Бронхолитин

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Бронхолитин

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Method of action: Antitussive, Bronchodilator

Treatment option:

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 Бронхолитин

Quick Facts

Property Description
Active Ingredients Ephedrine and Glaucine
Pharmacological Class Combined Bronchodilator and Antitussive Agent
Primary Form Oral Solution (Syrup)
Type Fixed-Dose Combination Preparation
Composition Origin Semi-synthetic (Ephedrine) and Natural Alkaloid Derivative (Glaucine)

What is the Pharmacological Type and Identity of Бронхолитин?

Бронхолитин is classified as a fixed-dose combination preparation intended for the symptomatic relief of respiratory irritation. Its pharmacological identity is defined as a combined bronchodilator and antitussive agent. The medicine is typically administered as an oral solution (syrup) and is manufactured by Sopharma, an established producer known primarily in Eastern Europe. This combination approach provides a coordinated strategy for managing dual symptoms often present in respiratory tract conditions, a strategy pharmacologically recognized for its efficiency in addressing both airway restriction and the cough reflex simultaneously.

What is the Composition of Бронхолитин?

The drug’s activity relies on two principal active ingredients: Ephedrine hydrochloride and Glaucine hydrobromide. The Ephedrine component is categorized as a sympathomimetic amine, a semi-synthetic compound that primarily affects the airways. Glaucine is classified as a non-narcotic protoalkaloid, which is derived from natural plant sources. The inclusion of Glaucine is a key differentiating feature, offering a central cough suppression mechanism that is clinically confirmed to be non-addictive and is often used over opiate-derived alternatives.

What is the General Purpose of Бронхолитин?

The general purpose of Бронхолитин is to offer comprehensive relief by targeting both bronchial airway constriction and the persistent central impulse for a dry, nonproductive cough. The Ephedrine component promotes bronchospasmolysis (airway widening), facilitating easier airflow. Simultaneously, the Glaucine component suppresses the cough reflex. The medication is generally intended for managing irritative cough associated with conditions like chronic bronchitis. This dual action ensures the medicine addresses the physical resistance in the airways while reducing the symptomatic irritation caused by coughing, resulting in symptomatic calm.

Regulatory References

  1. NIH, Ephedrine Overview

What side effects are possible with Бронхолитин?

Possible Side Effects and Safety Information

The following safety information is derived strictly from official government regulatory documents detailing the profiles of the active ingredients, Ephedrine and Glaucine. The information below reflects adverse reactions and explicit safety restrictions, without providing medical advice or guidance on use.

Documented Adverse Reactions

Adverse reactions associated primarily with the sympathomimetic component (Ephedrine) are officially categorized by the system affected:

System-Organ Class (SOC) Examples of Officially Documented Adverse Reactions
Nervous System Tremor, Headache, Insomnia, Dizziness, Seizures, Confusion
Cardiac Disorders Palpitations, Tachycardia, Chest pain, Coronary spasm
Vascular Disorders Hypertension (high blood pressure), Stroke
Psychiatric Disorders Anxiety, Tension, Paranoid psychoses
Gastrointestinal Nausea, Vomiting

Serious Adverse Reactions

Regulatory documents explicitly list severe events associated with the drug's components, including Stroke, Myocardial Infarction (MI), and potentially fatal Arrhythmias. Serious adverse events affecting the central nervous system, such as Seizures and Coma, have also been documented.

Safety Restrictions and Contraindications

Official labeling defines strict limitations for use:

  • Pre-Existing Conditions: Use is contraindicated in individuals with specific conditions, including closed angle glaucoma, pheochromocytoma, and specific types of severe hypertension.
  • Concurrent Therapy: Use is explicitly contraindicated with, or within 14 days of discontinuing, Monoamine Oxidase Inhibitors (MAO inhibitors).
  • Special Populations: The medicine is contraindicated for pregnant or lactating women. Self-medication use for bronchospasm is also contraindicated for pediatric patients under 12 years of age.

Regulatory reports note that adverse effects are variable and do not consistently depend on the dose consumed.

Overdose and Emergency Response

An overdose of Бронхолитин primarily presents with severe signs related to documented sympathomimetic toxicity. Regulatory information identifies initial manifestations that include Nausea, Vomiting, Fever, Hypertension, and Palpitations. Central Nervous System (CNS) effects such as Paranoid Psychosis, Delusions, and excessive Restlessness are also documented clinical presentations.

When to Seek Immediate Medical Help

Urgent medical care is required upon suspicion of overdose due to the potential for life-threatening outcomes cited in official labeling. These serious manifestations include Ventricular and Supraventricular Arrhythmias, Respiratory Depression, Convulsions, and progression to Coma. Given these risks, overdose management necessitates intensive supportive treatment as mandated by regulatory authorities.

The official documentation states that no specific antidote is known. Consequently, treatment procedures are defined by symptomatic management and continuous monitoring. These measures include Electrocardiograph (ECG) monitoring and procedures to correct physiological abnormalities, such as the management of severe hypertension and correction of Marked Hypokalaemia (a low potassium level). Special considerations note that elderly patients and individuals with pre-existing chronic hypertension or cardiac disorders are considered higher risk groups for complications.

Therapeutic Uses of Бронхолитин

What Бронхолитин Treats: Main Uses and Benefits

Бронхолитин is generally relevant for easing symptoms related to inflammatory or irritative states in the respiratory tract. It is applied across domains where additional symptomatic support is needed, primarily focusing on the challenging manifestations of a dry cough. The medication is commonly used to help with a dry, non-productive cough, and is relevant in contexts where additional symptomatic support is needed.

This supportive therapy is applied in clinical settings that involve acute or unstable symptom patterns, and is often used during phases when symptoms become more noticeable. It helps address symptom clusters that may become intense or disruptive, especially those that interfere with daily comfort. The symptom clusters it helps manage are commonly associated with conditions like acute upper respiratory infections, bronchitis, and tracheitis.

“The medicine provides support that helps ease the overall symptom burden, which is key during periods of heightened discomfort.”

Quick Fact: Relief for Dry Cough

The medicine supports general well-being during symptomatic phases by helping ease the overall symptom load when short-term symptomatic assistance is appropriate.

Eligibility and Restrictions for Use

The official regulatory guidelines for Бронхолитин (Ephedrine and Glaucine) establish clear population eligibility rules, primarily driven by the risks associated with the Ephedrine component, a sympathomimetic.

Populations Who Must Not Use the Medicine (Contraindications)

Use is absolutely contraindicated in patients with severe pre-existing conditions, including Ischemic Heart Disease, uncontrolled Arterial Hypertension, severe Tachyarrhythmias, and Hyperthyroidism (thyrotoxicosis). The medicine is also prohibited for patients with Pheochromocytoma, Angle-Closure Glaucoma, and Prostatic Hypertrophy presenting with urinary retention. Additionally, individuals who are currently taking or have recently discontinued Monoamine Oxidase Inhibitors (MAOIs) must not use this medication.


Age and Physiological Restrictions

The medicine is generally contraindicated in children typically under 3 years of age. Use in Older Adults and in patients with Severe Hepatic or Renal Impairment is restricted and requires caution. Furthermore, use is not recommended during both pregnancy and the period of lactation (breastfeeding).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define specific interaction constraints for Бронхолитин, primarily due to the Ephedrine component, which acts as a sympathomimetic. Interaction information for the Glaucine component is officially limited.

Contraindicated and High-Risk Combinations

Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is prohibited, and a 14-day washout period is mandated after stopping MAOIs before treatment initiation. Other contraindicated combinations include Ergot Alkaloids and Oxytocin, due to a heightened risk of blood pressure augmentation and cardiac arrhythmias. Use with other centrally acting cough suppressants, such as Codeine, is also prohibited.

Pharmacodynamic and Exposure Interactions

Interactions that reduce efficacy are documented with Antihypertensive Agents and Non-selective Beta-blockers, as Ephedrine can antagonize their therapeutic effects. The medicine also reduces the effect of Oral Antidiabetic Agents. Furthermore, Ephedrine is documented to accelerate the metabolism of Dexamethasone, leading to reduced exposure of the latter. Use with Cardiac Glycosides or certain Tricyclic Antidepressants may increase the risk of cardiac rhythm disturbances. The FDA has also issued warnings regarding the use of Dietary Supplements containing Ephedrine Alkaloids.

Mechanism of Action

Бронхолитин is a fixed-dose combination product containing two active pharmaceutical ingredients: Ephedrine and Glaucine.

Ephedrine

Ephedrine is a sympathomimetic amine that modulates the adrenergic receptor system through a dual mechanism. Its primary action is indirect, achieved by displacing and increasing the release of endogenous norepinephrine from presynaptic storage vesicles into the synaptic cleft. This elevated norepinephrine concentration enhances the stimulation of postsynaptic receptors. Additionally, Ephedrine acts as a direct agonist at both alpha- and beta-adrenergic receptors. Stimulation of beta2-adrenergic receptors located on airway smooth muscle cells initiates a cyclic AMP cascade, resulting in cellular relaxation and subsequent dilation of the bronchioles.

Glaucine

Glaucine, an aporphine alkaloid, exerts its primary effect through modulation of the cough reflex center located within the brainstem. Its direct action on this central neurological pathway lowers the central excitability required to initiate a cough. In peripheral airways, Glaucine functions as an antagonist of L-type calcium channels on smooth muscle cells and acts as a non-competitive, selective phosphodiesterase-4 (PDE4) inhibitor. These actions reduce the cellular influx of calcium ions and restrict the degradation of cyclic AMP, respectively, resulting in smooth muscle relaxation.

Dosage and Administration Information

Official Administration Guidelines

Бронхолитин is prescribed and used strictly according to specific instructions detailing its oral administration and fixed-dose regimen. The preparation is designated as an Oral Solution (Syrup), which is the sole approved route of intake. The product is a fixed-dose combination containing Ephedrine hydrochloride (4.6 mg/5 ml) and Glaucine hydrobromide (5.75 mg/5 ml).


Administration Scope

Field Official Instruction
Route of administration Oral only, using the measured liquid solution.
Timing in relation to meals Administration is typically prescribed after meals.
Preparation requirements For children aged 3 to 5 years, the prescribed 5 mL dose must be diluted immediately prior to intake with 10 mL of cooled, boiled water.
Special procedural conditions The medication is dispensed as a prescription-only drug, requiring authorization and professional supervision prior to use.

Labeled Dosing Regimens

Regulatory instructions specify distinct dosage protocols based on age, with the course of therapy generally limited to a duration of 5 to 7 days.

Age Group Standard Regimen
Adults and Children over 10 years 10 mL, administered 3 to 4 times per day.
Children 5 to 10 years 5 mL, administered 3 times per day.
Children 3 to 5 years 5 mL, administered 3 times per day (requires dilution).

Connection to the Overall Use Protocol

This protocol defines the standardized, controlled use of the combination product. The fixed oral route and specific dosing regimen ensure that both active components are administered simultaneously and consistently over a short-term, symptom-based duration as outlined by the regulatory bodies. Adherence to post-meal timing and required dilution for younger patients constitutes essential procedural steps for proper use.

Recent Clinical Evidence

Бронхолитин: Research Overview

Бронхолитин is a combination product traditionally containing glaucine (an antitussive) and ephedrine (a bronchodilator and decongestant). Clinical evidence concerning the combined formulation is generally limited, with research primarily focusing on the properties of its individual components or older formulations.

Studies involving glaucine focus on its ability to help suppress the cough reflex by acting on the central nervous system. Research has explored its use in managing different types of coughs, including those associated with acute upper respiratory infections. Findings suggest that glaucine may modulate the cough center, but the extent of this effect and its clinical relevance often require further large-scale evaluation.

Ephedrine and Safety Considerations

Ephedrine is a sympathomimetic amine, a type of compound that works by stimulating the nervous system. Its inclusion in the combination aims to help widen the air passages (bronchodilation) and reduce swelling in the nasal passages (decongestion). While these actions are well-established, studies on ephedrine and similar substances often highlight important safety considerations, particularly related to the cardiovascular and central nervous systems.

Research on similar ephedrine-containing formulations notes potential effects such as:

  • Cardiovascular: Increased heart rate and blood pressure.
  • Nervous System: Anxiety, restlessness, or trouble sleeping.
  • Other: Headache, dizziness, or dry mouth.

Given the complexity of combination products, large-scale, modern randomized controlled trials (RCTs) specifically assessing the safety and efficacy profile of the glaucine/ephedrine combination as a cough treatment are necessary to fully align with current medical and regulatory standards.

Key Studies & References

  1. Ephedrine. Drug Record
  2. WHO Model List of Essential Medicines - Cough and Cold Preparations

Frequently Asked Questions (FAQ)

Common questions about Бронхолитин (FAQ)

Q: Does Бронхолитин help with a chesty or wet cough?

Official product information specifies this medicine is formulated to help manage the central impulse for a dry, nonproductive cough. The official label does not include indications for managing a wet or chesty cough.

Q: What is the specific dosage for an adult?

Regulatory documents establish a standard regimen for adults. The specific dosing volume and frequency are detailed in the Labeled Dosing Regimens section of the official instructions.

Q: Is it safe to take this with an antibiotic?

Official product labeling lists several drug classes, such as MAOIs and certain heart medications, that should not be used with Бронхолитин. However, antibiotics are typically not listed among the core interaction warnings. Consult your healthcare provider regarding concomitant use with any other medications, including antibiotics.

Q: If I miss a dose, what should I do?

General regulatory instructions for immediate-release oral products usually advise against taking a double dose to compensate for a missed one. If a dose is forgotten, the general instruction is to skip the missed one and resume the usual dosing schedule at the next scheduled time.

Q: How do I properly dispose of expired or unused syrup?

The syrup must be discarded one month after the bottle is first opened to maintain stability. Unused or expired medication should be disposed of by following local regulatory guidelines for pharmaceutical waste. This involves following local regulatory guidelines for pharmaceutical waste.

Q: Why do I need to dilute the dose for my 3-year-old?

The dilution of the prescribed dose for children aged 3 to 5 years is a mandatory safety condition established in the official administration instructions. It is specified as an essential procedural step to ensure proper administration and help control the amount of medication given to younger patients.

Q: Is Бронхолитин habit-forming?

The Glaucine component is a non-narcotic antitussive. The Ephedrine component is a sympathomimetic, and regulatory information notes potential for abuse. The combination product's status regarding habit formation should be discussed with a healthcare professional.

Q: Where can I buy this medicine? Is it available over the counter?

According to the National Register of Medicines and official labeling, Бронхолитин is classified as a prescription-only drug. This means it requires authorization from a healthcare professional and is not available over the counter.

Q: What should I do if my symptoms do not improve after 7 days?

The course of therapy for Бронхолитин is generally limited to a duration of 5 to 7 days. Official regulatory warnings indicate that consultation with a healthcare professional is recommended if symptoms persist, worsen, or change after reaching the maximum treatment duration.

How should Бронхолитин be stored and disposed of?

Storage and Disposal of Бронхолитин Syrup

The storage requirements for Бронхолитин syrup are strictly defined in official regulatory labeling to ensure product stability.

Detail Regulatory Requirement
Storage Temperature Do not exceed 25°C
Protection Store in a dry place, protected from light
Prohibited Environment Do not freeze
Packaging Store in the original packaging
Child Safety Keep out of the sight and reach of children
Post-Opening Shelf-Life Discard 1 month after the bottle is first opened

The medicine must be kept out of the reach of children. The product must be stored in its original, light-protected packaging and not be frozen. While the total shelf-life is typically 4 years, official rules mandate the syrup be discarded after one month of opening. Unused or expired medication must be disposed of in accordance with local regulatory guidelines for pharmaceutical waste.

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

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