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

Composition
for 1 tablet:
Betahistine dihydrochloride	- 0.008 g	0.016 g	0.024 g

Auxiliary substances
[sodium croscarmellose;	-0.0127 g	0.0254 g		0.0381 g
sodium lauryl sulfate;	0.0042 g	0.0084 g			0.0126 g
cellulose	- 0.1810 g	0.3620 g			0.5430 g
microcrystalline;	- 0.0020 g	0.0040 grams			0.0060 grams
citric acid;	- 0.0021 g	0.0042 g			0.0063 g
magnesium stearate]
Average weight of a tablet	- 0.21 g	0.42 g			0.63 g

Description:

Tablets of white or almost white color, round, flat-cylindrical with a facet and a risk (at a dosage of 8 mg) or biconvex, oblong with rounded ends, with a risk (at a dosage of 16 mg and 24 mg).

Pharmacotherapeutic group:Histamine is a drug.

ATX: & nbsp

N.07.C.A.01 Betagistin

Pharmacodynamics:

The antagonist of H_1-histamine receptors of the vessels of the inner ear and antagonist H₃histamine 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 stripeinner 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, the connection with plasma proteins is low, less than 5%. The maximum concentration in the blood plasma (C_max) is reached after 1 hour. Metabolized to inactive metabolites: 2-pyridylacetic acid (basic metabolite) and demethyl betahistine. Almost completely (85-90%) is excreted by the kidneys in the form of a metabolite (2-peridylacetic 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 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 one of the components of the drug, children under 18 years (due to lack of data), pregnancy, lactation.

Carefully:

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

Pregnancy and lactation:

The drug is contraindicated for use during pregnancy, because there is insufficient data to assess the effect of the drug on pregnant women and the fetus. During lactation drug should not be used or at the time 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.

Tablet 24 mg: 1 tablet 2 times a day.

The course of treatment is determined individually. Improvement is usually noted 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.

Side effects:

Frequency: often - more than 1/100 and less than 1/10.

From the digestive system: often - nausea, indigestion.

Post-marketing experience:

Allergic reactions, hypersensitivity (including, anaphylactic reactions, angioedema, skin rash, urticaria, and Quincke's edema).

From the digestive system: vomiting, abdomen pain, bloating.

From the skin: itching.

Overdose:

Symptoms: nausea, vomiting, 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 (drugs).

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

Interaction:

Cases of interaction or incompatibility with other drugs are unknown.

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 drive a car or work on machines and mechanisms.

Form release / dosage:

Tablets 8, 16, 24 mg.

Packaging:

At 5, 7, 10, 12, 14, 15, 20, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

1, 2, 3, 4, 5, 6 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

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 printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-000084

Date of registration:15.12.2010

Date of cancellation:2015-12-15

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

GRUNENTHAL, GmbH Germany

Information update date: & nbsp13.07.2015

Illustrated instructions

Instructions

Betagistin (Betahistine)