Betagistin - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate (sugar milk) - 129.0 mg; cellulose microcrystalline - 70.5 mg; corn starch - 30.0 mg; Copovidone - 27,0 mg; sodium carboxymethyl starch - 15.0 mg; silicon dioxide colloidal - 1.5 mg; magnesium stearate - 3.0 mg.

Description:

Round tablets white or white with a cream shade of color of flat-cylindrical shape, with a facet from both sides and risk from one side.

Pharmacotherapeutic group:Histamine drug

ATX: & nbsp

N.07.C.A.01 Betagistin

Pharmacodynamics:

The agonist of H1-histamine receptors of the inner ear vessels and the antagonist of H3-histamine receptors of the vestibular nuclei of the central nervous system (CNS). By relaxing precapillary sphincters of the vessels of the inner ear improves blood circulation in the vascular stria of the inner ear.

It dose-dependently reduces the generation of action potentials in the neurons of the lateral and medial vestibular nuclei.

Accelerates the recovery of the vestibular function after unilateral vestibular neurectomy, speeding up and facilitating central vestibular compensation (due to antagonism with H3-histamine receptors).

It alleviates symptoms in Meniere's syndrome and vestibular vertigo (vertigo).

A stable therapeutic effect occurs after 14 days.

Pharmacokinetics:

It is absorbed quickly, communication with plasma proteins is less than 5%. Time to reach the maximum concentration in the blood plasma (TCmax) - 1h.

Metabolized to inactive metabolites: 2-pyridylacetic acid (the main metabolite) and demethylbetahistine. 85-90% is excreted by the kidneys in the form of 2-pyridylacetic acid for 24 hours. The excretion of betahistine and demethylbetahistine by the kidneys is negligible. Only a small part of betagistin and its metabolites are excreted by the intestine. When taking the drug with food, the maximum concentration of betahistin is lower than when taken on an empty stomach. However, the total absorption of betahistin is the same in both cases, indicating that eating only slows the absorption of betahistine.

Indications:

Treatment for Ménière's syndrome, characterized by dizziness (accompanied by nausea and vomiting), hearing loss and noise in the ears.

Symptomatic treatment of vestibular vertigo.

Contraindications:

Hypersensitivity to the components of the drug, pregnancy, lactation, children under 18, pheochromocytoma, lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Carefully:Stomach ulcer or 12 duodenal ulcer (in the anamnesis), bronchial asthma.

Dosing and Administration:

Inside, with food, 1 tablet (24 mg) 2 times a day. Treatment is long. The course of treatment is determined individually. Correction of the dose in the elderly is not required.

Side effects:

From the digestive system: nausea, dyspepsia, vomiting, abdominal pain, bloating.

Allergic reactions: hypersensitivity, incl. anaphylactic reactions.

From the skin: angioedema, hives, itching, rash.

From the nervous system: headache.

Overdose:

Symptoms: nausea, abdominal pain, drowsiness (when taken in a dose of up to 640 mg); convulsions,cardiopulmonary complications (if taken in a dose of more than 640 mg or in combination with other drugs).

Treatment: symptomatic.

Interaction:

The interaction of betahistine with H1-histamine receptor blockers with simultaneous application can theoretically affect the effectiveness of one of these agents.

Special instructions:

The therapeutic effect in a number of cases increases within a few months from the start of treatment.

Effect on the ability to drive transp. cf. and fur:

Influence is absent or insignificant.

Form release / dosage:Tablets 24 mg.

Packaging:

For 10, 20, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 10, 20, 30, 40, 50 or 100 tablets in cans of polymeric for medicines.

One jar or 1, 2, 3, 4, 5, 6, 8 or 10 contour mesh packages together with the instruction for use are placed in a cardboard box

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001656

Date of registration:17.04.2012 / 17.05.2013

Expiration Date:Unlimited

Date of cancellation:2017-04-17

The owner of the registration certificate:OZONE, LLC OZONE, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp24.01.2017

Illustrated instructions

Instructions

Betagistin (Betahistine)