Фенотерол

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Фенотерол

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Overview of Фенотерол

Quick Facts

Property Description
Active ingredient Fenoterol Hydrobromide
Form Inhalation solution, Metered-dose inhaler (MDI)
Pharmacological class Selective Beta-2 Adrenergic Agonist
Common use Relieving acute airway constriction (bronchospasm)
Origin Synthetic derivative

What is Fenoterol and What is its Pharmacological Class?

Fenoterol (Фенотерол) is a synthetic medicinal substance that belongs to the pharmacological class of Selective beta2-Adrenergic Agonists. The active component is typically administered as Fenoterol Hydrobromide, a salt form recognized for its immediate bronchodilator properties. The substance is chemically classified as a resorcinol derivative.


Fenoterol is officially categorized as a Short-Acting beta2 Agonist (SABA). This designation is clinically recognized for acute respiratory management, distinguishing it from long-acting formulations. It functions as a sympathomimetic agent characterized by rapid action. Popular preparations containing Fenoterol include the single-entity product Berotec and the well-known combination product Berodual (which includes Ipratropium).

The General Purpose and Forms of Fenoterol

The general purpose of Fenoterol is to cause rapid and effective bronchodilation, which works to widen constricted air passages in the lungs. This action provides immediate relief by relaxing the smooth muscles surrounding the bronchial tubes, thereby improving airflow. The substance achieves this airway widening through direct muscular relaxation.


Fenoterol is predominantly available in dosage forms suited for inhalation, which facilitates the quickest route to the affected respiratory muscles. The most common preparations are the inhalation solution (often used with a nebulizer) and the metered-dose inhaler (MDI). As a SABA, its differentiation lies in its swift, targeted delivery via the respiratory route, ensuring the substance reaches the site of action quickly for immediate relief.

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What side effects are possible with Фенотерол?

Possible Side Effects and Safety Information

The safety profile of Fenoterol is officially classified based on the standard frequency and System-Organ-Class (SOC) categories established by regulatory authorities. As a selective beta2-adrenergic agonist, many listed adverse reactions are consistent with sympathomimetic effects.

Officially Documented Adverse Reactions

Adverse effects are grouped by frequency, based on official regulatory prescribing information:

Frequency Classification Examples of Adverse Reactions (SOC Grouping)
Common Cough, Pharyngitis (Respiratory)
Uncommon Tachycardia, Arrhythmias, Dry mouth, Nausea, Skin reactions (Cardiac, GI, General)
Rare Anaphylactic reaction, Headache, Dizziness, Fine Tremor, Palpitations (Immune, Nervous, Cardiac)
Not Known Paradoxical bronchospasm, Myocardial ischaemia, Acute Narrow-Angle Glaucoma (Respiratory, Cardiac, Eye)

Serious Adverse Reactions and Constraints

The official label highlights the potential for serious, immediate reactions, including paradoxical bronchospasm—where the medicine unexpectedly worsens breathing—and immediate hypersensitivity reactions such as anaphylaxis and angio-oedema. Potential cardiovascular effects are a known class effect, and rare instances of myocardial ischaemia are documented. The profile also lists the risk of Acute Narrow-Angle Glaucoma if the inhalation mist contacts the eyes.

Population-specific constraints require careful assessment for individuals with pre-existing conditions such as severe heart disorders, uncontrolled diabetes mellitus, or hyperthyroidism. Furthermore, the use of beta2-agonists may lead to systemic changes like hypokalaemia (low potassium) and hyperglycemia, which are noted as safety constraints.

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Overdose and Emergency Response

Overdose and when to seek help

Overdosage of Fenoterol is officially described in regulatory documentation as presenting the effects of excessive beta-adrenergic stimulation. The documented clinical manifestations include tachycardia (increased heart rate), palpitations, and arrhythmias, as well as changes in blood pressure, such as hypertension or hypotension. Central nervous system effects may involve tremor, headache, and dizziness. A documented metabolic finding associated with overdosage is hypokalaemia, which requires monitoring of serum potassium levels.

Regulators mandate that patients must consult a physician immediately in the event of acute or rapidly worsening dyspnoea (difficulty breathing), as this indicates a need for urgent medical help. For severe cases of overdosage, intensive therapy in an appropriate unit may be necessary. Treatment involves discontinuing the drug and initiating appropriate symptomatic and supportive therapy.

A beta-adrenergic blocking agent may be considered to counteract severe effects; however, official prescribing information requires careful monitoring if this intervention is used, due to the regulatory warning regarding the risk of precipitating severe, potentially fatal bronchospasm. Administration of sedatives or tranquillisers may also be required, contingent on the immediate availability of resuscitation equipment.

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Therapeutic Uses of Фенотерол

Fenoterol is a medication relevant for managing respiratory conditions characterized by acute symptoms related to physical discomfort. The therapeutic focus is on providing supportive symptomatic relief and assistance during episodes of difficult breathing, and is commonly used across conditions presenting with acute episodes, such as asthma and COPD.

Fenoterol Hydrobromide is used to help manage symptoms related to airway narrowing, which addresses acute respiratory distress through its action on the bronchial passages.


Key Therapeutic Applications

This medication is relevant for individuals managing conditions such as bronchial asthma and Chronic Obstructive Pulmonary Disease (COPD), which are conditions characterized by periods of heightened symptoms due to reversible airway obstruction. It is commonly used to help with symptomatic assistance during acute symptomatic exacerbations, offering relief from acute wheezing, intense shortness of breath, and uncomfortable chest tightness. It may also be applied in an attempt to address symptoms that might otherwise be triggered by activity, such as in the prophylactic use against exercise-induced asthma.

“The primary therapeutic benefit is to contribute to easing difficulty in breathing, which assists with easing distress and supports patients during difficult episodes by easing distress.”


Quick Fact Block

Quick Fact: Relief for Acute Distress
Primary Symptom Focus Symptoms related to acute airway constriction
Typical Context Symptomatic management during acute episodes
Patient Benefit Contributes to easing the overall symptom load
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Eligibility and Restrictions for Use

Eligibility Map: Official Regulatory Information

The eligibility profile for Fenoterol is defined by regulatory documents based on absolute prohibitions and restrictions tied to age or pre-existing conditions.

Contraindicated Populations Conditions for Conditional Use
Known hypersensitivity to Fenoterol or excipients. Insufficiently controlled diabetes mellitus.
Hypertrophic obstructive cardiomyopathy. Recent myocardial infarction.
Tachyarrhythmia (abnormally rapid heart rhythm). Severe organic heart or vascular disorders.
Hyperthyroidism or pheochromocytoma.

Age-Related Rules: The medicine is generally established for use in adults and adolescents over 14 years of age. Use in children below 14 years is not recommended by regulators due to insufficient safety and efficacy data for some formulations.

Pregnancy and Lactation: Use during pregnancy is restricted to cases where the prescribing physician deems it essential, recognizing the drug's inhibitory effect on uterine contraction. Caution is required during lactation as the substance has been shown to be excreted into breast milk.

Eligibility Restrictions: The medicine must be used with special caution in patients predisposed to narrow-angle glaucoma or those with conditions like prostatic hyperplasia or bladder-neck obstruction.

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What should I know about interactions with other medicines?

Fenoterol's official interaction profile is defined primarily by pharmacodynamic effects concerning the cardiovascular and electrolytic systems. Co-administration with certain medicinal product categories may lead to additive or antagonistic outcomes, as documented in regulatory labeling.

Interactions Affecting Efficacy and Safety

  • Antagonistic Agents: The concurrent use of β-Adrenergic Blocking Agents is officially documented to cause an antagonism of the desired bronchodilatory effect, which may result in a serious reduction of clinical efficacy.
  • Cardiovascular Potentiation: The combination with Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs) is documented to enhance Fenoterol's action on the cardiovascular system, increasing susceptibility to adverse cardiac effects. A similar risk of cardiovascular potentiation is also officially noted with Halogenated Hydrocarbon Anaesthetics.
  • Additive Sympathomimetic Agents: There is a regulatory restriction against the co-administration of Other β-mimetics or sympathomimetic agents due to the documented risk of potentiating adverse cardiovascular reactions.
  • Electrolyte Risk: The potential for Fenoterol to induce hypokalaemia may be potentiated by concurrent use of Xanthine Derivatives, Corticosteroids, or Diuretics (non-potassium sparing). This hypokalaemia risk may also increase the susceptibility to arrhythmias in patients receiving Digoxin.

Population-Specific Caution

The risk of hypokalaemia-related interactions is explicitly stated as a particular concern in patients with severe airway obstruction when co-administered with the potentiating drug classes above.

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Mechanism of Action

️ How Фенотерол Works

Receptor Activation and Airway Muscle Relaxation

Fenoterol exerts its primary action by selectively engaging the β₂-adrenergic receptors found on the smooth muscle lining the airways, functioning as an agonist to initiate a specific intracellular cascade. This molecular signaling, mediated by the cAMP pathway, causes the enzyme Myosin Light-Chain Kinase (MLCK) to become inactive, which mediates relaxation of the bronchial smooth muscle (bronchodilation).

Modulation of Cellular Signaling and Mediators

The mechanism modulates key cellular processes by influencing the regulation of inflammatory mediator release. The heightened activity of the β₂-receptor pathway causes mast cell stabilization, suppressing their ability to release bronchoconstricting and inflammatory substances, thereby influencing pathways that affect smooth muscle tone.

Dual Autonomic Regulation (in Combination Products)

In combination formulations, Fenoterol's mechanism of sympathetic activation is complemented by the co-component's action as an antagonist at Muscarinic receptors. This dual approach results in the simultaneous modulation of both major autonomic branches by promoting muscle relaxation and blocking the constriction signals originating from the parasympathetic nervous system.

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Dosage and Administration Information

Fenoterol Hydrobromide is administered exclusively via oral inhalation, delivered through a metered-dose inhaler (MDI) or as an inhalation solution requiring a nebuliser. Usage follows standardized regimens that restrict dosing to an as-needed frequency for acute symptom relief and is not intended for continuous, routine daily maintenance, particularly for bronchial asthma.

Instruction Description
Dosing Schedule (Adults) Acute Relief (MDI): 1 actuation (100 mcg) initially. A second actuation may be taken after 5 minutes if symptoms persist. Maximum Daily Dose: Must not exceed 8 actuations (800 mcg).
Preparation Requirements Nebuliser: Must be diluted with physiological saline to a final volume of 3 mL to 4 mL immediately before use. MDI: Priming is required by actuating once if the device has been unused for more than three days.
Age-Group Rules Children: Administration requires medical advice and adult supervision. Dosing for children under 6 years is often calculated based on body weight (e.g., 0.1 mL per kg) and must be strictly monitored.

Resulting Procedural Structure

The administration protocol for Fenoterol is based on a structured, on-demand approach. This framework dictates the initial single dose, specifies the exact time interval for re-dosing, and establishes clear maximum limits, thereby governing the intermittent use pattern. For nebulised forms, the preparation step of saline dilution is used to ensure proper delivery.

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Recent Clinical Evidence

Research Evidence / Overview of Studies

Summary of Key Findings

This section summarizes research that has explored Fenoterol's role in patient outcomes, primarily in respiratory conditions such as asthma and Chronic Obstructive Pulmonary Disease (COPD). The drug has been the subject of multiple clinical trials and observational studies across different patient populations.


Research in Chronic Conditions

Research has examined whether the drug has a role in managing symptoms of asthma and COPD. Studies have focused on the following areas:

  • Lung Function: Clinical trials, including randomized controlled trials (RCTs), have examined the measured increase in lung capacity, such as Forced Expiratory Volume in one second (FEV1), compared to placebo. One study in children with acute bronchial obstruction compared Fenoterol's effect on asthma symptoms against Formoterol.
  • Acute Bronchitis: A placebo-controlled double-blind study evaluated the effect of inhaled Fenoterol in patients with acute bronchitis who showed objective signs of bronchial involvement.

Safety and Pharmacological Investigation

Studies also investigate the drug's activity and safety profile:

  • Biomarkers: Studies observed changes in certain biomarkers over a 12-month period, often in trials comparing different dosing strategies. Research has also investigated the drug's effect on eosinophil function, which may be relevant to inflammation in asthma.
  • Pharmacokinetics: Research has explored how genetic factors, specifically the presence of the Organic Cation Transporter 1 (OCT1) deficiency, influence the body's processing and exposure to Fenoterol. These studies suggest that genetic variations may impact systemic drug concentrations and subsequent cardiovascular and metabolic variables.

Other Indications

Research has explored the potential of Fenoterol and its specific forms (e.g., the R,R-form) in fields outside of respiratory medicine, including preliminary studies in areas such as heart function and metabolism.

Key Studies & References

  1. Increased Systemic Exposure and Stronger Cardiovascular and Metabolic Adverse Reactions to Fenoterol in Individuals with Heritable OCT1 Deficiency (Pharmacokinetics Study)
  2. Initial Study of Fenoterol as a Treatment for Heart Failure (Phase 1 RCT, NCT01440335)
  3. Do inhaled beta-agonists control cough in URIs or acute bronchitis? (Systematic Review including Fenoterol trial)
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Frequently Asked Questions (FAQ)

Common questions about Фенотерол (FAQ)

Q: What is Фенотерол (Fenoterol) used for?

A: Фенотерол is used in the management of symptoms associated with reversible airway obstruction in conditions such as asthma and chronic obstructive pulmonary disease (COPD). It is classified as a short-acting beta-2 agonist.


Q: How does Фенотерол work?

A: Фенотерол works by affecting specific receptors in the lungs, which helps to relax the muscles surrounding the airways. This action may contribute to the opening of the bronchial tubes, potentially making breathing easier.


Q: What is the typical effect timeline?

A: The bronchodilating effect of Фенотерол is typically observed shortly after administration, often within minutes. The duration of this effect generally lasts for several hours, but individual response may vary.


Q: What are the possible side effects of Фенотерол?

A: Common side effects that may be associated with Фенотерол include tremor, headache, and heart palpitations. Less common effects may include a temporary decrease in potassium levels. If any concerning effects occur, it is recommended to speak with a healthcare provider.


Q: Is Фенотерол safe to use for children?

A: The use of Фенотерол in children requires careful consideration and dosage determination by a qualified healthcare professional. The decision to use this medication in a pediatric population is based on the child's specific medical condition and is generally subject to professional medical guidance.

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How should Фенотерол be stored and disposed of?

How to Store and Dispose of Fenoterol

Official regulatory information details specific requirements for the storage, stability, and disposal of Fenoterol, particularly for the pressurized metered-dose inhaler (MDI) form.

Storage Requirements

Fenoterol must be kept out of the sight and reach of children.

Condition Requirement
Temperature Do not expose the pressurized canister to temperatures above 50 C and keep it away from direct heat. Avoid storing in extreme cold .
Environment Protect from sunlight and moisture; do not store in damp places like a bathroom .
Stability Any Fenoterol inhalation solution that is diluted must be freshly prepared and residual solution must be immediately discarded .

Disposal Instructions

Unused or expired Fenoterol must be handled as pharmaceutical waste. Disposal must be conducted in accordance with local, regional, and national regulations . To protect the environment, the product must not be flushed into surface water or sanitary sewer systems. Patients are often directed to return empty or out-of-date inhalers to a local pharmacy for proper disposal .

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

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