Беродуал Н

Quick links

Choose a section

Quick links to important sections

Advertisements

Беродуал Н

Selected form

Advertisements
Advertisements
Advertisements

Overview of Беродуал Н

Property Description
Active Ingredients (INN) Fenoterol, Ipratropium Bromide
Form Pressurized Metered Dose Inhaler (pMDI), Solution for Inhalation
Pharmacological Class Fixed-Combination Bronchodilator
General Purpose Immediate relief of bronchospasm
Origin Synthetic, Dual-agent combination

What Type of Medicine is Беродуал Н?

Беродуал Н (Berodual N) is a synthetic, fixed-dose combination bronchodilator preparation administered via inhalation. It is clinically recognized as a dual-agent therapy, distinguished by its inclusion of two distinct active ingredients that utilize complementary mechanisms to alleviate airway constriction. The preparation is typically encountered in two established dosage forms: a Pressurized Metered Dose Inhaler (pMDI) and an aqueous solution for inhalation via a nebulizer.

This combination product holds significant global standing, being recognized for its efficacy in the management of obstructive airway disorders. The preparation is positioned for patients who require the comprehensive benefit of two bronchodilator classes simultaneously, targeting the fundamental issue of reversible airflow limitation.

Composition: The Dual Active Ingredients

The medicinal entity contains the active ingredients Fenoterol and Ipratropium Bromide (INN), representing the two pharmacological classes central to its action. Fenoterol is classified as a selective beta2-adrenoreceptor agonist (beta2-agonist), and Ipratropium Bromide is defined as an anticholinergic agent. The use of these two distinct chemical entities is designed to provide enhanced muscle relaxation over monotherapies.

These compounds are synthetic and are optimized for pulmonary delivery. The beta2-agonist component stimulates specific receptors, leading to muscle relaxation, while the anticholinergic agent works by blocking the nerve signals that initiate muscle contraction.

General Purpose of the Combination

The fundamental general purpose of this combination preparation is to rapidly and effectively achieve maximum bronchodilation to relieve acute bronchospasm. The strategic use of both components ensures a highly synergistic effect, which is critical when immediate and pronounced widening of the airways is required, such as in episodes of sudden breathing difficulty.

This dual action is aimed at immediately facilitating easier and less restricted airflow within the lungs. The core benefit of Беродуал Н is its ability to rapidly counter the muscular tightening in the bronchial tubes, which is the physiological basis for reversible airflow limitation.

Advertisements

What side effects are possible with Беродуал Н?

Possible Side Effects and Safety Information

The safety profile for Беродуал Н is officially documented and categorized by the frequency and nature of adverse reactions, restrictions on use, and specific required precautions.


Frequency-Classified Adverse Reactions

The following are examples of documented side effects, categorized by how often they may occur:

  • Common (may affect up to 1 in 10 people): Headache, dry mouth, cough.
  • Uncommon (may affect up to 1 in 100 people): Nausea, tremor, nervousness, dizziness, throat irritation.
  • Rare (may affect up to 1 in 1,000 people): Urticaria (hives), angio-oedema (swelling), anaphylactic reaction (severe allergic reaction).

Side effects are also grouped by the System-Organ Class affected, including the Nervous System, Cardiac System, Respiratory System, Gastrointestinal System, and Immune System.

Serious and Clinically Significant Adverse Reactions

Specific serious reactions documented in regulatory sources include:

  • Paradoxical Bronchospasm: A sudden worsening of breathing difficulties immediately following use of the medicine, which is potentially life-threatening and requires immediate cessation of the product.
  • Acute Narrow-Angle Glaucoma: Ocular complications, signaled by symptoms such as eye pain, blurred vision, or visual halos.
  • Anaphylaxis: A severe, life-threatening allergic reaction.

Safety Restrictions and Contraindications

The medicine is strictly contraindicated (must not be used) in patients with:

  • Hypersensitivity to the active substances, atropine-like substances, or any excipients.
  • Hypertrophic obstructive cardiomyopathy (a serious heart condition).
  • Tachyarrhythmia (a type of rapid heart rhythm).

Caution and close monitoring are required in patients with pre-existing conditions, including but not limited to:

  • Narrow-angle glaucoma.
  • Insufficiently controlled diabetes mellitus.
  • Recent myocardial infarction or severe heart/vascular disorders.
  • Hyperthyroidism or phaeochromocytoma.
  • Urinary outflow tract obstruction.

Use in pregnant and breastfeeding women requires a careful risk/benefit assessment due to limited safety data. Higher than recommended doses are officially stated to increase the risk of potentially serious adverse reactions.

Advertisements

Overdose and Emergency Response

Overdose and When to Seek Help

The official overdose profile for Беродуал Н is primarily characterized by the effects of excessive Fenoterol exposure, which causes beta-adrenergic hyperstimulation. Documented clinical manifestations of overdose include signs of cardiovascular system stress such as tachycardia (rapid heartbeat), palpitation, tremor, hypertension, and anginal pain.

Less severe, transient effects from the Ipratropium Bromide component may also be present, notably dry mouth and visual accommodation disturbances. Severe outcomes associated with overdose include the risk of potentially serious hypokalaemia (low potassium levels) and cardiac events that may be associated with the excessive use of beta-agonists.

Immediate medical attention is required in the event of a suspected overdose. Official regulatory guidance mandates that patients seek medical advice immediately if they experience acute, rapidly worsening dyspnoea or specific ocular symptoms indicative of acute narrow-angle glaucoma, such as eye pain or blurred vision.

Treatment consists of the discontinuation of the product and institution of appropriate medical and supportive therapy. Management may involve the judicious use of a beta-receptor blocker under medical supervision to counteract the beta-agonist effects, and monitoring of serum potassium levels is recommended. Regulatory information also notes specific overdose risks for the newborn if high doses are used late in pregnancy.

Advertisements

Therapeutic Uses of Беродуал Н

What Беродуал Н Treats: Main Uses and Benefits

This medication is generally used for managing acute symptoms related to bronchospasm, which is the sudden muscular tightening of the airways, and for the symptomatic control of conditions involving episodic or fluctuating manifestations. It is commonly used across conditions presenting with acute episodes, specifically Bronchial Asthma and Chronic Obstructive Pulmonary Disease (COPD), including aspects of chronic bronchitis and emphysema. This approach is considered relevant for easing symptoms that create noticeable physiological strain, such as wheezing, chest tightness, and acute shortness of breath, as bronchodilators are utilized for easing these acute symptomatic episodes.

The medication provides support that helps ease the overall symptom burden in situations where symptoms may intensify temporarily. The combination assists with maintaining functional stability when symptoms interfere with daily functioning, supporting the patient during difficult respiratory episodes by easing distress.

“The combination assists with maintaining functional stability when symptoms interfere with daily functioning, supporting the patient during difficult respiratory episodes by easing distress.”


Quick Fact: Relief for Acute Respiratory Distress The medication is applied when symptoms intensify and supportive relief is needed to address symptoms that create noticeable physiological strain.

Regulatory References

  1. Ipratropium Bromide Monograph
Advertisements

Eligibility and Restrictions for Use

The eligibility for using Беродуал Н is determined by official regulatory documents, establishing populations who must not use the medicine and those who must use it with caution.

Contraindicated Populations

Use is strictly prohibited for individuals with known hypersensitivity to the active ingredients (fenoterol hydrobromide, ipratropium bromide), any excipients, or other atropine-like substances. The medicine is also contraindicated for patients with hypertrophic obstructive cardiomyopathy or tachyarrhythmia.

Age and Physiological Restrictions

Use is contraindicated in children under 6 years of age. For women, the medicine is contraindicated during the first and third trimesters of pregnancy, and its use in the second trimester and during breastfeeding requires caution.

Use Requires Caution (Restricted Eligibility)

Official labeling mandates that the medicine must only be used after careful risk/benefit assessment in patients with:

  • A predisposition to narrow-angle glaucoma.
  • Severe organic heart or vascular disorders (e.g., recent myocardial infarction).
  • Insufficiently controlled diabetes mellitus.
  • Hyperthyroidism or phaeochromocytoma.
  • Pre-existing urinary outflow tract obstruction (e.g., prostatic hypertrophy).
  • Renal or hepatic insufficiency.

These constraints establish the official regulatory profile of eligibility.

Advertisements

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Беродуал Н (Fenoterol/Ipratropium) is primarily driven by pharmacodynamic effects, as documented in regulatory information. It is important to review all concurrent medications with a healthcare provider, as certain combinations may lead to increased risks or reduced effectiveness.

Documented Interaction Categories

Interaction Type Interacting Agents / Classes Resulting Effect / Constraint
Antagonism / Contraindication Non-selective beta-blockers Abolition of bronchodilatory effect; risk of severe bronchospasm.
Additive Effects / Increased Risk Other beta-adrenergics, Anticholinergics, Xanthine derivatives Intensified bronchodilation and increased adverse effects.
Enhanced Hypokalemia Risk Corticosteroids, Diuretics, Xanthine derivatives Increased risk of low potassium levels (hypokalemia) due to the Fenoterol component.
Increased Arrhythmia Susceptibility Digitalis Glycosides Risk of arrhythmias increased if hypokalemia develops.
Potentiation of Sympathomimetic Action Monoamine Oxidase Inhibitors (MAOIs), Tricyclic Antidepressants (TCAs) Enhanced action of the beta-adrenergic component, requiring caution.

Co-administration with non-selective beta-blockers is generally restricted because they directly counteract the action of the beta2-agonist component. Other documented interactions focus on additive effects, which can increase the likelihood of side effects, particularly those affecting the cardiovascular system and electrolyte balance.

Advertisements

Mechanism of Action

How Беродуал Н Works

Беродуал Н is a fixed-dose combination product containing ipratropium bromide and fenoterol hydrobromide, which influence smooth muscle tone via two independent signaling pathways, resulting in a dual-pathway effect on the bronchi.


Sympathetic Pathway Modulation

Fenoterol acts as a selective beta2-adrenergic agonist, targeting receptors on bronchial smooth muscle cells. This interaction initiates a signaling cascade through Gs-protein activation, which increases the intracellular concentration of cyclic AMP (cAMP). The resulting surge in cAMP triggers the phosphorylation of specific proteins, ultimately causing the relaxation of the smooth muscle and a diminished response to constrictor signals.


Parasympathetic System Blockade

Ipratropium bromide acts as an anticholinergic agent. It competitively antagonizes the neurotransmitter acetylcholine at muscarinic receptors (primarily M3) located on the airway smooth muscle. Blocking this vagally-mediated reflex prevents the downstream increase in intracellular calcium concentration. This inhibition of the cholinergic signal leads to the suppression of muscle contraction and promotes the patency of the airways.

The combined, site-specific mechanism addresses both adrenergic and cholinergic regulatory inputs, thereby modulating smooth muscle tone through two distinct pathways.

Advertisements

Dosage and Administration Information

How to use Беродуал Н

Беродуал Н is administered strictly by inhalation to ensure the active ingredients (Fenoterol and Ipratropium Bromide) are delivered directly to the airways. This section details the established administration guidelines for this preparation.

Official Administration Protocol

Usage Instruction pMDI (Pressurized Metered Dose Inhaler) Solution for Inhalation (Nebulizer)
Route of Administration Inhalation only Inhalation only
Standard Adult Dose (Acute) 2 actuations (puffs) for immediate relief. Individualized dose in milliliters (mL), often under supervision.
Maximum Acute Dose Up to 4 actuations in total, to be considered only 5 minutes after the initial dose and with medical guidance. Dosing follows specific clinical protocols.
Minimum Dosing Interval 3 hours must pass between repeated doses. Determined by the treating professional.

Preparation and Procedural Rules

1. pMDI Technique: The inhaler must be shaken well before each use. Patients are instructed to coordinate a slow, deep inhalation with the actuation of the device to ensure optimal lung delivery.

2. Nebulizer Preparation: The nebulizer solution should be used immediately upon opening. It is explicitly stated that the solution must not be diluted or mixed with other solutions unless advised by a professional.

Population-Specific Use

Age-specific guidelines for administration include:

  • Pediatric Patients (6-12 years): The standard single dose for acute bronchospasm is typically 1 actuation (pMDI).
  • Other Populations: No specific dose adjustment is required for older adults or patients with renal or hepatic impairment.

Administration Constraints

The medication is primarily for as-needed (PRN) use. An increasing requirement for the medication (exceeding the maximum daily limit of 8 actuations) is a clinical indicator that necessitates immediate medical reassessment.

Advertisements

Recent Clinical Evidence

Recent Clinical Evidence

Efficacy Studies in Acute Bronchospasm

Research has consistently evaluated the efficacy of the combination of ipratropium bromide and fenoterol hydrobromide (the active components of Беродуал Н) in managing acute bronchospasm associated with chronic obstructive pulmonary disease (COPD) and asthma. Studies show that the combination of both bronchodilators generally leads to a greater and more rapid increase in forced expiratory volume in one second (FEV1) compared to using either component alone.

Evidence from trials, including randomized controlled trials (RCTs) and meta-analyses, suggests that the onset of significant bronchodilation occurs rapidly following administration. The greatest improvements in lung function are often observed within the first hour, with the effect lasting up to several hours.


Safety and Tolerability Profile

Adverse events reported in clinical settings are typically consistent with the known pharmacology of inhaled beta-agonists and anticholinergics. The most frequently reported adverse events are generally mild and transient.

System Organ Class Common Adverse Events Incidence (Study Range)
Nervous System Headache, Dizziness Low to Moderate
Cardiac Disorders Tachycardia (increased heart rate) Low
Gastrointestinal Dry mouth, Nausea Moderate

Serious adverse events, such as paradoxical bronchospasm or significant cardiovascular events, are reported infrequently but require immediate medical attention. Clinical data confirm that patients with underlying cardiovascular conditions or narrow-angle glaucoma were often excluded from studies or monitored closely due to potential risks.

Key Studies & References

  1. Effects of fenoterol/ipratropium bromide on FEV1 and hyperinflation in Thai COPD patients
  2. PRODUCT INFORMATION. BERODUAL® Metered Aerosol (HFA) Ipratropium bromide + Fenoterol hydrobromide
  3. Chronic obstructive pulmonary disease in over 16s: diagnosis and management (NICE Guideline NG115)
Advertisements

Frequently Asked Questions (FAQ)

Common questions about Беродуал Н (FAQ)

Q: What does the 'Н' stand for in Беродуал Н?

A: The 'Н' in Беродуал Н (Berodual N) signifies that the inhaler contains hydrofluoroalkane (HFA) as the propellant. This type of propellant was adopted to replace older chlorofluorocarbon (CFC) propellants, primarily due to environmental regulations aimed at protecting the ozone layer. This change is noted in the official product information.


Q: Can Беродуал Н make you feel shaky or nervous?

A: Yes, official safety information indicates that this is a documented side effect, often related to the beta2-agonist component. Both tremor (shakiness) and nervousness are listed as uncommon adverse reactions in the product's safety profile. If these effects occur, they are typically mild and transient.


Q: Are there any common foods or drinks that interact with Беродуал Н?

A: Regulatory documents and official product information focus on drug-drug and disease interactions, and they do not generally list specific interactions with common foods or non-alcoholic drinks. Therefore, based on official guidance, there are no specific warnings against consuming particular foods during the use of this medicine.


Q: Why is Беродуал Н sometimes prescribed instead of a single-ingredient inhaler?

A: Official studies show that the combination of the two active ingredients (ipratropium and fenoterol) is documented to achieve a greater and more rapid bronchodilation (airway widening) compared to using either ingredient alone. The dual-mechanism effect is often utilized when a strong and fast response is needed to manage symptoms of reversible airflow limitation.


Q: Can I use Беродуал Н if I am pregnant or breastfeeding?

A: Official regulatory documents state that use during pregnancy, especially in the first and third trimesters, is either contraindicated or requires extreme caution. For breastfeeding, while systemic exposure is generally low, its use during these periods requires a careful assessment by a healthcare professional.


Q: Does Беродуал Н contain lactose or other common allergens?

A: The pressurized metered-dose inhaler formulation does not contain lactose. Its documented excipients include citric acid, purified water, and absolute ethanol. The product is officially contraindicated if a person has a known hypersensitivity to the active substances, to atropine-like substances, or to any of the specific excipients listed in the product information.


Q: Can Беродуал Н be used before exercise to prevent breathing difficulty?

A: This medication is approved for the immediate relief of acute bronchospasm (sudden breathing difficulty) and is used on an as-needed (PRN) basis. While the medicine is effective at opening the airways rapidly, its official indication is to address symptoms when they occur, rather than being used as a generalized preventive treatment.


Q: Can using Беродуал Н cause headaches?

A: Yes, official product safety data confirms that headache is a common adverse event reported by patients using this medication. This means that up to 1 in 10 people in clinical studies may experience a headache. Other common side effects often involve the nervous system.


Q: Is Беродуал Н considered a maintenance medication or a reliever?

A: According to regulatory guidance, Беродуал Н is an effective bronchodilator for intermittent treatment. For chronic conditions like bronchial asthma, it is explicitly recommended to be used only on an as-needed basis (a reliever) rather than as a regular, long-term maintenance therapy.


Q: How does the propellent in Беродуал Н affect the environment?

A: The hydrofluoroalkane (HFA) propellant used in this inhaler was adopted as a replacement for older, ozone-depleting propellants (CFCs). While HFA propellants have a much lower environmental impact than CFCs, official guidance notes that they still contribute to global warming and are classified as greenhouse gases.


Q: Does Беродуал Н show up on drug tests?

A: One of the active ingredients, fenoterol, is a beta2-agonist which is listed on the World Anti-Doping Agency (WADA) Prohibited List. Although beta2-agonists are often permitted by inhalation within specific therapeutic limits, an excess dosage may lead to an Adverse Analytical Finding in sports drug testing, according to WADA guidelines.


Q: What should I know about the clinical trials for Беродуал Н?

A: Key clinical trials were conducted to evaluate the efficacy and safety of the combination of ipratropium and fenoterol, often compared to placebo or monotherapy. The trials focused primarily on confirming significant and rapid improvements in lung function, particularly measuring the Forced Expiratory Volume ( FEV1), in patients with conditions like COPD and asthma.


Q: Does alcohol consumption interfere with Беродуал Н?

A: Official product information does not typically list alcohol as a direct interaction. However, because the medication can cause side effects like a rapid heart rate and nervousness, combining it with other substances that affect the cardiovascular or central nervous system may increase the likelihood of experiencing these adverse effects.


Q: What is the shelf life of Беродуал Н once I open the package?

A: The canister's use is based on the labeled number of doses, not on a specific date after opening. Official guidelines indicate that the inhaler is designed to deliver a specific, labeled number of doses, after which it should be replaced regardless of residual propellant. This ensures that the user receives the correct dose of medicine.


Q: What happens if I accidentally use too much Беродуал Н?

A: Official regulatory warnings state that using a dose higher than recommended is associated with an increased risk of potentially serious adverse reactions. Overdose symptoms often relate to the beta2-agonist component and may include pronounced effects such as severe tremor, fast or irregular heartbeat, and chest pain.

Advertisements

How should Беродуал Н be stored and disposed of?

Storage and Disposal Conditions for Berodual N

The storage of Berodual N, a pressurized metered-dose inhaler, must comply with official regulatory standards to maintain product integrity and safety.


Storage Requirements

  • Temperature: Store the product at a temperature not exceeding 30°C (86°F).
  • Protection: The container must be strictly protected from heat and direct sunlight.
  • Prohibited Exposure: Exposure to temperatures above 50°C (122°F) is prohibited due to the risk of explosion of the pressurized canister.
  • Child Safety: The medicine must be kept out of the sight and reach of children.
  • Container: The product must remain in its original container.

Disposal Instructions

Unused or expired Berodual N must be disposed of according to local regulations for medicinal waste. Due to the pressurized nature of the canister, official guidelines advise against puncturing, breaking, or burning the container. The product must not be thrown into household trash or wastewater; authorized drug take-back programs are the recommended method for disposal.

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

Available in countries:

Equivalent of Беродуал Н found in:

A-Z Index: