Беротек Н

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Беротек Н

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Overview of Беротек Н

Property Description
Active ingredient Fenoterol Hydrobromide
Form Metered-dose inhaler (Aerosol inhalant)
Pharmacological class Selective beta2-adrenoreceptor agonist
General purpose Relief from reversible airway obstruction
Origin Synthetic organic compound

The medicinal entity Беротек Н is a foundational, single-component product whose identity is defined by the active ingredient Fenoterol Hydrobromide. Its primary function is derived from its pharmacological classification as a Selective beta2-adrenoreceptor agonist, a category of Sympathomimetic agent used for respiratory distress. Short-acting beta2-agonists like Fenoterol provide rapid symptomatic relief of acute bronchoconstriction in patients with asthma and COPD.

What Type of Medicine is Беротек Н?

Беротек Н is classified as a Selective beta2-adrenoreceptor agonist, a key sub-class of bronchodilator agents characterized by its rapid onset of effect in acute respiratory episodes. The core substance, Fenoterol, is a synthetic organic compound presented as a racemic mixture, ensuring consistent pharmacological properties as a short-acting agent. Fenoterol Hydrobromide is further categorized chemically as a phenethylamine derivative, which helps establish its precise identity within the broader class of adrenergic substances.

Form and Origin: Беротек Н as an Inhalant

The drug is primarily supplied as a pressurized Metered-dose inhaler (aerosol inhalant), a precise delivery system that characterizes the Беротек Н identity. It is also available as a sterile Solution for nebulization. Both preparations utilize the inhalation route, which is crucial for delivering the Fenoterol Hydrobromide directly and efficiently to the respiratory tract. The inhalant system optimizes local therapeutic concentration on the bronchial smooth muscle.

General Purpose: How Fenoterol Relieves Airway Obstruction

The general purpose of Беротек Н is to rapidly alleviate the immediate symptoms of reversible airway obstruction by opening constricted air passages. This action is achieved because the Fenoterol selectively targets and stimulates the beta2-receptors, causing the bronchial smooth muscle to relax swiftly. This bronchodilation facilitates easier and increased airflow, a physiological outcome that addresses the core issue of constricted airways observed in conditions like Bronchial asthma and Chronic obstructive pulmonary disease (COPD).

Regulatory References

  1. highly effective for rapid symptomatic relief of acute bronchoconstriction
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What side effects are possible with Беротек Н?

Possible Side Effects and Safety Information

The officially documented adverse effects of Fenoterol Hydrobromide are primarily linked to its classification as a selective beta2-adrenoreceptor agonist, leading to effects categorized by system-organ class and frequency.

Regulatory Classification of Adverse Reactions

The safety profile distinguishes between common, expected sympathetic effects and rare, serious reactions, as defined in regulatory documents. These effects may be more prominent at the start of treatment or with doses higher than recommended.

Frequency Classification Examples of Officially Documented Effects
Common Tremor, Headache, Palpitations, Tachycardia, Dizziness, Nausea, Dry mouth
Rare Paradoxical Bronchospasm, Severe Hypersensitivity Reactions (Anaphylaxis, Angioedema), Myocardial Ischaemia

Adverse effects are documented across several organ systems, including the Nervous System (e.g., tremor, headache), Cardiac Disorders (e.g., palpitations, tachycardia), Gastrointestinal Disorders, and Metabolism and Nutrition Disorders.

Serious Adverse Reactions and Safety Constraints

The label identifies certain reactions that are rare but potentially serious. These include Paradoxical Bronchospasm, which is severe and requires immediate consideration, and Hypokalemia (low potassium levels), which is potentially serious, particularly in patients with severe airway obstruction.

Regulatory documents specify safety considerations for certain patient populations. Caution is required in individuals with Severe Organic Heart or Vascular Disorders, Hyperthyroidism, or Insufficiently Controlled Diabetes Mellitus. Additionally, the label documents that use late in pregnancy may cause sympathetic effects in the newborn, such as tremor or tachycardia.

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Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation defines the overdose profile of Fenoterol Hydrobromide as manifestations of excessive beta-adrenergic stimulation, which represents an exaggeration of known pharmacological effects. If overdosage is suspected, or if acute symptoms rapidly worsen and require a dose exceeding the maximum prescribed limit, immediate medical attention must be sought, typically by consulting a doctor or the nearest hospital.


Documented Clinical Manifestations

The expected signs and symptoms documented in official labeling include Tachycardia (rapid heart rate), Palpitation, Tremor, Restlessness, Dizziness, Headache, Flushing, and alterations in blood pressure (increase in systolic, fall in diastolic).


Required Emergency Management and Monitoring

The treatment for overdosage is primarily defined as supportive and symptom oriented. A potentially serious consequence documented in regulatory text is Hypokalemia (low serum potassium levels), for which serum potassium levels should be monitored. Although no specific antidote is available, cardioselective beta-blockers are the preferred intervention for managing severe beta-adrenergic effects. This specific therapy must be administered with extreme caution due to the risk of precipitating severe bronchospasm.

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Therapeutic Uses of Беротек Н

What Беротек Н Treats: Main Uses and Benefits

The primary purpose of this medication is to provide supportive relief for challenging breathing difficulties. The active ingredient is used to address acute symptomatic episodes related to airway constriction.

This medication is commonly used across conditions presenting with acute episodes, such as bronchial asthma and Chronic Obstructive Pulmonary Disease (COPD). It helps address symptom clusters that may become intense or disruptive, including shortness of breath, wheezing, and the feeling of chest tightness.

In clinical settings, the medication is relevant when supportive symptom management is appropriate, especially during sudden flare-ups or when symptoms are anticipated. This supports patients during episodes of heightened discomfort by offering symptomatic relief. This contributes to improved comfort during periods of heightened symptoms and assists with maintaining functional stability, providing relief when symptoms interfere with routine activities.


Quick Fact: Relief for Acute Airway Symptoms This medication is used in the management of sudden, temporary symptoms of airway narrowing. It is applied in addressing recurrent or episodic manifestations.

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Eligibility and Restrictions for Use

Who can and cannot use Беротек Н?

Population eligibility for Беротек Н (Fenoterol Hydrobromide) is defined strictly by regulatory labeling, which establishes both permitted use and absolute prohibitions.

Eligibility Status

Population Group Regulatory Status
Adults Established Use
Children (Ages 6 to 12) Established Use (restricted dose schedule)
Children (Under 6) Use Not Established (not generally recommended)
Older Adults (Geriatric) No Specific Information documented in primary labels

Contraindications and Restrictions

Use of this medicine is absolutely prohibited (contraindicated) in patients with Hypertrophic obstructive cardiomyopathy, Tachyarrhythmia, or documented Hypersensitivity to Fenoterol Hydrobromide or its excipients.

Regulatory documents specify that use requires careful risk/benefit assessment in individuals with conditions such as severe organic heart or vascular disorders, hyperthyroidism, pheochromocytoma, or insufficiently controlled diabetes mellitus.

Pregnancy and Lactation

During pregnancy, especially the first trimester, usual precautions must be exercised. As Fenoterol is excreted into breast milk, caution should be exercised when administered to a nursing woman.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Беротек Н (Fenoterol) is primarily defined by pharmacodynamic effects that modify the drug's cardiovascular and metabolic risks when used concurrently with specific medications.


Documented Pharmacodynamic Interactions

Concomitant Medicine Class Documented Interaction Risk
Non-selective Beta-blockers Contraindicated/Strong Restriction: Antagonism of the bronchodilator effect; risk of severe bronchospasm.
Diuretics, Corticosteroids, Xanthine Derivatives Increased risk and/or severity of hypokalemia (low potassium levels) and/or related ECG changes.
Other Sympathomimetic Agents (including MAOIs & TCAs) Increased risk of adverse cardiovascular effects (e.g., potentiation of effects on the heart and circulation).

Other Interaction Considerations

The official regulatory documents note that Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs) may potentiate Fenoterol’s effect on the cardiovascular system, requiring caution during concurrent use. Specific pharmacokinetic data regarding enzyme (CYP) or transporter-mediated interactions that significantly alter Fenoterol's systemic exposure (AUC/Cmax) are not typically detailed in regulatory labeling for the inhaled product. There are no commonly documented clinically significant interactions with food, alcohol, or herbal products specified in the official prescribing information.

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Mechanism of Action

How Беротек Н Works

Беротек Н (fenoterol hydrobromide) functions as a direct-acting sympathomimetic agent whose pharmacodynamic action is confined to the modulation of specific adrenergic receptors.


Selective beta2-Adrenoreceptor Agonism

The primary mechanism involves the selective agonism of beta2-adrenergic receptors present on the surface of smooth muscle cells within the bronchi. This interaction initiates an intracellular signaling cascade, specifically through the activation of a G-protein coupled pathway, which is essential for modulating pathways linked to muscle tone.


cAMP Cascade and Physiological Modulation

Receptor occupation leads to the activation of adenylate cyclase and a subsequent rapid increase in the intracellular concentration of cyclic AMP (cAMP). Elevated cAMP levels reduce intracellular calcium availability, causing the relaxation of bronchial smooth muscle. This modulation directly affects the functional state of the airway smooth muscle.


Stabilization of Cellular Mediator Release

Furthermore, the increased cAMP concentration exerts effects on other resident cell populations, notably mast cells. This activity suppresses the processes required for the release and exocytosis of bronchoconstricting and pro-inflammatory mediators, inducing a reduction in local biochemical signaling and maintaining the modulation of these specific intracellular cascades.

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Dosage and Administration Information

How to Use Беротек Н: Administration Guidelines

Беротек Н (Fenoterol Hydrobromide) is a single-component bronchodilator for respiratory use. Its administration follows standardized instructions to ensure correct delivery and dosage.


Administration and Dosage

Feature Labeled Instruction
Route of Administration Inhalation (Oral inhalation only). The product is supplied as a Metered-Dose Inhaler (MDI) or a Solution for Nebulization.
Standard Acute Dosing For acute bronchospasm relief, the typical dose is 1 to 2 actuations (puffs). If breathing is not noticeably improved after 5 minutes, a second dose (another 1 to 2 actuations) may be administered.
Maximum Use Limit The total use must not exceed 8 actuations per day. Increasing the frequency of use or the total daily dose is restricted and indicates a need for immediate medical consultation.
Dosing Pattern Primarily used as-needed (on-demand) for acute symptoms. For regular use in appropriate cases, a typical regimen may be up to 4 times daily.

Essential Administration Technique

Proper preparation and technique are required for the medication to reach the lungs effectively. The procedure requires specific steps for MDI use:

  1. Priming: The device must be “primed” (usually by releasing 2 test sprays into the air) before first use and if it has not been used for several days.
  2. Inhalation: The patient must exhale fully, then coordinate the actuation of the canister with a slow, deep breath through the mouth.
  3. Breath Hold: The breath should be held for several seconds (e.g., 10 seconds) before slowly exhaling.

Special Conditions: The nebulization solution must be diluted with physiological saline to a specified volume (e.g., 3–4 ml) immediately before administration. Care must be taken to avoid spraying the mist into the eyes.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Беротек Н


Evidence for use in Bronchial Asthma

Research examined the use of Беротек Н (fenoterol hydrobromide) in individuals with conditions characterized by fluctuating or episodic manifestations like bronchial asthma. Studies explored how the product was evaluated in settings relevant in trials assessing short-term or episodic symptom patterns, often comparing it to a dummy treatment or an active comparator. The main focus of this research was on measurements of lung capacity (outcomes related to systemic or functional imbalance) shortly after use, and on patient-reported outcomes describing perceived discomfort related to breathing.

Findings describe patterns observed in the studies related to outcomes describing episodic or acute changes in breathing during periods of increased symptom activity. Research focused on short-term symptom changes in studies observing responses over defined time intervals. However, these results apply only to the populations studied, and follow-up durations were limited in many acute studies.


Evidence for use in Chronic Obstructive Bronchitis

Studies also explored the use of the compound in patients with conditions marked by functional limitations, such as those with chronic obstructive bronchitis (a component of COPD), where studies examined temporary changes in lung capacity. This research was primarily used in observational settings evaluating daily-life functioning and focused on outcomes reflecting daily functioning or activity level. Evidence is limited for these patients compared to those with asthma, with much of the data coming from less-controlled settings or aggregated reports.

What remains uncertain for this specific population is significant. Long-term effects are not fully established specifically for the sustained use of this product in conditions marked by functional limitations such as COPD. Comparative evidence is lacking to fully understand the place of this product alongside other research approaches.


Long-term studies and follow-up

Research has explored the use of Беротек Н over varying time intervals. Follow-up durations were limited in many of the key studies. A major area of uncertainty is that long-term effects are not fully established. There is limited information for long-term outcomes regarding the sustained effects of regular use. Studies monitored for safety, and findings indicate patterns related to adverse events were observed in some studies associated with regular use over time.


Evidence in special populations

The research has also examined Беротек Н in specific subgroups. The product was evaluated in children and adolescents; research examined outcomes related to physical discomfort and breathing difficulty in this age group. Findings describe patterns observed in the studies, but sample sizes were modest compared to adult trials. Data for certain groups remain insufficient. For instance, there is limited information for long-term outcomes in older adults or for patients with serious co-existing health conditions, as these groups can be underrepresented in the research.


What is still uncertain about Беротек Н

Research highlights what is known — and what is still uncertain. Evidence quality varies across studies, leading to some mixed findings, and the certainty remains low in areas such as understanding long-term outcomes or comparing the product's use across many different patient types. Data are still emerging regarding the full safety profile under real-world, prolonged use. Studies help show what has been observed so far, but the results apply only to the populations studied and reflect the specific conditions under which they were conducted.

Key Studies & References

  1. Fenoterol Hydrobromide: Product Information/Label (Regulatory Document)
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Frequently Asked Questions (FAQ)

Common questions about Беротек Н (FAQ)


Q: How long does the effect of one dose of Berotec N usually last?

Regulatory documents indicate that Berotec N is classified as a short-acting bronchodilator. Official information suggests that the therapeutic effect typically lasts for several hours, which is consistent with its use for immediate, on-demand relief of acute symptoms.


Q: Can I drink coffee or consume large amounts of caffeine while using Berotec N?

While alcohol and food are generally not specified as having clinically significant interactions, concurrent use with large amounts of caffeine or other stimulants may increase the risk of cardiovascular side effects. This may be due to the possibility of increased stimulating effects on the heart and circulation.


Q: Does Berotec N affect blood pressure or blood sugar levels?

Regulatory documents note that the medication can cause changes in blood pressure, specifically an increase in the systolic (upper) reading and a decrease in the diastolic (lower) reading. The official label includes a warning that caution is required for patients with insufficiently controlled diabetes, citing the potential for metabolic effects.


Q: Are there any components in Berotec N that can cause an allergic reaction?

Official prescribing information states that the medicine is strictly contraindicated (should not be used) in the event of a known hypersensitivity to the active ingredient, Fenoterol, or any of the inactive ingredients, known as excipients.


Q: What should I expect if I accidentally take an extra puff of Berotec N?

Regulatory documents describe that exceeding the recommended dose may result in increased side effects. These can include a very fast heart rate (tachycardia), rapid or irregular heartbeats (palpitations), and increased hand shaking (tremor).


Q: Do I need to clean the Berotec N inhaler?

Yes, official instructions recommend regular maintenance of the inhaler to ensure proper function. This involves removing the metal canister and rinsing the plastic mouthpiece with warm water until no residue is visible, then allowing it to air dry completely before reinserting the canister.


Q: Is it normal to experience a strange taste when using Berotec N?

Experiencing unusual tastes, referred to as taste disturbances, has been reported as an uncommon side effect of this class of medication. Additionally, if there has been a recent change in formulation, patients might notice that the taste is slightly different.


Q: Are sleep problems related to the use of Berotec N?

Regulatory information notes that the medication can cause psychiatric and nervous system side effects such as feelings of agitation or nervousness. Sleep disturbances, such as insomnia, have been reported with this class of medication, which is consistent with its classification as an agent that affects the nervous system.


Q: Can Berotec N affect my ability to drive or operate machinery?

Official documents state that because side effects like dizziness have been reported, caution is recommended regarding driving a car or operating machinery. Patients should be aware of how the medicine affects them before engaging in these activities.


Q: Are there any age restrictions or special precautions for the elderly using Berotec N?

Official regulatory documents indicate a current lack of specific information or dosage adjustment instructions documented for the older adults (geriatric) population in the primary prescribing labels.


Q: Can an allergic reaction to Berotec N appear as a skin rash?

Regulatory safety information indicates that skin reactions have been reported in rare cases, especially in sensitive patients. These reactions can include a rash, itching (pruritus), or hives (urticaria).


Q: Why does the instruction mention caution regarding glaucoma?

The regulatory label specifies that caution is required for patients who may be predisposed to a certain type of eye condition called narrow-angle glaucoma. To help prevent complications, patients are instructed to avoid spraying the mist directly into their eyes during inhalation.


Q: Is there a difference between using Berotec N as an aerosol versus using it through a nebulizer?

Yes, the method of administration differs based on the form. The aerosol (MDI) involves a dose delivered through a specific inhalation technique, while the solution for nebulization requires the medicine to be first diluted with physiological saline and delivered via specialized equipment.


Q: What should I pay attention to during the first use of Berotec N?

Official instructions require the device to be primed (releasing test sprays) before first use. Additionally, safety information indicates that common side effects, such as tremor (shaking) and palpitations (heart racing), may be more prominent at the start of treatment.


Q: How long can a Berotec N canister be kept and used after it has been opened?

Regulatory instructions state that the official method for determining when to replace the inhaler is based on dose counting, rather than a specific shelf life after opening. The inhaler should be replaced after the designated number of doses has been delivered.


Q: Why might I feel a slight burning sensation in my throat when using Berotec N?

Official documents list throat irritation or local irritation in the oropharyngeal area (back of the throat) as a documented undesirable effect associated with inhalation therapy.

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How should Беротек Н be stored and disposed of?

How to Store and Dispose of Беротек Н?

This section outlines the official, label-based requirements for storing and discarding the Беротек Н (Fenoterol Hydrobromide) metered-dose inhaler.

Official Storage Requirements

Feature Regulatory Requirement
Temperature Limit Do not expose the container to temperatures above 50 C (120 F). Store at room temperature in a cool and dry place.
Physical Protection The container is under pressure and must not be opened by force or left in direct sunlight.
Child Protection Keep out of the reach of children.

Stability and Use

Official instructions require the inhaler to be replaced after the designated number of doses has been delivered, even if it still feels like liquid remains inside. The supplied plastic mouthpiece must only be used with this aerosol and should not be used with other products.

Disposal Instructions

Disposal must follow special guidelines due to the pressurized nature of the container. The device should not be discarded in household waste or recycling. The official guidance is to return the unused or expired product to a special or hazardous waste collection point (e.g., a pharmacy take-back program) and not to flush it into water systems.

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

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