Betaserc pills 24mg, 60pcs

Composition

of 1 tab. : – betahistine dihydrochloride 24 mg

Auxiliary substances:

microcrystalline cellulose,

mannitol (E421),

citric acid monohydrate,

colloidal silicon dioxide,

talc.

Pharmacological action

of the pharmaceutical group:

 A drug that improves the microcirculation of the labyrinth, used in the pathology of the vestibular apparatus.

Pharmaceutical action:  

Betaserc is a synthetic analog of histamine. Agonist of histamine H1-receptors of the inner ear vessels and antagonist of histamine H3-receptors of the vestibular nuclei of the central nervous system. According to preclinical studies, by relaxing the precapillary sphincters of the inner ear vessels, 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. Accelerates the recovery of vestibular function after unilateral vestibular neurectomy, accelerating and facilitating central vestibular compensation (due to antagonism with histamine H3 receptors). Relieves symptoms of Meniere’s syndrome and vertigo.

Pharmacokinetics:

 When taken orally, betahistine is rapidly and almost completely absorbed from the gastrointestinal 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 detected in the urine in the form of 2-pyridylacetic acid. Elimination of betahistine by the kidneys or through the intestines is insignificant. The rate of elimination remains constant with oral use of 8-48 mg of the drug, indicating the linearity of the 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 food intake 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); tinnitus.
• symptomatic treatment of vestibular vertigo (vertigo).

Use during pregnancy and lactation

Pregnancy.

The available data 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 absolutely necessary.

Breast-feeding.

It is not known whether betahistine is excreted in human breast milk. Betahistine is excreted in human milk in rats. Animal studies have been limited to the use of the drug in very high doses. The question of prescribing a drug to the mother should be decided only after comparing the benefits of breastfeeding with the potential risk to the infant.

Fertility.

In animal studies (rats), no effect on fertility was found.

Contraindications

• pheochromocytoma;
• hypersensitivity to any of the components of the drug.
• Betaserc® is not recommended for use in children under 18 years of age due to insufficient data on efficacy and safety.

Side effects

Common: nausea and dyspepsia; headache; Frequency unknown: hypersensitivity reactions, including anaphylactic reaction, vomiting, gastrointestinal pain, bloating, angioedema, urticaria, pruritus, rash

Interaction

In vivo studies aimed at studying the interaction with other drugs have not been conducted.

Based on in vitro data, it can be assumed that the activity of cytochrome P450 isoenzymes is not inhibited in vivo.

In vitro data showed inhibition of betahistine metabolism by drugs that inhibit MAO, including MAO subtype B (for example, selegiline). Caution should be exercised when concomitantly prescribing betahistine and MAO inhibitors (including MAO-B).

Betahistine is a histamine analog, and the interaction of betahistine with_H1-histamine receptor blockers can theoretically affect the effectiveness of one of these drugs.

The patient should inform the doctor about taking any medications currently or in the recent past.

How to take, course of use and dosage

The drug is prescribed orally during meals. The dose should be selected individually depending on the response to treatment. For adults, the dose is 24-48 mg / day.

Betaserc® 8 mg: 1-2 tablets 3 times a day.

Betaserc ® 16 mg: 1/2-1 tablet 3 times / day.

Betaserc® 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 risk up and press it with your thumb.

Improvement is sometimes observed only after a few weeks of treatment, and a stable therapeutic effect is observed after several months of treatment. There is evidence that prescribing the drug at the beginning of the disease prevents its progression and / or hearing loss in later stages.

Despite limited data from clinical trials, extensive post-marketing experience suggests that dose adjustment may be necessary.

Betaserca is not required in elderly patients.

No specific clinical studies have been conducted in patients with renal and / or hepatic insufficiency, but post-marketing experience suggests that dose adjustment is not required in this group of patients.

Overdose

There are several known cases of overdose of the drug Betaserc.

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

More serious complications (seizures, cardiopulmonary complications) were observed with deliberate use of betahistine in increased doses, especially in combination with an overdose of other medications.

Treatment: performing symptomatic therapy.

Description

Tablets are white or almost white in color, round, biconvex, with beveled edges, with a risk on one side and engraved “289” on both sides of the risk.

Special instructions

It should be used with caution in patients with a history of gastric or duodenal ulcer, in the second and third trimesters of pregnancy, as well as in children.

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

For dyspeptic symptoms, betahistine is recommended to be taken during or after a meal.

Form of production

Betaserc tablets are white or almost white in color, round, biconvex, with beveled edges, with a risk on one side and engraved ” 289 “on both sides of the risk and” S “above the” ∇ ” icon on the other side of the tablet.

Storage conditions

In a dry place, at a temperature not exceeding 25 °C

Shelf life

1 year

Active ingredient

Betahistine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Cerebrovascular accident, Meniere ‘s Disease