Allergospasmin N

Quick links to important sections

Allergospasmin N

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 Allergospasmin N

Property Description
Active Ingredients Cromoglicic acid and Reproterol
Form Metered-Dose Inhaler (MDI) / Dosieraerosol
Pharmacological Class Fixed-Dose Combination (Mast Cell Stabilizer / Beta-Sympathomimetic)
General Use Prevention and symptomatic relief of bronchial spasms
Manufacturer Viatris Healthcare GmbH (Germany/Europe)

Allergospasmin N is a combination pharmaceutical medicine used for the symptomatic relief and prevention of respiratory distress caused by the simultaneous tightening of the airways (spasm) and allergic reactions. It integrates two powerful active ingredients—Cromoglicic acid and Reproterol—from two different pharmacological classes to provide comprehensive support for breathing.

The primary purpose of Allergospasmin N is to improve airflow and reduce hypersensitivity in the bronchial tubes. Unlike single-ingredient inhalers, Allergospasmin N is a prescribed product manufactured by Viatris Healthcare GmbH. It is presented as a Metered-Dose Inhaler (MDI), designed for delivering precise, consistent doses directly to the respiratory system.


What is Allergospasmin N Made Of?

Allergospasmin N is a compound synthetic medicine containing two distinct active components, which together define its unique pharmacological approach. This composition places it firmly in the category of fixed-dose combination drugs targeting complex respiratory symptoms.

The formula combines Reproterol, classified as a bronchodilator (specifically a Beta-Sympathomimetic), with Cromoglicic acid, which acts as a mast cell stabilizer and anti-allergic agent. A bronchodilator works by directly causing the smooth muscles surrounding the airways to relax, opening the breathing passages. The key takeaway for patients is that this dual action functions as a strategy for managing both the underlying allergic trigger and the resulting spasm.


How is Allergospasmin N Used for Respiratory Issues?

Allergospasmin N is used to manage and provide targeted relief from acute respiratory symptoms where both bronchospasm and allergic irritation are present, such as in cases of allergic or exercise-induced asthma. Its therapeutic role is to offer symptomatic improvement when the patient experiences difficulty breathing due to these specific concurrent issues.

As an MDI, the medicine is used locally in the respiratory tract to alleviate tightness and reduce inflammation. The combination of a mast cell stabilizer and a bronchodilator plays an important role in the supportive management of various allergic and spasmodic respiratory states, providing a strategic benefit for patients seeking comprehensive relief.

Regulatory References

  1. Bronchodilators - StatPearls - NCBI Bookshelf

What side effects are possible with Allergospasmin N?

Possible Side Effects and Safety Information

Allergospasmin N contains the active components Cromoglicic acid and Reproterol, and its safety profile is derived from the documented adverse reactions associated with these medicines as classified in official regulatory documents.


Classification of Documented Adverse Reactions

The officially documented adverse reactions for the components of this medicine are grouped by the affected System Organ Class (SOC) and assigned a frequency classification. Reactions related to the sympathomimetic action of Reproterol are common.

  • Common Reactions (Nervous/Cardiac): These include tremor (shaking), palpitations (feeling the heart pound), headache, and a feeling of nervousness. These effects are often most noticeable at the initiation of treatment.
  • Local and Less Common Reactions (Respiratory/GI): Effects may include a transient cough, throat irritation, dizziness, nausea, and an unpleasant taste.

Serious Adverse Reactions and Safety Constraints

The regulatory safety profile highlights certain reactions that are considered rare but clinically significant.

  • Serious Adverse Reactions: These include Paradoxical Bronchospasm (an acute, unexpected worsening of breathing immediately following administration) and severe systemic hypersensitivity reactions such as Anaphylaxis and Arrhythmias.
  • Metabolic/Systemic Risks: The medicine is associated with a risk of Hypokalemia (low potassium levels) and Hyperglycemia (high blood sugar), particularly in combination with certain other medicines.

Population-Specific Safety Notes

Regulatory documents highlight the need for caution in specific patient groups.

  • Cardiovascular Conditions: Use is restricted or requires caution in individuals with pre-existing conditions such as severe hypertension or certain tachyarrhythmias.
  • Metabolic Conditions: Patients with diabetes or thyroid disorders should be monitored closely due to the potential influence of the Reproterol component on blood sugar and thyroid function.

Overdose and Emergency Response

The official overdose profile for Allergospasmin N is defined primarily by excess exposure to the beta-sympathomimetic component, as no systemic intoxication is expected from high doses of the mast cell stabilizer. Overdose manifestations are an intensification of known effects, including cardiovascular signs such as tachycardia (accelerated heart rate), palpitations, and neurological symptoms like fine tremor, restlessness, and headache.

Severe outcomes documented in regulatory labeling include the risk of cardiac arrhythmias, myocardial ischemia (reduced blood supply to the heart), and significant fluctuations in blood pressure. High-dose exposure can also cause metabolic changes, notably hypokalemia (low serum potassium) and hyperglycemia (high blood sugar).

Regulators mandate that immediate medical attention must be sought for any sudden and increasing deterioration of asthma symptoms, particularly if the condition is life-threatening. Management is described as primarily supportive and symptomatic, with specific procedural requirements.

ECG monitoring is indicated for cardiac surveillance, and laboratory control of serum potassium and blood sugar is required. Cardioselective beta1-receptor blockers may be used to antagonize cardiac symptoms. Specific monitoring requirements are listed for patients with diabetes mellitus and those concurrently taking diuretics.

Therapeutic Uses of Allergospasmin N

What Allergospasmin N Treats: Main Uses and Benefits

Allergospasmin N is used in situations involving certain distressing symptoms and applied across domains where additional symptomatic support is needed, particularly when patients experience difficulty breathing due to a combination of muscular spasm and allergic irritation within the airways. The medicine is commonly used to help manage symptoms that interfere with daily comfort and supports patients during episodes of heightened discomfort.

The medicine is commonly used across conditions presenting with acute episodes, and is relevant in situations involving Bronchial Asthma, Allergic Asthma, and specific scenarios like Exercise-Induced Asthma (EIA). The medicine is generally used for supporting the management of bronchial asthma symptoms, and may be part of symptomatic management applied when managing the symptoms of acute bronchial spasms is the therapeutic focus, including in patients aged two years and older.


Clinical Focus

The dual focus of the medicine means it is applied in clinical settings that involve acute or unstable symptom patterns, and is relevant for easing symptoms related to sudden or worsening shortness of breath (dyspnea) and chest tightness. It supports the patient during difficult episodes by easing distress and assists with maintaining functional stability.

“The symptomatic relief offered may help patients cope more steadily with the distressing manifestations associated with allergic asthma and respiratory spasms.”


Quick Fact

Quick Fact: The medicine is commonly used to address clusters of symptoms that appear suddenly, such as spastic bronchial constriction, and is applied when supportive symptomatic relief is needed during periods of heightened discomfort.

Regulatory References

  1. StatPearls overview on Cromolyn Sodium

Eligibility and Restrictions for Use

Who Can and Cannot Use Allergospasmin N? — Official Regulatory Information

Allergospasmin N is officially approved for use in adults and children aged 2 years and older. The regulatory labeling dictates several absolute exclusions and restrictions primarily due to the sympathomimetic action of the Reproterol component.


Contraindications

  • Patients with known hypersensitivity to Sodium Cromoglicate, Reproterol Hydrochloride, or any excipient.
  • Infants and small children under 2 years (due to the documented risk of laryngeal spasm).
  • Patients with a recent myocardial infarction, specific tachycardic cardiac arrhythmias, severe coronary artery disease, hypertrophic obstructive cardiomyopathy, pheochromocytoma, or severe hyperthyroidism.

Conditional Eligibility

  • Pregnancy and Lactation: Use is restricted and requires a strict risk-benefit assessment; it is only permitted if deemed medically necessary, given the documented risks of neonatal tachycardia or hypoglycemia.
  • Diabetes Mellitus: Patients with diabetes may require regular blood sugar control while using the medicine.
  • Cardiac Arrhythmias: Patients with certain arrhythmias require special medical precautions and monitoring during use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Allergospasmin N is primarily defined by the Reproterol component, a beta2-sympathomimetic agent, and involves pharmacodynamic interactions rather than pharmacokinetic ones.

Interaction Classification Interacting Agents / Classes Restriction in Official Documents
Contraindicated Combinations Monoamine Oxidase Inhibitors (MAOIs) Formal Restriction due to potential for severe potentiation of cardiovascular effects.
Tricyclic Antidepressants (TCAs) Formal Restriction due to risk of enhanced cardiovascular side effects.
Pharmacodynamic Antagonism Non-selective Beta-Blockers (e.g., Propranolol) Avoidance advised; documented to counteract the bronchodilatory action.
Additive Risk Other Sympathomimetic Agents Caution required; risk of increased cardiovascular adverse effects.
QT-prolonging Agents Caution required; documented risk of additive effects on the heart's electrical activity.

Official regulatory documents classify the concurrent use of Allergospasmin N with MAOIs and TCAs as high-risk combinations that are formally restricted. The profile also highlights that non-selective Beta-Blockers are to be avoided due to the loss of therapeutic bronchodilation. There are no commonly documented interactions with food, alcohol, or herbal products in the product’s core regulatory labeling.

Mechanism of Action

Allergospasmin N is a dual-component formulation combining isoproterenol and atropine sulfate to modulate bronchial smooth muscle tone.

Isoproterenol acts as a non-selective beta-adrenergic receptor agonist, primarily targeting the beta2-adrenoceptors expressed on the smooth muscle cells of the bronchial airways. Agonism of the beta2-receptor activates adenylyl cyclase, which increases intracellular concentrations of cyclic adenosine monophosphate (cAMP). This increase in cAMP initiates a cascade leading to the phosphorylation of specific proteins and a subsequent reduction of intracellular calcium concentrations, resulting in the relaxation of the smooth muscle in the bronchial tubes and a decrease in bronchial smooth muscle tone.

Atropine sulfate functions as a competitive antagonist at muscarinic acetylcholine receptors, including the M3 subtype in the airways. By blocking the binding of endogenous acetylcholine, it inhibits the parasympathetic-mediated increase in intracellular calcium that drives smooth muscle contraction, thereby diminishing the cholinergic drive for bronchoconstriction. This combined activity addresses both beta2-mediated and M3-mediated pathways.

Dosage and Administration Information

How to Use Allergospasmin N

Allergospasmin N is administered exclusively via inhalation using a Metered-Dose Inhaler (MDI). The correct administration protocol is defined by the official prescribing information, which distinguishes between three primary usage patterns. Administration must only proceed when the user has confirmed the proper handling technique of the inhaler.


Labeled Dosing Regimens

The usage instructions define distinct regimens for controlling the medicine's application.

Usage Pattern Dosing Schedule Frequency & Timing Constraints
Duration Treatment (Maintenance) 2 sprays 4 times daily, observing a minimum interval of 3 hours between doses.
Prevention (e.g., Exercise-Induced) 2 sprays Administered 10 to 15 minutes before anticipated exertion.
Acute Relief 1 spray May be repeated once after a 5-minute wait if the initial effect is insufficient.

Dosing Rules and Protocol

The dosing rules apply uniformly to both adults and children aged 2 years and older. The duration of application is not temporally limited, confirming its suitability for long-term use. The overall control protocol strictly mandates that the total daily administration for duration treatment must not exceed 16 sprays per day.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Allergospasmin N

The Study Landscape for Allergospasmin N

The research on Allergospasmin N focuses on the fixed combination of its two active components: Cromoglicic acid and Reproterol. The evidence base primarily consists of Randomized Controlled Trials (RCTs) and Double-Blind Cross-Over Trials. These study designs explored a comparison of the combination against a placebo (an inactive substance) or against the use of the single ingredients alone. Studies explored how the medicine was evaluated in various acute respiratory scenarios, with outcomes related to physical discomfort and lung function changes.

This research contributes to the broader evidence landscape by providing context on how the dual-component approach has been measured under controlled conditions. The studies monitored outcomes related to physiological measures and patient-reported outcomes describing perceived discomfort.


Evidence for Use in Exercise-Induced Asthma (EIA)

Research has explored the use of Allergospasmin N in conditions characterized by episodic manifestations, specifically Exercise-Induced Asthma ( EIA). Researchers conducted short-term trials where participants were given the medicine before undergoing a standardized exercise challenge. The studies monitored key functional measures, primarily the Forced Expiratory Volume in one second ( FEV1), to observe measured shifts in the outcome following the exercise challenge.

These trials report how symptoms evolved in the observed populations during the acute study period. Findings describe patterns observed related to the measured shifts in the post-exercise FEV1. The evidence grade is characterized as Moderate for this specific context. However, data show patterns related to small sample sizes ( N) in some key combination studies, and research highlights changes measured only during the short study period immediately following the challenge.


What Remains Uncertain About the Research for Allergospasmin N

The overall research landscape has several acknowledged limitations, and certainty remains low in several key areas. First, sample sizes were modest in many of the crucial combination studies, meaning the data may not easily be extrapolated to a larger, diverse population. Second, the evidence quality varies across studies, and the follow-up durations were limited, mainly focusing on acute responses rather than long-term control. Long-term effects are not fully established, and comparative evidence is lacking against the wide array of contemporary asthma therapies was studied for today. The evidence highlights what is known—and what is still uncertain—about this dual-component approach.

Frequently Asked Questions (FAQ)

Common questions about Allergospasmin N (FAQ)


Q: Does Allergospasmin N require a prescription?

According to the official product information, Allergospasmin N is categorized as a prescription-only medicine. This means that regulatory approval requires a valid prescription from a qualified healthcare professional to obtain this medicine from a pharmacy.


Q: What is the primary action or function of Allergospasmin N?

Studies and official information indicate that Allergospasmin N contains two active substances, Reproterol and Disodium cromoglicate. The primary function of this combination is to relieve spasms (spasmolytic effect) and to prevent allergic reactions (anti-allergic effect), acting to relax the airways.


Q: What kind of conditions is Allergospasmin N used to treat?

Regulatory documents state that Allergospasmin N is used for the treatment of bronchial asthma and other conditions where there is reversible narrowing of the airways. It is specifically indicated for situations where both a bronchodilating (airway-widening) and an anti-allergic effect are needed.


Q: What is the method of administration for Allergospasmin N?

According to the official product information, Allergospasmin N is intended for inhalation using a suitable device. Inhalation is the route of administration designed to deliver the active ingredients to the lungs.


Q: Can Allergospasmin N be used for acute asthma attacks?

Official information indicates that Allergospasmin N is not intended for use in the immediate treatment of an acute, sudden asthma attack. Alternative medication, such as a fast-acting inhaler, is typically required for immediate relief of these episodes.


Q: What happens if a dose of Allergospasmin N is missed?

Regulatory documents state that if a dose of Allergospasmin N is missed, official guidance states that treatment should be continued at the next scheduled time. The regulatory documents advise against using a double dose to compensate for the missed one.


Q: What ingredients are in Allergospasmin N?

The official product information confirms that Allergospasmin N contains two active ingredients: Reproterol hydrochloride and Disodium cromoglicate. It also includes other components known as excipients, such as Propellants (HFA 134a) and Anhydrous citric acid, which are necessary components of the product.

How should Allergospasmin N be stored and disposed of?

Regulatory documents for Allergospasmin N metered-dose inhaler do not explicitly define specific, mandatory requirements for storage temperature, protection from light or moisture, or shelf-life after first opening. Official information primarily focuses on correct dosing and administration, emphasizing that patients must follow their doctor's individualized instructions.

General Storage Guidelines

  • Children: There are no specific child-proof storage requirements documented in the accessible official materials, but care should be taken to ensure that all medicines are kept out of the sight and reach of children.
  • Disposal: Specific disposal instructions, such as whether to dispose of the medicine through household waste or return it to a pharmacy, are not detailed in the available regulatory context. Any unused medicine or waste material should be disposed of according to local guidelines for medical waste.

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

Available in countries:

Equivalent of Allergospasmin N found in:

A-Z Index: