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

Excipients: cellulose microcrystalline 68 mg, lactose monohydrate 50 mg, crosspovidone 7.0 mg, magnesium stearate 1.4 mg, povidone 4.2 mg, silicon dioxide colloid (aerosil) 1.4 mg.

1 tablet with a dosage of 16 mg contains:

active substance: Betagistin dihydrochloride-16 mg.

Excipients: cellulose microcrystalline 109 mg, lactose monohydrate 100 mg, crosspovidone 12.5 mg, magnesium stearate 2.5 mg, povidone 7.5 mg, silicon dioxide colloid (aerosil) 2.5 mg.

1 tablet with a dosage of 24 mg contains:

active substance: Betahistine dihydrochloride 24 mg Excipients: cellulose microcrystalline 101 mg, lactose monohydrate 100 mg, crosspovidone 12.5 mg, magnesium stearate 2.5 mg, povidone 7.5 mg, silicon dioxide colloid (aerosil) 2.5 mg.

Description:

Dosage of 8 mg: Tablets are white or almost white in color. round, biconvex form.

Dosage of 16 mg: Tablets of white or almost white color, flat-cylindrical shape with a facet and a risk.

Dosage of 24 mg: Tablets of white or almost white color, flat-cylindrical shape with a facet and a risk.

Pharmacotherapeutic group:Histamine is a drug.

ATX: & nbsp

N.07.C.A.01 Betagistin

Pharmacodynamics:

Agonist H1-histamine receptors of the inner ear vessels and antagonist of H3-histamine receptors of the vestibular CNS nuclei. 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 dizziness.

A stable therapeutic effect occurs after 14 days.

Pharmacokinetics:

Absorbed quickly, communication with plasma proteins - less 5%. The maximum concentration in the blood plasma after 3 hours. Half-life after 3-4 hours.

Metabolized to inactive metabolites: 2-pyridylacetic acid (basic metabolite) and dimethylbetahistine. 85-90 %' is excreted by the kidneys in the form of 2-pyridylacetic acid for 24 hours. The excretion of betahistine and dimethylbetahistine by the kidneys is insignificant. Only a small part of betagistin and its metabolites are excreted by the intestine.

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, pregnancy, lactation, children's age.

Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption. Pheochromocytoma.

Carefully:

Stomach ulcer or 12 duodenal ulcer (in the anamnesis), 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:

The drug is administered orally, with meals.

Adult and elderly patients:

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

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

Tablets 24 mg: 1 tablet 2 times a day. .

Improvement is usually noted already at the beginning of therapy, a stable therapeutic effect occurs after two weeks of treatment and may increase over several months of treatment. Treatment is long. Duration of drug intake is selected individually.

For patients with renal and / or liver failure, there is no data on the need to change therapeutic dosages.

Side effects:Nausea, vomiting, dyspepsia, abdominal pain, bloating, urticaria, pruritus, rash, angioedema, headache.

Overdose:

Symptoms: nausea, vomiting, headache, flushing of the facial skin, dizziness, tachycardia, decreased blood pressure, bronchospasm; drowsiness (when taken in a dose of up to 640 mg); at a dose of 728 mg, there were reports of seizures.

Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.

Interaction:

The blockers of histamine receptors reduce the effect of betahistine.

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:

Betagistin does not have a sedative effect and does not affect the ability to

driving vehicles or working with mechanisms.

Form release / dosage:Tablets 8 mg, 16 mg and 24 mg.

Packaging:

For 10, 12 tablets per contour - cell pack of film polyvinylchloride and aluminum foil printed lacquered.

For 1,2 or 3 contour mesh packages together with the instruction for use are placed in a pack.

For hospitals: 500, 1000 or 2000 tablets in cans of polymeric with lids. By 1,2, 3,4,5, 6 cans along with instructions for use are placed in boxes. Storage conditions:

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-000732

Date of registration:29.09.2011

Date of cancellation:2016-09-29

The owner of the registration certificate:HEALTH OF CNT, CJSC HEALTH OF CNT, CJSC Russia

Manufacturer: & nbsp

RAFARMA, JSC Russia

Information update date: & nbsp21.08.2013

Illustrated instructions

Instructions

Betagistin (Betahistine)