Instruction for use: Betahistine

Dosage form: tablets

Active substance: Betahistine*

ATX

N07CA01 Betahistine

Pharmacological groups:

Angioprotectors and microcirculatory correctors

Histaminomimetics

The nosological classification (ICD-10)

H81.0 Meniere's disease: Meniere's syndrome/ disease; Meniere's disease; Meniere's syndrome; Labyrinth dropsy; endolymphatic hydrops

H81.9 Unspecified Violation of vestibular function: Labyrinth, vestibular disorders; Labyrinth disorders; vestibular nystagmus; kohleovestibulyarny disorder; Kohleovestibulyarny syndrome vascular origin; Violation of the microcirculation in the maze; Ischemic disorders of hearing and balance

H83.3 Noise in the inner ear: Noise in the ears; Idiopathic tinnitus

H91.9 Hearing loss, unspecified: Hearing loss; Hearing Impairment; Hearing loss; Cochleovestibular disorder; Cohleo-vestibular disorder of ischemic nature; Hearing impairment; Sudden Deafness; Hearing impairment of vascular genesis; Hearing loss age; Ischemic impairment of hearing and balance; The phenomenon of accelerated growth of loudness (FUNG)

R11 Nausea and vomiting: Postoperative vomiting; Nausea; Vomiting; Vomiting in the postoperative period; Vomiting medication; Vomiting in the background of radiation therapy; Vomiting uncontrollable; Vomiting in radiation therapy; Persistent vomiting; Indomitable vomiting; Postoperative nausea; Vomiting with chemotherapy; Vomiting of the central genesis; Vomiting with cytotoxic chemotherapy; Persistent hiccups; Repeated vomiting

R42 Dizziness and disturbance stability: vertigo; Dizziness; Dizziness and nausea during travel on transport; disorders of balance; vestibular disorders; disequilibrium; Ischemic disorders of hearing and balance

R51 Headache: pain in the head; cephalgia; Pain in sinusitis; Pain in the neck; Pain headache; Headache vasomotor origin; Headache vasomotor origin; Headache with vasomotor disturbances; Headache; Neurological Headache; Continuous headache

Composition and release form

Tablets - 1 table.

Betahistine dihydrochloride 16 mg

Auxiliary substances: MCC; Lactose (milk sugar); Citric acid monohydrate; Silicon dioxide colloid (aerosil); Crospovidone; talc; Magnesium stearate

In contour blister packing 10 pcs .; In a pack of cardboard 2, 3 or 5 packages.

Description of dosage form

Tablets are white or almost white, round biconvex, with a risk on one side.

Pharmachologic effect

Mode action - improving microcirculation, histaminergic.

Pharmacodynamics

The H1 receptor agonist of the inner ear receptacles and the antagonist of H3 receptors of the vestibular CNS nuclei. By direct agonistic action on the H1 receptors of the vessels of the inner ear, and also indirectly through the effect on the H3 receptors improves microcirculation and permeability of capillaries, normalizes the pressure of the endolymph in the labyrinth and cochlea, increases blood flow in the basilar artery.

Has a pronounced central effect, being an inhibitor of the H3 receptors of the nuclei of the vestibular nerve. Improves the conductivity in the neurons of the vestibular nuclei at the level of the brainstem.

Clinical manifestation of these properties is a decrease in the frequency and intensity of dizziness, a decrease in noise in the ears, and improvement in hearing in the event of a decrease in it.

Pharmacokinetics

Absorbed quickly, binding to plasma proteins is low. The time required to achieve Cmax is 3 hours.

It is almost completely excreted by the kidneys in the form of a metabolite (2-pyridylacetic acid) for 24 hours. T1 / 2 3-4 h.

Indications for Betahistine

Treatment and prevention of vestibular vertigo of various etiologies;

Syndromes including dizziness and headache, tinnitus, progressive hearing loss, nausea, vomiting;

Disease and Meniere's syndrome.

Contraindications

Hypersensitivity to any of the components of the drug;

Lactose intolerance;

Deficiency of lactase or glucose-galactose malabsorption;

Age to 18 years;

pregnancy;

Lactation period.

Carefully:

Peptic ulcer of stomach and duodenum (in the anamnesis);

Pheochromocytoma;

bronchial asthma.

These patients should be observed regularly during the treatment period.

Application in pregnancy and breastfeeding

There is insufficient data to assess the effect of the drug during pregnancy and lactation. In this regard, contraindicated in pregnancy. For the duration of treatment it is necessary to stop breastfeeding.

Side effects

Gastrointestinal disorders, allergic reactions from the skin (skin rash, itching, urticaria), Quincke's edema.

Interaction

Cases of interaction or incompatibility with other drugs are unknown.

Dosing and Administration

Inside, with food, 1 / 2-1 table. 3 times a day.

Improvement is usually noted already at the beginning of therapy, a stable therapeutic effect occurs after 2 weeks of treatment and may increase over several months of treatment. Treatment is long. The course of treatment is determined individually.

Overdose

Symptoms: nausea, vomiting, convulsions.

Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.

Special instructions

Betahistine does not have a sedative effect and does not affect the ability to drive a car or engage in activities requiring rapidity of psychomotor reactions.

Conditions of leave from pharmacies

On prescription.

Storage conditions of the drug Betahistine

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Betahistine

2 years.

Do not use after the expiry date printed on the package.