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

Excipients: lactose monohydrate (sugar milk) 43.00 mg, cellulose microcrystalline 23.50 mg, corn starch 10.00 mg, copovidone 9.00 mg, carboxymethyl starch sodium 5.0 mg, silicon colloidal dioxide 0.50 mg, magnesium stearate 1.00 mg.

1 tablet 16.00 contains:

active substance: betagistin dihydrochloride 16.00 mg.

Excipients: lactose monohydrate (milk sugar) 86.00 mg, cellulose microcrystalline 47.00 mg, corn starch 20.00 mg, copovidone 18.00 mg, sodium carboxymethyl starch 10,0 mg, silicon colloidal dioxide 1.00 mg, magnesium stearate 2.00 mg.

Description:

Tablets white or white with a cream color shade, flatcylinderwith a chamfer on both sides and a risk on one side.

Pharmacotherapeutic group:Histamine drug

ATX: & nbsp

N.07.C.A.01 Betagistin

Pharmacodynamics:

Betagistin acts mainly on histamine H₁ and H₃receptors of the inner ear and vestibular nuclei of the central nervous system. By direct agonistic effects on H₁receptors of the vessels of the inner ear, as well as indirectly on H₃-gistaminovye receptors of vestibular, nuclei central nervous system (CNS); improves microcirculation and permeability of capillaries, normalizes the pressure of the endolymph in the labyrinth and cochlea. At the same time betagistin increases blood flow in the basilar artery.

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).

Has a pronounced central effect, being an inhibitor of H₃receptors of the nuclei of the vestibular nerve. It dose-dependently reduces the generation of action potentials in the neurons of the lateral and medial vestibular nuclei.

It alleviates symptoms in Meniere's syndrome and vestibular dizziness.

A stable therapeutic effect occurs after 14 days.

Pharmacokinetics:

Absorbed quickly, the connection with plasma proteins is low.Time to reach the maximum concentration in the plasma (TC_mOh) 3 hours. 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 betagistin and demethylbetahistine by the kidneys is negligible. Only a small part of betagistin and its metabolites are excreted by the intestine.

Indications:

- Treatment of Ménière's syndrome characterized by dizziness (accompanied by nausea and vomiting), hearing loss and tinnitus;

- symptomatic treatment of vestibular vertigo (vertigo).

Contraindications:

- Hypersensitivity to any of the components of the drug;

- pregnancy and lactation (due to lack of data);

- childhood;

- lactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome.

Carefully:

Peptic ulcer of stomach or duodenum (including in anamnesis), pheochromocytoma, bronchial asthma.

These patients should be observed regularly during the treatment period.

Pregnancy and lactation:

There is insufficient data to assess the effects of the drug during pregnancy and lactation.In this regard, not recommended during pregnancy. For the duration of treatment it is necessary to stop breastfeeding.

Dosing and Administration:

Inside, with food.

Tablets 8 mg: 1-2 tablets 3 times a day.

Tablets 16 mg: ¹/₂-1 tablet 3 times a day.

Improvement is usually noted already at the beginning of therapy, a stable therapeutic effect occurs after two weeks of treatment and can onRaart.athe within a few months of treatment.

Treatment is long.

Duration of drug intake is selected indiein anddorally.

Side effects:

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

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

Allergic reactions: hypersensitivity, incl. anaphylactic reactions.

Overdose:

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

Treatment: symptomatic.

Interaction:

Cases of interaction or incompatibility with other drugs are unknown.

Special instructions:

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

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

Betagistin has no sedative effect and does not affect the ability to drive a car or engage in activities requiring rapidity of psychomotor reactions.

Form release / dosage:

Tablets, 8 mg and 16 mg.

Packaging:

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

For 10, 20, 30, 40, 50 or 100 tablets in cans of polyethylene terephthalate.

One jar or 1, 2, 3, 4, 5, 6, 8 or 10 contour squares, together with the instructions for use, are placed in a cardboard package (pack) of cardboard.

Storage conditions:

In a dry, the dark 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:LSR-008459/10

Date of registration:19.08.2010 / 16.01.2015

Expiration Date:Unlimited

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

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp24.01.2017

Illustrated instructions

Instructions

Betagistin (Betahistine)