Betagistin
Producer: CJSC Verteks Russia
Code of automatic telephone exchange: N07CA01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: 8 mg or 16 mg of a betagistin of dihydrochloride.
Excipients: dosage of 8 mg: cellulose microcrystallic – 6,64 mg, lactoses monohydrate – 40 mg, citric acid monohydrate – 2,5 mg, silicon dioxide colloid – 3,75 mg, talc – 3,1 mg, calcium stearate – 1,25 mg;
dosage of 16 mg: cellulose microcrystallic – 132,8 mg, lactoses monohydrate – 80 mg, citric acid monohydrate – 5 mg, silicon dioxide colloid – 7,5 mg, talc – 6,2 mg, calcium stearate – 2,5 mg.
Pharmacological properties:
Pharmacodynamics. H1 agonist - histamine receptors of vessels of an inner ear and the antagonist of H3 - histamine receptors of vestibular nuclei of the central nervous system. Due to relaxation of precapillary sphincters of vessels of an inner ear improves blood circulation in a vascular stripe to a strip of an inner ear.
Dozozavisimo reduces generation of action potentials in neurons of lateral and medial vestibular nuclei.
Accelerates recovery of vestibular function after a unilateral vestibular neurectomy, accelerating and facilitating the central vestibular compensation (due to antagonism with H3 - histamine receptors).
Pharmacokinetics. Communication with proteins of plasma – less than 5% is absorbed quickly. Time of achievement of the maximum concentration (Tcmax) in plasma – 1 h.
It is metabolized to inactive metabolites: 2-pyridylacetic acid (main metabolite) and dimetilbetagistina. 85–90% are removed by kidneys in the form of 2-pyridylacetic acid during 24 h. Removal of a betagistin and dimetilbetagistin kidneys slightly. Intestines remove only a small part of a betagistin and its metabolites.
Indications to use:
The treatment of a syndrome of Menyer who is characterized by dizziness (which is followed by nausea and vomiting), decrease in hearing and a sonitus. Symptomatic treatment of vestibular dizziness (вертиго).
Route of administration and doses:
Inside, during food, on 8-16 mg 3 times a day. The course of treatment is defined individually. Prolonged treatment. At patients with a renal or liver failure, and also it is not required from elderly patients of dose adjustment.
Features of use:
The therapeutic effect in some cases increases within several months from an initiation of treatment.
Influence on ability of control of vehicles, mechanisms. Reduction in the rate of psychomotor reactions is possible that reduces ability to manage vehicles and to work with exact mechanisms.
Use at pregnancy and during breastfeeding. There are not enough data for assessment of a possibility of use of drug at pregnancy and in the period of a lactation. In this regard administration of drug Betagistin is not recommended at pregnancy. If administration of drug is necessary in the period of a lactation, breastfeeding needs to be stopped.
Side effects:
From the alimentary system: nausea, dyspepsia.
From a nervous system: headache.
Allergic reactions: hypersensitivity, including anaphylactic reactions.
From the alimentary system: vomiting, abdominal pain, abdominal distention.
From integuments: Quincke's disease, small tortoiseshell, itch, rash.
Interaction with other medicines:
Betagistin is a histamine analog, interaction of a betagistin with blockers of histamine receptors can theoretically influence efficiency of one of these medicines.
Contraindications:
Hypersensitivity to drug components, a pheochromocytoma, pregnancy, the lactation period, children's age; deficit of lactase, lactose intolerance, glyukozo-galaktozny malabsorption.
With care. A peptic ulcer of a stomach or a 12-perstny gut (in the anamnesis), bronchial asthma.
Overdose:
Symptoms: nausea, abdominal pain, drowsiness (at reception in a dose to 640 mg); spasms, cardiopulmonary complications (at reception in a dose more than 640 mg or in combination with other medicines).
Treatment: gastric lavage, reception of absorbent carbon, symptomatic therapy.
Storage conditions:
In the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years. Not to use after a period of validity.
Issue conditions:
According to the recipe
Packaging:
Tablets on 8 mg and 16 mg. On 10 or 15 tablets in a blister strip packaging from a film of polyvinyl chloride and aluminum foil. 1, 2, 3, 5 or 6 blister strip packagings on 10 tablets or 2 or 4 blister strip packagings on 15 tablets together with the application instruction in a pack from a cardboard.