Betaserc – indications, contraindications, dosage and side effects. How much does Betaserc cost?

Description of the drug Betaserc ® (Betaserc) Based on the package insert of the drug, approved by the manufacturer and prepared for the printed edition of the Vidal 2023 guide.

Update date: 2022.12.20

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Central nervous system diseases are usually very difficult to diagnose and treat. One of the preparations that is used in the case of disturbances in the functioning of the nervous center is Betaserc. This medicine is primarily used to combat the symptoms of Ménière’s disease, such as dizziness and tinnitus. How does Betaserc work and how should it be dosed? What are the contraindications to the use of this preparation and what side effects may occur? How much does a pack of Betaserk cost?

Betaserc – general characteristics of the drug

Betaserc is a prescription drug. It is a preparation used in the treatment of Meniere’s disease and in reducing symptomatic dizziness and tinnitus. Betaserc is available as 8 mg and 24 mg tablets. Betaserc is not reimbursed by the National Health Fund.

Meniere’s disease is otherwise idiopathic labyrinthine hydrocele. This is a condition that happens once in every 2000 people. The cause of Meniere’s disease there is excessive accumulation and growth of endolymph in the labyrinth. The main symptoms of Meniere’s disease there are dizziness, tinnitus, and progressive hearing loss. The disease was first described in 1861 by Prosper Meniere, a physician of French origin.

The manufacturer of the drug Betaserc is the Mylan concern, which was established in 1961. Mylan initially operated as a pharmaceutical wholesaler that supplied drugs to customers in smaller towns. Today, Mylan is a leader among pharmaceutical companies, and their products are available in 145 countries and territories.

If you want to know more about Meniere’s disease, find out the causes and symptoms of this ailment, read on: Meniere’s disease

Betaserc – composition and action of the drug

The most important ingredient of the drug Betaserc, i.e. the active substance, is betahistine dihydrochloride. Each tablet contains 8 mg or 24 mg of this ingredient.

Betahistine is an analog of histamine. It is a substance used primarily in the treatment of vertigo. The mechanism of action of betahistine has not been fully understood yet, but it can be generally characterized. Betahistine as an active substance acts on histamine receptors, thanks to which it strongly blocks H3 receptors, and at the same time weakly stimulates H2 receptors. On the other hand, in the case of H2 receptors, it does not show any significant affinity. This type of interaction causes betahistine to increase the secretion of histamine in the nerve endings.

It is also indicated that the active substance of Betaserk improves blood flow in the brain and improves the blood supply to the labyrinth, and also has a positive effect on the vestibular system.

The action of betahistine reduces the frequency and intensity of dizziness. Bothersome tinnitus is also reduced, especially if treatment is started relatively early.

It is also worth mentioning that animal studies have shown that the drug improves blood flow inside the striatum in the inner ear. Experts say it may be due to the dilatation of the precapillary vessels, which are part of the microcirculation within the inner ear. In addition, clinical trials among patients who used Betaserk have shown that betahistine significantly affects blood flow in the brain.

The patient should notice an improvement in his health after a few days of use, sometimes the effect is visible after a few weeks. However, the optimal effects of treatment are observed only after a few months of using Betaserc. Therefore, it is recommended to use Betaserk for about 2-3 months.

However, it is worth remembering that the drug Betaserk does not affect the progression of Meniere’s disease, and also does not eliminate the development of dizziness that requires surgery.

Auxiliary components of the drug Betaserk are:

  1. microcrystalline cellulose;
  2. mannitol;
  3. colloidal anhydrous silica;
  4. citric acid monohydrate;
  5. talk.

What is histamine and what is its role in the body? Check: Histamine – role, action, intolerance. Histamine and allergy

Betaserc – drug metabolism and absorption

The active substance of Betaserk, i.e. betahistine, is absorbed relatively quickly from the gastrointestinal tract. In turn, its maximum concentration in plasma occurs approximately one hour after taking the drug. Betahistine is slightly bound to plasma proteins. The biological half-life is about 4-5 hours. This substance is metabolized mainly into pyridylacetic acid. It is excreted from the body by the kidneys in the form of metabolites within about 24 hours.

How should the drugs be used? Check: How to take medications effectively?

Betaserc – indications for use

Betaserc is prescribed to patients whose doctor has diagnosed Meniere’s disease. This preparation does not fight the disease itself, but it reduces the symptoms that create it. Indications for the use of Betaserc are dizziness, nausea, vomiting, progressive hearing loss and tinnitus.

What are the causes of tinnitus? Read: Tinnitus

Betaserc – contraindications to use

Despite its effectiveness, Betahecon cannot be used by all patients who struggle with Meniere’s disease. A contraindication to the use of this preparation is primarily hypersensitivity to the active substance or any of the excipients of the drug. In addition, this drug must not be administered to patients who have previously been diagnosed with phaeochromocytoma.

Particular care should be taken when administering Betaserc in cases of bronchial asthma or gastric or duodenal ulcer disease.

Can I take expired medications? Check: Late drugs: work or harm?

Betaserc – dosage

Correct dosage is very important for the highest effectiveness of Betaserk. The drug should be used according to the doctor’s instructions. If you have any doubts, always consult your doctor or pharmacist.

Correct dosage for adults ranges from 24 mg to 48 mg of the drug in divided doses. The doctor will decide the correct dose depending on the patient’s response to the drug being administered. The improvement of the patient’s health may not occur until several weeks after the first application, and the best results in therapy are achieved only after several months of using Betaserc.

Betaserc should not be given to children and adolescents under 18 years of age, as no proper studies have yet been conducted to determine its effectiveness in this age group.

In the elderly, there is no need to change the dosage of the drug, although studies in this age group are very limited.

If you miss a scheduled dose, just take the next dose at the regular time. Do not use a double dose to make up for a forgotten dose.

What are the most common causes of vertigo? Check: Dizziness – causes, diagnosis and treatment of balance disorders

Betaserc – effects of overdose

To date, a few cases of overdosage with Betaserk have been reported. Symptoms of overdose there are nausea, drowsiness or abdominal pain. More serious symptoms of overdose such as convulsions, pulmonary and cardiac complications have also been observed in patients.

In the event of an overdose of Betaserk, routine supportive measures are recommended.

Over-the-counter drugs and precautions, read: Dangerous over-the-counter drugs

Betaserc – side effects

The use of Betaserk may induce the desired effects in patients, although it should be remembered that they do not always occur.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data). According to the above rules, when using Betaserk, the following side effects may occur:

  1. Common side effects (may affect up to 1 in 100 people): nausea, digestive disorders, headache;
  2. Not known (frequency cannot be estimated from the available data): mild gastrointestinal complaints, vomiting, gastrointestinal pain, flatulence or gas, skin and subcutaneous allergic reactions, angioedema, urticaria, rash and pruritus, hypersensitivity reactions e.g. anaphylaxis.

What should you know about allergic reactions to medications? Check: Drugs are also allergenic

Betaserc – how to store the drug?

Betaserc should be stored in a place where the temperature does not exceed 25 degrees Celsius. It is also worth making sure that this place is invisible and inaccessible to children.

Why is proper drug storage so important? Check: Medications that are stored wrongly are poisonous

Betaserc – interactions with other drugs

When consulting a doctor, always include information about all medications that are currently used. This includes prescription, over-the-counter, and herbal products.

In the case of Betahecon, it is very important to inform your doctor about the medications you are taking, as this preparation may interact with:

  1. monoamine oxidase inhibitors such as selegiline – these drugs may increase the effect of betahistine;
  2. antihistamines – they can reduce the effect of betahistine, and betahistine can also reduce the effect of antihistamines.

Which drugs should never be combined with each other? Check: Dangerous interactions

Betaserc and pregnancy and breastfeeding

The use of drugs during pregnancy or breastfeeding must always be preceded by a medical consultation. In the case of Betaserc, there are insufficient data and studies to indicate the effect of betahistine on the course of pregnancy. Animal studies are insufficient to conclusively establish the effects of the drug on pregnancy, embryofoetal development, parturition and postnatal development. Therefore, unless absolutely necessary, Betahecon should not be used during pregnancy.

A similar situation occurs in the case of breastfeeding women. It is not known whether betahistine passes into the milk of nursing mothers. Before a woman starts taking Betaserk, the benefits for the nursing woman and the possible risks to the baby should be analyzed.

What is worth remembering when taking medications during pregnancy? Read: Pregnancy and medications

Betaserc and alcohol consumption

So far, the use of Betahecon has not been shown to interact with alcohol. However, special care should be taken when consuming alcohol during treatment. It is also recommended to consult a doctor or pharmacist.

What drugs should not be combined with alcohol? Check: Eight drugs that are better not to be combined with alcohol

How much does Betaserc cost?

Betaserc is not reimbursed by the National Health Fund. The price of the drug Betaserc may differ depending on the town where the preparation will be purchased or the selected pharmacy. It can be estimated that, on average, you pay for the drug Betaserk:

  1. Betaserc tablets; 24 mg; 120 tablets – PLN 85-90;
  2. Betaserc tablets; 24 mg; 20 tablets – PLN 45-50;
  3. Betaserc tablets; 24 mg; 50 tablets – PLN 50-55;
  4. Betaserc tablets; 24 mg; 60 tablets – 51-56 zlotys;
  5. Betaserc tablets; 8 mg; 100 tablets – PLN 65-70;
  6. Betaserc tablets; 8 mg; 30 tablets – PLN 25-30.

What are drug substitutes and when to ask about them? Read: Swap when you can

Betaserc – other drugs with betahistine

Betaserc is not the only drug on the Polish pharmaceutical market that contains betahistine. This substance is also found in the following medicinal preparations:

  1. ApoBetina in tablets;
  2. Betahistine dihydrochloride Accord in tablets;
  3. Betahistine Bluefish in tablets;
  4. Betanil forte in tablets;
  5. Betaserc ODT in orodispersible tablets;
  6. Histigen in tablets;
  7. Lavistina in tablets;
  8. Polvertic in tablets;
  9. Verhist in tablets;
  10. Vertix 8 mg in tablets;
  11. Vertix 16 mg in tablets;
  12. Vertix 24 mg in tablets;
  13. Vestibo in tablets;
  14. Virtago in tablets.
Бетасерк: инструкция по применению, показания, аналоги

Release form, packaging and composition of the drug Betaserk ®

Tablets are round, biconvex, white or almost white, with beveled edges, scored on one side and engraved “289” on both sides of the score. The notch on the tablet is intended to break the tablet for ease of swallowing and is not intended to be divided into two equal doses.

1 tab.
betahistine dihydrochloride24 mg
 which corresponds to the content of betahistine15.63 mg

Excipients : microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal silicon dioxide, talc.

10 pieces. – blisters (5) – packs of cardboard.
15 pcs. – blisters (2) – packs of cardboard.
20 pcs. – blisters (1) – packs of cardboard.
20 pcs. – blisters (2) – packs of cardboard.
20 pcs. – blisters (3) – packs of cardboard.
20 pcs. – blisters (5) – packs of cardboard.
25 pcs. – blisters (1) – packs of cardboard.
25 pcs. – blisters (2) – packs of cardboard.
25 pcs. – blisters (4) – packs of cardboard.

pharmachologic effect

The mechanism of action of betahistine is only partially known. There are several possible hypotheses supported by preclinical and clinical data.

Influence on the histaminergic system

A partial agonist of histamine H 1 receptors and an antagonist of histamine H 3 receptors of the vestibular nuclei of the central nervous system, has little activity against H 2 receptors. Betahistine increases histamine metabolism and release by blocking presynaptic H 3 receptors and reducing the number of H 3 receptors.

Increased blood flow to the cochlear region, as well as the entire brain

According to preclinical studies, betahistine improves blood circulation in the vascular stria of the inner ear by relaxing the precapillary sphincters of the vessels of the inner ear. Betahistine has also been shown to increase cerebral blood flow in humans.

Facilitating the process of central vestibular compensation

Betahistine accelerates the recovery of vestibular function in animals after unilateral vestibular neurectomy, accelerating and facilitating central vestibular compensation due to antagonism with histamine H 3 receptors. Recovery time after vestibular neurectomy in humans is also reduced with betahistine treatment.

Excitation of neurons in the vestibular nuclei

Dose-dependently reduces the generation of action potentials in neurons of the lateral and medial vestibular nuclei.

Pharmacodynamic properties identified in animals provide a positive therapeutic effect of betahistine in the vestibular system.

Clinical efficacy and safety

The effectiveness of betahistine has been demonstrated in patients with vestibular vertigo and Meniere’s syndrome, which was manifested by a decrease in the severity and frequency of dizziness.

Preclinical safety data

Chronic toxicity

Adverse reactions from the nervous system have been observed in dogs and baboons after i.v. administration to dogs and baboons at doses of 120 mg/kg and above.

Chronic toxicity studies with betahistine dihydrochloride lasted 18 months in rats and 6 months in dogs. Administration of the drug to rats at a dose of 500 mg/kg and to dogs at a dose of 25 mg/kg did not lead to deviations in biochemical and hematological parameters and was not accompanied by histological changes. After increasing the dose to 300 mg/kg, vomiting was observed in dogs. According to the literature data in an experimental study, the administration of betahistine to rats at doses of 39 mg/kg and above for 6 months led to the appearance of hyperemia in some tissues. This publication contains a limited amount of data. In this regard, the significance of the observation described in the study is unclear.

Mutagenic and carcinogenic potential

Betahistine does not have mutagenic potential.

Specific studies of the carcinogenic effect of betahistine dihydrochloride have not been conducted. However, in studies of chronic toxicity of the drug in rats lasting 18 months, histopathological examination did not reveal signs of any tumors, neoplasms or hyperplasia. Therefore, in this study of limited duration (18 months), there was no evidence that betahistine dihydrochloride at doses up to 500 mg/kg has a carcinogenic potential.

Reproductive toxicity

Betahistine did not affect the fertility of male and female rats and was not teratogenic in rats and rabbits at doses up to 1000 mg/kg in rats and up to 75 mg/kg in rabbits. In a study of toxic effects on pre- and postnatal development in rats, when the drug was administered at a maternally toxic dose of 1000 mg, effects such as a decrease in body weight of the pups, a decrease in the number of litters, a decrease in the survival rate of animals of the F1 generation, and an increase in post-implantation losses in animals were observed. generation F1. Animals of the F1 generation from the groups of drug administration at doses of 300 and 1000 mg/kg showed a decrease in the average reaction force during the startle reflex test. The drug at a dose of 100 mg/kg had no effect on pre- and postnatal development. The significance of the changes observed with the introduction of the drug in high doses,

Pharmacokinetics

Suction

When taken orally, betahistine is rapidly and almost completely absorbed from the gastrointestinal tract. After absorption, the drug is rapidly and almost completely metabolized to form the 2-pyridylacetic acid metabolite. The plasma concentration of betahistine is very low. Thus, pharmacokinetic analyzes are based on the measurement of the concentration of the 2-pyridylacetic acid metabolite in plasma and urine. When taking the drug with food C max betahistine in the blood is lower than when taken on an empty stomach. However, the total absorption of betahistine is the same in both cases, indicating that food intake only slows down the absorption of betahistine.

Distribution

The binding of betahistine to plasma proteins is less than 5%.

Metabolism

After absorption, betahistine is rapidly and almost completely metabolized to form the 2-pyridylacetic acid metabolite (which has no pharmacological activity). C max 2-pyridylacetic acid in plasma (or urine) is achieved 1 hour after ingestion. T 1/2 approximately 3.5 hours.

breeding

2-pyridylacetic acid is rapidly excreted in the urine. When taking the drug at a dose of 8-48 mg, about 85% of the initial dose is found in the urine. Excretion of betahistine by the kidneys or through the intestines is negligible.

Linearity

The elimination rate remains constant at oral doses of 8-48 mg of the drug, indicating the linearity of the pharmacokinetics of betahistine, and suggests that the metabolic pathway involved remains unsaturated.

Indications for Betaserc ®

Meniere’s syndrome, characterized by the following main symptoms:

  • dizziness (accompanied by nausea/vomiting);
  • hearing loss (hard of hearing);
  • noise in ears.

Symptomatic treatment of vestibular vertigo (vertigo).

Dosing regimen

Inside, during meals.

The dose of the drug for adults is 48 mg of betahistine per day.

Betaserc ® 24 mg should be taken 1 tablet 2 times a day.

The tablet can be divided into two equal parts. To do this, place the tablet on a hard surface with the risk up and press it with your thumb.

The dose should be selected individually depending on the response to treatment.

Improvement is sometimes seen only after a few weeks of treatment. The best results are sometimes achieved after several months of treatment. There is evidence that early treatment prevents disease progression and/or hearing loss in later stages.

Betaserc ® is not recommended for use in children under the age of 18 due to insufficient data on efficacy and safety.

Despite the limited data from clinical studies, extensive post-registration experience suggests that dose adjustment in elderly patients is not required.

Special clinical studies in patients with renal and / or hepatic insufficiency have not been conducted, however, post-registration experience suggests that dose adjustment is not required in this group of patients.

Side effect

From the digestive system: often (from ≥1/100 to <1/10) – nausea and dyspepsia.

From the side of the nervous system: often (from ≥1/100 to <1/10) – headache.

In addition to these effects identified in clinical studies, the following undesirable effects have been reported in post-marketing use and in the scientific literature. The available data are insufficient to estimate their frequency.

From the immune system: hypersensitivity reaction, incl. anaphylactic reaction.

From the digestive system: moderate vomiting, gastrointestinal pain, bloating. These effects usually disappear after taking the drug at the same time as food or after dose reduction.

From the skin and subcutaneous tissues: angioedema, urticaria, itching, rash.

Contraindications for use

  • pheochromocytoma;
  • hypersensitivity to the components of the drug.

Betaserc ® is not recommended for use in children and adolescents under the age of 18 due to insufficient data on efficacy and safety.

With caution and under the close supervision of a physician, Betaserc ® should be prescribed to patients with bronchial asthma, gastric ulcer and / or duodenal ulcer.

Use during pregnancy and lactation

Pregnancy

There are insufficient data on the use of betahistine in pregnant women. Animal studies have shown no direct or indirect reproductive toxicity. Betahistine should not be used during pregnancy unless clearly necessary.

Lactation

It is not known whether betahistine is excreted in human breast milk. Betahistine is excreted in breast milk in rats. Animal studies have been limited to the use of the drug at very high doses. The question of prescribing the drug to the mother should be taken only after comparing the benefits of breastfeeding with the potential risk to the nursing child.

Fertility

In animal studies (rats) no effect on fertility was found.

Application for violations of liver function

Special clinical studies in patients with hepatic insufficiency have not been conducted, however, post-registration experience suggests that dose adjustment in this group of patients is not required.

Application for violations of kidney function

Special clinical studies in patients with renal insufficiency have not been conducted, however, post-registration experience suggests that dose adjustment in this group of patients is not required.

Use in children

The drug is not recommended for use in children and adolescents under the age of 18 due to insufficient data on efficacy and safety.

Use in elderly patients

Despite the limited data from clinical studies, extensive post-registration experience suggests that dose adjustment in elderly patients is not required.

special instructions

The notch on the tablet is intended to break the tablet to make it easier to swallow and is not intended to divide it into 2 equal doses.

Influence on the ability to drive vehicles and mechanisms

Betahistine does not affect or slightly affects the ability to drive vehicles and work with mechanisms; in clinical studies, adverse reactions that could affect such ability have not been identified.

Overdose

There are several cases of drug overdose.

Symptoms: mild to moderate nausea, drowsiness, abdominal pain were observed in some patients after taking the drug in doses up to 640 mg. More serious complications (convulsions, cardiopulmonary complications) have been observed with the deliberate intake of betahistine in higher doses, especially in combination with an overdose of other drugs.

Treatment: symptomatic therapy is recommended.

drug interaction

In vivo studies aimed at studying interactions with other drugs have not been conducted.

Based on in vitro data, it can be assumed that there is no inhibition of the activity of isoenzymes of the cytochrome P450 system in vivo.

In vitro data have shown inhibition of betahistine metabolism by drugs that inhibit MAO, including MAO subtype B (eg, selegiline). Caution should be exercised when prescribing betahistine and MAO inhibitors (including MAO-B).

Betahistine is a histamine analogue, the interaction of betahistine with histamine H 1 receptor blockers could theoretically affect the effectiveness of one of these drugs.

The patient should tell the doctor if they are taking any medications now or in the recent past.

Storage conditions of Betaserc ®

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C.

Shelf life of Betaserc ®

Shelf life – 3 years. Do not use after the expiry date stated on the packaging.

Implementation conditions

The drug is released by prescription.

RUS2252235 (v1.3)

Before use, read the leaflet, which contains indications, contraindications, data on side effects and dosage as well as information on the use of the medicinal product, or consult your doctor or pharmacist, as each drug used improperly is a threat to your life or health. Do you need a medical consultation or an e-prescription? Go to halodoctor.pl, where you will get online help – quickly, safely and without leaving your home.

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