Betaserk, tablets 16 mg 30 pcs

Betaserk is a microcirculatory enhancer.

Pharmacodynamics

Betaserk (betahistine) acts mainly on histamine H1 and H3 receptors of the inner ear and vestibular nuclei of the CNS. By direct agonist effect on H1-receptors of the inner ear vessels and indirectly through effect on H3-receptors it improves micro-circulation and capillary permeability and normalizes the endolymph pressure in the labyrinth and cochlea.

At the same time, betahistine increases blood flow in the basilar arteries.

Betaserk® also has a pronounced central effect due to its effect on the H3-receptors of the vestibular nerve nuclei. It normalizes conduction in neurons of vestibular nuclei at brainstem level.

The clinical manifestation of these properties is reduction of the frequency and intensity of dizziness, decrease of tinnitus, improvement of hearing if it is reduced.

Indications

Active ingredient

Composition

1 tablet contains:

The active ingredient:

betahistine dihydrochloride – 16 mg.

Auxiliary substances:

Microcrystalline cellulose – 161.5 mg,

Mannitol (E421) – 50 mg,

Citric acid monohydrate – 5 mg,

Silicon dioxide colloid – 5 mg,

Talc – 12.5 mg.

How to take, the dosage

The drug is prescribed orally with meals. The dose should be adjusted individually depending on the response to treatment.

The dose for adults is 24-48 mg/day.

Dose/fold of administration:

The 16 mg tablet and the 24 mg tablet can be divided into 2 equal parts. This is done by placing the tablet on a hard surface with the ridges facing upward and pressing it down with the thumb.

Sometimes improvement is seen only after a few weeks of treatment, and a sustained therapeutic effect is seen after several months of treatment. There is evidence that prescribing the drug at the beginning of the disease prevents progression and/or hearing loss in the later stages.

While clinical trial data are limited, extensive post-registration experience suggests that no dose adjustment is necessary in elderly patients.

Special clinical studies have not been performed in patients with renal and/or hepatic impairment, but post-registration experience suggests that no dose adjustment is necessary in this group of patients.

Interaction

In vivo studies to study the interaction with other drugs have not been conducted.

Based on in vitro data, it can be assumed that there is no inhibition of cytochrome P450 isoenzyme activity in vivo.

In vitro data showed inhibition of betahistine metabolism by drugs that inhibit MAOIs, including MAO subtype B (e.g., selegiline). Caution should be exercised when concomitant administration of betahistine and MAO inhibitors (including MAO-B).

Betahistine is a histamine analog, an interaction of betahistine with H1-histamine receptor blockers could theoretically affect the effectiveness of one of these drugs.

The patient must tell the physician if he or she is currently or has recently taken any medications.

Special Instructions

Caution should be exercised in patients with a history of gastric or duodenal ulcer disease, in the second and third trimesters of pregnancy, and in children.

It should be taken into account that the desired clinical effect is achieved after several months of treatment.

In case of dyspeptic symptoms, betahistine is recommended to be taken with or after meals.

Synopsis

Contraindications

Side effects

Overdose

There have been several known cases of overdose of Betaserc.

Symptoms: mild to moderate nausea, drowsiness, abdominal pain have been observed in some patients after taking the drug in doses up to 640 mg.

More serious complications (seizures, cardiopulmonary complications) have been observed when betahistine is intentionally taken at higher doses, especially in combination with overdose of other medications.

Treatment: conduct symptomatic therapy.

Pregnancy use

Pregnancy.

The data available on the use of betahistine in pregnant women are insufficient. Animal studies have shown no direct or indirect reproductive toxicity. Betahistine should not be used during pregnancy unless clearly necessary.

Breastfeeding.

It is not known whether betahistine is excreted with breast milk in humans. Betahistine is excreted with breast milk in rats. Animal studies have been limited to the use of the drug at very high doses. Administration of the drug to the mother should be decided only after weighing the benefits of breastfeeding against the potential risks to the infant.

Fertility.

There has been no effect on fertility in animal studies (rats).

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