Mogulair

Quick links to important sections

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 Mogulair

Mogulair is a brand name for a prescription medication used in the chronic management of respiratory inflammation. The medicine is primarily defined by its active ingredient, its pharmacological class, and its non-inhaler route of administration.

Property Description
Active ingredient Montelukast sodium
Form Film-coated tablets, chewable tablets, oral granules
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
Origin Synthetic chemical compound
Route of administration Oral (by mouth)

Mogulair: A Definition by Composition and Class

Mogulair is a prescription-only pharmaceutical product whose active component is the single, synthetic compound Montelukast sodium. This drug is classified as a Leukotriene Receptor Antagonist (LTRA), a specific type of anti-inflammatory agent recognized for its targeted mechanism. Its classification distinguishes it from general bronchodilators, confirming its role as a focused agent for managing inflammation rather than merely providing symptom relief.

How the Leukotriene Antagonist Supports Respiratory Health

The overarching therapeutic purpose of Mogulair is to provide sustained support for stable airway function by counteracting specific inflammatory signals. The active ingredient, Montelukast, operates through selective antagonism, binding to the Cysteine-leukotriene receptors to block the action of inflammatory chemicals known as leukotrienes. This mechanism is recognized for mitigating the physiological effects of these mediators, which include the tightening of air passage muscles and fluid accumulation. By disrupting this inflammatory cascade, the medicine contributes to the maintenance of open airways.

Available Forms for Oral Administration

A key differentiating factor of Mogulair is its oral administration route. The drug is presented in forms optimized for ingestion: film-coated tablets, chewable tablets, and oral granules. This variety ensures accessibility and ease of use for a wide patient demographic, including pediatric groups, offering a viable systemic therapeutic option that does not necessitate the use of specialized inhalation devices.

Regulatory References

  1. Montelukast: MedlinePlus Drug Information
  2. Label: MONTELUKAST SODIUM- montelukast tablet - DailyMed

What side effects are possible with Mogulair?

Possible Side Effects and Safety Information

The official safety profile for Mogulair (Montelukast sodium) is established through frequency-based classifications and grouping of adverse reactions by the physiological system affected. This classification system ensures consistent regulatory communication of potential risks.

Commonly Documented Adverse Reactions

The frequency classification of adverse reactions, as documented in regulatory labeling, indicates that some effects occur more frequently than others in clinical use. For example, upper respiratory infection is generally categorized as a very common reaction. Effects such as headache and abdominal pain are typically classified as common.

Serious Adverse Reactions

The labeling identifies certain rare but clinically significant adverse reactions. These include neuropsychiatric events such as agitation, aggression, depression, and suicidal thinking and behavior, which are explicitly highlighted in the official prescribing information. Other documented serious reactions include various hypersensitivity reactions (e.g., angioedema), hepatitis, and Eosinophilic Granulomatosis with Polyangiitis (EGPA), a form of systemic vasculitis.

Population-Specific Safety Notes and Constraints

The regulatory profile outlines specific safety considerations. The neuropsychiatric events are noted as particularly important in the pediatric population. The medicine is explicitly not indicated for the reversal of acute asthma attacks (acute bronchospasm or status asthmaticus). Additionally, the official label notes that eosinophilic conditions, including EGPA, have been reported primarily in patients whose systemic or inhaled corticosteroid therapy was reduced or withdrawn while receiving Montelukast.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — Official Regulatory Information for Mogulair

Overdose Scope

Element Official Regulatory Documentation Statement
Documented overdose presentations The most frequently reported adverse experiences following acute overdose include abdominal pain, somnolence (sleepiness), thirst, headache, vomiting, and psychomotor hyperactivity (restlessness/agitation).
Physiological systems affected (as stated in label) Central Nervous System (CNS) effects and Gastrointestinal (GI) effects are explicitly documented.
Dose-related or exposure-related factors (if applicable) Overdose reports have included single doses as high as 1000 mg in adults and 445 mg in children.
Population-specific overdose notes (if applicable) Overdose has been reported in both adult and pediatric patients, with clinical findings generally consistent with the established safety profile across both age groups.
Emergency-response statements (as written in official documents) Treatment is symptomatic and supportive. Supportive measures include clinical monitoring and the removal of unabsorbed material from the gastrointestinal tract.
When immediate medical help is required (label-derived phrasing only) Immediate medical attention must be sought if the victim has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened. Users are directed to contact the poison control helpline or emergency services.

Overdose Classifications (High-Level)

Classification Element Official Regulatory Documentation Statement
Severity classification (as defined in official documents) Findings observed were generally consistent with the established safety profile; in the majority of reports, no adverse experiences were observed.
Overdose-context constraints (as defined in official documents) No specific antidote is known for Montelukast. It is not known whether Montelukast is removed by peritoneal dialysis or hemodialysis.

Resulting Overdose Structure

Official overdose statements:

  • Overdose may present with documented manifestations including abdominal pain, somnolence, headache, vomiting, thirst, and psychomotor hyperactivity.
  • No specific antidote is known, and treatment is officially managed with symptomatic and supportive measures and clinical monitoring.
  • Immediate medical attention is required and emergency services must be contacted in the event of severe clinical signs, such as collapse, seizure, or respiratory distress.

Connection to the overall overdose profile

Regulatory documents define the Montelukast overdose profile based on documented clinical manifestations that align with the medicine's known safety profile, including central nervous system and gastrointestinal effects. The absence of a specific antidote necessitates that regulatory guidance mandates a supportive treatment approach, focusing on clinical monitoring and the management of symptoms. The official guidance on seeking help is explicitly tied to the onset of severe clinical signs, dictating that emergency services must be contacted under those specific conditions.

Therapeutic Uses of Mogulair

What Mogulair Treats: Main Uses and Benefits

Mogulair is commonly used to help manage symptoms across three primary therapeutic domains, providing supportive relief in conditions characterized by inflammatory or irritative states. This medication is primarily relevant for easing symptoms associated with chronic asthma (for long-term control), seasonal and perennial allergic rhinitis, and for the prophylaxis of exercise-induced bronchoconstriction (EIB).


The treatment is applied in addressing symptom clusters that may become intense or disruptive, such as wheezing, chest tightness, nasal congestion, and sneezing. In the context of long-term symptomatic support, it may assist in reducing the overall symptom burden and contributes to easing the reliance on quick-relief medications. For patients coping with persistent allergic discomfort, it contributes to supportive symptomatic relief.

“This medicine is commonly used to help manage symptoms related to ongoing airway inflammation and certain allergic responses.”

A key benefit may assist with maintaining functional stability during symptomatic periods.

Quick Fact: Relief for Respiratory Stability
Mogulair is considered relevant for situations involving long-term symptomatic support, assisting in maintaining functional stability in the airways rather than providing immediate relief for sudden, acute symptom flare-ups.

Regulatory References

  1. DailyMed/NIH official label

Eligibility and Restrictions for Use

The drug name Mogulair is not currently documented as an officially approved or regulated medicine in the authoritative government regulatory databases of major international health agencies, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

Consequently, the official prescribing information, which typically contains legally binding eligibility and non-eligibility details (Contraindications, Special Populations, etc.), is not available for this specific brand name. This means that formal regulatory restrictions and exclusions for use have not been state-verified or published.

Eligibility Status: Official Regulatory Information

Eligibility scope Official Regulatory Status
Populations for whom use is contraindicated Not documented in official regulatory sources.
Age-related eligibility rules Not established in official regulatory sources.
Condition-specific limitations Not documented in official regulatory sources.
Pregnancy and lactation eligibility Not established in official regulatory sources.

All formal eligibility constraints—including specific exclusions for pediatric patients, pregnant or breastfeeding individuals, or patients with certain organ impairments—remain undefined in the public domain of government health agency labels. Only information explicitly stated in these official documents determines regulatory eligibility.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Mogulair (Montelukast sodium) centers on pharmacokinetic interactions involving Cytochrome P450 (CYP) enzymes and specific co-administration restrictions.

Interaction Type / Substance Official Mechanism / Outcome
Gemfibrozil Inhibitor of CYP 2C8 and 2C9; increases Montelukast systemic exposure (AUC by approximately 4.4-fold).
Phenobarbital CYP enzyme inducer; decreases Montelukast systemic exposure (AUC by approximately 40%).
Rifampicin, Phenytoin CYP enzyme inducers; caution is advised when co-administered.

Pharmacokinetic and Pharmacodynamic Restrictions

  • Contraindicated Combinations: The co-administration of Mogulair with any other medicinal product containing montelukast as an active ingredient is prohibited.
  • Aspirin and NSAIDs: Patients with known aspirin sensitivity must continue to avoid aspirin or non-steroidal anti-inflammatory agents while taking this medication, as Montelukast has not been shown to interrupt their bronchoconstrictor response.
  • Other Medications: No clinically important effects on the pharmacokinetics of Theophylline, Prednisone, Oral Contraceptives, Digoxin, or Warfarin have been documented in official studies.
  • Food Effect: A high-fat meal decreases the peak concentration ( Cmax) of the oral granule formulation by 35% but does not affect the overall systemic exposure ( AUC).
  • Timing Rule: For prevention of Exercise-Induced Bronchoconstriction, the dose must be administered at least 2 hours before exercise.

Mechanism of Action

How Mogulair Works: Mechanism of Action

Montelukast (Mogulair) operates through a singular, highly targeted pharmacodynamic mechanism designed to modulate the Cysteinyl Leukotriene signaling pathway. This action is essential for modulating the physiological processes of muscular constriction and tissue swelling in the airways.

Selective Functional Blockade of the CysLT1 Receptor

The drug functions as a competitive antagonist, binding specifically to the CysLT1 receptor found on smooth muscle cells and inflammatory cells. This binding creates a functional blockade, preventing the endogenous inflammatory mediators ( LTD4) from initiating the pro-constrictive and pro-inflammatory cascade. This action is crucial for modifying early molecular steps that shape systemic physiological outcomes.

Physiological Consequences: Modulation of Airway Caliber and Tissue Permeability

The molecular blockade of CysLT1 produces two key physiological adjustments: it interrupts the signal that triggers airway smooth muscle contraction and suppresses the signal that increases vascular permeability (reducing mucosal edema). This dual action supports the establishment of a more regulated state within the targeted pathways, leading to an increase in the airway caliber.

Interference with Leukotriene-Driven Inflammatory Cell Signaling

By limiting the activation of CysLT1 receptors on inflammatory cells, the drug helps dampen the leukotriene-driven inflammatory response. This mechanism is specific to leukotrienes and does not affect pathways mediated by other messengers like histamine or acetylcholine, contributing to a reduction in the reactivity of the airway over time.

Dosage and Administration Information

How to Use Mogulair: Official Administration Guidelines

Mogulair, containing Montelukast sodium, is administered via the oral route across all its approved dosage forms, including film-coated tablets, chewable tablets, and oral granules. The regimen is structured by age and condition to ensure correct systemic exposure, with the dosage tiered to the patient's age and not requiring adjustment for older adults or those with mild-to-moderate hepatic or renal impairment.

Dosage and Timing Structure

The maintenance dose for chronic conditions, such as asthma, is taken once daily and is typically administered in the evening to maintain consistent 24-hour coverage. For the prevention of exercise-induced bronchoconstriction (EIB), the medication is used intermittently, requiring a single dose taken at least two hours before the activity. A key constraint is that a patient already on a daily dose for chronic treatment must not take an additional EIB dose within the same 24-hour window.

Age Group Standard Daily Dose Form Availability (Official)
Age 15 years and older 10 mg Film-Coated Tablet
6 to 14 years 5 mg Chewable Tablet
6 months to 5 years 4 mg Chewable Tablet or Granules

Administration Requirements

The medication can be taken with or without food. Specific handling is required for the oral granule formulation: it must be administered within 15 minutes of opening the packet and may be mixed only with specific soft foods or 5 mL of baby formula or breast milk. Granules should not be dissolved in other liquids, and the mixed preparation must be consumed immediately, never stored for later use. If a daily dose is missed, it is recommended to take the next dose at the regular time, without doubling the dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Mogulair

Mogulair (Montelukast sodium) has been extensively evaluated in clinical trials and post-marketing studies. Research was studied for its application in conditions associated with inflammatory or irritative states. This overview summarizes the evidence base from authoritative sources, focusing on what types of studies exist and where research is still developing.


Evidence for use in Chronic Asthma Management

The research was studied for its application in conditions characterized by fluctuating or episodic manifestations such as persistent asthma. This research is primarily based on Randomized Controlled Trials (RCTs). The medicine was evaluated in studies against an inactive placebo or, in some cases, other medications. These studies were used in research exploring how symptoms change over time and how the overall burden of the condition may be managed. Findings describe patterns observed in the studies related to certain lung function measurements (such as FEV1) and the monitored usage frequency of rescue inhalers.

Study Endpoints and Measures of Success

In trials evaluating Mogulair, researchers studies explored various outcomes reflecting daily functioning or activity level. These included objective physiological tests and patient-reported outcomes describing perceived discomfort. Research describes how the frequency of episodes where symptoms become more noticeable (exacerbations) was monitored during the trial periods. The main focus was studied for measuring functional change and changes in the use of immediate-relief medications.


Evidence for Preventing Exercise-Induced Bronchoconstriction (EIB)

Research into Mogulair's application in conditions associated with acute or disruptive episodes triggered by physical activity has typically involved short-term, controlled trials. These studies included children (ages 6 and up), adolescents, and adults. The primary study outcomes examined were measures of post-exercise lung function, such as how severely a person's FEV1 measurement dropped after the challenge.


Areas of Research Gaps and Remaining Uncertainty

Continuous long-term effects are not fully established beyond the initial efficacy period, as follow-up durations were limited in many core efficacy trials. Comparative evidence for certain head-to-head comparisons against optimal standard care is lacking, and subgroup findings are uncertain in areas like very young children (under 6 months for most uses). It is vital to remember that study results reflect the specific conditions under which they were conducted and research does not determine whether an individual will respond similarly.

Key Studies & References

  1. Montelukast Sodium Official FDA Label (DailyMed)
  2. National Institute for Health and Care Excellence (NICE) Guidelines: Asthma: diagnosis, monitoring and chronic management

Frequently Asked Questions (FAQ)

Common questions about Mogulair (FAQ)

Q: How long does the effect of Mogulair last in the body?

A: The official product information indicates that after an oral dose of Montelukast sodium, the mean peak concentration in the blood is typically reached in three to four hours. The mean half-life of the drug is between 2.7 and 5.5 hours. This information is consistent with the recommended once-daily administration schedule.


Q: Are there specific warnings about sleep disturbances or vivid dreams while using Mogulair?

A: Yes, the official regulatory labeling includes specific warnings about neuropsychiatric events associated with Montelukast sodium. These reported side effects specifically include sleep disturbances, such as insomnia, nightmares, and vivid or unusual dreams.


Q: Does Mogulair cause a person to feel tired or fatigued?

A: Sleepiness, medically known as somnolence, is listed in the official post-marketing reports as an adverse experience associated with the medicine. However, in controlled clinical trials, the frequency of sleepiness was reported to be similar between those taking the drug and those taking an inactive placebo.


Q: Is it normal to have stomach pain when starting Mogulair?

A: Abdominal pain is listed as a commonly reported side effect in official clinical trials for Montelukast sodium. The regulatory labeling does not specifically distinguish if this pain is more frequent only at the beginning of treatment or throughout its use.


Q: Does Mogulair affect appetite or cause weight changes?

A: Based on a review of clinical studies, Montelukast sodium has not been reported to cause weight gain. The official product information does not include changes in appetite or body weight among the commonly documented adverse reactions.


Q: What is the official guidance on consuming alcohol while taking Mogulair?

A: The official prescribing information does not list a direct interaction between Montelukast sodium and alcohol. Alcohol consumption may potentially worsen asthma symptoms, and its consumption may be relevant to the drug’s rare but serious risk of hepatitis.


Q: What medical conditions would prevent someone from being able to use Mogulair?

A: According to the official regulatory documents, a known hypersensitivity to any component of the Montelukast sodium product is the only strict contraindication for its use. This restriction is in place due to the risk of an allergic reaction.


Q: Is Mogulair appropriate for children under the age of five?

A: Official product information states that Montelukast sodium is indicated for use in certain young populations. The medicine is approved for the chronic treatment of asthma in children as young as 12 months and for seasonal allergic rhinitis in children 2 years and older.


Q: What is the maximum duration of treatment mentioned in official documents?

A: Montelukast is approved for the chronic treatment (long-term use) of asthma and allergic rhinitis. Official documents do not define a specific maximum time limit for continuous treatment.


Q: Is a headache a common side effect when starting Mogulair?

A: Headache is listed as a commonly reported side effect in official clinical trials for Montelukast sodium. Regulatory documents classify the frequency of this effect generally, and do not specifically state if headaches are more noticeable when the patient first begins treatment.


Q: Is it necessary to use Mogulair at the exact same time every day?

A: For chronic asthma treatment, the medicine is directed to be taken once daily in the evening. If a daily dose is missed, regulatory documents direct patients to take the next dose at the regular time and explicitly advise against doubling a dose.


Q: Why is Mogulair often recommended to be taken in the evening?

A: The official administration guidelines for chronic asthma treatment recommend taking Montelukast sodium once daily in the evening. This timing is specified and intended to support consistent 24-hour coverage and systemic exposure for the medicine's preventative action.


Q: Are there any contraindications related to kidney function listed for Mogulair?

A: Montelukast sodium is eliminated from the body primarily through bile and feces, independent of kidney function. Official documents state that no dosage adjustment is required for patients with renal insufficiency of any severity. Therefore, kidney problems are not addressed as a general contraindication in the regulatory documents.


Q: What is the storage temperature requirement for Mogulair tablets?

A: The official labeling requires that Montelukast tablets be stored at Controlled Room Temperature, which is generally 20 C to 25 C (68 F to 77 F). The regulatory requirements specify the medicine must be protected from both light and moisture to maintain its stability and effectiveness.


Q: Is there a generic version of Mogulair available in my region?

A: Mogulair is a brand name for the active chemical ingredient, Montelukast sodium. The official FDA labeling for the generic drug confirms that Montelukast sodium is widely available in generic tablet and chewable tablet forms across regulated markets.


Q: Can a person with liver problems use Mogulair?

A: Official regulatory information indicates that no dosage adjustment is required for people with mild-to-moderate liver impairment (hepatic insufficiency). However, the way Montelukast is processed has not been evaluated in patients with more severe liver impairment.


Q: What happens in the body when someone suddenly stops using Mogulair?

A: Clinical studies in patients with asthma did not report a sudden worsening of the condition (a 'rebound effect') after discontinuing Montelukast. However, mood and behavior changes have been reported in some patients after they stopped using the medicine.


Q: Can Mogulair be taken alongside over-the-counter pain relievers?

A: Official interaction warnings specifically advise patients with known aspirin sensitivity to continue avoiding aspirin and other non-steroidal anti-inflammatory agents (NSAIDs) while using Montelukast sodium. Regulatory documents do not provide official interaction information for non-NSAID pain relievers.


Q: What is the official statement regarding the use of Mogulair during pregnancy?

A: Official clinical guidance emphasizes the importance of maintaining well-controlled asthma throughout pregnancy. Montelukast sodium use during pregnancy should be reviewed by a qualified healthcare provider.

How should Mogulair be stored and disposed of?

The official regulatory requirements dictate strict conditions for storing and disposing of Mogulair (Montelukast sodium) to preserve its stability.

Storage & Disposal Scope
Storage Temperature: Store at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F) [FDA/EMA].
Protection: Protect from light and moisture; do not store in excess heat [NIH/EMA].
Packaging Rules: Must be kept in the original container and kept tightly closed to maintain protection [FDA].
Child Safety: Keep this medicine out of the reach of children and out of their sight [NIH].
Disposal: Do not flush down a toilet. Dispose of unused or expired product through an official medicine take-back program or by following specific at-home disposal instructions on the medication guide [FDA].

These mandated conditions directly address the drug's known sensitivity to heat, light, and humidity, ensuring the product remains chemically stable for the labeled shelf-life. The disposal rules prevent release into the wastewater system and guide safe discarding procedures.

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

Available in countries:

Equivalent of Mogulair found in:

A-Z Index: