of sulpiride and/or increase the interval between doses of the drug.

Indications

As monotherapy or in combination with other psychotropic drugs: – acute and chronic schizophrenia; – acute delirious states; – depression of various etiologies; – neuroses; – dizziness of various etiologies (including with vertebrobasilar insufficiency, vestibular neuritis, Meniere’s disease, traumatic brain injury, otitis media); – auxiliary therapy for gastric and duodenal ulcers and irritable bowel syndrome.

Dosage regimen

It is not recommended to prescribe Betamax in the afternoon (after 16 hours) due to the increased level of wakefulness. The maximum recommended daily dose of Betamax is 1.6 g. For acute and chronic schizophrenia, acute delirious psychosis, the initial dose of Betamax depends on the clinical picture of the disease and is 600-1200 mg/day in several doses, maintenance doses are 300-800 mg/day. For depression, it is prescribed in doses from 150-200 mg to 600 mg/day, divided into several doses. For dizziness, 150-200 mg/day is prescribed; in severe conditions, the dose can be increased to 300-400 mg. The duration of treatment is at least 14 days. For auxiliary therapy of gastric and duodenal ulcers and irritable bowel syndrome, 100-300 mg/day is prescribed in 1 or 2 doses. Due to the fact that sulpiride is excreted from the body primarily by the kidneys, patients with impaired renal function are recommended to reduce the dose of the drug and/or increase the interval between single doses depending on the values ​​of creatinine clearance (CC):

For elderly patients , the initial dose of Betamax is 1/4 - 1/2 of the standard dose for middle-aged patients. For children over 14 years of age, the standard dose of Betamax is 3-5 mg/kg body weight.

Side effect

From the endocrine system: reversible hyperprolactinemia is possible, the most common manifestations of which are galactorrhea, menstrual irregularities; rarely - gynecomastia, impotence and frigidity; increased sweating, weight gain. From the digestive system: possible dry mouth, heartburn, vomiting, constipation. From the side of the central nervous system: sedation, drowsiness, dizziness are possible; rarely - extrapyramidal syndrome, dyskinesia, oral automatism, aphasia; when used in low doses, agitation and sleep disturbances are possible; in some cases - ZNS (mainly when prescribing sulpiride in high doses). From the cardiovascular system: possible increase in blood pressure; rarely - orthostatic hypotension. Allergic reactions: possible skin rash, itching.

Contraindications

– acute poisoning with alcohol, hypnotics, analgesics; – moderate and severe arterial hypertension; – pheochromocytoma; – epilepsy; – hyperprolactinemia; – patients in a state of passion and aggression, in whom there is a risk of provoking symptoms; – lactation (breastfeeding); – children under 14 years of age. – hypersensitivity to sulpiride.

Pregnancy and lactation

The use of Betamax during pregnancy is not recommended unless the expected benefit of therapy for the mother outweighs the potential risk to the fetus. The use of the drug during lactation (breastfeeding) is contraindicated.

special instructions

Prescribe Betamax with caution to patients with impaired renal function (since up to 95% of sulpiride is excreted by the kidneys), as well as patients with heart and vascular diseases, Parkinsonism, as well as young women with irregular menstrual cycles. If hyperthermia develops, the drug should be discontinued. During the treatment period, alcohol consumption is contraindicated. Effect on the ability to drive vehicles and operate machinery During treatment with Betamax, driving vehicles and working with machinery, which require increased attention and a high speed of psychomotor reactions, are contraindicated.

Overdose

Symptoms: There are no specific symptoms. Possible blurred vision, hypertension, sedation, nausea, extrapyramidal symptoms, dry mouth, vomiting, increased sweating and gynecomastia. Treatment: symptomatic and supportive therapy. A specific antidote is unknown.

Drug interactions

When taking Betamax simultaneously and drugs that have a depressant effect on the central nervous system (opioid analgesics, antihistamines, barbiturates, benzodiazepines and other anxiolytics), the sedative effect of these drugs may be enhanced. Betamax may enhance the sedative effects of ethanol. Co-administration with levodopa should be avoided due to the mutual antagonism of levodopa and sulpiride. When taking Betamax and antihypertensive drugs simultaneously, the risk of developing orthostatic hypotension increases.

Storage conditions and periods

List B. The drug should be stored at room temperature, in a dry place. Shelf life: 3 years.

Interaction

Sulpiride enhances the sedative effect of barbiturates , benzodiazepines , narcotic analgesics, alcohol and antihistamines.

With the simultaneous administration of Levodopa, mutual antagonism is observed - the effectiveness decreases.

There is a risk of orthostatic hypotension when antihypertensive drugs .

Antacids , sucralfate , drugs containing magnesium and aluminum reduce the bioavailability of the drug.

There is antagonism with neuroleptics and dopamine receptor agonists ( apomorphine , bromocriptine , amantadine , entacapone , lisuride , cabergoline , piribedil , pramipexole , pergolide , ropinirole , quinagolide ). If extrapyramidal syndrome has developed, anticholinergic drugs are prescribed.

Ventricular ari can develop when using:

• with class IA and III antiarrhythmic drugs, neuroleptics ( Haloperidol , Droperidol , Thioridazine , Chlorpromazine , Cyamemazine , Amisulpride , Levomepromazine , Trifluoperazine , Tiapride );
• with medications that cause bradycardia ( Clonidine , Guanfacine , Diltiazem , digitalis preparations, Donepezil , Verapamil , beta-blockers, Rivastigmine , Tacrine , Pyridostigmine , Neostigminam , benonia chloride, Galantamine );
• with medications that cause hypokalemia (diuretics, laxatives, corticosteroids, Amphotericin B , Tetracosactide ).

When used simultaneously with the dopamine receptor blocker sultopride, ventricular arrhythmias increases .

Betamax 50 mg No. 30 tablet.

APPROVED by the Order of the Chairman of the Pharmacy Committee of the Ministry of Health of the Republic of Kazakhstan Instructions for the medical use of the drug BETAMAX Trade name BETAMAX International nonproprietary name Sulpiride Dosage form Tablets 50 mg, 100 mg, 200 mg Composition One tablet contains the active substance - sulpiride 50 mg or 100 mg, or 200 mg, excipients: lactose monohydrate; methylcellulose; potato starch; potato starch, dried; colloidal silicon dioxide, anhydrous; magnesium stearate, talc. Description of 50 mg tablets: round flat-cylindrical tablets of white or almost white color with a bevel. Dimensions of tablets: diameter – (6.0±0.2) mm, height – (2.1±0.3) mm 100 mg tablets: round flat-cylindrical tablets of white or almost white color with a chamfer. Dimensions of tablets: diameter - (7.0±0.2) mm, height - (3.1±0.3) mm 200 mg tablets: round flat-cylindrical tablets of white or almost white color with a chamfer and a score on one side. Dimensions of tablets: diameter – (10.0±0.2) mm, height – (3.1±0.3) mm Pharmacotherapeutic group Drugs for the treatment of diseases of the nervous system. Psychotropic drugs. Neuroleptics. Benzamides. Sulpiride. ATX code: N05AL01 Pharmacological properties Pharmacokinetics Absorption After an intramuscular injection of 100 mg of sulpiride, the maximum plasma concentration (Cmax) of 2.2 mg/l is achieved within 30 minutes. After oral administration, sulpiride is absorbed within 4.5 hours. For an oral dose of 200 mg (tablets), Cmax is 0.5-1.8 mg/l. Distribution The bioavailability of the oral dosage form is 25%-35%, with large variations between individuals. The level of sulpiride in plasma is proportional to the dose. Sulpiride is rapidly distributed in body tissues, especially in the liver and kidneys. There is slight diffusion into the brain. Less than 40% is bound to plasma proteins. The distribution rate of red blood cells in plasma is 1. Metabolism Sulpiride is poorly metabolized in the body. Excretion Sulpiride is excreted from the body mainly through the kidneys by glomerular filtration. Renal clearance is usually equal to total clearance. 92% of the intramuscular dose is excreted unchanged in the urine. The amount excreted in mother's milk is 1/1000 of the daily dose. The half-life of elimination is 7 hours. The volume of distribution is 0.94 l/kg (0.6-1.5 l/kg). The total clearance is 126 ml/min. Pharmacodynamics Sulpiride specifically antagonizes D2 and D3 dopamine receptors. In patients with psychotic disorders causing negative symptoms, sulpiride is effective in doses of 150 to 600 mg/day. In this dose range, sulpiride has little or no effect on positive symptoms. Doses of 600 to 1600 mg/day improve positive symptoms in patients with acute and chronic psychosis. Only very high doses of sulpiride cause sedation. Indications for use: treatment of depressive disorders with psychotic symptoms in combination with antidepressants, if treatment with antidepressants alone was ineffective; treatment of other serious forms of depression resistant to antidepressants - treatment of vertigo in cases where there was no response to standard treatment vertigo - treatment of acute and chronic psychoses Method of administration and dosage Use orally, preferably before meals, swallowing the tablet whole. Doses are selected individually, depending on the nature of the disease and symptoms, taking into account the patient’s age, body weight and general condition. Adults The daily dose is divided into three doses throughout the day. Recommended doses are: - 150-300 mg/day for depressive disorders with psychotic symptoms and vertigo. - 200-1600 mg/day for acute and chronic psychoses. Treatment of acute and chronic psychoses should begin with an injectable solution of sulpiride. Children and adolescents under 18 years of age The effectiveness and safety of sulpiride in children and adolescents have not been fully studied. Therefore, its use is contraindicated in this group of patients. Patients with renal failure In renal failure, the dose should be adjusted according to creatinine clearance. The dose reduction can be 35-70%, as follows: - creatinine clearance 30-60 ml/min - use 50-70% of the usual daily dose - creatinine clearance 10-30 ml/min - use 35-50% of the usual daily dose doses - creatinine clearance <10 ml/min - use up to 35% of the usual daily dose Elderly patients Elderly patients may have increased plasma concentrations of sulpiride. Therefore, these patients may require a lower initial dose and a more gradual dose titration. Stopping the medication suddenly may cause nausea, vomiting, sweating, insomnia, restlessness, and voluntary movements. The use of the medicine should be discontinued, gradually reducing the dose. Side effects In the following, the mentioned side effects are ordered according to the MedDRA organ system classification and frequency database: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/10) 100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), unknown (cannot be determined from available data). Blood and lymphatic system disorders Uncommon: leukopenia. Unknown: neutropenia and agranulocytosis. Immune system disorders Not known: anaphylactic reactions (urticaria, shortness of breath, hypotension and anaphylactic shock). Endocrine system disorders Common: hyperprolactinemia. Mental disorders Common: insomnia. Nervous system disorders Common: sedation or somnolence, extrapyramidal disorders (these symptoms are usually reversible with the use of antiparkinsonian drugs), parkinsonism, tremors, akathisia. Uncommon: hypertension, dyskinesia, dystonia. Rare: voluntary movements of the eyeballs, usually upward. Not known: seizures, neuroleptic malignant syndrome, hypokinesia, tardive dyskinesia, which is characterized by rhythmic, unconscious movements of the face and/or tongue (as with other antipsychotics after use for more than 3 months). Antiparkinsonian medications are ineffective or may worsen symptoms. As with all antipsychotic drugs, neuroleptic malignant syndrome is a potentially fatal complication. Cardiac dysfunction Rare: ventricular arrhythmia, ventricular tachycardia, ventricular fibrillation. Not known: prolongation of the QT interval in the electrocardiogram, cardiac arrest, torsades de pointes, sudden death. Circulatory system disorders Rare: orthostatic hypotension. Not known: venous thromboembolism, pulmonary embolism (sometimes fatal), deep vein thrombosis and high blood pressure. Gastrointestinal disorders Uncommon: increased salivation. Disorders of the liver and/or biliary system Often: increased activity of liver transaminases. Damage to the skin and subcutaneous tissues Common: maculopapular rash. Damage to the musculoskeletal and related systems Not known: stiffness of the throat and pharynx. Pregnancy, postpartum and perinatal period Not known: extrapyramidal symptoms, drug withdrawal syndrome in newborns. Diseases of the reproductive system and breasts Often: galactorrhea, chest pain. Uncommon: amenorrhea, breast enlargement, orgasm and erectile dysfunction. Unknown: gynecomastia. General disorders and changes at the injection site Common: weight gain. Contraindications - hypersensitivity to the active substance or to any excipient of the drug - arterial hypertension of II-III degree - manic psychosis - pheochromocytoma - Parkinson's disease - epilepsy - acute porphyria - depression of the central nervous system (CNS) - coma - bone marrow depression - prolactin-dependent tumors (including breast cancer) - hyperprolactinemia - patients in a state of passion and aggression in whom there is a risk of provoking symptoms - patients with prolongation of the QT interval, for example, with congenital long QT syndrome, or clinical situations causing additional risk , for example: - clinically significant bradycardia (<50 beats per minute); - history of symptomatic arrhythmia; - any other clinically significant heart disease; - simultaneous treatment with antiarrhythmic drugs of class I or III; - simultaneous treatment with any drugs that can prolong the QT interval - simultaneous use with dopaminergic antiparkinsonian drugs - acute poisoning with alcohol, hypnotics, analgesics - pregnancy and lactation - children and adolescents under 18 years of age Drug interaction Interaction is contraindicated - levodopa, antiparkinsonian drugs medications (including ropinirole), as there is mutual antagonism between levodopa or antiparkinsonian drugs (including ropinirole) and antipsychotic drugs - use of grapefruit juice during treatment with sulpiride Interaction is not recommended - alcohol may increase the sedative effect of antipsychotic drugs; Therefore, the use of alcohol and alcohol-containing drugs should be avoided during treatment with sulpiride - combination with drugs that can cause arrhythmias such as torsade de pointes or prolong the QT interval: - drugs that cause bradycardia, such as beta blockers, calcium channel blockers and drugs that cause bradycardia, such as eg, diltiazem and verapamil, clonidine, guanfacine, cardiac glycosides - drugs that cause hypokalemia, such as diuretics, diarrhea-inducing agents, amphotericin B IV, glycocorticoids, tetracosactide; hypokalemia should be eliminated - class Ia antiarrhythmic drugs, for example, quinidine, disopyramide - class III antiarrhythmic drugs, for example, amiodarone, sotalol - other drugs, such as pimozide, sultopride, haloperidol, thioridazine, methadone, imipramine antidepressants, lithium, bepridil, cisapride, erythromycin IV, vincamine IV, halofantrine, pentamidine and sparfloxacin) Interactions may be assessed - sucralfate: When sulpiride and sucralfate are administered concomitantly, the absorption of sulpiride is reduced and plasma levels of sulpiride may decrease, which may lead to a decrease or loss of therapeutic activity . Between the use of sulpiride and these drugs, a 2-hour interval should be observed - antacids: with the simultaneous use of sulpiride and antacids containing magnesium or aluminum, the absorption of sulpiride is reduced and the level of sulpiride in plasma may decrease, which can lead to a decrease or loss of therapeutic activity. Between the use of sulpiride and these drugs, a 2-hour interval should be observed - antihypertensive drugs due to their antihypertensive effect and the ability to increase the risk of postural hypotension (additional effect). - CNS depressants, including opioid-containing analgesics, sedative H1 antihistamines, barbiturates, benzodiazepines and other anxiolytics, clonidine and other centrally acting antihypertensives - lithium increases the risk of extrapyramidal side effects. At the first sign of neurotoxicity, discontinuation of both medications is recommended. Special instructions Warnings Prolongation of the QT interval Sulpiride induces prolongation of the QT interval. It is known that this effect may increase the risk of severe ventricular arrhythmias, such as torsade de pointes. Before starting treatment, taking into account the clinical condition of the patient, it is recommended to monitor factors that may cause cases of disturbance of this rhythm, for example: - bradycardia (<55 beats/min) - electrolyte imbalances, especially hypokalemia - congenital prolongation of the QT interval - treatment not stopped drugs that can cause bradycardia (<55 beats/min) - hypokalemia - decreased intracardiac transmission - QT prolongation Stroke In randomized clinical trials, a threefold increase in the risk of stroke was observed in elderly patients with dementia using recommended atypical antipsychotics compared with placebo. The mechanism by which this risk increases is unknown. An increased risk cannot be excluded when other antipsychotics are used or in other patient groups. Patients with risk factors for stroke should use sulpiride with caution. Neuroleptic malignant syndrome (NMS) Like other antipsychotic drugs, sulpiride can cause a potentially fatal complication - neuroleptic malignant syndrome. It is characterized by hyperthermia, muscle rigidity and autonomic dystonia. In case of hyperthermia of undiagnosed origin, treatment with sulpiride should be discontinued. It should be taken into account that with simultaneous use of sulpiride and other antidopaminergic drugs, Parkinson's disease may worsen in patients. These medications should only be used when antipsychotic treatment is absolutely necessary. In this case, treatment should be carried out with caution. Children and adolescents under 18 years of age The effectiveness and safety of sulpiride in children have not been fully studied. Therefore, its use in this group of patients is contraindicated. Elderly patients with dementia Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. An analysis of clinical studies shows that the majority of patients who used atypical antipsychotics had a 1.6-1.7 times greater risk of mortality than patients who received placebo. The typical controlled mortality rate in patients treated with sulpiride was approximately 4.5% compared with approximately 2.6% in the placebo group. Although causes of death in clinical studies of atypical antipsychotics vary, most deaths appear to have been caused by either heart and blood vessel disease (eg, heart failure, sudden death) or infections (eg, pneumonia). Observations suggest that, like treatment with atypical antipsychotics, treatment with traditional antipsychotics may increase mortality. Venous thromboembolism Cases of venous thromboembolism, sometimes fatal, have been reported in association with the use of antipsychotics. Therefore, sulpiride should be used with caution in patients with risk factors for thromboembolism. Caution during use - In cases of hyperglycemia, patients who have used atypical antipsychotics, patients with diagnosed diabetes mellitus or with risk factors for diabetes who have started treatment with sulpiride, undergo appropriate monitoring of blood glucose levels. - Antipsychotic drugs, including sulpiride, may lower the seizure threshold. Therefore, patients with a history of epilepsy should be carefully monitored during treatment with sulpiride. — Sulpiride is excreted through the kidneys. In case of renal failure, the dose should be reduced. - Sulpiride, as well as other antipsychotic drugs, should be used with caution in elderly patients, as the risk of orthostatic hypotension, sedation and extrapyramidal disorders, such as tardive dyskinesia, may increase. Monitoring is recommended during treatment of the initial stages of tardive dyskinesia, reducing or stopping treatment to prevent the development of more severe symptoms. It is also recommended to monitor heart activity. Elderly patients may require a lower initial dose and a more gradual dose titration. - For patients with aggressive behavior or excitability with impulsivity, sulpiride can be used together with a sedative. - Leukopenia, neutropenia and agranulocytosis have been reported in association with the use of antipsychotics, including sulpiride. Unexplained infections or fever may indicate blood dyscrasia; in this case, immediate hematological examination is necessary. - Sulpiride should be used with caution in patients with glaucoma, intestinal obstruction, congenital stenosis of the stomach and intestinal tract, urinary retention or a history of prostate hyperplasia, since sulpiride has an anticholinergic effect. — Sulpiride should be used with caution in patients with hypertension, especially the elderly, due to the risk of hypertensive crisis. - Patients with rare hereditary galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption should not be prescribed this medicine, since the tablets contain lactose. Pregnancy and lactation Pregnancy Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonic/fetal development and/or postnatal development. Clinical data on use during pregnancy are very limited. In newborns, which during 3 trimester were subject to the action of antipsychotic drugs (among them sulpiride), after childbirth there is a risk of side effects, including extrapyramidal and/or the risk of a symptom of the cancellation of the drug, which can be of varying severity and duration. Messages have been received about excitability, increased or reduced muscle tone, trembling, drowsiness, respiratory child, or feeding disorders. Therefore, newborns should be carefully observed. Breastfeeding sulpiride enters the mother's milk of women who used this medicine. Therefore, breastfeeding is not recommended during treatment with sulpiride. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms of sulpyride acts on the central nervous system and can cause drowsiness, dizziness, visual impairment and slow down psychomotor reactions, therefore, during its application, work should be avoided and the implementation of which requires dexterity and a quick reaction (work with technical devices, driving vehicles, etc.). An overdose of symptoms The experience of an overdose of sulpyridis is limited. In case of an overdose, signs in the form of dyskinesia can appear as spastic crooked, protrusion of the tongue and tetanus. Some patients may develop life -threatening manifestations of parkinsonism and coma. There is no specific antidote. Symptomatic therapy. In the case of an overdose, it is necessary to rinse the stomach immediately. To remove the absorbed medicine, it is necessary to provide an alkaline reaction of urine and stimulate diuresis. Belief control and heart functions are necessary (the risk of lengthening of the QT interval). In the case of the development of severe extrapyramidal syndrome, an anticholinergic agent must be applied. Sulpiride can be partially removed with hemodialysis. The form of release and packaging tablets 50 mg, 100 mg, 200 mg. 10 tablets in the contour cell packaging of aluminum foil and polyvinyl chloride film. 3 contour strip packs together with instructions for use in the state and Russian languages ​​are placed in a cardboard pack. Storage conditions List B. Store at a temperature of not higher than 25 ° C. Keep out of the reach of children. Shelf life 3 years. Do not use after the expiration date. Conditions for the recipe, the owner of the registration certificate of Grindex JSC. St. Krustpils, 53, Riga, LV-1057, Latvia Phone: +371 67083205 Fax: +371 67083505 Email, Latvia Address of the Organization Accepting in the Republic of Kazakhstan claims from consumers on the quality of the products responsible for post-a-page observation of the safety of the drug. Grindeks 050010, Almaty, Ave. Dostyk, angle of ul. Bogenbai Batyr, d. 34a/87a, office No. 1

Analogs

Level 4 ATX code matches:
Solian

Tiapridal

Prosulpin

Tiapride

Sulpiride

Eglonil

Eglek , Sulpirid , Eglonil , Sulpirid, Belupo , Vero-Sulpirid , Depral , Dogmatil , Sulpiril .

Reviews of Betamax

Reviews about Betamax on forums mostly concern its use for panic attacks , depression and neuroses . Most often, the drug was taken for a long time on an outpatient basis.

“I’ve been taking 50 mg 3 times a day for 2 months. Everything is great - it relieved panic attacks, anxiety, and generally brought me to my senses.”

“..I’ve been drinking for a month now. The effect is positive."

“Betamax relieved panic and fear well within 2 weeks of taking it. But an emerging side effect (mastopathy) forced him to change it...”

“They prescribed it to me during panic attacks and during exacerbations of VSD. It helps a lot."

Many patients report the use of this drug in the complex treatment of gastrointestinal diseases. It was prescribed for peptic ulcers , colitis and cholecystitis .

It is noted that Betamax not only eliminated psychosomatic disorders (anxiety, depression, neuroses) that accompany gastrointestinal diseases, but also eliminated dyspeptic symptoms (nausea, belching, bloating), and normalized the motility of the stomach, gall bladder and intestines. For these diseases, the drug was prescribed in a small dose (150 mg/day, in 3 doses), was well tolerated and did not have any side effects.

Side effects include a decrease in blood pressure, an increase in prolactin levels, appetite, weight gain and the appearance of edema. With prolonged use, sleep disturbance was observed.

“I have been taking Betamax periodically for five years. It’s a good drug, but there are some side effects—I’m gaining weight terribly.”

“I took Betamax for 5 months, my prolactin levels increased, and my periods stopped altogether.”

A characteristic side effect of all neuroleptics (especially Aminazine , Triftazine , Fluorphenazine ) is extrapyramidal disorders. Much safer in this regard are “atypical neuroleptics” - Sulpiride , Betamax , Clozapine , Risperidone , which have the advantage of very rarely causing mild manifestations of parkinsonism .

Betamax

Neuroleptic malignant syndrome

Neuroleptic malignant syndrome, which is a potentially fatal complication, and the occurrence of which is possible with the use of any antipsychotics, is characterized by pallor, hyperthermia, muscle rigidity, dysfunction of the autonomic nervous system, and impaired consciousness. Signs of autonomic nervous system dysfunction, such as increased sweating and lability of blood pressure and pulse, may precede the onset of hyperthermia and be early warning symptoms. In case of unexplained increase in body temperature, treatment with sulpiride should be discontinued.

The genesis of the development of neuroleptic malignant syndrome remains unclear. It is assumed that blockade of dopamine receptors in the striatum and hypothalamus plays a role in its mechanism; 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 QT prolongation. This effect is known to increase the risk of developing severe ventricular arrhythmias, such as torsade de pointes (see section "Side Effects").

Before using the drug, if the patient's condition allows, it is necessary to exclude the presence of factors predisposing to the development of these severe rhythm disturbances (bradycardia less than 55 beats per minute, hypokalemia, hypomagnesemia, slow intraventricular conduction and congenital long QT interval or prolongation of the QT interval when using other drugs, prolonging the QT interval) (see sections “Precautions”, “Side effects”).

Patients with the above risk factors should be careful when prescribing sulpiride. Hypokalemia and hypomagnesemia should be corrected before starting the drug; in addition, medical supervision and constant monitoring of electrolytes in the blood and ECG should be ensured.

Except in cases of urgent intervention, patients requiring treatment with antipsychotics are advised to have their condition assessed and an ECG taken. Extrapyramidal syndrome

For extrapyramidal syndrome caused by antipsychotics, m-anticholinergic drugs (rather than dopamine receptor agonists) should be prescribed (see section “Interaction with other drugs”).

Stroke

In randomized clinical trials comparing 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 dementia-related psychosis, an increased risk of death was observed when treated with antipsychotic drugs. An analysis of 17 placebo-controlled studies (mean duration greater than 10 weeks) found that most patients treated with atypical antipsychotics had a 1.6 to 1.7 times greater risk of death than patients treated with placebo.

In a 10-week placebo-controlled study, the death rate was 4.5% with atypical antipsychotics in these patients and 2.6% with placebo. Although the causes of death in clinical studies with atypical antipsychotics varied, most causes of death were either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies have confirmed that, like treatment with atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may also increase mortality. The extent to which the increase in mortality may be due to the antipsychotic drug rather than certain patient characteristics is unclear.

Venous thromboembolic complications

Cases of venous thromboembolic complications, sometimes fatal, have been observed with the use of antipsychotic drugs. Therefore, sulpiride should be used with caution in patients with risk factors for the development of venous thromboembolic complications (see sections “With caution”, “Side effects”).

Patients with epilepsy

Due to the fact that antipsychotics can lower the epileptogenic threshold, when prescribing sulpiride to patients with epilepsy, the latter should be under strict medical supervision.

Patients with Parkinson's disease receiving dopamine receptor agonists

Except in exceptional cases, this drug should not be used in patients with Parkinson's disease. If there is an urgent need for antipsychotic treatment in patients with Parkinson's disease receiving dopamine receptor agonists, a gradual reduction in doses of the latter should be carried out until complete discontinuation (abrupt withdrawal of dopamine receptor agonists may increase the patient's risk of developing neuroleptic malignant syndrome) (see sections "With caution", "Interaction with other drugs").

Patients with impaired renal function

Smaller doses should be used (see section “Dosage and Administration”).

Patients with diabetes mellitus or with risk factors for developing diabetes mellitus

Since the development of hyperglycemia has been reported in patients taking atypical antipsychotics, patients with established diabetes mellitus or with risk factors for its development who are prescribed treatment with sulpiride should monitor blood glucose concentrations.

Ethanol consumption

The consumption of alcoholic beverages containing ethanol or the use of medications containing ethanol during treatment with BETAMAX is strictly prohibited.

Betamax price, where to buy

You can buy it in many pharmacies in Moscow with a doctor’s prescription. The estimated cost of 100 mg tablets No. 30 is from 240 rubles. up to 297 rubles, and 200 mg tablets No. 30 from 299 rubles. up to 353 rub.

• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

Pharmacy24

• Betamax 200 mg N30 tablets AT "Grindeks", Latvia
  219 UAH. order
• Betamax 100 mg N30 tablets AT "Grindeks", Latvia

  164 UAH order

• Betamax 50 mg N30 tablets AT "Grindeks", Latvia

  122 UAH order

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Betamax film-coated tablets 100 mg No. 30**

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