Betamax
Betamax: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Use in the elderly
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Betamaks
ATX code: N05AL01
Active ingredient: sulpiride (sulpiride)
Manufacturer: Grindeks, JSC (Latvia)
Description and photo updated: 2019-27-08
Prices in pharmacies: from 155 rubles.
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Betamax is an antipsychotic drug, neuroleptic.
Release form and composition
The drug is produced in film-coated tablets: round, biconvex, white (30 pieces in plastic bottles, 1 bottle in a cardboard box and instructions for using Betamax).
Active ingredient: sulpiride, in 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, white Opadrai dye 33G28707 (titanium dioxide, macrogol 3000, lactose monohydrate, triacetin, hypromellose).
Pharmacological properties
Pharmacodynamics
The active substance of Betamax, sulpiride, is an atypical antipsychotic agent (neuroleptic) with antidepressant, stimulating and antiemetic effects.
The antipsychotic effect is due to the ability to block the dopamine D 2 receptors of the mesolimbic and mesocortical systems. It manifests itself when using daily doses of more than 600 mg. In doses up to 600 mg per day, sulpiride has a predominantly antidepressant and stimulating effect.
Betamax stimulates the secretion of prolactin. Does not significantly affect histamine, cholinergic, adrenergic, serotonin and GABA receptors.
The antiemetic effect of sulpiride is due to its ability to block dopamine D 2 receptors in the trigger zone of the vomiting center.
The peripheral action is due to the suppression of presynaptic receptors.
In case of gastric ulcer and duodenal ulcer, sulpiride has a selective effect on the hypothalamus, as a result of which it suppresses the excitation of the centers of the sympathetic nervous system, increases the secretion of mucus in the stomach, improves the blood supply to the stomach and the proliferation of capillaries in the tissues, accelerates the proliferation of granulation tissue and forms a regenerated epithelium.
Pharmacokinetics
After taking Betamax inside, the maximum plasma concentration of sulpiride is 0.73 mg / l and is achieved within 3-6 hours.
Biological activity - 25–35%. About 40% of the substance binds to plasma proteins. It quickly penetrates into the kidneys and liver, more slowly into the brain tissue (it accumulates mainly in the pituitary gland). It is excreted in breast milk (0.1% of the daily dose).
In the central nervous system, the concentration of the drug is 2–5% of the plasma level.
The total clearance is 126 ml / min.
Sulpiride is not metabolized. It is excreted almost unchanged by the kidneys by glomerular filtration (92%).
The half-life is approximately 7 hours. With moderate and severe renal failure, this value increases significantly (up to 20–26 hours after intravenous administration), therefore, a decrease in the dose of the drug and / or an increase in the interval between doses is required.
Indications for use
Betamax tablets are prescribed as monotherapy or in combination with other drugs from the group of psychotropic drugs for the following diseases:
- Schizophrenia (acute and chronic);
- Depression of various origins;
- Acute delirious states (confusion, hallucinations, impaired self-awareness and disorientation in time and location, often observed in people after surgery (anesthesia), in chronic alcoholism, after heart attacks and severe intoxication);
- Neuroses;
- Migraine;
- Dizziness with vertebrobasilar insufficiency, vestibular neuritis, Meniere's disease, otitis media;
- Stomach and duodenal ulcers, irritable bowel syndrome (as an adjuvant).
Contraindications
- Hypersensitivity to Betamax components;
- Acute form of alcohol poisoning, sleeping pills, analgesics;
- Hypertonic disease;
- Epilepsy;
- Hyperprolactinemia;
- Pheochromocytoma;
- A state of passion and aggression;
- Breastfeeding period;
- Age under 18.
Betamax should be used with caution in the following cases: a predisposition to the development of hypokalemia or cardiac arrhythmias (with bradycardia <55 beats per minute, hypokalemia, congenital prolongation of the QT interval, concomitant use of drugs that can cause the development of severe bradycardia), slowing of intracardiac conduction or lengthening QT interval, a history of neuroleptic malignant syndrome, the presence of risk factors for stroke, Parkinson's disease, intestinal obstruction, diabetes mellitus or the presence of risk factors for the development of diabetes mellitus, renal failure, the presence of risk factors for the development of agranulocytosis, leukopenia, thromboembolism or neutropenia, epilepsy or seizures a history of aggressive behavior or agitation with impulsivity, old age,pregnancy (the use of Betamax in a given period of a woman's life is permissible only in cases where the effect of therapy exceeds the risk to the fetus), the simultaneous use of drugs containing ethanol.
Betamax, instructions for use: method and dosage
Betamax should be taken no later than 16:00. The dosage of the drug depends on the diagnosis and is determined by the attending physician individually.
In schizophrenia or delirious psychosis, the initial dose of Betamax is 600 to 1200 mg per day, divided into several doses, with maintenance therapy - from 300 to 800 mg per day.
With depression, Betamax is taken at 150-200 mg per day (maximum - 600 mg), dividing the dose into several doses, with neuroses - 400-600 mg per day.
In case of dizziness, the drug is taken at 150-200 mg per day (in severe cases - at 300-400 mg), with migraine - at 100-300 mg per day.
When the drug is included in the complex therapy of diseases of the gastrointestinal tract, Betamax is prescribed 150 mg per day in 3 divided doses. The duration of therapy is 1-1.5 months.
The daily dose of the drug for elderly patients is ¼-½ of the usual adult dose.
Side effects
- from the nervous system: akathisia, acute dyskinesia and acute muscular dystonia (trismus, torticollis, spasm, oculogyric crisis), extrapyramidal disorders and related disorders, including parkinsonism (muscular hypertonia, hypersalivation, hypokinesia, tremor) - these symptoms, as a rule, undergo a reverse development with the combined use of anticholinergic antiparkinsonian drugs; insomnia or drowsiness, sedation, tardive dyskinesia (stereotypical involuntary rhythmic movements, mainly of the tongue and / or facial muscles; usually occurs after 3 or more months of taking Betamax, while antiparkinsonian drugs are ineffective and may even increase symptoms), seizures, neuroleptic malignant syndrome;
- on the part of the organs of vision: blurred visual perception;
- from the immune system: hypersensitivity reactions (exfoliative dermatitis, macular-papular rash, urticaria, pigmentation, photosensitivity);
- from the digestive system: dry mouth, constipation;
- on the part of metabolism and nutrition: weight gain, hyperglycemia;
- on the part of the hematopoietic and lymphatic system: leukopenia, agranulocytosis, neutropenia;
- from the endocrine system: hyperprolactinemia;
- from the liver and biliary tract: increased activity of microsomal liver enzymes, jaundice;
- on the part of the cardiovascular system: prolongation of the QT interval, ventricular arrhythmias (ventricular tachycardia of the "pirouette" type), arterial hypertension or hypotension, orthostatic hypotension, ventricular tachycardia (can lead to the development of ventricular fibrillation, cardiac arrest, sudden death), thromboembolism (including thromboembolism of the pulmonary artery, deep vein thrombosis);
- from the genitals and mammary glands: disorders associated with hyperprolactinemia (enlargement and soreness of the mammary glands, gynecomastia, amenorrhea, galactorrhea, erectile dysfunction, orgasmic dysfunction);
- pregnancy, the postpartum period and neonatal period: drug withdrawal syndrome in newborns whose mothers took Betamax in the third trimester of pregnancy.
With a sudden cessation of therapy, withdrawal syndrome may develop: increased sweating, nausea, vomiting, voluntary movements (dystonia, akathisia, dyskinesia), insomnia, recurrence of psychotic symptoms.
Overdose
Information on sulpiride overdose is limited. There are no specific symptoms, the following disorders are possible: trismus, protruding tongue, dyskinesia with specific torticollis, parkinsonism syndrome, coma.
No antidote has been established. Conducting symptomatic and supportive therapy is shown. It is necessary to carefully monitor the respiratory function and cardiac activity until the patient is fully recovered. In the case of the development of a pronounced extrapyramidal syndrome, m-anticholinergic agents (for example, biperiden) are used. If necessary, hemodialysis is performed (allows you to partially remove sulpiride from the body).
special instructions
If hyperthermia develops, taking Betamax should be discontinued.
Influence on the ability to drive vehicles and complex mechanisms
During treatment with Betamax, special care must be taken when driving and working with complex mechanisms.
Application during pregnancy and lactation
In animal experiments and in the course of limited experience with the use of sulpiride during pregnancy, no teratogenic effect was detected. However, Betamax is not recommended for pregnant women. If the use of the drug is definitely necessary, careful medical supervision of the newborn should be provided.
The drug passes into breast milk, therefore, Betamax is contraindicated for breastfeeding women.
Pediatric use
Betamax tablets are not prescribed to patients under the age of 18.
With impaired renal function
Betamax in renal failure should be used with caution. A decrease 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;
- CC <10 ml / min: reduce the dose by 70% and increase the intervals between doses by 3 times.
Use in the elderly
In old age, Betamax should be used with caution. The starting dose for patients in this category is 1/4 to 1/2 of the adult dose.
Drug interactions
Due to the mutual antagonism of the effects, Betamax is contraindicated 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 pirouette-type ventricular tachycardia or lengthen the QT interval [class IA antiarrhythmics (disopyramide, quinidine), potassium-excreting diuretics, laxatives that stimulate intestinal motility, glucocorticosteroids, digitalis drugs, beta-blockers, guanfacine, diltiazem, verapamil, clonidine, tetracosactide, intravenous amphotericin B, class III antiarrhythmics (sotalol, amiodarone), other drugs such as oral antibiotics, antibiotics, antidepressants, antidepressants thioridazine, sultopride, pimozide, bepridil, methadone, cisapride, haloperidol, intravenous vincamine and erythromycin, sparfloxacin, pentamidine, halofantrine]. If the simultaneous appointment of these drugs is clinically justified, electrocardiographic observation, careful clinical and laboratory (blood electrolyte composition) control should be carried out.
Interactions to be considered:
- antihypertensive drugs: there is an increase in the hypotensive effect, the risk of orthostatic hypotension increases;
- drugs that depress the central nervous system (antidepressants, antihistamines, narcotic analgesics, barbiturates, blockers of H 1 histamine receptors with a sedative effect, benzodiazepines and other anxiolytics, clonidine and other antihypertensive drugs of central action): cumulative depression of the functions of the central nervous system and a decrease in the functions of the central nervous system and reactions;
- antacids, sucralfate: absorption of sulpiride decreases, therefore, the minimum interval between doses (2 hours) must be observed;
- ropinirole: mutual antagonism is noted;
- lithium preparations: the risk of developing extrapyramidal disorders increases.
Analogs
Structural analogues of Betamax include Eglonil, Sulpiride and Prosulpin.
Storage conditions and periods
Store at a temperature not exceeding 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Betamax
Reviews about Betamax are mostly positive. The drug is effective for depression, neurosis, panic attacks, as well as for peptic ulcer disease, cholecystitis and colitis. Patients note that the drug eliminates well both psychosomatic disorders and dyspeptic disorders, normalizes the motility of the stomach, intestines and gallbladder, and is well tolerated.
Side effects include a decrease in blood pressure, increased appetite and weight gain, the appearance of edema, an increase in prolactin levels, sleep disturbances, and extrapyramidal disorders.
The price for Betamax in pharmacies
Approximate prices for Betamax: 30 tablets of 50 mg - 196 rubles, 30 tablets of 100 mg - 290 rubles, 30 tablets of 200 mg - 330 rubles.
Betamax: prices in online pharmacies
Drug name Price Pharmacy |
Betamax 100 mg film-coated tablets 30 pcs. 155 RUB Buy |
Betamax 200 mg film-coated tablets 30 pcs. 292 r Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!