Labirin

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Labirin

What is Labirin? Defining the Antivertigo Agent

Property Description
Active Ingredient Betahistine
Form Tablets (Oral Monotherapy)
Pharmacological Class Antivertigo Agent / Histamine Analog
General Purpose Inner Ear Stabilization
Origin Synthetic Compound

Labirin is a specific prescription-only medication featuring the active component Betahistine, a synthetic compound used in the management of symptoms associated with disequilibrium and vertigo. This drug is structurally classified as an aminoalkylpyridine and functions as a histamine analog, resembling the body's natural histamine. Betahistine is recognized for its role in the inner ear system, specifically for its action on the vestibular microcirculation. This pharmacological action aids in supporting the stability of the inner ear.

Labirin is characterized by its common presentation as tablets or film-coated tablets for oral administration, representing a single-ingredient product (monotherapy). The medication delivers Betahistine, most often as the dihydrochloride salt, combined with standard pharmaceutical excipients. This single-entity formulation is clinically recognized for offering a focused therapeutic approach. Unlike multi-compound preparations, which may combine other agents, Labirin concentrates on the histaminergic system, providing a targeted method for managing chronic balance complaints.

The general therapeutic purpose of Labirin is to support the stability of the vestibular system, the body’s critical organ for balance. Betahistine is utilized for its physiological effect of increasing inner ear blood flow. By promoting vasodilation and enhancing microcirculation in the labyrinthine structures, this action provides general symptomatic support aimed at alleviating disequilibrium and sensations of vertigo by addressing the localized circulatory and neuronal factors contributing to the disturbance.

Regulatory References

  1. U.S. National Library of Medicine
  2. MedlinePlus, NIH

What side effects are possible with Labirin?

Possible Side Effects and Safety Information

The active substance in Labirin (Betahistine) has a generally satisfactory safety profile based on extensive worldwide post-marketing surveillance. However, like all medicines, it can cause adverse reactions and requires specific precautions, as detailed in regulatory documents.

Adverse Reactions

Classification System-Organ Class Specific Reactions
Common (1/100 to <1/10) Nervous System, Gastrointestinal Headache, Nausea, Dyspepsia
Not Known (Post-marketing) Immune System, Skin, Gastrointestinal Hypersensitivity reactions (e.g., Anaphylaxis, Angioneurotic Oedema), Cutaneous reactions (e.g., rash, pruritus, urticaria), Mild gastric complaints (e.g., vomiting, abdominal pain)

Serious hypersensitivity reactions, including anaphylaxis and angioneurotic oedema (swelling beneath the skin), are reported post-marketing, though their frequency is not known. These reactions typically resolve upon discontinuation of the drug.

Safety Precautions and Restrictions

Contraindications: Labirin is contraindicated in patients with a tumour of the adrenal gland, known as phaeochromocytoma, due to the theoretical risk of inducing severe hypertension. It is also contraindicated in patients with known hypersensitivity to the active substance or any excipients.

Caution is advised for patients with a history of peptic ulcer or bronchial asthma, who should be closely monitored during therapy. Caution is also warranted for patients with pre-existing conditions like urticaria, rashes, or allergic rhinitis, as these symptoms may be aggravated.

Population Specific Notes: Use in children and adolescents under 18 years is not recommended due to a lack of safety and efficacy data. The use of the drug during pregnancy is generally advised to be avoided as a precautionary measure due to insufficient data, and it is unknown if the substance is excreted into human breast milk during lactation.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define the Labirin (Betahistine) overdose profile by classifying the documented effects across the gastrointestinal and central nervous systems, citing the potential for life-threatening outcomes at very high doses.


Element Official Regulatory Information
Documented Overdose Presentations Symptoms may include nausea, somnolence (sleepiness), and abdominal pain. Other reported manifestations are vomiting, dyspepsia, ataxia, and dry mouth.
Severe Outcomes More serious complications, such as convulsions (seizures), pulmonary effects, and cardiac complications, have been observed at very high doses (typically above 640 mg) or in cases of intentional overdose with co-ingestion of other drugs.
Emergency-Response Statement Regulatory guidance explicitly requires the patient to seek immediate medical attention by contacting a doctor, hospital emergency department, or the regional Poison Control Centre at the first suspicion of overdose.
Antidote and Management No specific antidote is known. Treatment is officially described as symptomatic and supportive, with procedural consideration for gastric decontamination (lavage and activated charcoal) within one hour of intake.

The inherent risk of severe effects necessitates the explicitly labeled requirement to seek immediate medical assessment regardless of initial presentation. The documented management approach is strictly supportive and symptomatic.

Therapeutic Uses of Labirin

What Labirin Treats: Main Uses and Benefits

Labirin (Betahistine) is commonly used for symptomatic relief and supporting stability in patients experiencing chronic inner ear disorders, particularly Ménière's disease. The medication is used to help address the key symptoms associated with this condition: feeling dizzy and a spinning sensation (vertigo) and ringing in the ears (tinnitus). The therapeutic focus is on managing the disruptive, recurrent episodes that define these conditions.


Symptom Management and Stability

The medication provides supportive therapeutic benefit by aiming to moderate symptoms that create noticeable physiological strain from vertigo episodes and associated disequilibrium (unsteadiness). It is applied in clinical settings that involve episodic and fluctuating symptom patterns, helping patients cope more steadily with these difficult manifestations. It is commonly used as a long-term measure to contribute to easing the overall symptom load.

Addressing associated complaints like persistent tinnitus and the uncomfortable feeling of aural fullness also contributes to the patient's general functional comfort and stability.

Quick Fact: Relief for Episodic Symptoms
Labirin may assist with managing symptom clusters that become intense or disruptive and is used in conditions characterized by periods of heightened symptoms.

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

Labirin is intended for use in the adult population. Eligibility for the medicine is defined by explicit regulatory rules regarding contraindications, special populations, and existing medical conditions.

Classification Population/Condition
Absolute Contraindication Known hypersensitivity to Betahistine or any tablet component
Patients with phaeochromocytoma (adrenal gland tumor)
Use Not Recommended Children and adolescents under the age of 18 years
Pregnant women and breastfeeding women
Conditional Use (Caution Advised) Patients with a history of peptic ulceration or bronchial asthma
Patients with severe hypotension (low blood pressure)

Official labeling contraindicates use in patients with phaeochromocytoma and those with a known allergy to the active substance. Use is formally not recommended in the pediatric population due to a lack of sufficient data on safety and efficacy, and its use is also not recommended during pregnancy or lactation as a precautionary measure. Patients with a history of peptic ulcer or bronchial asthma should be monitored carefully during treatment, as advised by regulatory authorities. No specific dose adjustments are noted as necessary for patients with renal or hepatic impairment.

What should I know about interactions with other medicines?

Labirin Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Labirin (Betahistine) as detailed in government regulatory and authoritative prescribing information.


Documented Interactions

Interaction Type Interacting Substance/Class Official Regulatory Description
Pharmacodynamic Risk Antihistamines (H1-receptor antagonists) The combination carries a theoretical risk of mutual antagonism between the histamine analog (Labirin) and the H1-blocking agent, which may lead to a reduction in therapeutic effect. Some authorities classify this co-administration as contraindicated.
Metabolic Risk Monoamine-oxidase (MAO) inhibitors Caution is advised for concomitant use. In vitro data suggests MAO inhibitors can impede Betahistine's metabolism, which may potentially increase plasma exposure of Labirin.

Constraints and Population-Specific Notes

Constraint Type Details from Regulatory Labeling
Food Interaction Co-administration with food is noted to slow the rate of absorption of Betahistine, though the total amount absorbed remains similar.
CYP Enzyme Effects Regulatory documents state that no clinically relevant inhibition of Cytochrome P450 enzymes by Betahistine is expected.
Hepatic Impairment Caution is advised because Labirin is highly metabolized, and no specific pharmacokinetic data is available in patients with liver impairment to assess interaction severity.

All interaction statements are strictly based on label text and official risk classifications.

Mechanism of Action

How Labirin Works

Labirin acts as an anti-resorptive agent that selectively modulates bone turnover. Its mechanism begins at the molecular level with the inhibition of the enzyme Cathepsin K (CTSK), which is expressed primarily within the osteoclast bone-resorbing cell line. Labirin is a small molecule that binds reversibly to the active site of CTSK.

This specific molecular interaction reduces the catalytic efficiency of CTSK, thereby limiting the enzyme's capacity to degrade bone matrix collagen. Collagen degradation is an essential step in the cellular process of bone resorption. By interrupting this specific step via CTSK inhibition, Labirin decreases the overall rate of matrix breakdown. This action preserves the integrity of the bone structure at the physiological level without directly altering the function or viability of osteoblasts, the cells responsible for bone formation. The resulting system-level physiological consequence is the modulation of bone mineral density and structure.

Dosage and Administration Information

How Labirin is Used: Official Administration Guidelines

Labirin (Betahistine) is a prescription-only medication that follows specific official administration principles. The drug is presented as tablets and is intended for oral administration as a long-term treatment.


Administration and Dosage Patterns

The total daily dose of Labirin is flexible but typically ranges from 24 mg to 48 mg of Betahistine dihydrochloride, with a maximum recommended daily dose of 48 mg. The administration frequency is structured to deliver this total dose in two or three divided doses throughout the day. This divided schedule is intended to maintain consistency during the daily course of use.

Instruction Category Official Guidance
Route of Administration Oral
Frequency 2 to 3 times daily (divided doses)
Timing Relative to Meals Take tablets with or immediately after meals
Missed Dose Rule Skip the missed dose and take the next dose at the regular time; do not double dose

Contextual Use and Duration

For proper consumption, the tablets should be swallowed whole with water and taken with food. The clinical course often requires long-term continuous administration, as observed benefits may take a couple of weeks to manifest, with optimal results sometimes appearing after several months of continuous use.

Population-Specific Guidance

No specific dose adjustment is required for older adults (the elderly). However, Labirin is not recommended for use in children and adolescents under the age of 18 years.

Recent Clinical Evidence

Labirin: Recent Clinical Evidence

Research has explored Labirin's mechanism of action and its associated therapeutic potential, primarily focusing on conditions characterized by inner ear disturbances, such as vertigo and certain types of dizziness. Its proposed mechanism involves the histamine H1 and H3 receptor systems, with studies investigating its effect on vestibular compensation.


Overview of Study Findings

Clinical research, including randomized controlled trials (RCTs), has examined the use of Labirin in adult patients experiencing peripheral vestibular vertigo. These studies compared the outcomes of patients receiving Labirin versus those receiving placebo or alternative treatments, evaluating endpoints related to the frequency, intensity, and duration of vertigo attacks.

Available evidence suggests that the use of Labirin was associated with an observed reduction in the number and severity of vertigo attacks in some patient populations. Research also documented findings on the agent's potential to influence the rate of recovery from acute vertigo episodes, primarily by examining changes in nystagmus and postural stability over time.


Tolerability and Adverse Events

Clinical trials have examined the tolerability profile of Labirin across different patient groups. The research documented the incidence of adverse events, which are typically mild to moderate in nature. The most commonly reported side effects in the study population were gastrointestinal upset, such as nausea and dyspepsia, and headache. In some long-term studies, research explored whether continuous use was associated with specific systemic effects, documenting a generally favorable tolerability profile at standard doses.

Key Studies & References

  1. NICE Guideline: Diagnosis and Management of Vertigo and Dizziness in Adults

Frequently Asked Questions (FAQ)

Common questions about Labirin (FAQ)


Q: Does Labirin affect my blood pressure?

Official product information advises caution for healthcare professionals when Labirin is prescribed to patients with severe hypotension (low blood pressure). The medicine is also contraindicated (should not be used) in patients with a specific adrenal gland tumour called phaeochromocytoma. This is based on the theoretical risk of inducing severe high blood pressure, as stated in the official labeling.

Q: Are there any foods I should avoid while on this medication?

According to official regulatory guidance, there are no specific foods listed for avoidance while taking Labirin. Official administration guidance is to take the tablets with or immediately after meals. Taking Labirin with food may slightly slow the rate at which the active substance is absorbed by the body, but the total amount absorbed remains the same.

Q: Can I drink alcohol while taking Labirin?

Core regulatory documents do not list a direct interaction between Labirin and alcohol. However, caution is generally advised, as alcohol consumption may potentially worsen the symptoms of the underlying condition (such as vertigo) or known side effects (like headache or dizziness). Any decision regarding alcohol should be based on a person's individual circumstances.

Q: Does Labirin make you drowsy or affect driving?

Official labeling generally states that Labirin is not likely to affect the ability to drive or operate machinery. However, the condition being treated, or some mild side effects such as dizziness, could potentially impair these abilities. Individuals are advised to exercise caution until they understand how the medication affects them.

How should Labirin be stored and disposed of?

How to Store and Dispose of Labirin

Labirin (Betahistine) must be stored according to official regulatory specifications to maintain its stability and integrity.


Storage Requirements

Condition Requirement (Official Labeling)
Temperature Store at a temperature not exceeding 30 C (86 F) in a cool, dry place.
Packaging Keep the tablets strictly in the original container or package.
Protection The medicine must be kept out of the sight and reach of children.
Stability The shelf life is typically 3 years when stored correctly.

Disposal Instructions

Do not dispose of Labirin via wastewater (sinks or toilets) or general household waste. If the medicine is expired or no longer needed, you must ask a pharmacist or utilize a local medicine take-back program for safe and appropriate pharmaceutical waste handling. This product is not classified as a hazardous medicinal product.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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