Active substanceBetagistinBetagistin
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: betahistine dihydrochloride 8.0 mg, 16.0 mg, 24.0 mg;

    Excipients: microcrystalline cellulose 54.75 / 109.5 / 164.25 mg, povidone (kollidone 25) 9.0 / 18.0 / 27.0 mg, potato starch 20.0 / 40.0 / 60.0 mg, citric acid 2.0 / 4.0 / 6.0 mg, silicon dioxide colloid (aerosil) 3.0 / 6.0 / 9.0 mg, talc 2.8 / 5.6 / 8.4 mg, magnesium stearate 0.45 / 0.9 / 1.35 mg.

    Description:

    Tablets are almost white or white with a creamy shade of color, flat-cylindrical, with a facet and a risk.

    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 action on H1receptors of the vessels of the inner ear, as well as indirectly through exposure to H3-receptors 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.

    Has a pronounced central effect, being an inhibitor of H3receptors of the nuclei of the vestibular nerve. Normalizes the conductivity in the neurons of the vestibular nuclei at the level of the brainstem.

    The clinical manifestation of these properties is a decrease in the frequency and intensity of dizziness, a decrease in noise in the ears, and improvement in hearing in the event of a decrease in it.

    Pharmacokinetics:

    Absorbed quickly, the connection with plasma proteins is low. Time to reach the maximum concentration in blood plasma is 3 hours. It is almost completely excreted by the kidneys in the form of a metabolite (2-pyridylacetic acid) for 24 hours. The half-life period is 3-4 hours.

    Indications:

    - LPrevention and prevention of vestibular vertigo of various origin;

    - syndromes including dizziness and headache, tinnitus, progressive hearing loss, nausea and vomiting;

    - bDisease or Meniere's syndrome.

    Contraindications:

    - Pincreased sensitivity to any of the components of the drug;

    - age under 18 years (due to lack of data);

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

    Carefully:

    Stomach ulcer or duodenal ulcer (incl.in the anamnesis), pheochromocytoma, bronchial asthma.

    These patients should be observed regularly during the treatment period.

    Dosing and Administration:

    Inside, with food.

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

    Tablets 16 mg: by ½ - 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. The duration of treatment is determined individually.

    Side effects:

    Gastrointestinal disorders, the emergence of reactions of hypersensitivity from the skin (rash, itching, urticaria), Quincke's edema.

    Overdose:

    Symptoms: nausea, vomiting, convulsions.

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

    Interaction:

    Cases of interaction or incompatibility with other drugs are unknown.

    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, 16 mg and 24 mg.

    Packaging:

    When produced at OOO Makyz-Pharma, Russia

    For 10 or 30 tablets in a planar cell pack of a polyvinylchloride film and aluminum foil.

    For 3 or 5 out-of-round cell packs of 10 tablets, 1, 2 or 3 contour packs of 30 tablets together with instructions for use in a pack of cardboard.

    When manufactured at LLC Hemofarm, Russia

    For 10 or 30 tablets in a contour cell packaging from a polyvinylchloride film and aluminum foil or in a planar cell pack of aluminum foil.

    For 3 or 5 out-of-round cell packs of 10 tablets, 1, 2 or 3 contour packs of 30 tablets together with instructions for use in a 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 stated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-006480/08
    Date of registration:13.08.2008
    The owner of the registration certificate:Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSCNizhny Novgorod Chemical and Pharmaceutical Plant, OJSC
    Manufacturer: & nbsp
    Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
    Information update date: & nbsp13.11.2015
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