Product Overview
Composition
1 tab.:
- betahistine dihydrochloride 24 mg
Excipients:
microcrystalline cellulose,
mannitol (E421),
citric acid monohydrate,
silica colloidal
talc.
pharmachologic effect
Farmgroup:
A drug that improves the microcirculation of the labyrinth, used in the pathology of the vestibular apparatus.
Farm action:
Betaserk is a synthetic analogue of histamine. An agonist of histamine H1 receptors of the vessels of the inner ear and an antagonist of histamine H3 receptors of the vestibular central nervous system nuclei. According to preclinical studies, by relaxing the precapillary sphincters of the vessels of the inner ear, it improves blood circulation in the vascular shelf of the inner ear.
Dose-dependently reduces the generation of action potentials in neurons of the lateral and medial vestibular nuclei. It accelerates the restoration of vestibular function after unilateral vestibular neurectomy, accelerating and facilitating central vestibular compensation (due to antagonism with histamine H3 receptors). Relieves symptoms in Meniere's syndrome and vertigo.
Pharmacokinetics:
When ingested, betahistine is rapidly and almost completely absorbed from the digestive tract. After absorption, the drug is rapidly and almost completely metabolized to form an inactive metabolite of 2-pyridylacetic acid.
When taking the drug at a dose of 8-48 mg, about 85% of the initial dose is found in the urine in the form of 2-pyridylacetic acid. Excretion of betahistine by the kidneys or through the intestines is negligible. The excretion rate remains constant with oral administration of 8-48 mg of the drug, indicating the linear pharmacokinetics of betahistine, and suggests that the involved metabolic pathway remains unsaturated.
When taking the drug with food, the maximum concentration of the drug in the blood is lower than when taken on an empty stomach. However, the total absorption of betahistine is the same in both cases, which indicates that eating only slows down the absorption of betahistine.
Indications
Meniere's syndrome, characterized by the following main symptoms:
- dizziness (accompanied by nausea, vomiting);
- hearing loss (hearing loss);
- noise in ears.
Symptomatic treatment of vestibular dizziness (vertigo).
Pregnancy and lactation
Available data on the use of betahistine in pregnant women is not enough.
The potential risk to humans is unknown. Betagistin should not be used during pregnancy unless absolutely necessary.
It is not known whether betahistine and breast milk are excreted.
You should not prescribe the drug during breastfeeding.
The question of the appointment of Betaserk® to the mother should be taken only after comparing the benefits of breastfeeding with the potential risk to the infant.
Contraindications
- pheochromocytoma;
- Hypersensitivity to the components of the drug.
Betaserk® is not recommended for use in children and adolescents under the age of 18 years due to insufficient data on efficacy and safety.
With caution and under the close supervision of a physician, Betaserk® should be prescribed to patients with bronchial asthma, gastric ulcer and / or duodenal ulcer.
Side effects
From the digestive system: often (from ≥ 1/100 to <1/10) - nausea and dyspepsia.
From the nervous system: often (from ≥ 1/100 to <1/10) - headache. The incidence of headaches in patients receiving betigistin was similar to the incidence in the group of patients receiving placebo.
In addition to these effects identified during clinical trials, the following undesirable effects have been reported in the post-marketing process and in the scientific literature. Available data are insufficient to estimate their frequency.
From the digestive system: moderate vomiting, gastrointestinal pain, bloating. As a rule, these effects usually disappear after taking the drug simultaneously with food or after a dose reduction.
Allergic reactions: hypersensitivity reactions, incl. angioedema, urticaria, pruritus, rash, anaphylactic reaction.
Interaction
In vivo studies aimed at studying the interaction with other drugs have not been conducted.
Based on in vitro data, we can assume the absence of inhibition of the activity of isoenzymes of the cytochrome P450 system in vivo.
Betagistin is an analogue of histamine, the interaction of betahistine with blockers of H1-histamine receptors can theoretically affect the effectiveness of one of these drugs.
The patient should inform the doctor about taking any medications now or in the recent past.
How to take, course of administration and dosage
The drug is prescribed orally with meals. The dose should be selected individually depending on the response to treatment.
For adults, the dose is 24-48 mg / day.
Betaserk® 8 mg: 1-2 tablets 3 times / day.
Betaserc® 16 mg: 1 / 2-1 tablets 3 times / day.
Betaserk® 24 mg: 1 tablet 2 times / day.
A 16 mg tablet and a 24 mg tablet can be divided into 2 equal parts. To do this, place the tablet on a hard surface with the scuff up and press on it with your thumb.
Improvement is sometimes observed only after a few weeks of treatment, and a stable therapeutic effect after several months of treatment. There is evidence that the appointment of the drug at the onset of the disease prevents its progression and / or hearing loss at later stages.
Despite the limited clinical trial data, extensive post-registration experience suggests dose adjustment
Betaserka in elderly patients is not required.
Special clinical studies in patients with renal and / or liver failure have not been conducted, but post-registration experience suggests that dose adjustment in this group of patients is not required.
Overdose
Several cases of an overdose of Betaserk are known.
Symptoms: mild and moderate nausea, drowsiness, abdominal pain were observed in some patients after taking the drug in doses up to 640 mg.
More serious complications (convulsions, cardiopulmonary complications) were observed with the deliberate use of betagistin in high doses, especially in combination with an overdose of other drugs.
Treatment: symptomatic therapy.
Special instructions
With caution, Betaserk should be prescribed to patients with a history of gastric ulcer or duodenal ulcer. During the use of the drug, patients with pheochromocytoma and bronchial asthma should be under medical supervision.
The risk of 24 mg tablets is intended to break the tablets in order to facilitate its swallowing and is not intended to be divided into 2 equal doses.
Influence on the ability to drive vehicles and control mechanisms
It is believed that the effect of betahistine on the ability to drive vehicles and other mechanisms is absent or insignificant, since during clinical trials associated with the use of betahistine, effects that potentially affect this ability were not detected.
Release form
Betaserc tablets are white or almost white in color, round, biconvex, with beveled edges, with a notch on one side and an engraving "289" on both sides of the risks and an "S" above the "∇" on the other side of the tablet.
