Betahistine-Teva 16mg 30 tablets — Made in Germany — Free Delivery
(Betahistine-Teva)
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Description Betahistine-Teva 16mg 30 tablets — Made in Germany — Free Delivery
Pharmacological properties
Pharmacodynamics. Betahistine dihydrochloride is a synthetic analogue of histamine for oral administration. The mechanism of action of betahistine has been studied only partially. there are several reliable hypotheses, which are supported by data from studies obtained in animals and with the participation of humans.
The effect of betahistine on the histaminergic system. It was found that betahistine partially exhibits agonistic activity against H1 receptors, as well as antagonistic activity against histamine H3 receptors in the nervous tissue and has little activity against histamine H2 receptors. Betahistine increases the metabolism and release of histamine by blocking presynaptic H3 receptors and inducing the process of decreasing the number of corresponding H3 receptors.
Effect on increasing blood flow to the cochlear zone, as well as to the entire brain. Pharmacological studies in animals have demonstrated an improvement in blood circulation in the vessels of the stria vascularis of the inner ear, possibly due to the relaxation of the precapillary sphincters in the microcirculation of the inner ear. Betahistine also causes an increase in cerebral blood flow in the human body.
Promoting vestibular compensation. Betahistine accelerates the restoration of vestibular function after unilateral neuroectomy in animals, accelerating and facilitating the process of vestibular compensation. This effect is achieved by increased metabolism and release of histamine and is realized as a result of H3 receptor antagonism. In humans, treatment with betahistine also decreased the recovery time of vestibular function after neurorectomy.
Influence on the activity of neurons in the vestibular nuclei. It was found that betahistine has a dose-dependent inhibitory effect on the generation of peak potentials in the neurons of the medial and lateral vestibular nuclei.
The pharmacodynamic properties of betahistine, as has been shown in animals, provide a positive therapeutic effect of the preparation on the vestibular system.
The effectiveness of betahistine has been shown in studies in patients with vestibular dizziness and Meniere's disease, which was manifested by a decrease in the severity and frequency of dizziness attacks.
Pharmacokinetics
Suction. When administered orally, betahistine is rapidly and almost completely absorbed in all parts of the gastrointestinal tract. After absorption, the preparation is rapidly and almost completely metabolized to form a metabolite of 2-pyridylacetic acid. The concentration of betahistine in blood plasma is very low. Therefore, all pharmacokinetic analyzes are performed by measuring the concentration of the 2-pyridylacetic acid metabolite in blood plasma and urine.
When taking the preparation with food, the Cmax of the preparation is lower than when taken on an empty stomach. In this case, the complete absorption of betahistine is identical in both cases, which indicates that food intake only slows down the absorption of the preparation.
Distribution. The proportion of betahistine, which binds to blood plasma proteins, is less than 5%.
Biotransformation. After absorption, betahistine is rapidly and almost completely metabolized to 2-pyridylacetic acid (which does not exhibit pharmacological activity). After taking betahistine inside, Cmax of 2-pyridylacetic acid in blood plasma and in urine is reached 1 hour after taking the preparation and decreases from T½, which is about 3.5 hours.
Excretion. 2-pyridylacetic acid is rapidly excreted in the urine. When taking the preparation at a dose of 8–48 mg, about 85% of the initial dose is determined in the urine. Excretion of betahistine by the kidneys or with feces is insignificant.
Linearity. The recovery rate remains constant with oral administration of 8–48 mg, which indicates the linearity of the pharmacokinetics of betahistine and suggests that the metabolic pathway involved is unsaturated.
Indications
Meyer disease and syndrome, characterized by three main symptoms:
- dizziness accompanied by nausea and vomiting;
- noise in ears;
- hearing loss (deafness).
Symptomatic treatment of vestibular vertigo of various origins.
Application
Apply internally. take with or after meals with plenty of fluids.
The daily dose for adults is 24-48 mg, evenly distributed over 2-3 doses.
Betahistin-Teva 8 mg: 1-2 tablets 3 times a day (morning, afternoon and evening).
Betahistin-Teva 16 mg: ½ – 1 tablet 3 times a day (morning, noon and evening).
Betahistin-Teva 24 mg: 1 tablet 2 times a day (morning and evening).
The dose is selected individually depending on the effect. A decrease in the severity of symptoms of the disease is sometimes observed only after 2-3 weeks of treatment. Optimal results are achieved when the preparation is taken for several months. There is evidence that prescribing treatment early in the disease prevents progression and / or later hearing loss.
Elderly patients. Although at the moment the results of clinical studies in this group of patients are limited, the wide experience of using betahistine in the post-registration period suggests that dose adjustment for this population is not required.
Patients with renal or hepatic impairment. In this group of patients, special clinical trials were not carried out, but in accordance with the experience of post-registration use of betahistine, dose adjustment is not required.
Contraindications
Hypersensitivity to any of the components of the preparation. Pheochromocytoma.
Side effects
The following adverse reactions were observed in patients with such a frequency: very often (≥1 / 10), often (≥1 / 100 to 1/10), infrequently (from ≥1 / 1000 to 1/100), rarely (from ≥1 / 10,000 to 1/1000), very rare (1/10,000), frequency unknown (cannot be determined from available data).
From the digestive system: often - nausea and dyspepsia.
From the nervous system: often - headache.
In addition to cases reported in clinical trials, the following side effects have been reported spontaneously during post-marketing use and are known from the scientific literature. The frequency cannot be determined from the available data, so it is classified as unknown.
Adverse reactions, the frequency of which is unknown.
From the immune system: hypersensitivity reactions, such as anaphylaxis.
From the gastrointestinal tract: complaints of minor indigestion (vomiting, gastrointestinal pain, bloating and flatulence). These side effects usually disappear when the preparation is taken with food or when the dose is reduced.
On the part of the skin and subcutaneous tissue: hypersensitivity reactions of the skin and subcutaneous fat were observed, in particular angioedema, rash, itching and urticaria.
Special instructions
Care should be taken to prescribe and carefully monitor the condition of patients with:
peptic ulcer of the stomach and duodenum (including a history);
BA.
The preparation contains lactose, so it should not be prescribed to patients with rare hereditary forms of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome.
Application during pregnancy or lactation. There are no data on the use of betahistine in pregnant women. Since reproductive toxicity studies in animals do not always allow assessing the possibility of toxic effects on pregnancy, embryo / fetal development, childbirth and postnatal development in humans, betahistine should be used only when there is an undeniable need.
The penetration of betahistine into breast milk has not been studied. The benefits of using the preparation for the mother should be weighed against the benefits of breastfeeding and the potential risk to the baby.
Children. Due to the lack of data on the safety and efficacy of the preparation, it is not recommended to prescribe it to children (under the age of 18).
The ability to influence the reaction rate when driving or working with other mechanisms. Betahistine is indicated for the treatment of Meniere's syndrome, which is characterized by a triad of main symptoms: dizziness, hearing loss, tinnitus, and also for the symptomatic treatment of vestibular vertigo. Both conditions can negatively affect the ability to drive and operate machinery. According to studies that studied the effect on the ability to drive a car and work with mechanisms, betahistine did not affect or had an insignificant effect on this ability.
Interactions
In vivo studies to study the interaction of betahistine with other preparations have not been conducted. the data of in vitro studies suggest that there is no inhibition of the activity of cytochrome p450 enzymes in vivo.
Data obtained in vitro indicate the inhibition of betahistine metabolism by preparations that inhibit MAO activity, including MAO subtype B (for example, selegiline). Betahistine and MAO inhibitors (including selective MAO B subtype) should be used with caution.
Betahistine dihydrochloride is a histamine analogue, the simultaneous use of histamine H1 receptor antagonists may affect the effectiveness of one of these preparations.
Overdose
There are several known cases of betahistine overdose. some patients experienced mild to moderate symptoms (nausea, drowsiness, abdominal pain) after taking the preparation at a dose of up to 640 mg. more serious complications (convulsions, cardiopulmonary complications) were noted with the deliberate intake of betahistine in high doses, especially in combination with an overdose of other preparations.
Treatment. Overdose treatment should include standard supportive measures.
Storage conditions
In its original packaging at a temperature not exceeding 25 ° c.
Tags: Betahistine
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