Instruction for use: Vestibo

Dosage form: tablets

Active substance: Betahistine*

ATX

N07CA01 Betahistine

Pharmacological groups:

Histamine preparation [Angioprotectors and microcirculation correctors]

Histamine preparation [Histaminomimetics]

The nosological classification (ICD-10)

F07.2 Post-contusion syndrome: Post-traumatic encephalopathy; Postcommentary syndrome

G45.0 Vertebrobasilar arterial system syndrome: Vertebral-basilar insufficiency; Syndrome of the vertebral artery; Benign positional dizziness; Benign positional dizziness after neurosurgical operations

G58.8 Other specified types of mononeuropathy

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

H81.4 Vertigo of central origin: Vertigo labyrinthine origin; vestibular vertigo; Vertigo of vascular origin

H83.0 Labyrinthite: Otogenic labyrinthite; Labyrinthitis purulent; Dropsy of the labyrinth of the inner ear

H91 Other hearing loss: Age-related vascular hearing loss; Age-related vascular drop in hearing; Age-related hearing impairment; Idiopathic hearing loss; Decreased acuity of hearing; Hearing loss; Deteriorating hearing of vascular or toxic origin; Perceptual hearing loss

H93.1 Tinnitus (subjective): Tinnitus; kohleovestibulyarny disorder; Cochle-vestibular disorders ischemic nature; tinnitus

I67.2 Cerebral atherosclerosis: Atherosclerosis of the arteries of the brain; Atherosclerosis of cerebral vessels; Atherosclerotic changes in cerebral vessels; Vascular diseases of the brain; Sclerotic ischemic attacks; Sclerosis of cerebral vessels

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 8 mg; 16 mg; 24 mg

Auxiliary substances: povidone K90; MCC; Lactose monohydrate; Silicon dioxide colloid; Crospovidone; Stearic acid; Purified water (not contained in the finished product)

In the blister 10 pcs .; In a pack of cardboard 3 blisters.

Description of dosage form

Tablets 8 mg: round flat tablets with beveled edges, white or almost white, marked "B 8" on one side.

Tablets 16 mg: round flat tablets with bevelled edges, white or almost white, marked "B 16" on the one side and risk on the other side.

Tablets 24 mg: round biconvex tablets, white or almost white, with a risk on one side.

Characteristic

Synthetic analog of histamine.

Pharmachologic effect

Mode action - vasodilating, histamine-like.

Pharmacodynamics

It is a weak H1 receptor agonist and a rather potent antagonist of H3 receptors. Affects the cochlear blood flow and the central vestibular apparatus. Action of betahistine comprising: vasodilation in the inner ear (indirectly through H3- and H1-receptors), inhibitory effect on the vestibular nuclei (via H3-receptors) and impulse activity ampullar receptors. By direct agonistic effects on H1-receptors receptacles inner ear and precapillary sphincters microvasculature disposed in the vascular strip (stria vascularis), as well as indirectly via the H3-receptors improves microcirculation and capillary permeability normalizes endolymph pressure in the labyrinth and the cochlea, increases blood flow in the Basilar artery. Has a pronounced central effect, as H3-receptor antagonist vestibular nerve nuclei, normalises neuronal transmission in the vestibular nuclei polysynaptic neurons at the level of the brainstem. Mediating indirectly on H3 receptors, it increases the serotonin content in the brain stem, which reduces the activity of the vestibular nuclei. Promotes elimination of violations from both the vestibular and cochlear system: reduces the frequency and intensity of vertigo, reduces noise in the ears, it helps to improve hearing in cases of loss. Stimulates H1-receptors, so it does not have a sedative effect and does not cause drowsiness.

Pharmacokinetics

Absorbed quickly, binding to plasma proteins is low. Cmax -. 3 hrs almost completely excreted by the kidneys as a metabolite of (2-pyridylacetic acid) for 24 hrs T1 / 2 -. 4.3 hours.

Indications of the Vestibo

Edema of the labyrinth of the inner ear;

Vestibular and labyrinthine disturbances: dizziness, noise and pain in the ears, headache, nausea, vomiting, hearing loss; vestibular neuritis, labyrinthitis, benign positional vertigo (including after neurosurgical operations), Meniere's disease.

As part of complex therapy:

Vertebrobasilar insufficiency;

Post-traumatic encephalopathy;

Atherosclerosis of cerebral vessels.

Contraindications

Hypersensitivity;

Pheochromocytoma;

bronchial asthma;

Peptic ulcer of the stomach and duodenum in the phase of exacerbation;

Pregnancy (I trimester).

Carefully:

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

Pregnancy (II-III trimester);

childhood.

Side effects

Dyspepsia (nausea, vomiting), skin rash, angioedema.

Interaction

Antihistamines reduce the effect.

Dosing and Administration

Inside, with food, not liquid, squeezed a small amount of liquid.

Tablets with a dosage of 8 and 16 mg: 8-16 mg 2-4 times a day. Treatment is long.

Tablets with a dosage of 24 mg: 1 / 2-1 table. 2 times a day. The maximum daily dose is 48 mg.

Overdose

Symptoms: headache, hyperemia of the face, dizziness, tachycardia, decreased blood pressure, bronchospasm.

Special instructions

Therapeutic effect in a number of cases appears only a few months after the start of treatment.

Storage conditions of the drug Vestibo

In a 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 Vestibo

Tablets 8 mg - 3 years.

Tablets 8 mg - 3 years.

Tablets 16 mg - 3 years.

Tablets 16 mg - 3 years.

Tablets 24 mg - 2 years.

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