Vestibo, tablets 16 mg 30 pcs
€7.13 €6.24
Pharmacotherapeutic group: Histamine drug
ATX code: N07CA01
Pharmacological properties
.Pharmacodynamics
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
Partial agonist of H1-histamine and antagonist of H3-histamine receptors of the vestibular nuclei of the central nervous system (CNS), with little activity against H2 receptors. Betahistine increases histamine metabolism and release by blocking presynaptic H3 receptors and decreasing H3 receptors.
Augment blood flow to the cochlear region as well as the entire brain
According to preclinical studies, betahistine improves blood flow in the inner ear vasculature by relaxing the precapillary sphincters of the inner ear vessels. Betahistine has also been shown to increase cerebral blood flow in humans.
Easing central vestibular compensation
Betahistine accelerates the recovery of vestibular function in animals after unilateral vestibular neurectomy by accelerating and facilitating central vestibular compensation through antagonism with H3-histamine receptors.
The recovery time after vestibular neurectomy in humans is also reduced with treatment with betahistine.
Anxiety 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 found in animals provide a positive therapeutic effect of betahistine in the vestibular system.
The efficacy of betahistine has been demonstrated in patients with vestibular vertigo and Meniere’s syndrome, as evidenced by a reduction in the severity and frequency of dizziness.
Pharmacokinetics
absorption
. When taken orally, betahistine is rapidly and almost completely absorbed in the gastrointestinal (GI) tract. After absorption, betahistine is rapidly and almost completely metabolized to form the metabolite 2-pyridylacetic acid. The plasma concentration of betahistine is very low. Thus, pharmacokinetic assays are based on measuring the concentration of the metabolite 2-pyridylacetic acid in plasma and urine.
When the drug is taken with food, the maximum concentration (Cmax) of 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 the absorption of betahistine.
Distribution
The binding of betahistine to plasma proteins is less than 5%.
Biotransformation
After absorption, betahistine is rapidly and almost completely metabolized to form the metabolite 2-pyridylacetic acid (which has no pharmacological activity). The maximum concentration (Cmax) of 2-pyridylacetic acid in blood plasma (or urine) is reached one hour after taking the drug. The elimination half-life (T1/2) is approximately 3.5 h.
Elimation
2-pyridylacetic acid is rapidly excreted in the urine. When the drug is taken at a dose of 8 to 48 mg, about 85% of the initial dose is detected in the urine. Excretion of betahistine by the kidneys or through the intestine is insignificant.
Linearity
The rate of excretion remains constant with oral administration of 8 – 48 mg of the drug, indicating linearity in the pharmacokinetics of betahistine, and suggesting that the metabolic pathway involved remains unsaturated.
Indications
Cerebral Circulatory Disorder, Meniere’s Disease, DizzinessMeniere’s Syndrome, characterized by the following main symptoms:
– vertigo (accompanied by nausea/vomiting);
– hearing loss (hearing loss);
– tinnitus;
Symptomatic treatment of vestibular vertigo (vertigo).
Active ingredient
Betahistine
Composition
1 8 mg tablet contains:
the active ingredient: betahistine dihydrochloride 8.0 mg;
excipients: povidone K90 2.0 mg, microcrystalline cellulose (Vivapur 101) 33.0 mg, lactose monohydrate 70.0 mg, colloidal silicon dioxide 2.5 mg, crospovidone 6.0 mg, stearic acid 4.5 mg.
1 16 mg tablet contains:
the active ingredient: betahistine dihydrochloride 16.0 mg;
excipients: povidone K90 4.0 mg, microcrystalline cellulose (Vivapur 101) 66.0 mg, lactose monohydrate 140.0 mg, colloidal silicon dioxide 5.0 mg, crospovidone 12.0 mg, stearic acid 9.0 mg.
How to take, the dosage
Ingestion, with meals.
The dose of the drug for adults is 24 – 48 mg of betahistine per day.
Vestibo 8 mg
The 8 mg dosage should be taken 1 to 2 tablets 3 times daily.
Vestibo 16 mg
. The 16 mg dose should be taken in ⅟ 2 – 1 tablet 3 times a day. The 16 mg tablet can be divided into two equal parts.
The dose of the drug should be adjusted individually depending on the response to treatment.
Sometimes improvement is seen only after a few weeks of treatment. Sometimes the best results are seen after a few months of treatment. There is evidence that early treatment prevents progression and/or hearing loss in later stages of the disease.
Elderly age
Despite limited clinical trial data, extensive post-registration experience suggests that dose adjustment in this patient group is not necessary.
Patients with renal/hepatic impairment
Special clinical studies have not been performed in this patient group, but post-registration experience suggests that no dose adjustment is necessary in this patient group.
Always take the drug as prescribed by your doctor. If you have any questions, you should talk to your doctor.
Interaction
If you are currently or have recently taken other medicinal products, including without a prescription, please inform your attending physician.
In vivo studies to study the interaction with other medicinal products have not been conducted. Based on in vitro data, it can be assumed that there is no inhibition of cytochrome P450 isoenzyme activity in vivo.
In vitro data showed inhibition of betahistine metabolism by drugs that inhibit monoamine oxidase (MAO), including MAO subtype B (such as selegiline). Caution should be exercised when concomitant administration of betahistine and MAOI inhibitors (including MAO subtype B).
Betahistine is a histamine analog, the interaction of betahistine with H1-histamine receptor blockers could theoretically affect the effectiveness of one of these drugs.
Special Instructions
Influence on driving and operating machinery
Betahistine has no or negligible effect on driving and operating machinery, no adverse reactions that could affect such ability have been identified in clinical trials.
Synopsis
Tablets with dosage of 8 mg: round flat tablets with beveled edges, white or almost white, marked “B 8” on one side.
Tablets with a dosage of 16 mg: round flat tablets with beveled edges, white or nearly white, marked “B 16” on one side and a groove on the other side.
Contraindications
– hypersensitivity to any of the drug components;
– pheochromocytoma;
Betahistine is not recommended for use in children under 18 years of age due to insufficient data on efficacy and safety.
The drug contains an adjuvant – lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or glucose-galactose malabsorption should not use it.
Caution
Patients with bronchial asthma, peptic ulcer disease and/or duodenal disease require close monitoring during treatment.
Side effects
According to the World Health Organization (WHO) classification, all reactions are categorized by organ system and frequency of occurrence: Very frequent (> 1/10); frequent (> 1/100, < 1/10); infrequent (> 1/1000, < 1/100); rare (> 1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (cannot be determined from available data).
Nervous system disorders:
frequent: headache.
Gastrointestinal (GI) disorders:
frequent: nausea and dyspepsia.
In addition to the above adverse effects identified in clinical studies, the following adverse effects have been reported during post-registration use and in the scientific literature. There is insufficient data available to estimate their frequency.
Immune system disorders:hypersensitivity reactions, including anaphylactic reactions.
Gastrointestinal (GI) disorders:moderate disorders such as vomiting, gastrointestinal pain, bloating. These effects usually disappear after taking the drug simultaneously with food or after reducing the dose.
Skin and subcutaneous tissue disorders:
Hypersensitivity reactions, especially angioedema, urticaria, skin itching, and rash.
If you notice any side effects not mentioned in these instructions, or if any side effect is serious, please notify your doctor.
Overdose
Several cases of drug overdose are known. Mild to moderate symptoms (nausea, drowsiness, abdominal pain) have been observed in some patients after taking the drug in doses up to 640 mg. More serious complications (seizures, cardiopulmonary complications) were observed when deliberately taking high doses of betahistine, especially in combination with overdose of other drugs.
Symptomatic treatment is recommended.
Pregnancy use
Pregnancy
There is insufficient data available 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.
Breastfeeding
It is not known whether betahistine is excreted with breast milk in humans. Betahistine is excreted with breast milk in rats. Animal studies have been limited to the use of the drug at very high doses. Administration of the drug to the mother should be considered only after weighing the benefits of breastfeeding against the potential risks to the infant.
Fertility
No effect on fertility was found in animal studies (rats).
Similarities
Betaserk, Vestibo, Betahistine, Betahistine NW, Tagista, Vertran
Weight | 0.019 kg |
---|---|
Shelf life | 3 years. Do not use after the expiration date. |
Conditions of storage | At the temperature not more than 25 ° C. Keep out of reach of children! |
Manufacturer | Catalent Germani Schorndorf GmbH, Germany |
Medication form | pills |
Brand | Catalent Germani Schorndorf GmbH |
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