Airon

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Medically reviewed

Laura Arias

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 Airon

Property Description
Active Ingredient Montelukast sodium
Form Tablet (chewable, film-coated), oral granules
Pharmacological Class Leukotriene receptor antagonist (LTRA)
General Purpose Manage chronic airway inflammation and constriction
Origin Synthetic compound

Airon is the commercial designation for a medicinal product whose active ingredient is Montelukast sodium, a highly selective, synthetic chemical entity administered exclusively by the oral route. The substance Montelukast is chemically characterized by the empirical formula C35H35ClNNaO3S. This medicine is formulated as a single active ingredient product, presented in various dosage forms, including the standard film-coated tablet, the chewable tablet, and oral granules, accommodating administration to both adults and pediatric patients. The availability of multiple oral forms is a key feature for ensuring patient compliance.

Airon is classified pharmacologically as a Leukotriene receptor antagonist (LTRA), a subcategory of drugs also termed Leukotriene modifiers. This classification signifies that the drug functions by specifically blocking the activity of potent inflammatory messengers in the body, primarily the cysteinyl leukotrienes (CysLT4, D4, E4). Pharmacological studies have consistently confirmed that Montelukast is an orally active and highly selective antagonist, binding with strong affinity to the CysLT1 receptor without displaying any agonist activity. This selective antagonism is clinically recognized for its role in maintaining stable airway function. The general purpose of this targeted intervention is to suppress the biological pathways that lead to bronchoconstriction and chronic inflammation, providing a foundational element in the long-term management of conditions where airway function needs sustained support.

What side effects are possible with Airon?

Possible Side Effects and Safety Information

Regulatory documentation structures the safety profile of Airon (Montelukast sodium) by classifying possible adverse reactions according to frequency and affected physiological systems. This information is derived from clinical studies and post-marketing surveillance.

Adverse Reaction Frequencies

Classification Examples of Documented Effects
Very Common Upper respiratory infection.
Common Headache, abdominal pain, diarrhea, nausea, vomiting, rash, and fever.
Uncommon Hypersensitivity reactions (including anaphylaxis), psychiatric disorders (e.g., agitation, insomnia), dizziness, seizures, and dry mouth.
Very Rare Eosinophilic Granulomatosis with Polyangiitis (EGPA), hallucinations, suicidal thinking and behavior, and hepatitis.

Serious Safety Considerations

The official labeling emphasizes the risk of serious neuropsychiatric events, including suicidal ideation, depression, and agitation, which have been reported across all age groups. Furthermore, the very rare occurrence of Eosinophilic Granulomatosis with Polyangiitis (EGPA) is documented, sometimes associated with the reduction of systemic corticosteroid therapy in patients taking Airon.

Safety Restrictions

Airon is formally contraindicated for individuals with known hypersensitivity to the active substance or any of its components. Safety notes also exist for specific populations, including the requirement for awareness regarding potential behavioral changes in pediatric patients and increased systemic exposure in patients with mild-to-moderate hepatic impairment. Patients with known aspirin sensitivity should continue to avoid aspirin and other non-steroidal anti-inflammatory agents.

Overdose and Emergency Response

Official Regulatory Overdose Profile

The regulatory data for Airon (Montelukast sodium) overdose establishes a profile based on observed clinical manifestations and required emergency actions.

Property Official Regulatory Statement
Documented Manifestations Symptoms following acute overdose, including exposures up to 1000 mg, include abdominal pain, vomiting, somnolence (sleepiness), headache, thirst, and psychomotor hyperactivity.
Severity Classification The majority of reports indicated a benign clinical course, with manifestations consistent with the drug’s established safety profile.
Population Notes Overdose cases have been specifically documented in pediatric patients (including high single-dose ingestions).

Emergency Response and Management

  • Mandated Action: Seek emergency medical attention immediately for any suspected overdose exposure.
  • Urgent Help Required: Immediate medical help is required if severe signs are present, such as collapse, seizures, trouble breathing, or inability to be awakened.
  • Antidote Status: No specific antidote is known for Montelukast overdose.
  • Management: Treatment requires the employment of symptomatic and supportive treatment, including clinical monitoring.
  • Procedural Constraint: Advanced removal procedures such as dialysis are officially stated to be unlikely to be effective for drug elimination.

Connection to the overall overdose profile:

Regulatory documents define the overdose profile by listing the expected manifestations, which affect the gastrointestinal and central nervous systems. This profile mandates that emergency medical attention must be sought for suspected over-exposure or the onset of severe symptoms. Management is strictly limited to supportive care, as there is no specific antidote known.

Therapeutic Uses of Airon

Airon (Montelukast) is commonly used to help with conditions characterized by symptoms that interfere with daily functioning across multiple respiratory and allergic domains.


The medication is commonly used to help with conditions characterized by periods of heightened symptoms such as persistent asthma, the prevention of exercise-induced bronchoconstriction (EIB), and the symptomatic relief of allergic rhinitis (including both seasonal and perennial types). It plays a role in managing symptom clusters that may become disruptive, such as frequent wheezing, chronic coughing, chest tightness, and nasal congestion. This application provides supportive relief when symptoms interfere with routine activities.

“Airon helps address symptom clusters that may become disruptive and contributes to improved comfort during periods of heightened symptoms.”


Quick Fact: Relief for Allergic Nasal Symptoms

Airon is relevant in contexts marked by increased discomfort from allergic rhinitis, where it is applied in addressing both seasonal (hay fever) and perennial (year-round) manifestations. This use offers symptomatic relief for stuffy nose, sneezing, and itching, assisting with maintaining functional stability during symptomatic periods.

Regulatory References

  1. NIH DailyMed Drug Label

Eligibility and Restrictions for Use

Airon (Montelukast sodium) eligibility is strictly defined by regulatory guidelines concerning patient age, physiological state, and existing conditions.

Populations for Whom Use is Contraindicated

Use of Airon is contraindicated (prohibited) for individuals with a known hypersensitivity to Montelukast sodium or any component of the product. It is also contraindicated in patients with rare hereditary metabolic problems, including galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.

Age-Related Eligibility Rules

Eligibility is defined by minimum age thresholds that vary by condition:

Indication Minimum Approved Age
Asthma (Chronic Treatment) 12 months and older
Seasonal Allergic Rhinitis 2 years and older
Perennial Allergic Rhinitis 6 months and older
Exercise-Induced Bronchoconstriction (EIB) 6 years and older

Safety and effectiveness are not established below these age thresholds. Patients 15 years and older are eligible for all indications. For older adults (65 years and over), no age-related dosage adjustment is required.

Eligibility-Related Restrictions

The medicine is not indicated for the reversal of bronchospasm in acute asthma attacks. For allergic rhinitis, use is reserved for patients who are inadequately treated with or cannot tolerate other allergy medicines (U.S. labeling). Use during pregnancy or lactation is only permitted if considered clearly essential. No dosage adjustment is required for patients with renal impairment or mild-to-moderate hepatic impairment.

What should I know about interactions with other medicines?

Airon Interactions with other medicines and products

The regulatory profile for Airon (Montelukast) is defined by pharmacokinetic changes related to its metabolism, primarily via the Cytochrome P450 (CYP) enzyme system (CYP3A4, 2C8, 2C9).


Exposure-Modifying Medicinal Products

Co-administration with enzyme modulators results in formal changes to Montelukast systemic levels:

  • Enzyme Inducers: The potent inducer Phenobarbital is documented to decrease Montelukast exposure, resulting in a reduction of approximately 40% in the Area Under the Curve (AUC). Other CYP inducers, such as Rifampicin, are also noted in official regulatory documents.
  • Enzyme Inhibitors: Co-administration with the enzyme inhibitor Gemfibrozil leads to a significant increase in Montelukast systemic exposure, documented as a 4.4-fold rise in drug levels.

Montelukast has been formally documented as having no clinically important effects on the pharmacokinetics of co-administered medicines such as Theophylline, Warfarin, or Prednisone.


Formal Restrictions and Constraints

Patients with a documented aspirin sensitivity must continue the avoidance of Aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) while taking Montelukast. This is a disease-related restriction noted in official prescribing information.

Regarding the formulation, when the oral granules are taken with a high-fat meal, the maximum plasma concentration ( C max) is documented to be decreased by 35%. A specific caution is also noted when co-administering Montelukast with CYP inducers, such as Phenytoin or Phenobarbital, particularly in children.

Mechanism of Action

Selective Blockade of Cysteinyl Leukotriene 1 Receptors

Airon (Montelukast) engages the inflammatory signaling cascade by acting as a selective antagonist at the CysLT1 receptor. This mechanism prevents the pro-inflammatory messengers, the Cysteinyl Leukotrienes ( LTC4, LTD4, LTE4), from binding to and activating their target sites. The molecule does not induce intrinsic agonist activity.

Interruption of Pathological Airway Signaling

The sustained receptor blockade initiates a mechanistic cascade that suppresses three primary downstream effects of CysLTs. This molecular suppression prevents LTD4-mediated bronchial smooth muscle contraction and reduces the CysLT-driven increase in microvascular permeability, thereby influencing factors that determine mucosal volume ( edema). This mechanism also modulates the recruitment of eosinophils, influencing the chronicity of the inflammatory process in the respiratory system.

Mechanism Specificity and Physiological Reactivity

This action, specific to the CysLT pathway, influences the factors determining airway diameter and airway reactivity over time. The mechanism's effect is fundamentally prophylactic against CysLT signaling, focused on modulating the inflammatory environment, and is mechanistically distinct from agents that induce immediate smooth muscle relaxation for acute events. The resultant physiological effect is realized as chronic inflammation is suppressed over time.

Dosage and Administration Information

How to Use Airon: Official Administration Guidelines

Administration of Airon (Montelukast) is defined by a standardized set of official instructions governing the route, dosage, and timing of the medication.


General Usage Instructions

Instruction Details
Route of Administration Airon is administered exclusively via the oral route in all its approved forms.
Dosing Frequency The standard schedule for maintenance therapy is once daily.
Timing Relative to Meals Film-coated tablets and chewable tablets may be taken with or without food.
Missed Dose Protocol If a daily dose is missed, it should be skipped. The next dose must be taken at the regular scheduled time; two doses should not be taken simultaneously.

Dosage and Context-Specific Rules

Dosages are fixed according to age, and timing depends on the condition being addressed.

  • Adults and Adolescents (15 years): The standard maintenance dose is one 10 mg film-coated tablet daily.
  • Pediatric Dosing: Lower strengths and forms are mandated for children: 5 mg chewable tablets for patients 6 to 14 years old, and 4 mg chewable tablets or oral granules for those 6 months to 5 years old.
  • Timing for Chronic Asthma: For the continuous treatment of asthma, the prescribed daily dose must be taken in the evening.
  • Exercise-Induced Bronchoconstriction (EIB): For EIB prevention, a single 10 mg dose is taken at least two hours before exercise. This specialized dose must not be repeated within 24 hours of a previous dose.
  • Oral Granule Preparation: Granules must be administered within 15 minutes of opening the sachet and may be mixed with a small amount of soft food or liquid, such as formula or applesauce.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Summary of Clinical Trials

Research has explored the study of this medication in adults with specific conditions. A systematic review investigated whether the medication was associated with changes in symptoms in patients with the specified condition, focusing primarily on randomized, controlled trials (RCTs).

  • Study Design: The majority of the evidence comes from double-blind, placebo-controlled trials of 12-week duration.
  • Primary Findings: Research explored the study participants' reported quality of life in these patients. Studies have evaluated the drug in relation to the severity and frequency of specific symptoms.
  • Timing of Changes: Research evaluated the timing of initial changes reported by participants during the trials.

Proposed Research Areas

Research has explored the changes in reported pain levels among participants.

  • Long-Term Research: Follow-up studies, including open-label extensions, have examined observations over periods up to one year. These studies focused on monitoring participant status and safety.
  • Combination Studies: Studies have compared observations when the medication is combined with standard-of-care treatments versus monotherapy. Research investigated the status of participants when the combination was used in certain subgroups.

Tolerance and Exclusion Criteria

Clinical trials evaluated tolerance and adverse events in adults over 18 years of age. Adverse events frequently noted in the research included mild gastrointestinal distress and headache.

  • Exclusion Criteria: The inclusion and exclusion criteria of studies excluded participants with condition X, as well as those with severe kidney or liver impairment.

Key Studies & References

  1. Systematic review and meta-analysis of intravenous iron therapy for adults with non-anaemic iron deficiency: An abridged Cochrane review
  2. Systematic review and meta-analysis of intravenous iron therapy for patients with heart failure and iron deficiency

Frequently Asked Questions (FAQ)

Common questions about Airon (FAQ)

Q: How quickly should I expect to feel the effects of Airon after starting it?

A: Airon is a medication intended to suppress chronic inflammation in the airways, not to provide immediate relief from acute symptoms. As a result, the full effect of the chronic inflammation suppression mechanism is generally observed over several weeks of continuous daily use.

Q: What are the most commonly reported side effects of taking Airon?

A: Based on official clinical trials, the adverse reactions reported most often include upper respiratory infection, headache, and pharyngitis (sore throat). These effects were reported at an incidence rate higher than placebo in the clinical trials.

Q: What research supports the effectiveness of Airon for its main purpose?

A: The drug's activity is supported by data from multiple double-blind, placebo-controlled clinical trials, typically lasting 12 weeks. These studies evaluated the ability of Airon to improve measures related to disease control and enhance quality of life for participants.

Q: What is the typical timeframe for Airon to reach its full therapeutic effect?

A: The medication works to modulate the chronic inflammatory process in the body over time. Clinical studies commonly track effectiveness over a 12-week timeframe, suggesting the maximum benefit from the chronic inflammation suppression mechanism is generally observed over several weeks of continuous administration.

Q: Is Airon safe for older adults or elderly patients?

A: Official product information indicates that no age-related dosage adjustment is typically required for older adults (65 years and over). This suggests that Airon is generally used in this population without need for specialized dosing.

Q: How long does Airon stay in your system after you stop taking it?

A: The active ingredient in Airon (Montelukast) has a mean plasma half-life typically ranging from 2.7 to 5.5 hours in healthy young adults. This short half-life indicates the time it takes for half of the drug to be eliminated from the bloodstream.

Q: Can women who are planning pregnancy or are breastfeeding take Airon?

A: Official regulatory documents indicate that use during pregnancy or lactation should only occur if the prescribing healthcare provider determines it is clearly essential. This determination is based on the individual risk-benefit assessment.

Q: Does Airon need to be gradually stopped, or can I stop taking it suddenly?

A: Official guidance does not require Airon to be gradually reduced or tapered upon discontinuation. However, the drug should never be used as an abrupt substitute for inhaled or oral corticosteroids.

Q: What level of scientific evidence supports the long-term safety of Airon?

A: Clinical trials have evaluated the drug’s safety profile over periods up to one year. Beyond this, long-term safety is continuously monitored through official post-marketing surveillance, which captures the reporting of all adverse events, including rare ones like neuropsychiatric events.

Q: Does Airon interact with common supplements like vitamins or herbal remedies?

A: Official product information on concurrent use with vitamins, complementary medicines, or herbal remedies is limited. Regulatory documents primarily focus on interactions with prescription drugs and known enzyme modulators.

Q: Does Airon affect my sleep patterns or cause insomnia?

A: Sleep-related issues, including insomnia (difficulty sleeping) and abnormal dreams, have been reported in the post-marketing setting. These are recognized as potential adverse reactions to the medication.

Q: Is Airon commonly prescribed for conditions other than its primary use?

A: Airon has regulatory approval for: the chronic treatment of asthma, the prevention of exercise-induced bronchoconstriction (EIB), and the relief of symptoms of seasonal and perennial allergic rhinitis. Prescribing for uses outside of these indications is considered off-label.

Q: Is Airon considered a controlled substance?

A: No. Official documents confirm that the active ingredient in Airon (Montelukast) is not classified as a controlled substance by regulatory agencies and is considered a Human Prescription Drug with a DEA Schedule of None.

Q: Why do some people experience initial drowsiness or dizziness when starting Airon?

A: Dizziness has been noted in clinical trials, and excessive sleepiness (somnolence) has been reported in post-marketing experience. These are related to the drug’s potential influence on the central nervous system.

Q: What happens if I accidentally take two doses of Airon too close together?

A: In documented cases of acute overdose, the most frequently reported events have included abdominal pain, somnolence (sleepiness), headache, vomiting, and psychomotor hyperactivity (agitation). Regulatory bodies recommend against taking two doses simultaneously.

Q: Is Airon available in different strengths or formulations (e.g., tablet, liquid)?

A: Airon is officially available as a film-coated tablet, chewable tablets, and oral granules. A specific liquid formulation is not listed in the official regulatory product information.

Q: What are the signs that Airon is actually working for my condition?

A: As a maintenance medication, signs of effectiveness may include a reduction in the frequency and severity of chronic symptoms, such as less wheezing or coughing, or improvement in allergic rhinitis symptoms over time.

Q: Do I need regular blood tests while I am taking Airon?

A: Official regulatory documents do not indicate that routine blood tests are required to monitor the medication itself. Additionally, the drug is not known to significantly affect the results of common diagnostic tests like allergy skin testing.

Q: Is the severity of side effects related to the dosage of Airon?

A: In adult studies testing various doses, no clear relationship between the dosage and the occurrence of adverse events was established for the standard range of use. However, acute overdose exposures have been linked to specific adverse events.

Q: Is Airon effective for preventing future occurrences of the condition it treats?

A: Airon is officially indicated for the specific prevention of exercise-induced bronchoconstriction (EIB). For chronic conditions like asthma, its primary role is to suppress the underlying inflammation as a long-term management strategy.

Q: Why is Airon sometimes prescribed for chronic vs. acute conditions?

A: The drug's mechanism of action is to target and suppress chronic inflammation in the airways over time. Official regulatory information specifically states that Airon is not indicated for use in acute asthma attacks.

Q: Can Airon be crushed or split if a person has trouble swallowing pills?

A: The standard film-coated tablets should be swallowed whole. For patients who have trouble swallowing, the product is formulated by the manufacturer as chewable tablets or oral granules to facilitate administration.

Q: Why do some patients report feeling 'foggy' or having concentration issues on Airon?

A: Official labeling notes potential neuropsychiatric events, including problems with attention, confusion, and memory impairment. Patients and caregivers should be observant for these mental health-related events.

Q: Does taking Airon at a specific time of day make a difference in its effectiveness?

A: For the chronic treatment of asthma, the product label specifies that the dose should be taken once daily in the evening. For the treatment of allergic rhinitis symptoms, the dose can be taken once daily without a specific time constraint.

Q: What is the patent status of Airon or its main compound?

A: The original patents and marketing exclusivity for the brand-name product have officially expired. As a result, the active ingredient, Montelukast, is widely available through generic versions.

Q: Can Airon be taken with other prescription medications for chronic conditions?

A: Clinical studies have found no clinically important changes to the absorption or action of commonly co-administered medicines such as Theophylline, Warfarin, and Prednisone. It is important to discuss all concurrent prescription drugs with your healthcare provider.

How should Airon be stored and disposed of?

Airon (Montelukast sodium) must be stored and handled according to specific official requirements to preserve its stability.

Storage Conditions and Stability

Requirement Official Constraint
Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F), with excursions permitted to 15 C to 30 C (59 F to 86 F).
Protection Keep in the original package and store in a dry place to protect from light and moisture.
Granule Stability The oral granules must be administered within 15 minutes of opening the packet. Any mixture of granules with food must be discarded and must not be stored for later use.

Disposal and Safety

All medicine must be kept out of the reach of children.

Unused or expired Airon must be disposed of in accordance with local regulations. The FDA recommends using a drug take-back program. If this is unavailable, the medicine should be removed from its container, mixed with an undesirable substance (e.g., used coffee grounds), sealed in a bag, and then placed in the household trash. The product should not be flushed down the toilet unless specific instructions in the labeling direct this action.

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

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