Betahistine is a tablet drug. It is used to relieve symptoms that appear against the background of malfunctions of the vestibular apparatus associated with impaired functioning of the central nervous system.
Betahistine tablets, the instructions focus on this, are used to treat Meniere's syndrome. Typically, the disease is confirmed when problems with hearing function or coordination appear. Additional signs are frequent, causeless dizziness. In the acute stage, symptoms manifest as a stroke. If left untreated, a secondary attack can be life-threatening.
The drug is also used for symptomatic treatment of vestibular dizziness - vertigo. Its causes are most often inflammatory diseases of the inner ear, as well as traumatic brain injury, intoxication and metabolic disorders.
Analogs
Drug name | Manufacturer country | price, rub. |
Vertran | Croatia | 267 |
Betaserk | USA | 415 |
Vestibo | Germany | 161 |
Tagista | Serbia | 89 |
Betaver | Russia | 239 |
Westicap | Russia | 319 |
The action of these drugs is similar to Betagistine. Patients have a choice between domestic and foreign drugs.
Today, pharmacies offer a large selection of Betagistine and its analogues.
Prices for the drug vary greatly, and are directly dependent on:
- manufacturer;
- drug dosage;
- number of pills in the package.
Patients have the opportunity to purchase the medicine at a pharmacy located within walking distance or order online. The second option is more profitable due to lower prices.
The availability of the drug can be found out and ordered in the following online pharmacies in Moscow:
- Eapteka-ru.
- Piluli-ru.
- Apteka-ru.
- Zdravciti-ru.
- Risnet-ru.
This product is presented by the following pharmaceutical companies:
- Vertex;
- Canonpharma;
- North Star;
- Pranapharm;
- Medisorb;
- OZONE LLC.
Manufacturers supply Betahistine in any dosage. The price varies from 91 to 556 rubles.
The most affordable prices are offered by pharmacists Pranapharm and OZON LLC (from 56 to 156 rubles). And the Vertex company produces the most expensive versions of Betagistin, starting from 153 rubles.
In pharmacies in St. Petersburg, prices for Russian-made Betagistine are slightly different:
- 8 mg, 30 tab. — from 13.80 to 89 rub.
- 16 mg, 30 tab. — from 67 to 89 rub.
- 24 mg, 20 tab. — from 61.70 to 77 rub.
- 24 mg, 30 tab. — from 71 to 89 rub.
The drug can be purchased at low prices in the following pharmacies:
- Pharmacy No. 186 - 2nd line, 51, Kingisepp.
- PetroPharmacy - Kamennoostrovsky pr., 42; DK im. Lensoveta, 2nd floor.
- Sita-Farm - 8th Sovetskaya, 41A.
The lowest prices for the drug in the following pharmacies:
- Vita-Express - Ispytatelev Ave., 6, bldg. 1; st. Yesenina, 32, bldg. 1; Novocherkassky Ave., 43/17A.
- Pharmacy for the thrifty - Sredny pr., 46.
- Pharmacy on Marata - st. Marata, 41.
- Pharmacy on Marata - st. Marata, 41.
- Homeopathic pharmacy - Bolshoy pr-t, P.S., no. 2.
- Care - Zagreb blvd., 9.
- Rigla - Bolshoi Sampsonievsky Ave., 55.
- Available pharmacy - Kosygina Ave., 27, bldg. 1.
- Pulse - Moskovsky Ave., 2/6.
An analysis of prices for Betagistine in various regions of Russia showed that they differ slightly even in cities remote from the capital.
In pharmacies in Saratov, Rostov-on-Don, Nizhny Novgorod, Kemerovo, the drug is available in all available dosages (8, 16, 24 mg). The pills, which according to the prescription must be taken three times a day, are packaged in 30 pieces. Tablets with the highest content of active ingredient (24 mg) can be purchased in quantities of 20, 30 and 60 pieces.
Prices for the drug fluctuate (in rubles):
- 8, 30 - from 71 to 116;
- 16, 30 - from 81.10 to 286;
- 24, 20 - from 71.90 to 336;
- 24, 30 - from 88 to 336;
- 24, 60 - from 163 to 603.
The therapeutic effect of taking Betahistine is achieved if the patient trusts the specialist and strictly follows the prescribed recommendations. Reviews from patients who took the drug fully confirm this.
Article design: Vladimir the Great
Common forms of release (more than 100 offers in Moscow pharmacies) | |||||
Name | Release form | Packaging, pcs. | Manufacturer country | Price in Moscow, r | Offers in Moscow |
Betaserc - original | tablets 8mg | 30 | Netherlands, Solvay and France, Abbott | 330- (average 402↗) -470 | 820↗ |
Betaserc - original | tablets 16mg | 30 | Netherlands, Solvay | 420- (average 592↘) -700 | 821↗ |
Betaserc - original | tablets 24mg | 20 and 60 | France and the Netherlands, Solvay | for 20pcs: 413- (average 521↗) -609; for 60pcs: 1017- (average 1176) - 1289 | 1077↗ |
Betaver | tablets 8mg | 30 | Russia, Veropharm | 105- (average 149↗) -322 | 451↘ |
Betaver | tablets 16mg | 30 | Russia, Veropharm | 162- (average 222↗) -296 | 796↗ |
Betaver | tablets 24mg | 20, 30 and 60 | Russia, Veropharm | for 20 and 30 pieces: 172- (average 221↗) -275; for 60pcs: 199- (average 491↗) - 564 | 684↗ |
Betahistine | tablets 8mg | 20 and 30 | Russia, Canonpharma | 35- (average 58) -171 | 423↘ |
Betahistine | tablets 16mg | 30 | Russia, Canonpharma | 54- (average 89) -190 | 680↗ |
Betahistine | tablets 24mg | 20 and 30 | Russia, Canonpharma | for 20 pieces: 35- (average 115↘) -187; for 30 pieces: 76- (average 199) -296; for 60 pcs: 248- (average 386) -402 | 688↘ |
Vestibo | tablets 8mg | 30 | Germany, Catalent | 117- (average 151↗) -180 | 919↗ |
Vestibo | tablets 16mg | 30 | Germany, Cardinal Health | 198- (average 250↗) -286 | 1036↗ |
Vestibo | tablets 24mg | 30 | Germany, Catalent and Cardinal Health | 287- (average 345↗) -403 | 983↗ |
Tagista | tablets 8mg | 30 | Russia, Makiz | 55- (average 84↘) -109 | 446↘ |
Tagista | tablets 16mg | 30 | Russia, Makiz | 68- (average 106) -133 | 681↗ |
Tagista | tablets 24mg | 30 | Russia, Makiz | 91- (average 123) -157 | 670↗ |
Rarely encountered and discontinued release forms (less than 100 offerings in Moscow pharmacies) | |||||
Vasoserc | tablets 24mg | 30 | Türkiye, Abdi | 120 | 1↘ |
Vertran | tablets 16mg | 30 and 60 | Croatia, Belupo | 159- (average 214) -298 | 21 |
Vertran | tablets 24mg | 30 and 60 | Croatia, Belupotd{amp}gt; | 262- (average 299) -570 | 72 |
Vertran | tablets 16mg | 30 and 60 | Croatia, Belupotd{amp}gt; | 129- (average 182) -205 | 12 |
Vestikap | capsules 8mg | 30 | Russia, Ozone | 131- (average 146) -163 | 6 |
Vestikap | capsules 16mg | 30 | Russia, Ozone | 199-275 | 11↘ |
Vestikap | capsules 24mg | 30 | Russia, Ozone | 306-353 | 18↗ |
Denoize | tablets 16mg | 30 | Russia, Izvarino Pharma | 168-170 | 2↘ |
Denoize | tablets 24mg | 20 | Russia, Izvarino Pharma | 170 | 1↘ |
Asniton | tablets 8mg | 30 | Russia, Vertex | No | No |
Which generic is better?
Where can I buy?
Betagistine's analogs
The pharmacy chain offers a sufficient number of analogues of the drug Betahistine from different pharmaceutical companies that have equivalent indications and act in a similar way. You can purchase them in the form:
- generics;
- combined agents;
- synonyms.
A wide variety of Betagistine analogues in 24 mg tablets makes it possible to select medications for the treatment of various types of dizziness with maximum effectiveness.
Table of Betagistine analogues with price and country of origin
Analogue | Cost in rubles | Manufacturer country |
Betagistine | 70-350 | Russia |
Betaserk | 450-1300 | France |
Tagista | 100-130 | Russia |
Vestibo | 130-300 | Germany |
Cinnarizine | 50-130 | Russia |
Mexidol | 400-850 | Russia |
Vertran | 120-450 | Croatia |
Omaron | 180-400 | Russia |
The list of Betagistine analogues with prices includes domestic and imported drugs. The doctor will give recommendations on which Betagistine substitute to choose, taking into account the clinical manifestations of the pathological process.
What else can replace Betahistine, what effective means? You can supplement the list of analogues by the following means:
- Vinpocetine;
- Phezam;
- Cavinton;
- Westicap;
- Betahistine Vertex;
- Betahistine Ozone;
- Betahistine Canon;
- Cytoflavin;
- Piracetam;
- Stugeron.
Among these drugs, there are Betagistine analogs that are cheaper and at a higher cost, used for adults in neurological and ENT practice.
Forms of release and composition of the drug Betahistine
The drug is available in tablet form (8, 16, 24 mg) and in the form of drops (100 ml contains 1.25 g of the drug, 30 ml in a bottle).
In addition to the active substance, the drug contains the following auxiliary components:
- magnesium stearate - binder (anti-adhesive) substance;
- colloidal silicon dioxide (Aerosil) - gives the tablets a sliding property;
- microcrystalline cellulose - allows you to press the medicinal mixture;
- lactose - improves the flowability of the tablet mass;
- crospovidone - promotes better dissolution of tablets.
Additional ingredients are absolutely harmless:
- do not suppress brain activity;
- do not affect the speed of reactions;
- do not cause drowsiness.
Betagistine
Currently, pharmacists are working on creating a long-acting drug Betahistine. Scientists plan to release a tablet form in a dosage of 48 mg with the release of the active substance within 12 hours.
This will reduce the frequency of taking the medication. With a long course of treatment, this approach will protect patients from side effects.
Betahistine or Betaserc
Manufacturer: MYLAN LABORATORIES SAS (France)
Release form: tablets
Active ingredient: betahistine
Both drugs are histamine medications of synthetic origin. The drugs have equivalent indications, mechanisms of action and are prescribed for dizziness of various origins. The difference between the drugs lies in the composition of the excipients. The structure of Betaserc contains mannitol, which has the ability to remove fluid from the body and relieve tissue swelling, which is an important point in relieving inflammation.
The use of the imported drug Betaserk will be more effective due to the high quality of purification of the original ingredients, which reduce allergic manifestations in sensitive patients.
pharmachologic effect
Betahistine acts on the enzyme diamine oxidase, which delays the course of physicochemical processes to reduce the activity of histamine, stabilizes the production of this hormone, and has a histamine-like effect.
A drug that improves microcirculation of the labyrinth, used for pathology of the vestibular apparatus
Synthetic analogue of histamine. An agonist of histamine H1 receptors in the vessels of the inner ear and an antagonist of histamine H3 receptors in the vestibular nuclei of the central nervous system. According to preclinical studies, by relaxing the precapillary sphincters of the vessels of the inner ear, it improves blood circulation in the vascular shelf of the inner ear.
Dose-dependently reduces the generation of action potentials in neurons of the lateral and medial vestibular nuclei. Accelerates the recovery of vestibular function after unilateral vestibular neurectomy, accelerating and facilitating central vestibular compensation (due to antagonism with histamine H3 receptors). Relieves symptoms of Meniere's syndrome and vertigo.
The use of betahistine drugs for dizziness
L.M. ANTONENKO
, Ph.D.,
N.V.
Bestuzheva ,
V.A.
PARFENOV , Doctor of Medical Sciences, Professor,
Department of Nervous Diseases and Neurosurgery of the First Moscow State Medical University named after.
THEM. Sechenova A post-registration, open, randomized, comparative study of the clinical efficacy and safety of betahistine drugs Vesticap and Betaserc in patients with vestibular vertigo was conducted. The observation included 62 patients who met the inclusion criteria, 17 men and 45 women, the average age of the participants was 47 ± 13.1 years. All 62 patients completed the treatment program. A significant clinical effect in the form of a decrease in the severity of dizziness according to the dizziness severity scale and an improvement in quality of life according to the DHI scale of decreased quality of life due to dizziness was obtained when taking both drugs. There were no significant differences in efficacy, tolerability and safety during treatment with Vesticap and Betaserc.
Treatment of dizziness is one of the pressing problems of practical healthcare. A complaint of dizziness is the reason for about 10% of patients visiting an outpatient neurologist or otolaryngologist [1, 4, 8]. The most common causes of vertigo are benign paroxysmal positional vertigo (BPPV), phobic postural vertigo, Meniere's syndrome and disease, vestibular neuronitis and central vestibular vertigo [4,8,9].
Among the drugs effective in the treatment of various types of dizziness, the leading place is occupied by betahistine, which affects the histamine H1 and H3 receptors of the inner ear and vestibular nuclei of the brain [3, 4, 6, 8, 9, 12]. Betahistine was first registered in 1968 and has now been approved in more than 115 countries for the treatment of Meniere's disease and the symptomatic treatment of various causes of vestibular vertigo [14]. Treatment with betahistine leads to a reduction in the number of attacks of vestibular vertigo in many diseases, which is due to an increase in blood flow in the inner ear, a decrease in increased endolymphatic pressure, and restoration of the balance between the production and reabsorption of endolymph in the labyrinth [14, 15, 16, 17, 22]. Betahistine helps normalize vestibular function in vestibular neuronitis, unilateral and bilateral vestibulopathy [4, 20, 23]. Treatment of BPPV is carried out using special exercises and therapeutic maneuvers aimed at removing otoliths from the semicircular canals of the labyrinth to the vestibule and their faster dissolution. Carrying out positional maneuvers of Semont and Epley in 90% of cases allows achieving improvement within a week [4, 9, 10]. Betahistine accelerates the processes of vestibular compensation in BPPV [4, 14, 21].
Betahistine stimulates the H1 receptors of the vessels of the inner ear, as well as indirectly the H3-histamine receptors of the vestibular nuclei of the central nervous system (CNS) and, as a result, improves microcirculation and capillary permeability, normalizes endolymph pressure in the labyrinth and cochlea, and increases blood flow in the basilar artery. It accelerates the restoration of vestibular function, facilitates central vestibular compensation, and reduces the generation of action potentials in neurons of the lateral and medial vestibular nuclei. Betahistine has a very strong affinity for histamine H3 receptors and weak affinity for histamine H1 receptors [14, 15]. It is assumed that betahistine increases the level of a neurotransmitter in the brain stem, such as serotonin, which reduces the activity of the vestibular nuclei. Pharmacological studies in animals revealed a clear decrease in the electrical activity of the vestibular nuclei after the administration of betahistine. Interaction with H3 receptors may be the main mechanism through which betahistine exerts its clinical effects [15].
In our country, the original betahistine drug, Betaserc, produced by Abbott Healthcare Products B.V., the Netherlands, is widely used [4]. Currently, the Russian pharmaceutical company Ozon LLC produces the betahistine drug Vesticap. Comparison of the effectiveness and safety of the drugs Vesticap and Betaserc in patients with peripheral vestibular vertigo is of undoubted clinical and practical interest to obtain information about the clinical effectiveness and safety of Vesticap.
The purpose of this study was to comparatively study the clinical effectiveness and safety of the drugs Vesticap and Betaserc in patients with vestibular vertigo.
Characteristics, patients and research methods
Study design: post-registration, open-label, randomized, comparative study in parallel groups, phase IV clinical trial. The objectives of the study were to conduct a comparative assessment of the effectiveness of the drugs Vesticap and Betaserc in relation to the severity of dizziness, the quality of life of patients with dizziness, as well as their safety and tolerability in patients who received at least one dose of the drug.
Inclusion/exclusion criteria are presented in Table 1.
Table 1. Inclusion/exclusion criteria | |
Inclusion criteria | Exclusion criteria |
Men and women from 18 to 55 years old | Lactose intolerance, malabsorption syndrome |
Presence of peripheral vestibular vertigo | Hypersensitivity to betahistine or other components of the drug |
Severity of dizziness 1 point or higher on a 5-point scale of dizziness severity | Taking antihistamines or monoamine oxidase inhibitors one month before participating in this study |
Absence of severe or unstable somatic or mental illnesses, known malignant neoplasms | Presence of severe or unstable somatic or mental illnesses, known malignant neoplasms |
For women - no pregnancy | Pregnancy and/or lactation period |
After signing the informed consent form, patients meeting the inclusion/exclusion criteria were randomized in a 1:1 ratio (envelope method) into the study and control groups to receive treatment with the test drug Vesticap or the comparator drug Betaserc [27].
In accordance with the design, 62 patients who successfully completed the screening period and met all inclusion criteria were included in the observation.
Of the 62 patients included in the study, all 62 patients completed the treatment program. Among the patients included in the analysis, there were 17 men and 45 women, representing 27% and 73%, respectively. The youngest participant in the observation was 19 years old, the oldest was 55 years old. The mean age is 47 ± 13.1 years, the median age is 50 years. Men and women included in the study did not differ significantly in age (P > 0.05).
The group of patients taking Vesticap included 21 women (68%) and 10 men (32%). The group of patients taking Betaserc included 24 women (77%) and 7 men (23%). The average age in the group of patients taking Vesticap was 45 ± 2.7 years, the youngest participant in the group was 19 years old, the oldest was 55 years old. The average age in the group of patients taking Betaserc was 49 ± 2.6 years, the youngest participant in the group was 33 years old, the oldest was 55 years old. There were no significant differences in the compared groups of patients taking Vesticap or Betaserc in terms of gender and age (P > 0.05).
In the group of patients receiving Vesticap, the following diseases were diagnosed: BPPV in 27 cases (87%), Meniere's syndrome in 2 cases (7%), vestibular neuronitis in 1 case (3%), bilateral vestibulopathy in 1 case (3%) .
In the group of patients receiving Betaserc, the following diseases were diagnosed: BPPV in 21 cases (68%), Meniere's syndrome in 4 cases (13%), vestibular neuronitis in 3 cases (10%), secondary labyrinthine hydrops in 2 cases (6% ), bilateral vestibulopathy in 1 case (3%).
Before the start of therapy, as well as on the 30th and 60th days of therapy, all patients underwent a physical neurological examination. Laboratory examination, including general blood and urine analysis, was carried out before the start of therapy and on the 60th day of taking the drugs. Patients took Vesticap and Betaserc orally, 24 mg 2 times a day (with an interval of 12 hours). The duration of therapy was 60 ± 4 days. A preliminary assessment of the effectiveness of treatment was carried out on the 30th day of treatment, the final assessment was carried out on the 60th day of therapy.
The severity of dizziness was assessed using a 5-point dizziness severity scale [18]. The quality of life of patients was determined using the DHI scale [18].
The tolerability and safety of the drugs was assessed based on medical examination data (blood pressure, heart rate, body temperature, respiratory rate), and analysis of laboratory examination data (general blood and urine analysis).
Statistical processing of the material was carried out using the STATISTICA program, version 12. To compare the groups of patients receiving Vesticap or Betaserc on the dizziness severity scale, the nonparametric Mann-Whitney U test was used.
A parametric Student's t-test for independent samples was used to compare the groups of patients receiving Vesticap or Betaserc on the DHI scale of decreased quality of life due to dizziness [25, 26]. Research results
The observation results on a 5-point scale for the severity of dizziness in the group of patients receiving Vesticap at the beginning of treatment, on the 30th and 60th days of therapy are presented in
Figure 1
.
As can be seen from Figure 1, at the 1st visit (beginning of therapy) in the group of patients taking Vesticap, patients with severe dizziness prevailed - 19 people (65%), 6 people (19%) had moderately severe dizziness, 5 people (16%) experienced very severe dizziness. At the 3rd visit (60th day of therapy with Vesticap), this group was dominated by patients with mild dizziness, which was detected in 15 people (48%), in 12 people (39%), dizziness was completely absent, in 4 people (13 %) moderate dizziness was noted. There were no patients with severe or very severe dizziness. At the same time, there was a significant (P<0.05) decrease in the severity of dizziness on a 5-point scale of dizziness severity on the 60th day of therapy with Vesticap.
The observation results on a 5-point scale for the severity of dizziness in the group of patients receiving Betaserc are presented in Figure 2
.
As can be seen from Figure 2, at the 1st visit (beginning of therapy) in the group of patients taking Betaserc, patients with severe dizziness prevailed - 26 people (84%), 1 patient (3%) had moderately severe dizziness, 4 people (13%) experienced very severe dizziness. At the 3rd visit (60th day of therapy), this group was dominated by patients with mild dizziness, which was detected in 20 people (65%), in 9 people (29%) dizziness was completely absent, in 2 people (6%) Moderate dizziness was noted; no patients with severe or very severe dizziness were identified.
Significant differences (P<0.05) were identified on a 5-point scale of dizziness severity at the 1st and 3rd visits in the group of patients receiving Betaserc, indicating a significant reduction in the severity of dizziness on the 60th day of treatment with Betaserc.
The dynamics of reduction in the severity of dizziness while taking the drugs Vesticap or Betaserc is shown in Figure 3
.
As can be seen from Figure 3, there was a significant reduction in the severity of dizziness after 30 days of treatment (2nd visit) and 60 days of therapy (3rd visit) in the groups of patients taking Vesticap or Betaserc. The decrease in the average score on a 5-point scale of the severity of dizziness over a treatment period of 2 months in the group of patients taking Vesticap was 2.23 points, in the group of patients taking Betaserc it was 2.32 points. This indicates the high effectiveness of treatment with Vesticap and Betaserc on the 60th day of taking both drugs.
Thus, in both groups of patients receiving Vesticap or Betaserc, a result was achieved that corresponded to the primary effectiveness criterion: a decrease in the severity of dizziness (a decrease in the average score on a 5-point scale of the severity of dizziness by one point or more) over a treatment period of 2 months, which was significant (P<0.05).
The results of observation on the scale of decreased quality of life due to dizziness (on the DHI scale) in the groups of patients receiving Vesticap or Betaserc are presented in Table 2
and in
Figure 4
.
Table 2. Average values on the scale of decreased quality of life due to dizziness (DHI) in the groups of patients receiving Vesticap or Betaserc at visits 1-3 | ||
Visit number | Average DHI score | |
In the group of patients taking Vesticap | In the group of patients taking Betaserc | |
Visit 1 | 62,90 ± 7,19 | 71,80 ± 6,61 |
Visit 2 | 34,71 ± 6,32 | 38,19 ± 6,14 |
Visit 3 | 15,68 ± 5,18 | 17,03 ± 4,48 |
From Figure 4 it can be seen that the average values on the scale of decreased quality of life due to dizziness (DHI) after 30 days (2nd visit) and 60 days (3rd visit) decreased exponentially and were significantly different, which indicates a significant effect treatment on the 30th and 60th day of taking both drugs. Significant differences (P<0.05) were identified on the scale of decreased quality of life due to dizziness (DHI) at the 1st and 3rd visits in the groups of patients receiving Vesticap or Betaserc, which indicates a significant improvement in quality of life at the 60th day of therapy with both drugs.
A comparison of the effectiveness of treatment with Vesticap and Betaserc in terms of the severity of dizziness is shown in Table 3
, according to the quality of life of patients - in
Table 4
.
Table 3. Comparison of the severity of dizziness in the groups of patients receiving Vesticap or Betaserc after 30 and 60 days (according to the Mann-Whitney U test) | ||||
Severity of dizziness | Rank Sum in the group of patients taking Vesticap | Rank Sum in the group of patients taking Betaserc | U | p |
Start of therapy | 1029 | 1024 | 428 | 0,48 |
In 30 days | 1006 | 1002 | 443 | 0,53 |
After 60 days | 998 | 955 | 459 | 0,76 |
As can be seen from the data presented in Table 3, when comparing groups of patients receiving Vesticap or Betaserc, no significant differences were obtained on the dizziness severity scale (P>0.05).
Table 4. Comparison of quality of life due to dizziness (DHI) in the groups of patients receiving Vesticap or Betaserc after 30 and 60 days (by Student's t-test for independent samples) | ||||
Quality of life due to dizziness | Average values | Standard deviation | t | p |
Start of therapy | 62,90 | 71,80 | -1,86 | 0,08 |
In 30 days | 36,23 | 17,45 | -0,96 | 0,17 |
After 60 days | 15,67 | 15,03 | -0,40 | 0,68 |
As can be seen from the data presented in Table 4, when comparing the groups of patients receiving Vesticap or Betaserc, no significant differences were obtained on the scale of decreased quality of life due to dizziness (DHI) (P>0.05).
During the entire observation period, no changes in vital signs (blood pressure, heart rate, body temperature, respiratory rate), or laboratory tests (general blood and urine tests) were detected in any of the 62 patients.
During the study, adverse events (AEs) were reported in three patients: two patients taking Vesticap (6%) and one patient taking Betaserc (3%). The differences between the groups are not statistically significant (p˃0.05). These AEs were classified as mild and did not serve as a reason for excluding patients from the study. AEs manifested themselves in the form of nausea after taking Vesticap or Betaserc. Patients were given recommendations on following a diet and taking medications after meals. In all cases, AEs regressed and did not require discontinuation of the drug.
The recorded AEs were typical for betahistine drugs and are described in the instructions for use of the drugs Vesticap and Betaserc [14, 15, 20]. A comparison of the frequency of AEs in the groups of patients taking Vesticap or Betaserc is presented in Table 5
.
Table 5. Frequency of adverse events in groups of patients receiving Vesticap or Betaserc (according to the Mann-Whitney U test) | ||||
Index | Rank Sum in the group of patients taking Vesticap | Rank Sum in the group of patients taking Betaserc | U | p |
Frequency of AEs | 961,00 | 992,00 | 465,00 | 0,83 |
As can be seen from the data presented in Table 5, there were no significant differences in the incidence of AEs in the groups of patients taking Vesticap or Betaserc (P>0.05).
Discussion
This study noted the therapeutic efficacy and safety of the drug Vesticap (betahistine dihydrochloride) in comparison with the original drug Betaserc. The data obtained are consistent with the results of other studies that noted the effectiveness of betahistine in Meniere's syndrome and disease [14, 15, 17, 22], BPPV [10, 11, 21], and vestibular neuronitis [7, 14, 20].
A significant clinical effect in the form of a decrease in the severity of dizziness, assessed by the Dizziness Severity Scale, and an improvement in quality of life, determined by the DHI scale, was obtained with both drugs. There were no significant differences in the effectiveness of Vesticap and Betaserc. These data indicate the therapeutic effectiveness of the compared drugs in the treatment of dizziness with vestibular disorders of various etiologies.
A reliable therapeutic effect was obtained in the treatment of vestibular vertigo using both drugs: Vesticap and Betaserc, in patients with BPPV, vestibular neuronitis, Meniere's syndrome, bilateral vestibulopathy, secondary labyrinthine hydrops. Treatment of patients with BPPV included therapeutic maneuvers to remove otoliths from the semicircular canals of the labyrinth and the administration of drugs Vesticap or Betaserc to improve vestibular compensation, as well as to prevent relapses of otolithiasis [4, 9, 10, 11, 21].
Statistical analysis revealed a significant reduction in the main symptoms of dizziness and an improvement in the quality of life of patients, while no significant differences were found between the studied drugs.
There were no significant differences in the tolerability and safety of both drugs, as well as the nature and frequency of AEs when treated at the recommended therapeutic dose of 48 mg per day.
Thus, according to the results of the study, the drug Vesticap in terms of therapeutic effectiveness in relation to the symptoms of vestibular vertigo, tolerability and safety does not differ significantly from the original drug Betaserc.
Literature
1. Bornstein A., Lempert T. Dizziness: a practical approach to diagnosis and treatment M., GEOTAR, 2010 – 216 p. 2. Weiss G. Dizziness // Neurology / Ed. M. Samuels. - M., 1997. - P. 9–120. 3. Kryukov A.I., Fedorova O.K., Antonyan R.G., Sheremet A.S. Clinical aspects of Meniere's disease. - M., Medicine 2006. - 239 p. 4. Parfenov V.A., Zamergrad M.V., Melnikov O.A. Dizziness: diagnosis and treatment, common diagnostic errors. M., MIA, 2009 – 152 p. 5. Albera R., Ciuffolotti R., Di Cicco M. et al. Double-blind, randomized, multicenter study comparing the effect of betahistine and flunarizine on the dizziness handicap in patients with recurrent vestibular vertigo // Acta Otolaryngol. 2003;123:588–593. 6. Baloh RW Dizziness, Hearing Loss, and Tinnitus. —New York: Oxford University Press, 1998. —240 p. 7. Benecke H. et al. OSVaLD (Observational Study in patients suffering from recurrent peripheral vestibular Vertigo to Assess the effect of betahistine 48 mg/day on quality of Life and Dizziness symptoms) // Int Tinnitus J. 2010;16:14-24. 8. Brandt T. Vertigo. Its Multicensory Syndromes. – 2nd Ed. – London, 2000. 9. Brandt T. Dieterich M. Vertigo and dizziness: common complaints. Springer. 2004 10. Brandt T., Huppert D., Hecht J. et al. Benign paroxysmal positional vertigo: A long-term follow-up (6-17 years) of 125 patients // ActaOtolaryngol. - 2006. - Vol. 126. - P. 160-163. 11. Guneri EA, Kustutan O. The Effects of Betahistine in Addition to Epley Maneuver in Posterior Canal Benign Paroxysmal Positional Vertigo //Otolaryngol Head Neck Surg. 2011 Aug 22 12. Hanley K., O'Dowd T., Considine N. A systematic review of vertigo in primary care. // Br J Gen Pract. 2001;51: 666-671. 13. Kawabata A, Sasa M, Kishimoto T, et al. Effects of anti-vertigo drugs on medial vestibular nucleus neurons activated by horizontal rotation, Jpn J Pharmacol 1991; 55: 101-6. 14. Lacour M, Sterkers O. Histamine and betahistine in the treatment of vertigo. Elucidation of mechanisms of action. CNS Drugs 2001; 15: 853-70. 15. Lezius F, Adrion C, Mansmann U, Jahn K, Strupp M. High-dosage betahistine dihydrochloride between 288 and 480 mg/day in patients with severe Menière's disease: a case series // Eur Arch Otorhinolaryngol. 2011; 268:1237–1240 16. Meyer P, Schmidt R, Grutzmacher W et al. Inner ear blood flow with betahistine – an animal experiment study. Laryngorhinootologie 1994; 73: 153-156. 17. Minor LB, Schessel DA, Carey JP Meniere's disease. // Curr Opin Neurol. 2004;17:9–16. 18. Morris AE, Lutman ME, Yardley L. Measuring outcome from vestibular rehabilitation, part II: refinement and validation of a new self-report measure. Int J Audiol 2009; 48:1:24-37. 19. Neuhauser HK Epidemiology of vertigo. // Curr Opin Neurol. 2007; 20:40–46. 20. Oosterveld WJ Betahistine dihydrochloride in the treatment of vertigo of peripheral vestibular origin. A double-blind placebo-controlled study // J Laryngol Otol. 1984; 98:37–41. 21. Stambolieva K, Angov G. Effect of treatment with betahistine dihydrochloride on the postural stability in patients with different duration of benign paroxysmal positional vertigo // Int Tinnitus J. 2010; 16:32-36. 22. Strupp M, Hupert D, Frenzel C, Wagner J, Hahn A, Jahn K, Zingler VC, Mansmann U, Brandt T. Long-term prophylactic treatment of attacks of vertigo in Menière's disease—comparison of a high with a low dosage of betahistine in an open trial. Acta Otolaryngol. 2008; 128(5):520-4. 23. Swartz R., Longwell P. Treatment of vertigo. // Am Fam Physician. 2005; 71:1115–1122. 24. Tighilet B, Leonard J, Lacour M. Betahistine dihydrochloride treatment facilitates vestibular compensation in the cat. J Vestib Res 1995; 5: 53-66. 25. Rebrova O.Yu. Statistical analysis of medical data. Application of the Statistica software package M., MediaSphere, 2002, 2003, 2006, 312 p. 26. Yunkerov V.I., Grigoriev S.G. Mathematical and statistical processing of medical research data. - St. Petersburg: Military Medical Academy, 2002. - 266 p. 27. Assessment of bioequivalence of medicines: Guidelines. Ministry of Health and Social Development of the Russian Federation, Federal Service for Surveillance in the Sphere of Health and Social Development, Federal State Institution Scientific Center for Expertise of Medical Products. - M., 2008. - 33 p.
Source:
Medical Council, No. 18, 2014
What is better to take for dizziness - Vestibo or Betaserc?
Betaserc is an original drug, so if the price doesn’t bother you, it’s better to take it. Vestibo is a copy, but a copy of a German manufacturer, so if you have limited funds, questions about quality should not arise either.
Betagistine is produced by a young Russian company, but I can’t say anything about the quality of its products.
Commercial names abroad (abroad) - Balanse, Betahirex, Evolis, Hiserk, Lectil, Lobione, Microser, Normini, Noverty, Serc, Vasomotal, Verhistine, Vertin, Vertiserc, Vertizox.
All drugs for the treatment of dizziness
All nootropics and drugs that improve cerebral circulation
All drugs used in neurology and psychiatry.
or leave a review about the medicine (please, do not forget to indicate the name of the drug in the text of the message) here.
Betahistine or Vestibo
Manufacturer: JSC SINTEZ (Russia)
Release form: tablets
Active ingredient: betahistine
Both drugs have the same active substance, mechanism of action and are produced by a domestic manufacturer. Used for dizziness of various etiologies. The difference between medications is in the composition of excipients and dosage. The structure of Vestibo contains crospovidone, which has the ability to remove endogenous toxins from the body, which is important in the treatment of inflammation. Vestibo will be more effective in stopping pathological processes.
Pharmacodynamics and pharmacokinetics
When taken orally, betahistine is quickly and almost completely absorbed from the gastrointestinal tract. After absorption, the drug is quickly and almost completely metabolized to form the inactive metabolite 2-pyridylacetic acid.
When taking the drug at a dose of 8-48 mg, about 85% of the initial dose is found in the urine in the form of 2-pyridylacetic acid. Excretion of betahistine by the kidneys or through the intestines is negligible. The rate of elimination remains constant with oral dosing of 8-48 mg of the drug, indicating linear pharmacokinetics of betahistine and suggesting that the metabolic pathway involved remains unsaturated.
Pharmacodynamics
The drug strengthens the H1 receptors of the vessels of the inner ear, and at the same time weakens the H3 receptors of the vestibular nuclei of the central nervous system.
This coordinated effect leads to:
- improving microcirculation and penetration of necessary substances into the capillaries;
- normalization of endolymph pressure in the labyrinth and cochlea;
- increased blood flow in the basilar artery;
- increased conductivity in neurons of the vestibular nuclei of the brain stem.
This affects the patient's well-being:
- instability of coordination manifests itself less frequently and less intensely;
- Noisy sensations in the ears are reduced;
- hearing capabilities increase.
Pharmacokinetics
When ingested, the drug dissolves easily in water. Betahistine hydrochloride is immediately released and absorbed in all parts of the gastrointestinal tract. This process slows down if you swallow the pills with food, but this does not change the effectiveness.
The substance accumulates maximum within 3 hours. Under the influence of metabolic reactions, Betahistine breaks down and 2-peridylacetic acid is formed, which leaves the body in the urine within 24 hours.
Contraindications to the use of BETASERC®
Betahistine is a synthetically produced substance similar to histamine. In 1970, it was registered in Europe for the treatment of Meniere's disease (a disease of the inner ear).
It is characterized by the following symptoms:
- attacks of deafness (each subsequent manifestation aggravates hearing problems);
- noise in ears;
- dizziness;
- imbalance;
- autonomic disorders.
Betahistine (reviews from patients who took the drug confirm its effectiveness) is also prescribed when diagnosed:
- vestibular neuritis;
- labyrinthitis;
- weakening of blood flow in the arteries;
- development of encephalopathy after severe injury;
- atherosclerosis.
The drug expands the source of blood vessels in the inner ear, improves blood movement.
Treatment with Betahistine is contraindicated in:
- pheochromocytoma (tumor of chromaffin cells in the adrenal glands);
- exacerbation of ulcerative lesions of the stomach and duodenum;
- carrying a child (possibly in urgent need);
- breastfeeding;
- bronchial asthma;
- allergic reactions to the components of the drug;
- lactose intolerance;
- Lactose deficiency or galactose malabsorption.
Meniere's syndrome, characterized by the following main symptoms:
- dizziness (accompanied by nausea, vomiting);
- hearing loss (hearing loss);
- noise in ears.
Symptomatic treatment of vestibular dizziness (vertigo).
- hypersensitivity to the components of the drug.
Betaserc® is not recommended for use in children and adolescents under 18 years of age due to insufficient data on efficacy and safety.
Vertran
Manufacturer: BELUPO, MEDICINES AND COSMETICS d. d. (Croatia)
Release form: tablets
Active ingredient: betahistine
Betahistine analogue 16 mg drug Vertran belongs to the histamine group. Having the ability to expand precapillaries and stimulate microcirculation in the labyrinth. The medication has a positive effect in the treatment of symptoms of dizziness of various origins, eliminates tinnitus, improves hearing if it is partially lost, and restores coordination of movements.
Overdose
The drug is prescribed orally during meals. The dose should be adjusted individually depending on the response to treatment.
For adults, the dose is 24-48 mg per day.
Betaserc® 8 mg - 1-2 tablets 3 times a day.
Betaserc® 16 mg - 1/2-1 tablet 3 times a day.
Betaserc® 24 mg - 1 tablet 2 times a day.
The 16 mg tablet and the 24 mg tablet can be divided into 2 equal parts. To do this, place the tablet on a hard surface with the ridge facing up and press it with your thumb.
Improvement is sometimes observed only after several weeks of treatment, and a stable therapeutic effect is observed after several months of treatment. There is evidence that administration of the drug at the onset of the disease prevents its progression and/or hearing loss in later stages.
In elderly patients, as well as in patients with renal and/or liver failure, no dose adjustment is required.
It is believed that the effect of betahistine on the ability to drive vehicles and other mechanisms is absent or insignificant, since during clinical studies associated with the use of betahistine, no effects potentially affecting this ability were detected.
There are several known cases of drug overdose.
Symptoms: after taking the drug in doses up to 640 mg, mild to moderate nausea, drowsiness, and abdominal pain are possible. More serious complications (convulsions, cardiopulmonary complications) have been observed with deliberate use of betahistine in higher doses, especially in combination with overdose of other drugs.
Treatment: symptomatic therapy.
When treated with Betahistine, patients need to be prepared to take the drug for a long time, but a decrease in symptoms occurs already at the beginning of therapy. The best results are felt after 2-3 months. To avoid deterioration or loss of hearing, it is necessary to start taking the medicine as soon as possible.
Treatment regimens are as follows:
- 8 mg - 1-2 tablets. three times a day;
- 16 mg - ½-1 tablet. 3 times;
- 24 mg - 1 tablet. in 2 doses.
The dosage is selected by the doctor, who takes into account the disease and condition of the patient. Do not exceed 48 mg of medication per day.
For dizziness
During dizziness, a person feels movement that is not actually happening (false). This symptom occurs due to problems in the inner ear. It is this organ that is responsible for balance in the body. The use of Betagistine helps to cope with dizziness of any origin (peripheral, central).
Processes occurring in the vestibular apparatus cause dizziness and nausea. The cause of violations is only external factors, and not the disease of the device itself
As a result:
- microcirculation in the basilar basin is improved;
- the movement of endolymph in the inner ear is restored;
- the function of nerve cells is activated;
- interneuron conduction improves.
Treatment tactics involve taking Betahistine three times (8 and 16 mg) or twice (24 mg) per day, which continues until a positive result is achieved.
For hearing loss
A decrease in auditory perception that appears due to damage to any part of the sound-receiving section of the auditory analyzer is called hearing loss.
The cause of the pathology is factors such as:
- diseases of the middle ear of an acute and chronic nature;
- acute infectious lesions;
- use of drugs that affect hearing;
- severe emotional shock;
- work related to noise and vibrations.
If hearing loss is not treated, the process begins to progress. The end result is hearing loss.
To stop the development of pathology, use the following steps:
- exclude provoking factors;
- use medications that restore microcirculation in the inner ear;
- start treatment as early as possible.
Betahistine is prescribed for a period of at least 3 months. The frequency of administration depends on the dose of the drug: 8 and 16 mg 3 times a day, 24 mg - 2 doses.
For noise in the ear
Noise in the ear is one of the symptoms characteristic of the development of hearing loss. It is a manifestation of pathological changes in any part of the auditory analyzer. Therefore, taking Betahistine according to the regimen prescribed for the treatment of a hearing problem, the patient simultaneously solves two problems. It is important to start treatment at the initial stage of the disease
The cause of dizziness in cervical osteochondrosis is a violation of blood flow in the vertebrobasilar system, which is formed from the arteries of the spine. It supplies blood to the posterior parts of the brain. This condition can also occur in young patients.
Betahistine changes the situation for the better. As a result of treatment, vestibular compensation occurs. Typically, the doctor uses the following prescription: take 24 mg of the drug twice a day for 3 months.
For headaches
In chronic cerebrovascular insufficiency (CCF), diseases develop in the vestibular regions, the main symptoms of which are pain in the head and loss of balance:
- vegetative-vascular paroxysms;
- vascular disorders (hypertension);
- atherosclerosis.
In patients with CNMK, the condition gradually worsens (from the first to the fourth stage).
During treatment the following drugs are prescribed:
- hypotensive;
- anti-sclerotic;
- improving cerebral blood flow;
- normalizing blood fluidity.
Betahistine has a complex effect, which improves blood supply to the brain and increases blood flow in the inner ear. Prescription of the drug: 24-48 mg per day in 2-3 doses until a positive result is obtained.
Clinical studies on volunteers revealed several cases of overdose after taking up to 640 mg of the drug per day.
The patients' condition was mild or moderate, which was expressed by the following symptoms:
- nausea;
- desire to lie down and sleep;
- abdominal pain.
When intentionally taking high doses of the drug, the following occur:
- convulsions;
- heart problems;
- pulmonary complications.
To get rid of intoxication, proceed as follows:
- wash the stomach;
- sorbents are prescribed (activated carbon, Enterosgel);
- use vitamins;
- restore microflora (preparations with bifidobacteria and lactobacilli, yogurt);
- cleanse the liver and kidneys.
Taking medication
Positive results appear in the first days after starting treatment with the drug. After two weeks of use, a stable therapeutic effect is recorded. When treated with betahistine for several months, the condition of patients with Meniere's syndrome improves significantly.
Understanding what betahistine is prescribed for, you need to know how to take the tablets. The dosage is prescribed individually by the doctor, taking into account the patient’s condition. The maximum daily dose is 48 mg. Taking tablets is indicated during meals. 2-3 times a day. The recommended course duration is 2 - 3 months. Sometimes periodic treatment is carried out.
Correction during treatment is usually not required. The effectiveness of the drug decreases when combined with other antihistamines. Betahistine does not have sedative properties, so there are no restrictions regarding driving a car during treatment. It is also allowed to work on various complex mechanisms without any restrictions.
Side effects
Betahistine (reviews from patients who took the drug indicate its good tolerability) in rare cases has a negative effect on the gastrointestinal tract.
This is expressed by the following symptoms:
- nausea;
- discomfort in the upper abdomen;
- bowel dysfunction;
- formation of gases.
Patients with sensitive skin may:
- rashes;
- itchy sensations;
- pale pink blisters (urticaria).
If you are hypersensitive to any component of the drug, swelling of the mucous membrane may begin.
During clinical trials
From the digestive system: during clinical studies, often (from {amp}gt;1/100 to {amp}lt;1/10 - nausea and dyspepsia.
During post-marketing use and based on scientific literature
From the digestive system: the available data is insufficient to estimate the frequency - vomiting, gastrointestinal pain, bloating. In general, these effects usually disappear after taking the drug with food or after reducing the dose.
Allergic reactions: the available data is insufficient to estimate the frequency of hypersensitivity reactions, incl. angioedema, urticaria, itching, rash, anaphylactic reaction.
special instructions
Betahistine (reviews from patients who took the drug warn of possible complications) has not been sufficiently studied, so taking the tablets is under the supervision of a doctor in the following cases:
- during pregnancy - treatment is possible if the potential threat to the mother outweighs the harm to the child;
- during breastfeeding - it is unknown whether the active substance passes into mother's milk or not;
- in the presence of a gastrointestinal ulcer in the medical history.
Betahistine does not cause a hypnotic effect, therefore it does not affect driving or other mechanisms. During therapy, it is necessary to refrain from drinking alcoholic beverages to avoid unexpected individual reactions.
No dosage adjustment of the drug is required:
- elderly patients;
- with renal failure;
- for liver problems.
The drug should be prescribed with caution to patients with a history of gastric or duodenal ulcers. During the period of use of the drug, patients with pheochromocytoma and bronchial asthma should be under medical supervision.
Drug interactions
In vivo studies aimed at studying interactions with other drugs have not been conducted.
These in vitro studies suggest the absence of inhibition of the activity of isoenzymes of the cytochrome P450 system in vivo.
The patient should tell the doctor if they are currently or recently taking any medications.
Betahistine (reviews from patients who took the drug warn about observing safety measures) is not prescribed in parallel with the following medications:
- antiallergic - reduce the effectiveness of Betahistine or an antihistamine;
- antidepressants - prevent the release of the active substance;
- Hydroxyzine and Selegiline inhibit the metabolism of betahistine.
Betahistine or Cinnarizine
Manufacturer: PFC JSC UPDATE (Russia)
Release form: tablets
Active ingredient: cinnarizine
The drug Cinnarizine is a calcium channel blocker that has a vasodilating effect that stimulates cerebral circulation and peripheral blood flow. Betahistine will be more effective for relieving vestibular disorders, since it acts directly on the endolymph system, and its analogue Cinnarizine only dilates blood vessels.
Use of BETASERC® during pregnancy and breastfeeding
There is insufficient data available on the use of betahistine in pregnant women. The potential risk to humans is unknown. The use of Betaserc® during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.
It is not known whether betahistine is excreted in breast milk. The drug should not be prescribed during breastfeeding. The question of prescribing Betaserc® to a mother should be taken only after comparing the benefits of breastfeeding with the potential risk for the infant.