Бронал

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Бронал

Treatment option: Angioedema, Asthma, Edema, Rhinitis

Medically reviewed

Rosario Oropesa

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 Бронал

Quick Facts

Property Description
Active ingredient Terfenadine (INN)
Form Oral tablet, Oral suspension
Pharmacological class Second-generation Antihistamine
General purpose Counteracts allergic responses
Origin Synthetic, Piperidine derivative

What is Бронал and How is it Classified?

Бронал is the trade name for a synthetic medicinal product primarily known by its active ingredient, Terfenadine, which belongs to the therapeutic group of antihistamines. The drug is specifically classified as a selective H1-receptor antagonist.

Chemically, Terfenadine is classified as a Piperidine derivative, and it was recognized in pharmacological studies as one of the earliest compounds designated as a second-generation antihistamine. This classification signifies that it was intended to target peripheral histamine receptors more selectively. Its identity is further defined by its nature as a prodrug, meaning the body must metabolize Terfenadine into its fully active component, Fexofenadine, to achieve its sustained therapeutic effects.

What is the General Purpose of Бронал?

The general therapeutic purpose of Бронал is to stabilize the body's reaction to allergens by counteracting the inflammatory effects of histamine. Terfenadine is globally classified under the R06AX category of the Anatomical Therapeutic Chemical (ATC) system.

The key mechanism is rooted in selective blockade, supported by pharmacological evidence showing it competitively binds to the H1 receptors found on various tissue cells, thereby preventing histamine from initiating the allergic response. The primary objective is to generally relieve common allergic discomfort, such as persistent sneezing or skin itching, by inhibiting the immune-mediated inflammatory cascade at its source.

In What Forms Was Бронал Available?

Бронал was intended for systemic delivery via the oral route of administration and was supplied primarily in solid dosage forms, notably the standard oral tablet, and also as an oral suspension. The preparation is a single-substance product, containing only the active ingredient Terfenadine combined with necessary pharmaceutical excipients. This systemic delivery method was strategically chosen to allow the active agent to be absorbed and distributed widely, ensuring comprehensive action against allergic symptoms across different areas of the body.

What side effects are possible with Бронал?

Possible Side Effects and Safety Information

This section describes the adverse reactions and safety characteristics of Terfenadine (Бронал) as documented in official government regulatory labeling. The safety profile is defined by a primary concern over cardiovascular risk and categorized less severe systemic effects.

Adverse Reaction Classifications

Side effects are officially classified by the physiological systems affected, including Cardiac Disorders, Nervous System Disorders, and Gastrointestinal Disorders.

Classification Examples of Reactions
Common Headache, drowsiness, dry mouth
Serious / Rare Ventricular Arrhythmias (Torsades de Pointes), QT Interval Prolongation

Serious Safety Considerations

The most critical adverse reaction officially documented is the potential for serious and potentially fatal ventricular arrhythmias, specifically Torsades de Pointes, which is linked to a prolongation of the QT interval in the heart's electrical activity. Severe hypersensitivity reactions are also listed as serious adverse events.

Population and Exposure Constraints

The risk of serious cardiotoxicity is officially documented to increase under specific conditions. These include use in individuals with significant liver dysfunction, which can impair metabolism, and in patients with certain pre-existing cardiac risk factors, such as known QT interval prolongation or specific electrolyte imbalances (e.g., hypokalemia). The risk is also substantially heightened by the concomitant use of other substances known to inhibit Terfenadine's metabolism, leading to elevated plasma concentrations of the parent drug.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information for Бронал

The overdose profile for Бронал (Terfenadine) is primarily defined by a documented risk of severe cardiovascular toxicity, which distinguishes it from routine safety concerns.

Category Official Regulatory Statement
Documented Overdose Presentations Symptoms may include headache, drowsiness, nausea, and vomiting. The most critical clinical sign is the occurrence of an irregular heartbeat [FDA].
Physiological Systems Affected Primarily the cardiovascular system, where life-threatening ventricular arrhythmias and prolonged QT interval can occur [FDA].
Dose-Related Factors Overdose risk is significantly linked to elevated plasma concentrations of unmetabolized terfenadine, which can be caused by large ingestions [FDA].
Population-Specific Overdose Notes Patients with underlying liver disease carry an increased risk of severe cardiotoxicity due to impaired drug accumulation [FDA].
Emergency-Response Statements Management requires symptomatic and supportive treatment and procedures to remove any unabsorbed medicinal product; no specific antidote is known [HPRA/EMA-aligned].
When Immediate Medical Help is Required Individuals must seek immediate medical attention if an overdose is suspected, or if symptoms such as irregular heartbeat, syncope (fainting), or seizures occur [FDA].

Overdose Classifications (High-Level)

Category Regulatory Statement Summary
Severity Classification The potential for life-threatening ventricular arrhythmias, specifically Torsades de pointes, leading to cardiac arrest or death, defines the severe nature of the overdose [FDA].
Overdose-Context Constraints The procedural approach to overdose is constrained by the knowledge that no specific antidote is known [HPRA/EMA-aligned].

Connection to the overall overdose profile (3 sentences):

The regulatory documents define the overdose profile by its core risk of severe cardiovascular compromise, specifically linking overdose to life-threatening arrhythmias that necessitate urgent action. This established risk mandates that individuals who suspect an overdose or experience signs like an irregular heartbeat must immediately seek emergency medical help. The required actions are procedural and supportive, focusing on stabilization and continuous cardiac monitoring due to the absence of a known reversal agent.

Therapeutic Uses of Бронал

What Бронал treats: Main Uses and Benefits

Бронал is commonly used to help with symptomatic relief across domains where the body displays heightened physiological activity related to allergens. Its application is focused on easing the discomfort and functional strain associated with these episodes. The main therapeutic areas of focus for terfenadine include seasonal allergic rhinitis, perennial allergic rhinitis, and chronic urticaria.

This medication may be part of symptomatic management in conditions characterized by episodic or fluctuating manifestations, such as during hay fever season or when managing persistent allergic skin reactions. It helps address symptom clusters that may become intense or disruptive, including sneezing fits, runny nose, itching, and the presence of hives (welts).

It provides support that helps ease the overall symptom burden, assists with maintaining functional stability when symptoms become more noticeable. It contributes to improved day-to-day comfort during symptomatic periods, which supports patients during episodes of heightened discomfort.

Summary of Therapeutic Focus
Primary Focus Nasal, ocular, and cutaneous symptoms
Focus on Symptoms Easing itching and reducing discharge
Context Episodic and seasonal flare-ups

Regulatory References

  1. Federal Register (FDA)

Eligibility and Restrictions for Use

Eligibility for Бронал (Terfenadine)

Official regulatory documents define the eligibility for Бронал primarily through a set of strict contraindications related to cardiac and metabolic health.


Populations Who Must NOT Use Бронал (Contraindications)

Category Restriction Rationale Basis
Hepatic Function Patients with significant liver dysfunction Impaired metabolism leads to cardiotoxic accumulation.
Cardiovascular Status Patients with pre-existing cardiac disease or congenital QT prolongation High risk of fatal ventricular arrhythmias (Torsades de Pointes).
Concomitant Use Patients taking potent CYP3A4 inhibitor medications Prohibited interaction prevents drug breakdown and elimination.
Metabolic State Patients with significant electrolyte imbalances (e.g., hypokalemia) Increased risk of serious heart rhythm disturbances.

Restricted or Cautionary Use

Population Regulatory Status
Pregnancy/Lactation Not Recommended; use only if benefit outweighs risk (FDA Category C).
Older Adults Use with caution due to potential cardiac/hepatic comorbidities.
Children under 12 Use restricted or not established; minimum age varies by region.

The medicine is generally permitted for adults requiring symptomatic relief only if none of the contraindications above are present. Use in all non-adult populations is subject to explicit restrictions and cautionary statements in official labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Terfenadine (Бронал) based on its metabolism, which is prone to inhibition by other substances. These interactions are primarily pharmacokinetic, leading to a significant increase in the parent drug’s plasma levels due to reduced clearance.

Interaction Entity Map (High-Level) Entity / Specific Documented Substance
Formal Contraindicated Combinations Azole Antifungals: Ketoconazole, Itraconazole, Fluconazole
Macrolide Antibiotics: Erythromycin, Clarithromycin, Troleandomycin
Mechanistic Basis Pharmacokinetic interaction via inhibition of CYP3A4 metabolic clearance
Exposure-Modifying Substances Any potent CYP3A4 Inhibitor
Specific Food/Beverage Interaction Grapefruit Juice (acts as a metabolic inhibitor)
Pharmacodynamic Reinforcement CNS Depressants (including alcohol)

Co-administration with potent inhibitors of the CYP3A4 enzyme system, such as certain Azole Antifungals and Macrolide Antibiotics, is formally classified as a contraindicated combination in regulatory labeling. This metabolic inhibition results in significantly elevated plasma concentrations of unmetabolized Terfenadine. The label also specifies that patients with pre-existing significant liver or heart disease are at increased risk due to impaired metabolism, which mimics a drug interaction. Furthermore, a pharmacokinetic interaction with grapefruit juice, which inhibits the same metabolic pathway, is documented. The concurrent use of CNS depressants, including alcohol, may result in an additive pharmacodynamic interaction, potentially increasing effects such as drowsiness.

Mechanism of Action

Бронал, containing levodropropizine, functions as a peripherally-acting antitussive agent. Its biological targets are the sensory afferent nerve fibers, specifically the unmyelinated C-fibers, located within the tracheobronchial tree. The drug's mechanism involves the modulation of the afferent arc of the cough reflex.

At the cellular level, levodropropizine exerts an inhibitory interaction, reducing the excitability of these sensory neurons. This effect is believed to be mediated by the inhibition of transient receptor potential vanilloid 1 (TRPV1) channels and voltage-gated sodium channels. Furthermore, the molecule has been demonstrated to inhibit the release of neuropeptides, such as Substance P, from the C-fiber endings in the airways.

The intracellular consequence of these interactions is a reduction in the transmission of afferent impulses from the peripheral respiratory system to the medullary cough center. The downstream cascade results in a systemic physiological modulation, specifically a diminishment of the cough reflex motor output without affecting the central nervous system's respiratory drive.

Dosage and Administration Information

How to Use Бронал

This section outlines the general principles for the administration of Бронал (Terfenadine).

The medication is designed for systemic delivery and is administered via the oral route using available dosage forms, primarily the 60 mg oral tablet or the oral suspension. The standardized adult regimen involves taking 60 mg of Terfenadine twice daily.

Administration Protocol

There is a specific schedule and manner for intake. The total daily dosage must not exceed 120 mg. The doses should be taken approximately 12 hours apart, once in the morning and once in the evening. Furthermore, instructions for the tablet specify that the dose should be taken with a full glass of water and generally administered on an empty stomach.

Administration Constraint Requirement
Dose Limit Must not exceed 120 mg per 24 hours
Form Handling Tablets must be swallowed whole (do not crush or chew)

Population-Specific Use

Administration of the standardized dose is generally limited to adults and children 12 years of age and older. Dosing parameters may include a minimum body weight threshold, often ge 50 kg, for use in adolescents to ensure correct dosing. Additionally, dose modification or cautious use is required for individuals with pre-existing hepatic or renal impairment, as these conditions can affect how the body processes the medicine. The duration of use is aligned with symptomatic management, typically during periods of episodic allergic manifestation.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Бронал (Terfenadine)

Evidence for Use in Seasonal Allergic Rhinitis

Research on Terfenadine was studied for seasonal allergic rhinitis, primarily through short-term, randomized controlled trials (RCTs). These studies were designed to measure changes in outcomes related to physical discomfort, such as sneezing, congestion, and itching. The studies included both adults and children.

These trials were used in research exploring how symptoms change over time when Terfenadine was evaluated against placebo or other allergy medication. Findings described patterns observed in the measurements of these symptoms over the short term, particularly through patient-reported outcomes describing perceived discomfort. Follow-up durations were limited, meaning the evidence is often used to explore short-term symptom patterns but provides limited information for long-term outcomes.


Evidence for Use in Chronic Urticaria (Hives) and Perennial Allergic Rhinitis

Terfenadine was studied for chronic urticaria, a condition characterized by fluctuating manifestations like hives and intense itching. Controlled clinical trials applied in research contexts involving unstable symptoms examined outcomes related to physical discomfort, focusing on wheal parameters and pruritus severity.

Evidence related to perennial allergic rhinitis—symptoms that occur year-round—is supported by randomized controlled trials (RCTs) exploring how symptoms evolved in adult populations. For both chronic conditions, the evidence is limited because studies were often short-term, meaning there is limited information for long-term outcomes regarding the sustained measurements of symptoms over many months or years.


What is Still Uncertain About Бронал's Research Profile

The research profile is characterized by several key limitations. The majority of trials focused on short-term symptom changes over a few weeks, and the evidence base does not definitively address sustained measurements of symptoms in chronic conditions. Furthermore, data for certain groups remain insufficient, meaning subgroup findings are uncertain for specific comorbid or vulnerable populations.

Key Studies & References

  1. Regulatory History and Indication Summary for Fexofenadine and Terfenadine (Federal Register, FDA)
  2. Terfenadine Anatomical Therapeutic Chemical (ATC) Classification (WHO)

Frequently Asked Questions (FAQ)

Common questions about Бронал (FAQ)

Q: How quickly does Бронал usually start working?

A: Studies and official information indicate that the active component of the medicine, which provides the therapeutic effect, typically begins to work within 1 to 3 hours after a dose is taken. This information is based on the pharmacodynamics of the active metabolite, which is responsible for the effect within the body.

Q: Can consuming alcohol affect how Бронал works in the body?

A: Official documents state that the concurrent use of Central Nervous System (CNS) depressants, including alcohol, may result in an additive pharmacodynamic interaction. This means the combination could potentially increase effects such as drowsiness.

Q: Is it okay to crush or chew the Бронал tablet?

A: According to the official administration instructions for the tablet form, the dose should be swallowed whole. The regulatory guidance specifies that the tablets should not be crushed or chewed.

Q: What should be done if I experience an unexpected effect while taking Бронал?

A: Regulatory information provides guidance for different types of effects. For serious adverse effects, such as an irregular heartbeat or difficulty breathing, the official guidance describes stopping treatment immediately and seeking emergency medical attention. For less serious effects, official instructions describe continuing the medicine while consulting a healthcare professional.

Q: Is Бронал used for long-term health issues or just temporary relief?

A: Official documents describe the medicine's use as aligned with symptomatic management, meaning it is intended to relieve discomfort during periods of episodic allergic manifestation. Evidence for measuring sustained symptoms over long periods in chronic conditions is explicitly stated as being limited.

Q: What is the typical length of time people take Бронал?

A: Regulatory guidelines describe the use of the medicine as aligned with symptomatic management. Therefore, the duration of intake is intended to align with the period that the patient experiences episodic allergic symptoms, rather than a predefined fixed length of time.

Q: Is it possible to take Бронал at different times each day?

A: Official administration guidelines state that the daily doses should be taken approximately 12 hours apart, once in the morning and once in the evening. This indicates that some minor daily time variation is accounted for in the dosing schedule.

Q: Is there a generic version of Бронал available?

A: The active ingredient, Terfenadine, has been withdrawn from regulatory markets worldwide due to documented safety concerns over cardiovascular risk. As a result, the medicine is generally no longer available in either brand name or generic formulations.

Q: Is Бронал ever used in combination with other prescription medicines?

A: Official regulatory documents focus on a list of medicines and products that are formally classified as contraindicated combinations, meaning they should not be used together due to interaction risk. The documentation does not list specific approved or commonly used combinations for co-administration.

Q: What kind of research has been done on the long-term use of Бронал?

A: Research reviewed by regulatory bodies primarily included short-term, randomized controlled trials spanning a few weeks. Official documents state that the evidence base has limited information for long-term outcomes regarding the sustained measurements of symptoms over many months or years.

Q: Does the evidence for Бронал include studies on children?

A: The research evidence reviewed by regulatory bodies includes studies involving both adults and children for conditions such as seasonal allergic rhinitis. The administration protocol specifies use is generally limited to adults and children 12 years of age and older.

Q: Is it necessary to avoid certain foods while using Бронал?

A: Official regulatory documents specify a pharmacokinetic interaction with Grapefruit Juice, which should be avoided due to the risk of altering how the body processes the medicine. No other common foods or general dietary restrictions are explicitly mandated in the drug's official interaction profile.

Q: What are the main things people commonly misunderstand about Бронал?

A: The active ingredient is classified as a second-generation antihistamine, a class intended to act more selectively than earlier types. A frequent general patient question relates to the entire class of antihistamines being sedating, which this drug was intended to address through its mechanism of action.

Q: Is it true that Бронал is only available by prescription?

A: The active ingredient, Terfenadine, was historically available only as a prescription medicine before its eventual withdrawal from regulatory markets worldwide.

Q: Are there different strengths or formulations of Бронал?

A: The medicine was supplied for oral use primarily in solid dosage forms, notably the standard oral tablet (commonly 60 mg) and it was also available as an oral suspension.

Q: Can the effectiveness of Бронал change over time?

A: Studies exploring the general antihistamine class have examined the question of whether a tolerance to the therapeutic effects develops over time with continued use. The evidence base is not conclusive on whether tolerance occurs with this specific medication.

Q: How does the use of Бронал relate to changes in diet or lifestyle?

A: Official regulatory documents focus on specific restrictions related to pharmacokinetic interactions, such as avoiding Grapefruit Juice and CNS depressants (including alcohol). No broad guidance on necessary changes to diet or general lifestyle is provided.

Q: Is the medication designed to treat the underlying cause or just the symptoms?

A: The general purpose of the medicine is described in documents as counteracting the inflammatory effects of histamine by selectively blocking H1 receptors. This action is intended to relieve common allergic discomfort (symptoms), rather than treating the underlying cause of the allergy itself.

How should Бронал be stored and disposed of?

How to Store and Dispose of Бронал?

The storage and disposal of Бронал (Terfenadine) are governed by specific regulatory requirements to ensure product stability and environmental safety.

Official Storage Conditions

Requirement Official Instruction
Temperature Store between 20^circ and 25 C (68^circ and 77 F).
Protection Keep away from excessive moisture and heat.
Stability Rule Do not use if the original carton is opened or if individual blister units are torn.

Official Disposal Requirements

Unused or expired product must be discarded according to national and local regulations for pharmaceutical waste. Due to the chemical properties of the active ingredient, the product should not be emptied into drains or released into the environment, as mandated by official environmental safety classifications.

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

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