Betamax: instructions for use, reviews on forums and price

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 .

For impaired renal function

Betamax should be used with caution in renal failure. A reduction in the dose of the drug and/or an increase in the intervals between doses is required, which depends on the creatinine clearance (CC):

CC 30–60 ml/min: reduce the dose by 30% and increase the intervals between doses by 1.5 times;
CC 10–30 ml/min: reduce the dose by 50% and increase the intervals between doses by 2 times;
QC < 10 ml/min: reduce the dose by 70% and increase the intervals between doses by 3 times.

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.

Overdose

Information on overdose of sulpiride is limited. There are no specific symptoms, the following disorders are possible: trismus, tongue protrusion, dyskinesia with specific torticollis, parkinsonism syndrome, coma.

No antidote has been established. Symptomatic and supportive therapy is indicated. It is necessary to carefully monitor respiratory function and cardiac activity until the patient recovers completely. In the case of the development of severe extrapyramidal syndrome, m-anticholinergic drugs (for example, biperiden) are used. If necessary, hemodialysis is performed (allows sulpiride to be partially removed from the body).

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.

Release form and composition

The drug is available in film-coated tablets: round, biconvex, white (30 pieces in plastic bottles, 1 bottle in a cardboard box and instructions for use of Betamax).

Active substance: sulpiride, 1 tablet – 50 mg, 100 mg or 200 mg.

Additional components of the tablets:

excipients: microcrystalline cellulose, crospovidone, magnesium stearate, corn starch, povidone;
shell composition: carnauba wax, Opadry white dye 33G28707 (titanium dioxide, macrogol 3000, lactose monohydrate, triacetin, hypromellose).

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 .

Drug interactions

Due to the mutual antagonism of the effects, Betamax is contraindicated for use in combination with dopamine receptor agonists (rotigotine, kinagolide, cabergoline) and levodopa.

The simultaneous use of the following drugs is not recommended: ethanol (the sedative effect of sulpiride is enhanced), drugs that can cause torsades de pointes or prolong the QT interval [class IA antiarrhythmics (disopyramide, quinidine), potassium-removing diuretics, laxatives that stimulate intestinal motility , glucocorticosteroids, digitalis preparations, beta-blockers, guanfacine, diltiazem, verapamil, clonidine, tetracosactide, amphotericin B intravenously, class III antiarrhythmic drugs (sotalol, amiodarone), other drugs such as oral antibiotics, antidepressants, lithium preparations, imipramine derivatives, thioridazine, sultopride, pimozide, bepridil, methadone, cisapride, haloperidol, intravenous vincamine and erythromycin, sparfloxacin, pentamidine, halofantrine]. If the simultaneous administration of these drugs is clinically justified, electrocardiographic monitoring and careful clinical and laboratory (blood electrolyte composition) monitoring should be carried out.

Interactions to consider:

antihypertensive drugs: there is an increase in the hypotensive effect, the risk of developing orthostatic hypotension increases;
drugs that depress the central nervous system (antidepressants, antihistamines, narcotic analgesics, barbiturates, sedative H1-histamine receptor blockers, benzodiazepines and other anxiolytics, clonidine and other centrally acting antihypertensives): possible cumulative depression of the functions of the central nervous system and decreased response ;
antacids, sucralfate: absorption of sulpiride is reduced, so it is necessary to maintain a minimum interval between doses (2 hours);
ropinirole: mutual antagonism is noted;
Lithium preparations: the risk of developing extrapyramidal disorders increases.

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 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