Composition
Active ingredient-betahistine dihydrochloride.
Auxiliary substances:
microcrystalline cellulose;
lactose (milk sugar);
citric acid;
colloidal silicon dioxide (aerosil);
talc;
magnesium stearate;
sodium lauryl sulfate;
starch 1500 (pregelatinized starch).
Description:
tablets of 16 mg are white or almost white in color, flat-cylindrical in shape, with a chamfer and risk.
Pharmacological action
Pharmacotherapeutic group:
histamine preparation.
ATX code: [N07CA01].
Pharmacodynamics :
Betahistine acts mainly on histamine H1-and H3-receptors of the inner ear and vestibular nuclei of the central nervous system. By direct agonistic action on the H1-receptors of the inner ear vessels, as well as indirectly through exposure to H3-receptors, it improves microcirculation and capillary permeability, normalizes endolymph pressure in the labyrinth and cochlea. At the same time, betahistine increases blood flow in the basilar artery.
It has a pronounced central effect, being an inhibitor of H3 – receptors of the vestibular nerve nuclei. Improves conduction in neurons of the vestibular nuclei at the level of the brain stem. The clinical manifestation of these properties is a decrease in the frequency and intensity of dizziness, a decrease in tinnitus, and an improvement in hearing in the case of its decrease.
Pharmacokinetics: Â
It is absorbed quickly, and the binding to plasma proteins is low. Maximum concentration in blood plasma after 3 hours. The elimination half-life is 3-4 hours. It is almost completely excreted by the kidneys as a metabolite (2-peridylacetic acid) within 24 hours.
Indications
- treatment and prevention of vestibular vertigo of various origins;
- syndromes including dizziness and headache, tinnitus, progressive hearing loss, nausea and vomiting;
- Meniere’s disease or syndrome.
Contraindications
-hypersensitivity to any of the components of the drug, children under 18 years of age (due to lack of data), pregnancy and lactation (due to lack of data);
With caution: peptic ulcer of the stomach or duodenum 12 (including in the anamnesis), pheochromocytoma, bronchial asthma. These patients should be monitored regularly during treatment;
– pregnancy and lactation.
There is insufficient data to assess the effects of the drug during pregnancy and lactation. In this regard, it is not recommended to take it during pregnancy. Breast-feeding should be discontinued for the duration of treatment.
Side effects
Gastrointestinal disorders, the appearance of hypersensitivity reactions from the skin (rash, itching, urticaria), angioedema.
Interaction
Interactions or incompatibilities with other medicinal products are unknown.
How to take, course of use and dosage
Inside, while eating. 1/2-1 tablet 3 times / day.
Improvement is usually noted at the beginning of therapy.
A stable therapeutic effect occurs after two weeks of treatment and may increase over several months of treatment.
Long-term treatment. The duration of taking the drug is selected individually.
Overdose
Symptoms: nausea, vomiting, convulsions.
Treatment: gastric lavage, taking activated charcoal, symptomatic therapy.
Special instructions
Influence on the ability to drive a car and other mechanisms. Betahistine has no sedative effect and does not affect the ability to drive a car or engage in activities that require rapid psychomotor reactions.
Form of production
Tablets
Storage conditions
List B. In a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of reach of children.
Shelf
life is 5 years. Do not use after the expiration date.
Active ingredient
Betahistine
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
For adults as prescribed by a doctor, For adults
Indications
Cerebrovascular accident, Meniere ‘s Disease
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Side effects of Betahistine-SZ, Tablet 16mg, 60pcs.
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