Airokast

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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 Airokast

Property Description
Active ingredient Montelukast (as Montelukast sodium)
Form Oral tablets (film-coated, chewable) and granules
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
General purpose Long-term control of inflammation in airways
Origin Synthetic compound

Airokast is a prescription-only medicinal product containing the active ingredient Montelukast sodium, which belongs to the distinct pharmacological class of Leukotriene Receptor Antagonists (LTRAs). This classification means the medicine is specifically designed to interfere with certain chemical pathways involved in allergic and inflammatory responses. Pharmacological studies have clinically recognized the efficacy of Montelukast in reducing inflammation and improving respiratory parameters in chronic conditions.

The general purpose of Airokast is to stabilize the function of the airways and reduce the chronic swelling associated with respiratory and allergic issues, helping to maintain consistent airflow. The drug works by selectively binding to the CysLT1 receptor, thereby preventing cysteinyl leukotrienes—compounds released during inflammatory events—from binding and triggering their downstream effects, which include airway muscle contraction and mucus secretion.

The medication relies on the single, synthetic active ingredient, Montelukast sodium, delivered exclusively via the oral route of administration. Airokast is supplied in various oral dosage forms, including standard film-coated tablets, chewable tablets (often suited for pediatric patients), and oral granules. This structural variety ensures the active compound can be reliably delivered without complex inhaler techniques.

Regulatory References

  1. Montelukast: MedlinePlus Drug Information

What side effects are possible with Airokast?

The safety characteristics of Airokast are based on officially documented adverse reactions classified by regulatory authorities, encompassing effects observed in clinical trials and post-marketing surveillance.

Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized by incidence rate in regulatory labeling, with Very Common (1/10) effects including upper respiratory infection. Common effects (1/100 to < 1/10) typically involve headache, fever, abdominal pain, diarrhea, and rash. Effects classified as Uncommon (1/1,000 to < 1/100) include hypersensitivity reactions, agitation, depression, and dream abnormalities. Rarer events, such as increased bleeding tendency, are reported in the Rare category (1/10,000 to < 1/1,000).

System-Organ-Class Groupings

The most commonly affected System-Organ Classes (SOCs), as described in official documents, include Infections and Infestations, Gastrointestinal Disorders, and Nervous System Disorders. The label also documents adverse effects in the Psychiatric Disorders and Hepatobiliary Disorders SOCs.

Serious Safety Concerns

Specific serious adverse reactions highlighted by government agencies include neuropsychiatric events—such as suicidal thoughts and behavior—which have been reported in all age groups taking the medicine and are addressed by a formal Boxed Warning in the U.S. label. Cases of systemic eosinophilia, sometimes presenting with features of vasculitis consistent with Churg-Strauss syndrome, have also been reported, occasionally associated with the reduction of concurrent oral corticosteroid therapy.

Population-Specific Notes

The chewable tablet form contains aspartame, a source of phenylalanine, which requires specific caution for patients with Phenylketonuria (PKU). Additionally, official regulatory data notes that patients with mild-to-moderate hepatic insufficiency may experience higher systemic exposure to the active ingredient.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Airokast overdose focuses on documented clinical findings and mandated emergency actions. Acute overdose exposure has been reported in both adult and pediatric patients, including documented exposures up to 1000 mg in adults.

Clinical Signs and Manifestations

Clinical manifestations documented in post-marketing and study reports include signs affecting the gastrointestinal system and general well-being. These specific manifestations are abdominal pain, vomiting, somnolence (sleepiness), thirst, headache, and restlessness or agitation.

When Immediate Help Is Mandated

Regulatory guidance requires seeking immediate emergency medical attention for all suspected overdoses, particularly if critical symptoms are observed. This includes calling emergency services immediately if the patient has collapsed, experienced a seizure, has trouble breathing, or is unable to be awakened. Contacting a Poison Control Center is also a mandated action.

Management and Supportive Care

No specific antidote is known or documented in the official prescribing information for Montelukast overdose. Consequently, management relies on supportive and symptomatic measures. Procedures include employing clinical monitoring and removing unabsorbed material from the gastrointestinal tract. Regulatory labels state that procedures like hemodialysis are not expected to be effective, due to the drug’s high plasma protein binding.

Therapeutic Uses of Airokast

What Airokast Treats: Main Uses and Benefits

Airokast is commonly used to help manage symptoms related to specific respiratory and allergic conditions. The medication is applied in the context of three main therapeutic areas: long-term asthma treatment, the prevention of breathing difficulties triggered by exercise, and the symptomatic relief of allergic rhinitis.

The primary therapeutic goal is to assist patients by easing symptom clusters that may become intense or disruptive. For chronic asthma, this application involves daily maintenance support that may assist with maintaining functional stability in the airways, addressing recurring wheezing and persistent coughing. For allergies, Airokast is relevant for easing symptoms like pronounced nasal congestion and runny nose associated with seasonal and perennial allergies. As a preventative measure, it helps manage breathing difficulty specifically triggered by physical exertion.

“This therapy contributes to easing the overall symptom load and helping to manage the frequency and intensity of symptoms.”

This supportive relief is applied across conditions where symptoms create noticeable physiological strain, and may assist with maintaining functional stability to support general well-being.


Quick Fact: Relief for Nasal Congestion Airokast is commonly used to help manage the symptom of nasal congestion (stuffy nose) associated with allergic rhinitis, providing supportive relief for symptoms that create noticeable physiological strain.

Eligibility and Restrictions for Use

Who Can and Cannot Use Airokast?

Airokast (Montelukast) eligibility is strictly defined by regulatory authorities based on age, acute health status, and hypersensitivity.

Contraindications and Restrictions

Category Regulatory Status
Absolute Contraindication Contraindicated in patients with known hypersensitivity to Montelukast sodium or any component of the product.
Acute Status Not indicated for the treatment of acute asthma attacks or reversal of acute bronchospasm.
Metabolic Precaution Chewable tablets contain aspartame and carry a warning for patients with Phenylketonuria (PKU).

Age-Specific Eligibility

The approved minimum age for Airokast use varies by indication:

  • Adults and Adolescents (15+ years): Eligible for all approved uses.
  • Pediatric Patients: Eligibility ranges from 6 months (for perennial allergic rhinitis) to 6 years (for exercise-induced bronchoconstriction) and 12 months (for chronic asthma), depending on the specific condition being addressed. Use is not established below these age thresholds.
  • Older Adults (Geriatric): No dosage adjustment is necessary.

Organ Function and Special Status

No dosage adjustment is recommended for patients with renal impairment or mild-to-moderate hepatic impairment. For severe hepatic impairment, pharmacokinetics are not established. Use during pregnancy and lactation is generally permitted only if considered clearly essential by a physician.

What should I know about interactions with other medicines?

The official interaction profile of Airokast focuses on changes in drug exposure and specific co-administration restrictions documented in government regulatory labeling. The active ingredient, Montelukast, is cleared from the body through metabolism primarily by Cytochrome P450 (CYP) enzymes, including CYP2C8, CYP3A4, and CYP2C9.

Interaction Category Regulatory Statement
Exposure Modification Co-administration with the CYP2C8 inhibitor Gemfibrozil significantly increases Montelukast systemic exposure (AUC) by approximately 4.4-fold.
Metabolic Inducers Potent enzyme inducers like Phenobarbital and Rifampin are known to decrease Montelukast plasma concentration by about 40%. Clinical monitoring is advised when combining with these agents.
Administration Restrictions Airokast must not be abruptly substituted for oral or inhaled corticosteroids. Patients with documented aspirin sensitivity must continue to avoid aspirin and NSAIDs while taking this medicine.
Food Interaction For the oral granule formulation, a high-fat meal decreases the drug’s maximum concentration (C max) by 35% but does not alter the total overall systemic exposure (AUC).

The official profile includes a note for specific populations: patients with mild-to-moderate hepatic insufficiency show a 41% higher systemic exposure to Montelukast, a documented pharmacokinetic finding. The structure is characterized by specific pharmacokinetic clearance alterations and mandatory procedural cautions regarding concurrent anti-inflammatory therapy.

Mechanism of Action

How Airokast Works: Biological and Physiological Mechanism

CysLT1 Receptor Antagonism and Signal Blockade

This domain covers Airokast's core molecular function: selectively and competitively binding to the Cysteinyl Leukotriene Receptor type 1 ( CysLT1). This action effectively blocks inflammatory mediators (cysteinyl leukotrienes) from initiating a cascade, resulting in the suppression of excessive signaling patterns that drive airway pathology.

Disrupting the Leukotriene Inflammatory Cascade

Airokast engages mechanisms that modify the early molecular steps of the leukotriene pathway. By interfering with this specific cascade, the drug limits the downstream effects, influencing systems involved in muscle tone and vascular permeability, which dampens exaggerated physiological responses in the airways.

Physiological Modulation of Airway Structure and Function

The drug's targeted action translates to predictable physiological adjustments. Primarily, it influences airway smooth muscle contraction and modulates processes driven by leukotriene-induced swelling and cell recruitment, contributing to a more regulated and less reactive physiological state in the lungs.

Dosage and Administration Information

How to Use Airokast

This section outlines the general principles of administering Airokast (Montelukast), focusing strictly on high-level usage patterns and instructions, not clinical advice or therapeutic outcomes. Airokast is intended for long-term, continuous oral administration.


Administration Protocol

The medicine is taken once daily, with or without food. For chronic conditions like asthma, the dose is typically taken in the evening. If a patient has both asthma and allergic rhinitis, a single daily dose, preferably in the evening, is administered.

Age Group Standard Daily Dose Approved Form(s)
Adults and Adolescents (ge 15 yrs) 10 mg Film-coated tablets
Pediatric (6 to 14 yrs) 5 mg Chewable tablets
Pediatric (2 to 5 yrs) 4 mg Chewable tablets or Oral granules

Specific Use Instructions

Exercise-Induced Bronchoconstriction (EIB) Prevention: To prevent EIB, a single 10 mg dose is taken at least two hours before exercise. Patients already receiving a daily dose for maintenance must not take an extra dose for EIB prevention on the same day.

Oral Granules: The 4 mg oral granules must be administered within 15 minutes of opening the packet. They can be placed directly in the mouth, dissolved in five milliliters of formula or breast milk, or mixed with a spoonful of soft food such as applesauce. Granules must never be stored for later use.

Missed Dose: If a dose is missed, the user should simply take the next scheduled dose; an additional dose should not be taken to make up for the missed one. No dose adjustments are required for older adults or patients with mild to moderate kidney or liver impairment.

Recent Clinical Evidence

Airokast: Recent Clinical Evidence

Evidence for Use in Long-Term Asthma Control

Research examined this compound primarily in short-term to intermediate-term Randomized Controlled Trials (RCTs) for the management of chronic asthma. These studies included both adult and pediatric patients with mild to moderate persistent asthma. Findings describe patterns observed in the studies related to the frequency of using rescue inhalers and the reporting of acute symptom flare-ups when Airokast was used as an addition to other existing therapies.

However, certainty remains low regarding the full picture. Evidence is limited for long-term outcomes spanning multiple years, which are not fully established by the primary registration trials. Research exploring short-term symptom changes demonstrated varied findings across different patient severity groups.


Evidence for Prevention of Exercise-Induced Bronchoconstriction (EIB)

The research relevant to this use was primarily explored in acute, single-dose, Placebo-Controlled Challenge Trials. These controlled studies evaluated the compound in adolescents and adults with documented EIB, assessing the response to a single dose versus a placebo. Findings describe patterns observed in these studies where the maximum post-exercise fall in lung function (the FEV1) was less pronounced in the active compound group compared to the placebo group. The evidence contributes to understanding symptom patterns and suggests a pattern related to the compound's short-term effects on this specific physical outcome.


Evidence for Use in Allergic Rhinitis (Seasonal and Perennial)

Airokast was evaluated in research exploring how symptoms change over time for Allergic Rhinitis (AR). Studies primarily used short-term RCTs on adults and children (as young as 2 years old), measuring composite scores for nasal symptoms like congestion and runny nose. Findings describe patterns observed in the studies related to symptom scores reported by the groups. Data for certain groups remain insufficient, as follow-up durations were limited, and measured changes on key nasal symptoms are described as having varied intensity across different trials and outcome measures.

Frequently Asked Questions (FAQ)

Common questions about Airokast (FAQ)

Q: What is the general mechanism of action for Airokast?

According to official product information, Airokast is described as a leukotriene receptor antagonist. This means it works by blocking the action of inflammatory chemicals called leukotrienes. The drug's action influences processes related to airway swelling and smooth muscle tone.

Q: Is Airokast meant to be taken every day, even if a person feels well?

Official information states that this medicine is intended for long-term, continuous oral administration. To maintain the intended effect of stabilizing airway function, it is described as intended for continuous use every day, even when a person is not currently experiencing symptoms.

Q: How quickly should a person expect Airokast to start working?

The therapeutic effect of the medicine on clinical parameters of asthma control is described in official documents as occurring within one day of starting treatment. However, changes in overall chronic symptoms are described as having varied intensity across different trials and outcome measures.

Q: What happens if I miss a dose of Airokast?

Official instructions specify that if a dose is missed, the next dose should be taken at the regularly scheduled time. The documentation further states that an additional dose should not be taken to make up for the missed one.

Q: Is Airokast safe to use during pregnancy?

Official documents describe the medicine as being used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This is because official human experience data with the drug during pregnancy is considered limited.

Q: Is it safe to use Airokast while breastfeeding?

It is not known whether the active ingredient in Airokast is excreted in human breast milk. Official product information describes that its use during lactation is considered after weighing the potential risks and benefits.

Q: Does Airokast affect the ability to drive or perform tasks that require focus?

Patients should be aware that adverse effects like dizziness, drowsiness, or difficulty concentrating have been reported in official documents. Due to these reported effects, caution is noted in regulatory information regarding driving or operating machinery.

Q: Can Airokast be used for all types of allergies?

The medicine is officially approved to treat allergic rhinitis, which includes both seasonal and perennial (year-round) allergies. In addition to allergic rhinitis, regulatory documents note the use of this medicine for chronic urticaria, which is a type of hives that lasts for more than six weeks.

Q: Does Airokast help with nasal congestion specifically?

Studies relating to the use of the medicine for allergic rhinitis examined how the compound influences nasal symptoms. This research included the measurement of composite scores for issues like nasal congestion and runny nose.

Q: Can Airokast cause issues with mood or behavior?

Regulatory documents highlight that this medicine is associated with reports of serious neuropsychiatric events. These events can include changes in mood and behavior, and reports have been noted in all age groups taking the medicine.

Q: Have there been reports of nightmares or unusual dreams with Airokast?

Official adverse reaction reports document the possibility of dream abnormalities, including nightmares. This side effect is typically classified in the official labeling as an uncommon effect.

Q: Does Airokast cause anxiety or feelings of restlessness?

Reports of neuropsychiatric events associated with this medicine include feelings of anxiousness and restlessness. Other related behaviors such as irritability are also among the reported effects.

Q: Does Airokast carry a special boxed warning or strong caution from regulatory bodies?

The U.S. Food and Drug Administration (FDA) requires a Boxed Warning for this medicine due to the risk of serious neuropsychiatric events. This warning is intended to strengthen the caution regarding these reported risks.

Q: Is it possible for Airokast to cause liver-related issues?

Official postmarketing surveillance includes reports of adverse reactions affecting the liver and bile ducts (hepatobiliary disorders). These reports include different types of hepatitis.

Q: What is known about the interaction between Airokast and NSAIDs like ibuprofen?

The official interaction profile does not list a specific metabolic interaction between the active ingredient and non-aspirin NSAIDs like ibuprofen for the general population. However, official caution is noted for patients with known aspirin sensitivity to continue avoiding aspirin and NSAIDs while taking this medicine.

Q: Can Airokast be taken at the same time as an oral antihistamine?

Regulatory documentation states that the medicine may be administered with other therapies routinely used for the chronic treatment of allergic rhinitis. This category of co-administered treatments includes common oral antihistamines.

Q: Does Airokast interact with herbal supplements like St. John's Wort?

The drug's active ingredient is cleared by liver enzymes that can be affected by certain strong enzyme-inducing substances. Official documents mention that concurrent use with strong inducers may result in a decrease in the medicine’s plasma concentration.

Q: Can Airokast cause headaches or dizziness?

Headache is listed in official documents as a common adverse reaction associated with the medicine. Dizziness is also a reported adverse effect that has been noted during post-marketing surveillance.

Q: Is it true that Airokast can cause aggression or hostility?

Official reports of neuropsychiatric events associated with this medicine include behaviors such as agitation, aggressive behavior, and hostility. These events have been reported in all age groups.

Q: What is the evidence for Airokast use in treating allergic rhinitis?

Research examined this medicine in short-term randomized trials for allergic rhinitis, as described in official evidence summaries. These studies measured changes in composite nasal symptom scores, such as those related to congestion and runny nose.

Q: What are the general expectations if Airokast is working as intended?

Official research evidence describes patterns related to the frequency of rescue inhaler use and reporting of acute symptom flare-ups when the medicine is used for asthma. The drug is intended to contribute to the long-term stabilization of airway function.

Q: How is Airokast described in official documents compared to inhaled corticosteroids for asthma?

Official documents describe the active ingredient as belonging to a different pharmacological class (LTRA) than inhaled corticosteroids. Official information states that Airokast should not be abruptly substituted for either oral or inhaled corticosteroids.

Q: At what age is Airokast generally considered for children?

Regulatory approval for use in children is specific to the condition being treated. Eligibility begins at 6 months for perennial allergic rhinitis, 12 months for chronic asthma, and 6 years for exercise-induced bronchoconstriction.

How should Airokast be stored and disposed of?

Airokast (montelukast sodium) must be stored under specific conditions to maintain its stability and integrity, as defined by regulatory documents.

Storage Requirements

Condition Regulatory Specification
Temperature Controlled room temperature: 20^circC to 25^circC (68^circF to 77^circF).
Protection Must be protected from light and moisture; store in a dry place.
Packaging Keep the medication in the original container.
Child Safety Must be kept out of the sight and reach of children.

Stability and Disposal

Official labeling requires specific handling for the oral granule formulation: the entire dose must be administered within 15 minutes of opening the packet or mixing with food/liquid. The mixture must not be stored for future use, and any unused portion must be immediately discarded. Expired or unneeded tablets and chewable tablets should be disposed of in accordance with local guidelines for pharmaceutical waste.

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

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