VESTIBO

Active material: Betagistin
When ATH: N07CA01
CCF: Preparation, improving microcirculation maze, used with the pathology of the vestibular apparatus
ICD-10 codes (testimony): F07.2, G45.0, H81, H81.0, H81.1, H81.2, H93.0, I67.2, I69, R42
When CSF: 24.11.01.01
Manufacturer: ACTAVIS GROUP hf. (Iceland)

Pharmaceutical form, composition and packaging

Pills round, flat, with beveled edges, white or nearly white, с маркировкой “В8” с одной стороны.

Excipients: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, krospovydon, stearic acid, Purified water (is not contained in the finished product).

10 PC. – блистеры (3) – пачки картонные.

Pills round, flat, with beveled edges, white or nearly white, с маркировкой “В16” с одной стороны и риской с другой стороны.

Excipients: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, krospovydon, stearic acid, Purified water (is not contained in the finished product).

10 PC. – блистеры (3) – пачки картонные.

Pills from white to almost white, round, lenticular, scored on one side.

Excipients: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, krospovydon, stearic acid.

10 PC. – блистеры (3) – пачки картонные.

Pharmacological action

The synthetic analogue of histamine. He is a weak agonist of the histamine H₁-receptor antagonist and a fairly powerful histamine H₃-receptors. It has a vasodilating effect and histamine. Influences on cochlear blood flow and central vestibular system.

Effects of the drug include vasodilatation in the inner ear (indirectly through histamine H₃– и H₁-receptors), inhibitory effect on vestibular nuclei (through histamine H₃-receptors) and impulse activity ampullar receptors. By direct agonistic effects on the histamine H₁-blood vessels of the inner ear receptors and precapillary sphincters microvasculature, located in the vascular strip (vascular striae), as well as indirectly through the histamine H₃-receptors, improves microcirculation and capillary permeability of the inner ear, normalizes blood pressure, and the endolymph in the labyrinth of the cochlea, It increases blood flow in the basilar artery.

It has a strong central effect, As an antagonist of histamine H₃-nuclear receptors of the vestibular nerve. Normalizes polysynaptic conduction in the neurons of the vestibular nuclei at the level of the brain stem. Indirectly affecting the histamine H₃-receptors, increases in the brainstem serotonin, reduces the activity of the vestibular nuclei.

It promotes the elimination of infringements on the part of the vestibular, and cochlear apparatus: reduces the frequency and intensity of vertigo, reduces noise in the ears, helps improve hearing in cases of reduction.

Betahistine stimulate histamine H₁-receptors, however no sedative effect and does not cause drowsiness.

Pharmacokinetics

Absorption and distribution

After oral administration, betahistine dihydrochloride is rapidly absorbed from the gastrointestinal tract. C_max plasma achieved through 3 no. Plasma protein binding is low.

Deduction

T_1/2 is 3-4 no.

Almost completely excreted in urine as metabolites (2-pyridylacetic acid) during 24 no.

Testimony

- Edema of the labyrinth of the inner ear;

- Vestibular and labyrinth disorders, incl. dizziness, noise and ear pain, headache, nausea, vomiting, hearing loss;

- Vestibular neuritis;

- Laʙirintit;

- Benign positional vertigo (incl. after neurosurgical operations);

- Meniere's disease;

- Vertebrobasilar insufficiency, traumatic encephalopathy, cerebral atherosclerosis (in the complex therapy).

Dosage regimen

The drug in the tablets 8 mg should be prescribed by 1 tab. 2-4 times / day.

The drug in the tablets 16 mg should be prescribed by 1 tab. 2-4 times / day.

The drug in the tablets 24 mg should be prescribed by 1/2-1 tab. 2 times / day.

The maximum daily dose - 48 mg. Treatment long.

The tablets should be taken orally with meals, without chewing, drinking a small amount of liquid.

Side effect

From the digestive system: dyspepsia (nausea, vomiting).

Allergic reactions: skin rash, angioedema.

Contraindications

- Pheochromocytoma;

- Bronchial asthma;

- Gastric ulcer and duodenal ulcer in the acute phase;

- I trimester of pregnancy;

- Hypersensitivity to the drug.

FROM caution should be prescribed with gastric ulcer or duodenal ulcer history, in the II and III trimesters of pregnancy, as well as children.

Pregnancy and lactation

The drug is contraindicated for use in the I trimester of pregnancy.

Cautions

The therapeutic effect of the drug in some cases there is only a few months of starting treatment.

Overdose

Symptoms: headache, facial flushing, dizziness, tachycardia, decrease in blood pressure, bronchospasm.

Drug Interactions

Antihistamines while receiving reduce the effect of the drug Vestibo^®.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in a dry, protected from light, inaccessible to children at temperature not exceeding 25 ° C. Shelf life of the drug in tablet form 8 mg 16 mg - 3 year, in the form of tablets 24 mg - 2 year.