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, labeled “AT 8” one side.
| 1 tab. | |
| betagistina digidrohlorid | 8 mg |
Excipients: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, krospovydon, stearic acid, Purified water (is not contained in the finished product).
10 PC. – blisters (3) – packs cardboard.
Pills round, flat, with beveled edges, white or nearly white, labeled “B16” on one side and scored on the other side.
| 1 tab. | |
| betagistina digidrohlorid | 16 mg |
Excipients: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, krospovydon, stearic acid, Purified water (is not contained in the finished product).
10 PC. – blisters (3) – packs cardboard.
Pills from white to almost white, round, lenticular, scored on one side.
| 1 tab. | |
| betagistina digidrohlorid | 24 mg |
Excipients: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, krospovydon, stearic acid.
10 PC. – blisters (3) – packs cardboard.
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– and 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. Cmax plasma achieved through 3 no. Plasma protein binding is low.
Deduction
T1/2 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.
