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

Excipients: cellulose microcrystalline 38 mg, lactose monohydrate 75.1 mg, crospovidone 2.8 mg, povidone K90 7 mg, magnesium stearate 1.4 mg, silicon dioxide colloid 3.5 mg, talc 4.2 mg.

One tablet with a dosage of 16 mg contains: active substance: betahistine dihydrochloride 16 mg;

Excipients: cellulose microcrystalline 68 mg, lactose monohydrate 132.25 mg, crospovidone 5 mg, povidone K90 12.5 mg, magnesium stearate 2.5 mg, silicon dioxide colloid 6.25 mg, talc 7.5 mg.

One tablet with a dosage of 24 mg contains:

activesAqueous substance: betahistine dihydrochloride 24 mg;

Excipients: cellulose microcrystalline 100 mg, lactose

monohydrate 196,05 mg, crospovidone 7.4 mg, povidone K90 18.5 mg, magnesium stearate 3.7 mg, silicon dioxide colloid 9.25 mg, talc 11.1 mg.

Description:

Tablets with a dosage of 8 mg: tablets white or almost white, round, biconcave.

Tablets with a dosage of 16 mg and 24 mg: Tablets are white or almost white in color, round, flat-cylindrical with a facet and a risk.

Pharmacotherapeutic group:Histamine drug

ATX: & nbsp

N.07.C.A.01 Betagistin

Pharmacodynamics:

Betagistin is an agonist H1-gistaminovyh receptors, does not affect the H3-histamine receptors, which improves blood circulation in the vascular stria of the inner ear due to a relaxing effect on the precapillary sphincters of the cochlea and labyrinth.

Pharmacokinetics:Quickly and completely absorbed in the digestive tract, communication with plasma proteins - low, less than 5%. The maximum concentration in the blood plasma is achieved after 3 hours. Half-life after 3-4 hours. Metabolised in the liver. Almost completely (90.7%) is excreted by the kidneys in the form of a metabolite (2-pyridylacetic acid) for 24 hours.

Indications:

Treatment of dizziness, noise in the ears, hearing loss and nausea caused by Ménière's disease. Symptomatic treatment of vestibular vertigo.

Contraindications:

- Hypersensitivity to any of the components of the drug.

- Pregnancy.

- Lactation period.

- Children under 18 years (due to insufficient data on efficiency and safety).

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

- Simultaneous use of other drugs that affect histamine receptors.

- Pheochromocytoma.

- Bronchial asthma.

- Stomach ulcer and duodenal ulcer.

Pregnancy and lactation:

The drug intake during pregnancy and during breastfeeding is contraindicated (insufficient data to evaluate the effect of the drug).

If pregnancy is detected during treatment with betahistine, the drug should be discontinued. For the duration of treatment it is necessary to stop breastfeeding.

Dosing and Administration:

Inside, with food, not liquid, squeezed a small amount of liquid.

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

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

Tablet 24 mg: 1 tablet 2 times a day.

The improvement is usually noted already at the beginning of therapy, a stable therapeutic effect occurs within a few days of treatment and can grow for several weeks, depending on the response to treatment.Duration of drug intake is selected individually by the attending physician.

Side effects:

From the digestive system: very often ≥ 1/10) - nausea, vomiting, abdominal pain, diarrhea.

From the nervous system: often (from ≥ 1/100 to <1/10) - headache, weakness, fatigue, dizziness, lethargy, drowsiness, insomnia.

From the cardiovascular system: rarely (from ≥ 1/10000 to <1/1000) - a sensation of heat, a heartbeat.

There are reports of other undesirable effects (the available data are insufficient to estimate the frequency):

- from the digestive system: pain in epigastrium, heartburn;

- allergic reactions: hypersensitivity (including anaphylactic reactions, angioedema);

- from the skin: itching, skin rash, hives, redness.

Overdose:

When taking doses of more than 200 mg, there may be mild and moderate symptoms, such as nausea, abdominal pain, drowsiness. There are reports of seizures in case of an overdose (if taken at a dose of 728 mg), cardiopulmonary complications (if taken in a dose of more than 640 mg or in combination with other medicines).

Treatment: symptomatic.

Interaction:

When used simultaneously with blockers H1-histamine receptors, the therapeutic effect of betahistine may decrease.

Special instructions:

Patients with peptic ulcer of the gastrointestinal tract (in the anamnesis),

pheochromocytoma and bronchial asthma should be under medical supervision.

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

Care must be taken when driving vehicles and machinery, since betagistin can cause unwanted drug reactions from the nervous system.

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

Packaging:For 10 tablets in a planar cell package. For 1, 2 or 3 contour mesh packages 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.

Terms of leave from pharmacies:On prescription

Registration number:LP-002363

Date of registration:10.02.2014

Expiration Date:10.02.2019

The owner of the registration certificate:ZIO-HEALTH, JSC ZIO-HEALTH, JSC Russia

Manufacturer: & nbsp

ZIO-HEALTH, JSC Russia

Information update date: & nbsp24.01.2017

Illustrated instructions

Instructions

Betagistin (Betahistine)