Montair

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Medically reviewed

Marina Burgos

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 Montair

Quick Facts

Property Description
Active ingredient Montelukast sodium
Form Tablets, Chewable Tablets, Oral Granules
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
Common use Long-term maintenance of respiratory inflammation
Origin Synthetic chemical compound

What Type of Medicine is Montair (Montelukast)?

Montair is the specific trade name for a prescription-only medication whose active ingredient is Montelukast sodium (INN). The medication is classified pharmacologically as a Leukotriene Receptor Antagonist (LTRA), a distinct category of synthetic drugs designed to interrupt potent chemical signals in the body.

This medication is defined as a selective prophylactic agent that works by binding to and blocking the activity of the Cysteinyl Leukotriene Receptor Type 1 (CysLT1). Montelukast is clinically recognized for its role in long-term control and is considered a non-corticosteroid option, which differentiates its therapeutic action from that of broader anti-inflammatory agents.

Composition and Available Pharmaceutical Forms

Montair is a single-ingredient product, containing only the active substance, Montelukast sodium, combined with necessary pharmaceutical excipients to ensure its structure and systemic delivery. It is manufactured for oral administration and is available in multiple dosage forms: a standard film-coated tablet, a flavored chewable tablet, and oral granules that can be mixed with soft food.

The availability of various forms, particularly the granules and chewable tablets, is a key feature that supports patient adherence, which is vital for effective, sustained maintenance therapy across diverse patient groups.

The General Purpose of a Leukotriene Receptor Antagonist

Montelukast's primary general purpose is to provide sustained, long-term management by addressing the chronic inflammatory processes within the respiratory system. By achieving functional blockade of the CysLT1 receptor, the medication reduces the negative effects of potent inflammatory chemicals called leukotrienes. The mechanism shows it inhibits the physiologic actions of LTD4 at the receptor. The medicine helps keep the airways more open and settled over time by reducing swelling and tightening caused by these specific chemical messengers.

Regulatory References

  1. Montelukast - StatPearls
  2. Montelukast FDA Label

What side effects are possible with Montair?

Possible Side Effects and Safety Information

The safety profile of Montair (Montelukast) is defined by official regulatory documents, which categorize adverse reactions by frequency and affected organ system.

Classification Examples of Documented Adverse Reactions
Very Common Upper respiratory infection.
Common Headache, abdominal pain, diarrhea, nausea, vomiting, pyrexia (fever), rash, elevated liver enzymes.
Uncommon Hypersensitivity reactions, agitation, anxiety, depression, insomnia, dream abnormalities (including nightmares), dizziness, seizures, enuresis (bedwetting) in children.
Rare/Very Rare Thrombocytopenia (low platelets), palpitations, increased bleeding tendency, Hepatitis, Churg-Strauss Syndrome (CSS).

Serious adverse reactions are explicitly noted in regulatory labeling. The FDA has issued a Boxed Warning concerning serious neuropsychiatric events, including reports of suicidal thinking and behaviour, hallucinations, and aggressive behavior, which have been documented across all age groups. Other serious events include systemic eosinophilia and vasculitis, which have sometimes presented as CSS, and rare reports of severe liver injury (hepatitis).

Safety notes for specific populations include the listing of enuresis as an uncommon effect in children. The chewable tablet formulation contains a source of phenylalanine, a necessary consideration for individuals with Phenylketonuria (PKU). The medicine is contraindicated in patients with a known hypersensitivity to the active substance or any component of the formulation. Certain neuropsychiatric symptoms may continue even after the medication is discontinued, as documented in official safety updates.

Overdose and Emergency Response

Overdose Manifestations and When to Seek Help

Regulatory documentation provides specific details on the clinical manifestations reported in cases of acute overdosage with Montair (montelukast). These reported manifestations primarily affect the gastrointestinal and central nervous systems.

Overdose Manifestation Physiological Area
Gastrointestinal: Abdominal pain, Vomiting Digestive System
Neurological: Somnolence (drowsiness), Headache Central Nervous System
Other: Thirst, Psychomotor hyperactivity General & Behavioral

Overdose has been reported in both adult and pediatric populations, including high doses in children (up to 61 mg/kg in one case). The official documentation notes that clinical and laboratory findings in these acute overdose reports were generally consistent with the established safety profile. Importantly, no specific antidote is known for Montelukast. Furthermore, regulatory documents indicate that the efficacy of removal by hemodialysis or peritoneal dialysis has not been established.

Immediate medical attention must be sought for any suspected or confirmed acute over-exposure. The mandated management is defined by the requirement for symptomatic and supportive treatment. Official procedures include employing usual supportive measures, ensuring clinical monitoring, and facilitating the removal of unabsorbed material from the gastrointestinal tract. These actions define the regulatory response to overdosage.

Therapeutic Uses of Montair

What Montair Treats: Main Uses and Benefits

Montair (Montelukast) is generally used across three main therapeutic domains. It is commonly used as a daily, long-term treatment to help manage the symptoms of chronic asthma, provides prophylactic support against exercise-induced bronchoconstriction, and is relevant for easing symptoms associated with seasonal and perennial allergic rhinitis.

This supportive therapeutic benefit focuses on addressing symptoms related to inflammatory or irritative states, such as wheezing, chest tightness, coughing, nasal congestion, and sneezing. It contributes to easing the overall symptom load, which may help support a greater sense of breathing comfort and provides support that helps ease the symptom burden across relevant patient groups.

When used as a preventative measure before physical activity, this application may assist with managing symptoms associated with physical exertion that create noticeable physiological strain, and may support general well-being and functional stability during physical effort. Similarly, for allergies, it helps address symptom clusters that interfere with daily functioning, contributing to improved day-to-day comfort during symptomatic periods. It offers symptomatic relief that may help patients cope more steadily with symptom fluctuations.


Quick Fact: Relief for Respiratory Symptoms

Therapeutic Focus Primary Symptom Axes Addressed
Asthma Maintenance Symptoms related to physical discomfort and functional stress (wheezing, chest tightness).
Exercise Prophylaxis Symptoms associated with acute or episodic changes triggered by exertion.
Allergy Management Symptoms related to inflammatory or irritative states (congestion, sneezing, runny nose).

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Montair?

This section outlines the official, label-based eligibility requirements for Montair (Montelukast).


Eligibility Scope

Classification Rule Summary (Based on Regulatory Documents)
Contraindicated Patients with a known hypersensitivity to Montelukast or any of the product's components.
Not Indicated Acute asthma attacks or status asthmaticus (Montair is for chronic, prophylactic use only).
Conditional Use Use during pregnancy and lactation is permitted only if clearly essential due to limited safety data.

Age-Related Eligibility Rules

Eligibility for children is specific to the condition being treated:

  • Asthma: Approved for patients 12 months of age and older.
  • Exercise-Induced Bronchoconstriction (EIB): Approved for patients 6 years of age and older.
  • Allergic Rhinitis: Approved for Seasonal AR in patients 2 years of age and older, and Perennial AR in patients 6 months of age and older.
  • Use Not Established: Safety and efficacy are not established for EIB prevention in children under 6 years or for asthma in children under 12 months.

Condition-Specific Considerations

Patients with severe hepatic impairment have not been assessed for safety and effectiveness. No dosage adjustment is required for patients with renal impairment or mild-to-moderate hepatic impairment. For patients with Phenylketonuria (PKU), the chewable tablets contain phenylalanine.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information addresses interactions involving the metabolism of Montelukast and specific co-administered substances, as well as necessary patient management constraints.

Documented Exposure-Altering Interactions

Montelukast is metabolized by certain liver enzymes (CYP2C8, 2C9, and 3A4). Co-administration with enzyme-modifying medicinal products can alter Montelukast's systemic exposure (AUC).

Interacting Substance Official Exposure Outcome
Gemfibrozil (Enzyme Inhibitor) Increases Montelukast systemic exposure (AUC) by approximately 4.4-fold.
Phenobarbital (Enzyme Inducer) Decreases Montelukast systemic exposure (AUC) by approximately 40%.

Clinical monitoring is considered appropriate when potent enzyme inducers like Rifampicin are co-administered. However, regulatory documents indicate that Montelukast had no clinically important effects on the pharmacokinetics of Theophylline, Warfarin, Prednisone, or oral contraceptives.

Administration and Therapeutic Constraints

Montelukast is not a substitute for oral or inhaled corticosteroids; it must not be abruptly substituted for these medicinal products. Patients with known aspirin sensitivity must continue avoidance of aspirin or non-steroidal anti-inflammatory agents, as Montelukast does not modify the bronchoconstrictor response to these substances. Furthermore, the maximum plasma concentration of the oral granules may be decreased by 35% when co-administered with a high-fat meal.

Mechanism of Action

Montair's mechanism of action is defined by influencing signaling mediated by the cysteinyl leukotriene pathway in the respiratory system. The molecule is classified as a selective Leukotriene Receptor Antagonist that operates by blocking the Cysteinyl Leukotriene Receptor Type 1 (CysLT1).

Molecular Action and Pathway Interruption

Montelukast binds with high affinity to the CysLT1 receptor, preventing endogenous inflammatory chemicals, particularly Leukotriene LTD4, from causing receptor activation. This molecular action suppresses the signal transmission of the Eicosanoid Pathway, which is associated with physiological responses in the airways. This interruption contributes to the molecule's profile as a sustained pathway modulator.

️ Physiological Consequences in Airway Tissue

By blocking the CysLT1 receptors on target cells, the mechanism limits several downstream physiological consequences. This directly prevents receptor activation responsible for smooth muscle contraction (tightening) and decreases the signal leading to vascular permeability, which results in reduced fluid accumulation and swelling in the airway lining. The mechanism thus contributes to maintaining the inhibition of receptor activation, which influences the dynamics of the targeted pathways.

Dosage and Administration Information

How to Use Montair: Official Administration Guidelines

Montair (montelukast) is administered via the oral route for long-term management, with specific dosing regimens defined by a patient’s age group and the treated condition.

Standard Dosing and Administration

The primary use pattern is once-daily dosing for chronic, continuous treatment. The medicine is available in several official strengths and forms:

Age Group Standard Once-Daily Dose Forms
Adults and Adolescents (Age ge 15) 10 mg Film-Coated Tablet
Pediatric Patients (Age 6 to 14) 5 mg Chewable Tablet
Pediatric Patients (Age 6 months to 5 years) 4 mg Chewable Tablet, Oral Granules

For maintenance treatment of asthma, the daily dose should be taken in the evening. If the drug is used solely for allergic rhinitis, administration may occur in the morning or evening. When the drug is used to manage both conditions, the single daily dose should be taken in the evening.

Contextual and Procedural Instructions

Exercise-Induced Bronchoconstriction (EIB) Prophylaxis requires a specific administration schedule: a single dose must be taken at least 2 hours before exercise. A patient already receiving a daily dose for chronic use should not take a second, additional dose for EIB prophylaxis within a 24-hour period. Standard and chewable tablets may be taken with or without food.

Oral Granules must be administered within 15 minutes of opening the packet. The granules can be mixed with a spoonful of soft foods such as applesauce, rice, or ice cream, or with baby formula or breast milk. Granules must never be dissolved in other liquids or stored for later use after mixing.

If a dose is missed, patients are instructed to resume the schedule with the next dose at the regular time and should not take a double dose to compensate.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Montair (Montelukast)

Evidence for Use in Chronic Asthma Maintenance

Research explored how symptoms evolved in groups receiving Montair over time in populations with asthma, a condition characterized by fluctuating or episodic manifestations. The evidence base includes Randomized Controlled Trials (RCTs) that compared Montair to a placebo or to standard inhaled controller therapies, like inhaled corticosteroids (ICS). These studies monitored key physiological measures, such as objective lung function tests, alongside patient-reported outcomes describing perceived discomfort.

Studies described patterns observed in the research related to outcomes linked to inflammatory or irritative states. In the observed populations, Montair was observed in trials exploring how symptoms change over time. In trials comparing Montair to inhaled corticosteroids, the ICS groups often described different patterns in objective lung function measures.

There are limitations regarding the certainty in the research. Comparative evidence is lacking in large-scale studies that track outcomes over many years. Furthermore, data for certain groups remain insufficient because the majority of studies focused on individuals with mild to moderate persistent asthma.


Evidence for Use in Acute Prevention of Exercise-Induced Bronchoconstriction (EIB)

Research was studied for its role in addressing outcomes related to acute or episodic changes triggered by physical exertion. The study designs used here were specialized, involving short-term, controlled trials where participants were observed before undertaking a standardized, laboratory-based exercise challenge. Studies monitored the immediate physiological response and tracked how long any temporary physiological imbalance persisted after the exercise.

What remains uncertain is how consistently the observed patterns in controlled laboratory challenge settings translate to real-world physical activities, which are generally more varied. The results apply only to the populations studied, which were largely adults and children over the age of six with diagnosed EIB.


Evidence for Use in Allergic Rhinitis (Seasonal and Perennial)

Montair was evaluated in trials exploring outcomes linked to inflammatory or irritative states characteristic of both seasonal and year-round allergies. The research involved randomized trials where Montair was compared to a placebo or to other available allergy treatments. Researchers examined changes in detailed patient-reported outcomes describing perceived discomfort using symptom scoring systems.

Comparative evidence is lacking to firmly establish Montair's standing against common first-line allergy treatments. Consequently, the use of Montair for allergic rhinitis may be positioned in clinical contexts for patients who may not have responded sufficiently to or cannot tolerate other therapies.

Key Studies & References

  1. Montelukast in paediatric asthma and allergic rhinitis: a systematic review and meta-analysis (Compares Montelukast efficacy to ICS in children/adolescents)
  2. Efficacy of Montelukast in Allergic Rhinitis Treatment: A Systematic Review and Meta-Analysis (Compares Montelukast, OAH, and Combination Therapy)
  3. Study Details | NCT00090142 | Montelukast in Exercise-Induced Bronchospasm - 2004 (RCT on single dose EIB prevention)
  4. Clinical Practice Guideline: Allergic Rhinitis (Context for treatment comparisons)

Frequently Asked Questions (FAQ)

Common questions about Montair (FAQ)

Q: How long does it take for Montair to start working after I take the first pill?

According to official product information, Montelukast is absorbed rapidly after taking a dose by mouth. The maximum concentration of the medication in the blood is typically reached within 3 to 4 hours.

Q: Can Montair cure my asthma completely?

Regulatory documents indicate that Montelukast is used for the long-term management and control of asthma and allergic rhinitis symptoms. This medicine is considered a maintenance treatment and is not a cure for these chronic conditions.

Q: Can I take Montair if I'm pregnant?

Official labeling states that the medicine may be used during pregnancy only if its use is considered clearly essential.

Q: What is the full list of ingredients in the chewable tablet besides the active ingredient?

The chewable tablets contain the active ingredient, Montelukast sodium, along with several inactive ingredients (excipients). These include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, red ferric oxide, croscarmellose sodium, a flavoring agent (cherry or orange), aspartame, and magnesium stearate.

Q: I have severe liver problems, do I need a dose adjustment?

Regulatory documents indicate that no dose adjustment is suggested for patients with mild-to-moderate liver impairment. However, the pharmacokinetics of the drug have not been studied in patients with severe hepatic impairment.

Q: Is Montair available as a generic drug?

Yes, the active ingredient in Montair, which is montelukast sodium, is widely available as a generic prescription medication from various manufacturers.

Q: Is Montair safe for my 4-year-old with asthma?

Official labeling indicates that Montelukast is approved for the treatment of asthma in pediatric patients 12 months of age and older. The official labeling specifies the appropriate dose form and strength for children in the 2-to-5-year age group.

Q: Where exactly does the Montelukast bind in the body?

Montelukast works by binding to and blocking the Cysteinyl Leukotriene Receptor Type 1 (CysLT1). This receptor is primarily found in the human airway on cells such as airway smooth muscle and other pro-inflammatory cells.

Q: How does Montair work to open up my airways?

The mechanism of action involves blocking the activity of the CysLT1 receptor. This action reduces the negative effects of specific inflammatory chemicals (leukotrienes), which helps to minimize the inflammation, narrowing, and swelling within the airways.

How should Montair be stored and disposed of?

How to Store and Dispose of Montair (Montelukast)

Montair (montelukast) must be stored in specific environmental conditions to maintain its stability, as defined in official regulatory labeling.

Official Storage Requirements

Storage Category Requirement
Temperature Store below 25 C (77 F).
Protection Keep in the original package to protect from light and moisture.
Safety Must be stored out of the sight and reach of children.

Specific Handling and Disposal

Montelukast oral granules must be administered within 15 minutes of opening the sachet or mixing with food/liquid; the mixture must not be stored for later use. Any unused or expired product, including leftover mixed granules, must be disposed of in accordance with local requirements for pharmaceutical waste.

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

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