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Betaserc tablets

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Betaserc tablets, white or almost white, round, double radius, beveled-edged, with a score mark on one side and "256" embossing on both sides of the score mark.

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Betaserc

Clinico-pharmacological group

The drug improving microcirculation in the labyrinth, used in case of pathology of the vestibular apparatus

Dosage form, composition and packaging

Betaserc tablets, white or almost white, round, flat, beveled-edged, with "256" embossing on one side of the tablet.

 

1 tab.

betahistine dihydrochloride

8 mg

Betaserc tablets, white or almost white, round, double radius, beveled-edged, with a score mark on one side and "256" embossing on both sides of the score mark.

 

1 tab.

betahistine dihydrochloride

16 mg

Betaserc Pharmacological action

A synthetic analogue of histamine. The mechanism of action of betahistine is only partially known. There are several possible hypotheses which have been confirmed by preclinical and clinical data:

1. Impact on the histaminergic system

Partial agonist of histamine H1-receptors and antagonist of histamine H3-receptors of the CNS vestibular nuclei has little activity regarding H2-receptors. Betahistine increases histamine exchange and release by blocking presynaptic H3-receptors and reducing the amount of H3-receptors.

2. Increased regional blood flow in the cochlea, as well as the whole brain

According to preclinical studies, betahistine improves blood circulation in the inner-ear vascular strip by relaxing the precapillary sphincters of the inner ear blood vessels. It is also shown that betahistine increases blood flow in the human brain.

3. Facilitating of central vestibular compensation

Betahistine accelerates the recovery of vestibular function in animals after unilateral vestibular neurectomia, accelerating and facilitating central vestibular compensation through antagonism with histamine H3-receptors.

Recovery time after vestibular neurectomia in humans is also reduced in case of betahistine treatment.

4. Excitation of neurons in the vestibular nuclei

It reduces the generation of action potentials in neurons of the lateral and medial vestibular nuclei in a dose-dependent manner.

Pharmacodynamic properties identified in animals provide a positive therapeutic effect of betahistine in the vestibular system.

The effectiveness of betahistine has been demonstrated in patients with vestibular vertigo and Meniere's disease, which manifested by a decrease in the severity and frequency of vertigo.

Betaserc Overdose

There are several known cases of drug overdose.

Symptoms: slight and 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) were observed in case of deliberate administration of betahistine in high doses, especially in combination with other drugs overdose.

Treatment: symptomatic therapy.

Betaserc interactions

Studies in vivo, aimed at studying of the interactions with other drugs, have not been conducted.

Based on in vitro data, we can assume that there is no inhibition of cytochrome P450 isozymes in vivo.

The data in vitro showed an inhibition of betahistine metabolism by the action of drugs which inhibit MAO, including MAO of subtype B (e.g., selegiline). One should exercise caution in case of simultaneous use of betahistine and MAO inhibitors (including MAO-B).

Betahistine is an analogue of histamine, interaction of betahistine and H1-histamine receptor blockers can theoretically affect the efficacy of one of these drugs.

The patient should inform their doctor about taking any medicines now or in the recent past.

Betaserc in Pregnancy and lactation

Available data on the use of betahistine in pregnant women are not sufficient. The potential risk for humans is unknown. Betahistine should not be used during pregnancy except in cases of absolute necessity.

It is not known whether betahistine is excreted in breast milk. The drug should not be prescribed during breastfeeding. The decision concerning Betaserc prescription for the mother should be made only after comparing the benefits of breastfeeding to the potential risk to the infant.

Betaserc Side effects

Digestive system: often (from ≥ 1/100 to <1/10) - nausea and dyspepsia.

Nervous system: often (from ≥ 1/100 to <1/10) - headache.

Apart from these effects identified in clinical trials, during post-marketing use and in the scientific literature the following adverse effects have been reported. Available data are insufficient to estimate their frequency.

Digestive system: moderately expressed vomiting, gastrointestinal pain, bloating. Typically, these effects usually disappear after taking the drug with food or after a dose reduction.

Allergic reactions: hypersensitivity reactions, including angioedema, urticaria, itching, rash, anaphylactic reaction.

Storage time and conditions

List B. The drug should be stored out of children’s reach in a dry place at a temperature not exceeding 25°C. Shelf life - 5 years.

Betaserc Indications

Meniere's disease, characterized by the following main symptoms:

  • dizziness (accompanied by nausea, vomiting);
  • hearing loss (deafness);
  • tinnitus.

Symptomatic treatment of vestibular vertigo.

Betaserc Contraindications

  • pheochromocytoma;
  • hypersensitivity to the drug components.

Betaserc is not recommended for use in children and adolescents under the age of 18 due to insufficient data on its safety and efficacy.

The Betaserc drug should be prescribed with caution and under close medical supervision to patients with bronchial asthma, gastric and/or duodenal ulcers.

Betaserc Cautions

The score mark on 24 mg tablets is intended for breaking the tablet in order to facilitate swallowing and is not intended for division of it into 2 equal doses.

Effects on the ability to drive and use machines

Betahistine does not affect or only slightly affects the ability to drive and use machines, adverse reactions that could affect this ability have not been revealed in clinical trials.

In case of renal impairment

Special clinical studies in patients with renal insufficiency have not been conducted, but the post-registration experience gives reason to believe that dose adjustment in these patients is not required.

In case of abnormal liver function

Special clinical studies in patients with hepatic impairment have not been conducted, but the post-registration experience gives reason to believe that dose adjustment in these patients is not required.

Use in the elderly

Despite the limited data from clinical studies, extensive post-registration experience suggests that dose adjustment in elderly patients is not required.

Betaserc Application in children

Betaserc is not recommended for use in children and adolescents under the age of 18 due to insufficient data on its safety and efficacy.

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