Airomed

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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 Airomed

Property Description
Active ingredient Montelukast sodium
Form Oral (Tablets, Chewable Tablets, Granules)
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
Common use Maintenance therapy for chronic respiratory inflammation
Origin Synthetic compound

The Identity and Class of Airomed

Airomed is a synthetic single-ingredient product whose active chemical substance is Montelukast sodium, placing it in the specific pharmacological class of Leukotriene Receptor Antagonists (LTRAs). This classification identifies it as a medication that selectively modulates the body’s inflammatory pathways, a key characteristic distinguishing it from other broad-spectrum anti-inflammatory agents. This drug entity is strictly a prescription-only medication (POM), reflecting its role in managing chronic conditions under medical supervision.

Montelukast sodium is clinically recognized for its ability to inhibit the CysLT1 receptor. The medication's focused synthetic mechanism allows it to consistently suppress the effects of pro-inflammatory messengers known as cysteinyl leukotrienes, which are key chemical components in chronic airway diseases.

Composition and Available Oral Forms

The essential component of the preparation is Montelukast sodium, delivered via the oral route of administration in a format intended for daily use. This makes it a convenient, systemic treatment option compared to localized therapies. Airomed is characterized by its wide range of solid forms, including film-coated tablets, chewable tablets, and oral granules, accommodating both adults and pediatric patients. The availability of different oral forms supports consistent patient adherence.

General Purpose: Targeting Chronic Inflammation

The primary purpose of Airomed is to provide maintenance therapy for chronic conditions by modifying the underlying inflammatory response. A typical neutral use scenario involves the drug being prescribed to help stabilize respiratory function over time. It functions by focusing on the chemical mediators that contribute to swelling and bronchoconstriction in the airways, supporting a more consistently open and functional respiratory system, making it a critical component of a foundational, long-term therapeutic strategy.

What side effects are possible with Airomed?

Possible side effects and safety information

Official regulatory documents classify adverse reactions to Airomed (Montelukast sodium) based on the frequency observed in clinical data and post-marketing surveillance. These classifications organize the documented risks by how often they may occur and the specific physiological systems they affect.

Documented Adverse Reactions

Adverse reactions are formally grouped by System-Organ Class (SOC) and incidence rates, such as Common (may affect up to 1 in 10 people) and Uncommon. Common reactions primarily affect the Nervous System (e.g., headache) and the Gastrointestinal System (e.g., abdominal pain). Uncommon effects may include hypersensitivity responses, psychiatric disturbances, dizziness, or rash.

Serious Adverse Reactions and Safety Constraints

The official labeling highlights specific serious events reported, including neuropsychiatric events such as suicidal ideation and behaviour, aggression, and hallucinations, reported across adults and pediatric patients. Rare occurrences of systemic conditions, such as eosinophilia and vasculitis (sometimes resembling Churg-Strauss syndrome), have also been documented, sometimes associated with the reduction of concurrent oral corticosteroid therapy.

Airomed is specifically intended for chronic maintenance therapy and is not indicated for the reversal of acute bronchospasm in asthma attacks, which is an explicit restriction in the product's official safety information. The medicine is also not intended for the abrupt substitution of inhaled or oral corticosteroids.

Overdose and Emergency Response

The regulatory documentation for Airomed (Montelukast sodium) details specific clinical manifestations observed in cases of acute overdose, with reports covering both adult and paediatric patient populations. The clinical findings observed in these reports are generally consistent with the medication’s established safety profile.

The most frequently cited manifestations observed following an overdose include gastrointestinal disturbances such as abdominal pain, vomiting, and thirst. Other officially documented effects pertain to the central nervous system, including somnolence (drowsiness or sleepiness), headache, and reports of psychomotor hyperactivity (restlessness or agitation).

Regulatory authorities mandate that any suspected overdose scenario requires the patient to seek immediate medical attention or contact a healthcare provider for professional evaluation. The official management strategy involves the employment of the usual supportive measures, including necessary clinical monitoring of the patient’s condition and the institution of supportive therapy. Official prescribing information states that no specific information is available on the treatment of overdosage with Montelukast, confirming the absence of a specific known antidote.

Therapeutic Uses of Airomed

What Airomed Treats: Main Uses and Benefits

Airomed (Montelukast) is used for the long-term management of symptoms associated with chronic respiratory and allergic inflammation. It assists with maintaining daily stability and general comfort for those managing these conditions.

Airomed is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.

Long-Term Asthma Control

The medication addresses chronic inflammatory processes and persistent symptoms related to airway restriction, such as recurrent wheezing, chronic cough, and chest tightness. It provides a therapeutic benefit that supports a reduction in the overall frequency and severity of asthma episodes, helping individuals manage symptom fluctuations more steadily.

Symptom Management for Allergic States

The medication is used to manage discomfort related to allergic rhinitis, including both seasonal and perennial forms. It addresses symptom clusters that may become intense or disruptive, specifically relieving sneezing, nasal congestion (stuffy nose), and runny nose. This application helps improve day-to-day comfort during periods of heightened sensitivity to allergens.

Furthermore, it is utilized for the prevention of acute breathing restriction triggered by physical activity, known as Exercise-Induced Bronchoconstriction (EIB). This is a preventative use that assists with maintaining functional stability during and after exercise.

Quick Fact: Supporting Respiratory Comfort
Assists with managing symptoms related to inflammatory or irritative states to ease discomfort from wheezing and coughing.

Eligibility and Restrictions for Use

Official Population Eligibility for Airomed

Regulatory documents define specific populations who are eligible and non-eligible to use the medicine (Montelukast).

Eligibility Scope Official Regulatory Status
Contraindicated Populations Individuals with documented hypersensitivity to Montelukast or any excipient in the formulation.
Acute Condition Not indicated for the reversal of acute asthma attacks or acute bronchospasm.
Age Groups Allowed Adults and adolescents ge 15 years; pediatric patients for asthma (from mathbf12 months) and perennial allergic rhinitis (from mathbf6 months).
Organ Function Eligible for patients with renal insufficiency or mild-to-moderate hepatic impairment (no adjustment required).
Severe Hepatic Impairment Use not evaluated; caution is implied by regulatory documents.
Pregnancy/Lactation Conditional use; authorized only if considered clearly essential by a healthcare provider.

These official statements establish the eligibility structure. Contraindications prohibit use entirely based on allergies or excipient-related intolerances. Age minimums govern pediatric access to various indications, while use during acute life-threatening events is strictly excluded. Furthermore, eligibility is restricted for women who are pregnant or breastfeeding, defined as appropriate only under conditions deemed clearly essential in regulatory labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Airomed (Montelukast sodium) is defined by its sensitivity to metabolic alterations by co-administered medicines and specific restrictions outlined in regulatory labeling.

Pharmacokinetic and Metabolic Interactions

Montelukast elimination is primarily mediated by the CYP2C8 enzyme, with minor involvement from CYP3A4 and CYP2C9. This metabolic pathway determines the potential for altered exposure:

  • Increased Exposure: Co-administration with the strong enzyme inhibitor Gemfibrozil results in a formal, several-fold increase in Montelukast systemic exposure (AUC).
  • Decreased Exposure: Potent enzyme inducers, including Phenobarbital, Rifampicin, and Phenytoin, are documented to potentially decrease Montelukast plasma concentrations.
  • No Clinically Important Effect: Official data confirms no clinically important interaction with agents such as Theophylline, Warfarin, Digoxin, or the strong CYP3A4 inhibitor Itraconazole.

Mandatory Restrictions and Administration Rules

Regulatory documents establish several explicit restrictions and co-treatment management rules:

  • Prohibited Combination: Combination with any other medicinal product containing the active ingredient, Montelukast, is strictly restricted.
  • Co-treatment Management: Airomed must not be abruptly substituted for inhaled or oral corticosteroids; any reduction in corticosteroid dosage must be performed gradually and under supervision.
  • Population-Specific Restrictions: Patients with known aspirin sensitivity or intolerance must maintain their avoidance of Aspirin or NSAIDs. Additionally, the chewable tablet formulation contains phenylalanine, which is a mandated consideration for patients with Phenylketonuria (PKU).

Mechanism of Action

Selective Blockade of the CysLT₁ Receptor

The mechanism of action centers on highly selective antagonism of the Cysteinyl Leukotriene Type-1 Receptor (CysLT1), preventing the strong contractile and pro-inflammatory signals transmitted by endogenous cysteinyl leukotrienes (LTD4). This molecular intervention suppresses the downstream signals that cause tightening of the smooth muscle surrounding the airways, which initiates the drug's primary physiological action.

Modulation of Leukotriene-Driven Cellular Activity

By neutralizing the signaling pathway, the drug modulates sustained inflammatory responses. This mechanism results in a reduction in the infiltration and activity of eosinophils and a subsequent decrease in fluid leakage (edema) in the respiratory mucosa. Sustained receptor blockade of this leukotriene-driven cascade results in sustained reduction of leukotriene-mediated cellular activity and tissue changes.

Mechanistic Constraints and Action Speed

Airomed’s action is reliant on sustained receptor blockade to modify biological processes, classifying its mechanism as a prophylactic intervention. Due to the time required for sustained pathway interference and the regression of cellular changes, the drug cannot provide the immediate, rapid smooth muscle relaxation necessary to override severe, acute bronchospasm.

Dosage and Administration Information

How Airomed is Used: Administration Guidelines

Airomed (Montelukast sodium) is a systemic medication administered strictly via the oral route as a daily maintenance treatment. Its use is standardized to ensure proper delivery across different patient groups.


Standard Dosing and Frequency

The approved dosage of Airomed is administered once daily. For chronic conditions like asthma, the dose is generally taken in the evening to align with treatment protocols.

Age Group Standard Daily Dose Dosing Form Timing
Adults (≥ 15 years) 10 mg Film-Coated Tablet Evening
Children (6–14 years) 5 mg Chewable Tablet Evening
Children (2–5 years) 4 mg Chewable Tablet or Granules Evening

Airomed can be taken with or without food. If a patient is managing both asthma and allergic rhinitis, only a single daily dose should be administered.


Administration for Exercise-Induced Bronchoconstriction (EIB)

For the prevention of EIB, a single 10 mg dose for adults (≥ 15 years) or 5 mg for children (6–14 years) is taken at least 2 hours before exercise. Patients already taking a daily dose for chronic treatment should not take an additional dose for EIB on the same day. No dose should be taken within 24 hours of a previous dose.


Form-Specific Instructions

Chewable tablets must be chewed completely before swallowing.

Oral granules are specifically intended for mixing with small amounts of soft foods (e.g., applesauce, rice) or baby formula/breast milk, and the resulting mixture must be consumed within 15 minutes of preparation to ensure full delivery of the dose.

Recent Clinical Evidence

Research evidence / Overview of studies for Airomed

The evidence base for Airomed (Montelukast) consists of clinical trials and supporting research. This overview focuses on the structure of the studies, the outcomes researchers monitored, and the acknowledged gaps in the current body of knowledge, based exclusively on official regulatory and peer-reviewed scientific sources.


Research Examining Chronic Asthma Management

Research exploring Airomed’s use in chronic asthma relies primarily on Randomized Controlled Trials (RCTs), supported by Systematic Reviews and Meta-analyses. These studies were conducted across a broad range of patients, spanning from young children (aged 12 months and older) up through adolescents and adults who had persistent, typically mild-to-moderate, asthma.

Researchers routinely monitored measurements of lung function (like FEV1) and tracked records of rescue medication utilization and the frequency of acute asthma exacerbations. Studies monitored patterns related to changes in lung function and records of acute episodes, providing insight into the group outcomes over defined time intervals.


Research Examining Allergic Rhinitis

Research was studied for its application in addressing two types of allergic rhinitis: Seasonal (SAR) and Perennial (PAR). The evidence is derived mostly from short-term to intermediate-term RCTs.

Trials concerning SAR reported measurements of change in Total Nasal Symptom Scores (TNSS) and patterns observed in nighttime/daytime eye symptoms. For PAR, studies explored symptoms that may vary in intensity throughout the year and monitored outcomes related to chronic nasal congestion during longer observation periods.


Research Gaps and Areas of Uncertainty

Regulatory and scientific sources highlight areas where data remain insufficient. A key limitation is that comparative evidence is lacking in some areas for direct, head-to-head trials against all alternative treatments for long durations. Furthermore, researchers note that follow-up durations were limited in many controlled studies; consequently, long-term effects are not fully established.

Frequently Asked Questions (FAQ)

Common questions about Airomed (FAQ)

Q: Can people who are generally healthy take Airomed?

According to the official product information, Airomed is indicated for the acute prevention of Exercise-Induced Bronchoconstriction (EIB). This specific use is restricted to a single dose taken before exercise in individuals 15 years of age and older. Regulatory documents include this indication, which expands the use to individuals who may not have chronic asthma or allergic rhinitis.

Q: What should I know about driving or operating machinery while on Airomed?

Regulatory documents list several adverse reactions that are relevant to mental alertness. Official information specifies that side effects such as dizziness and somnolence (drowsiness) have been reported. These warnings indicate that mental alertness may be affected during the course of treatment.

Q: What type of monitoring (like blood tests) is sometimes needed for people taking Airomed?

Clinical trials for Airomed documented monitoring of liver function tests (ALT and AST) in some studies. Additionally, the official label highlights the potential for rare, systemic eosinophilic conditions to occur. The decision to perform specific monitoring is made based on clinical judgment and individual patient circumstances.

Q: Does Airomed interact with commonly prescribed anxiety or sleep medications?

While specific drug classes like anxiety or sleep medicines are not typically listed in interaction tables, the official warnings highlight a risk of neuropsychiatric events. These documented events include anxiety, depression, and insomnia. Official documentation notes that these warnings are documented for all patients.

Q: Why does the official information say Airomed 'may' cause a certain side effect?

Official documents use probabilistic phrasing like 'may cause' because side effects are categorized by the frequency they were observed in clinical trials. For example, a common side effect was reported in up to 1 in 10 patients, meaning it is a potential outcome, not a guaranteed one.

Q: What should I do if I notice a change in my mood while taking Airomed?

The official label advises patients to be alert for neuropsychiatric events, such as changes in mood, behavior, or thinking. The official guidance advises patients to notify their prescriber if these changes occur.

Q: How can I tell if Airomed is actually working for me?

Clinical research studies measured the drug's effectiveness by tracking key markers. These included changes in lung function (measured by doctors) and records of rescue medication use over time. These monitored outcomes reflect that the drug is functioning as a maintenance therapy to help reduce symptoms.

Q: Why do some patient information leaflets suggest avoiding certain foods with Airomed?

This specific warning applies only to the chewable tablet formulation. This form contains phenylalanine, which is a mandated consideration for patients with the rare metabolic condition Phenylketonuria (PKU). Beyond this specific warning, the medicine can typically be taken with or without food.

Q: Can I take cold and flu medicines while I am on Airomed?

Regulatory documents establish a restriction that applies to patients with known aspirin sensitivity. These individuals must continue avoidance of aspirin or NSAIDs while taking the medicine, as these substances are components of many common cold and flu medications.

Q: Is Airomed available in generic form?

Yes, the active ingredient in Airomed is Montelukast sodium. The U.S. Food and Drug Administration (FDA) and other regulatory bodies have approved generic versions of products containing this substance.

Q: How quickly should a person expect to feel the effects of Airomed?

The medicine is a prophylactic treatment intended for chronic use, not acute relief. Pharmacokinetic data indicates that the peak concentration (Cmax) of the medicine is typically reached in 3 to 4 hours following administration of the 10 -mg tablet in adults.

Q: If I miss a dose of Airomed, what is the general guidance on what to do?

Official guidance states that patients who miss a dose should take the next dose at their regular scheduled time. It is specifically advised that patients should not take two doses at the same time to make up for the missed one.

Q: Is it true that Airomed is sometimes used for things other than its primary listed use?

The medicine is officially indicated for the prophylaxis and chronic treatment of asthma, the acute prevention of exercise-induced bronchoconstriction, and the relief of symptoms of allergic rhinitis. Regulatory documents only support these specific uses.

Q: Are there any known issues with drinking coffee or caffeine while taking Airomed?

Official regulatory documentation based on studies of the drug's metabolism does not specifically list an interaction between the active ingredient and coffee or caffeine.

Q: Is Airomed safe for older adults to take?

Official regulatory documents indicate that the medicine's absorption and elimination are similar in older adults compared to younger adults. Therefore, no routine dosage adjustment is required based on age alone.

Q: How long does Airomed stay in the system after the last dose?

The mean plasma half-life—the time it takes for half the drug to be eliminated from the bloodstream—is documented in healthy young adults. This value is officially reported to range from 2.7 to 5.5 hours.

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

In regulatory reports of accidental overdose, the most frequently reported adverse experiences include somnolence (drowsiness), abdominal pain, thirst, and headache. Official documentation highlights these as the experiences most frequently reported.

Q: Why is it important to keep taking Airomed even if I feel better?

Official warnings state the medicine is for chronic maintenance treatment, meaning it is designed to manage ongoing underlying inflammation. It must be taken daily to work properly and prevent symptoms from recurring, rather than just treating immediate symptoms.

Q: Why do some people experience sleeping difficulties with Airomed?

Sleeping difficulties are reported as a potential neuropsychiatric adverse event in the official label. Specific reports associated with the medicine include insomnia, sleep problems, vivid dreams, and sleepwalking.

Q: Does Airomed interact with alcohol?

Official regulatory documentation and interaction studies state there are no known drug-drug interactions between the active ingredient and alcohol.

Q: Do other medications need to be stopped before starting Airomed?

Regulatory documents state the medicine must not be abruptly substituted for inhaled or oral corticosteroids. Any dosage reduction or stopping of those other medicines must be performed gradually and under the supervision of a healthcare provider.

How should Airomed be stored and disposed of?

Official Storage and Disposal Requirements

Storage and disposal rules for Airomed (Montelukast) are mandated by regulatory agencies to ensure the medication's stability and public safety.

Storage Domain Regulatory Requirement
Temperature & Environment Store at 25 C (77 F) (Controlled Room Temperature), with excursions permitted between 15 C and 30 C.
Protection Medication must be protected from light and moisture. Do not store in the bathroom or areas with excess heat.
Packaging Keep the product in the original container, tightly closed.
Stability (Granules) Oral granules, once mixed with food or liquid, must be given within 15 minutes; the mixture must not be stored for later use.
Child Safety As an official requirement, keep this and all medicines out of the sight and reach of children.
Disposal Unused or expired medication must be disposed of according to local regulations. Do not flush the product down the toilet or sink. Recommended disposal is through drug take-back programs.

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

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