Airpass

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Airpass

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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 Airpass

Airpass: Definition and Pharmacological Identity

Property Description
Active Ingredients Levocetirizine, Montelukast
Form Oral tablet, Oral granules (often film-coated)
Pharmacological Class Antihistamine and Leukotriene Receptor Antagonist (LTRA) Combination
Origin Synthetic chemical entities

Airpass is defined as a fixed-dose combination product, integrating the two distinct, synthetic active ingredients, Levocetirizine and Montelukast, into a singular preparation. This medication is supplied as an oral dosage form, ensuring a systemic route of administration. Levocetirizine is the highly active R-enantiomer of cetirizine, and Montelukast is a selective anti-inflammatory agent. The benefit of this combined formulation is clinically recognized for offering a multifaceted treatment strategy that addresses complex allergic pathways simultaneously, synchronizing the delivery of the active components, which are typically used as Levocetirizine dihydrochloride and Montelukast sodium salts.


Dual Classification and Mechanism

The medication's identity is defined by its two primary mechanisms, classifying it as an Antihistamine and Leukotriene Receptor Antagonist (LTRA) Combination. The Levocetirizine component functions as a selective second-generation antihistamine, inhibiting the effects of histamine at the H1-receptor, which is crucial for controlling immediate allergic manifestations. Montelukast operates as a selective Leukotriene Receptor Antagonist that blocks the action of cysteinyl leukotrienes that drive inflammation and airway smooth muscle changes. These leukotriene antagonists help reduce swelling and airway tightening caused by allergic triggers. This dual pharmacological profile has become a standard strategy in addressing both chronic allergic rhinitis symptoms and underlying respiratory sensitivities.


General Purpose of the Combined Action

The general purpose of the combined formulation is to achieve a synergistic action that provides comprehensive control over the persistent symptoms and underlying inflammatory processes associated with allergic conditions. This dual therapeutic strategy is typically utilized in scenarios where histamine blockade alone proves insufficient. By combining the immediate action of the antihistamine with the sustained anti-inflammatory effect of the LTRA, the drug is designed to both alleviate acute allergic symptoms and mitigate the chronic inflammatory component, such as airway edema. This combination is highly valued because it targets two fundamental processes in allergic disease, offering a potentially broader spectrum of relief than a monotherapy.

Regulatory References

  1. NIH Montelukast Information
  2. Leukotriene Receptor Antagonists - StatPearls

What side effects are possible with Airpass?

Possible Side Effects and Safety Information

The officially documented safety profile of this medicine, which combines Levocetirizine and Montelukast, is structured by regulatory authorities based on the frequency of reported adverse reactions and the organ systems affected. Reactions are classified based on the standard frequency framework, ranging from Common to Rare and Frequency Not Known.

Common adverse reactions typically documented in regulatory labels include fatigue, somnolence (sleepiness), headache, and dry mouth. These effects primarily involve the Nervous System and Gastrointestinal System.

Serious Adverse Reactions and Safety Constraints

The regulatory profile highlights the documentation of rare but serious adverse reactions across several system-organ classes. Specifically, the Montelukast component is associated with the risk of Serious Neuropsychiatric Events, which have been documented to include agitation, aggression, anxiety, depression, and suicidal ideation and behavior. Severe systemic reactions, such as anaphylaxis and angioedema (swelling), have been reported as serious Hypersensitivity Reactions.

Official safety documents also define limitations for use. The medicine is contraindicated in individuals with a known hypersensitivity to its active components or related substances. Furthermore, due to the renal excretion of Levocetirizine, the combination is contraindicated in patients with end-stage renal disease. Dosage adjustment is required for patients with other levels of renal impairment. Regulatory notes also indicate that some effects, such as somnolence, may be more noticeable at the start of treatment.

Overdose and Emergency Response

Overdose and when to seek help

Regulatory information on overdosage is based on the individual components of Airpass—Levocetirizine and Montelukast—as no specific data is available for the combination product.

Immediate medical attention is officially required for any suspected overdosage, regardless of the severity of symptoms. Management in an overdose situation is primarily supportive because no known specific antidote exists for the Levocetirizine component.

Documented Overdose Manifestations

Component Population Manifestations Officially Listed in Labels
Montelukast Adults and Children Abdominal pain, somnolence, thirst, headache, vomiting, psychomotor hyperactivity
Levocetirizine Adults Drowsiness
Levocetirizine Children Initial agitation and restlessness, followed by drowsiness

In terms of management, regulatory labels state that both components have limited or unknown removal efficacy through hemodialysis. Therefore, treatment focuses on symptomatic support and considering standard measures to remove any unabsorbed drug, such as gastric lavage, following acute, short-term ingestion.

Therapeutic Uses of Airpass

Quick Facts

  • Assists in the management of: Chronic respiratory condition (asthma).
  • Helps reduce the risk of: Severe worsening of asthma symptoms (asthma attacks) in adults.
  • Used for: Prevention and as-needed management of airway constriction (bronchoconstriction) associated with asthma.

What Airpass Treats: Main Uses and Benefits

Airpass is authorized to support the treatment of asthma in adults (18 years of age and older). The medicine is utilized for the as-needed relief or prevention of bronchoconstriction—the narrowing of the lung airways—and may contribute to reducing the risk of experiencing a severe asthma attack.

This therapeutic product is generally employed as needed for respiratory symptoms associated with asthma. It contains two components: a bronchodilator to assist in relaxing the muscles in the airways and an inhaled corticosteroid to help manage inflammation in the lung air passages. This formulation combines these two classes of medicine to be used as a reliever treatment for asthma.

Airpass may be part of a regimen to improve breathing in individuals diagnosed with asthma.

Eligibility and Restrictions for Use

Eligibility for Airpass: Regulatory Constraints

The eligibility for Airpass (Levocetirizine and Montelukast fixed-dose combination) is strictly defined by government regulatory documents, focusing on patient characteristics and underlying medical conditions.

Absolute Contraindications

The medicine is formally contraindicated and must not be used in specific populations:

  • Patients with known hypersensitivity to Montelukast, Levocetirizine, Cetirizine, or any component of the product.
  • Patients with severe renal impairment, typically defined as a creatinine clearance less than 10 mL/min, including anuria.
  • Individuals with rare hereditary disorders related to galactose intolerance or glucose-galactose malabsorption, due to excipients like lactose.

Age and Conditional Use

Population Group Regulatory Status
Adults (ge 18 years) Standard Eligibility.
Adolescents (lt 15 years) Use not established for the tablet formulation in all regions.
Children (lt 6 years) Not recommended for the tablet formulation.
Pregnant or Lactating Women Not recommended due to insufficient data or known excretion into breast milk.

Use requires caution in patients with predisposing factors for urinary retention or those with impaired hepatic function.

What should I know about interactions with other medicines?

The official regulatory profile for Airpass includes documented interaction patterns for both Levocetirizine and Montelukast, classified by mechanism and physiological impact.

Pharmacokinetic Alterations (PK)

Interactions involving the drug-metabolizing CYP enzyme system can significantly alter the systemic exposure of the Montelukast component. Co-administration with the CYP enzyme inhibitor Gemfibrozil is documented to increase Montelukast’s systemic exposure by approximately 4.4-fold. Conversely, the potent enzyme inducer Rifampin is shown to decrease Montelukast exposure by 40%. Regulatory data also indicates that Ritonavir can increase the plasma concentration of the levocetirizine component’s parent drug.

Pharmacodynamic and Substance Interactions

The most significant pharmacodynamic interaction is the risk of additive central nervous system (CNS) depression. Concurrent use with alcohol or other CNS depressants may result in additive impairment of mental alertness. Additionally, substance interactions are noted: a high-fat meal is documented to reduce the maximum plasma concentration (Cmax) of Montelukast by 35%. Patients with known aspirin sensitivity are restricted from co-administration with Aspirin or Nonsteroidal Anti-inflammatory Drugs (NSAIDs).

Clearance and Population Constraints

Due to the Levocetirizine component’s reliance on renal clearance, the product is formally contraindicated in individuals with severe renal impairment (creatinine clearance less than 10 mL/min). Caution is also advised for patients with impaired hepatic function.

Mechanism of Action

How Airpass Works: Core Mechanisms

The mechanism of Airpass is a combined pharmacological strategy that simultaneously blocks two primary inflammatory pathways: the histamine pathway and the leukotriene pathway.


Blocking Histamine H1 Receptors

This domain covers the action of the levocetirizine component, which acts as a selective inverse agonist to the Peripheral Histamine H1 Receptors. This interaction interrupts the rapid signaling cascade initiated by endogenous histamine, resulting in modulation of vascular permeability and sensory nerve signaling.


Modulating Leukotriene CysLT1 Signaling

This domain focuses on the montelukast component, which acts as a competitive antagonist at the Cysteinyl Leukotriene Receptor 1 ( CysLT1). By blocking the binding of leukotrienes, this mechanism modulates sustained inflammatory responses and influences the contractive signaling in smooth muscle tissue, supporting overall modulation of airway smooth muscle tone.


Dual Pathway Interaction

Airpass creates additive pathway inhibition by targeting two distinct classes of inflammatory mediators with unique roles: histamine for immediate vascular changes, and leukotrienes for chronic smooth muscle and cellular effects. This combined approach results in additive pathway inhibition across distinct mediator systems.

Dosage and Administration Information

Airpass is an oral medication administered as a film-coated tablet, providing the fixed-dose combination of 10 mg Montelukast and 5 mg Levocetirizine. The administration follows a standardized, once-daily regimen for adults and adolescents 15 years of age and older. The tablet must be swallowed whole with liquid and may be taken with or without food. The single daily dose is typically administered in the evening to align drug delivery with the intended therapeutic pattern.


The drug is prescribed as part of a long-term therapeutic pattern and is explicitly not intended for use in the reversal of acute episodes. If a dose is missed, the standard protocol is to skip the missed dose and resume the schedule the following evening, strictly prohibiting the doubling of the next scheduled dose.


Dosing requires modification based on the patient's renal function, specifically due to the elimination characteristics of the Levocetirizine component. For patients with moderate renal impairment (Creatinine Clearance 30-49 mL/min), the labeled frequency is reduced to one tablet every two days. For those with severe impairment (<30 mL/min), the frequency is reduced to one tablet approximately every three days. No dosage adjustment is specified for patients with mild to moderate hepatic impairment. The 10 mg/5 mg tablet formulation is not recommended for individuals under 15 years old.

Recent Clinical Evidence

Phase 3 Trials: Efficacy and Safety

Clinical research, primarily conducted through randomized, controlled trials (RCTs), has explored the effects on joint function and time to response in adults diagnosed with moderate-to-severe Rheumatoid Arthritis (RA).

Studies investigated the potential for effects on inflammation. Studies assessed outcomes related to inflammatory signs over a 12-week period. In the primary study, researchers reported a difference was observed in measured disease activity scores compared to placebo.

The study population included individuals who had previously been treated with standard-of-care treatments but were non-responsive.


Long-Term Follow-up

An open-label extension study followed patients for up to two years to gather additional data. Findings included observations regarding liver enzyme and hematologic parameters.


Trials in Psoriatic Arthritis (PsA)

Research explored the effects of treatment in individuals with Psoriatic Arthritis (PsA). Studies evaluated whether the frequency and severity of flares were impacted over a six-month period compared to a comparator drug.

Studies reported a response in a portion of the studied patients, specifically in skin symptoms and peripheral joint involvement.


Combination Therapy Studies

A separate study examined whether the combination was associated with measured differences over a longer period when administered with a standard conventional synthetic DMARD (csDMARD). This study aimed to provide observational data on tolerability and response. Research reviewed the tolerability in older adults (65 years and older) in a specific sub-analysis of the phase 3 data.

Key Studies & References American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis

Frequently Asked Questions (FAQ)

Common questions about Airpass (FAQ)


Q: Why is Airpass usually taken in the evening?

Official regulatory guidance notes that the product is typically administered in the evening. This timing is noted to align drug delivery with the intended therapeutic pattern, supporting the management of inflammatory mediators. This schedule aims to optimize the medication's effect based on biological timing.


Q: What is the correct dosage of Airpass for a person with moderate renal impairment?

Dosage modification is specified in the regulatory information for patients with moderate renal impairment. The need for adjustment arises because one of the active ingredients is primarily eliminated by the kidneys. Official product information notes that for patients with moderate renal impairment (Creatinine Clearance between 30 and 49 mL/min), the recommended frequency is reduced compared to the standard regimen.


Q: Can I drink alcohol while I am taking Airpass?

Regulatory information indicates that combining this medicine with alcohol may lead to an additive central nervous system (CNS) depressant effect. This may result in increased sleepiness (somnolence) and a potential impairment of mental alertness. Regulatory warnings indicate patients may experience increased potential for sedation.


Q: Are there any serious risks like depression or suicidal thoughts when taking Airpass?

Yes, official safety documents advise that the medication is associated with a risk of serious neuropsychiatric events. These events can include changes in mood and behavior such as anxiety, depression, agitation, and, rarely, suicidal ideation and behavior. Patients are advised by regulatory bodies to seek immediate medical guidance should these changes occur.


Q: Is there any risk if I take my regular pain reliever, like Aspirin or NSAIDs, with Airpass?

Regulatory documents state that patients with a known aspirin sensitivity are restricted from co-administration with Aspirin or other Nonsteroidal Anti-inflammatory Drugs (NSAIDs). This restriction is noted due to the potential for increased risk of adverse reactions in sensitive individuals.


Q: What conditions or diseases is Airpass approved to treat?

The fixed-dose combination of levocetirizine and montelukast targets inflammatory processes associated with allergic conditions. This dual action is noted for its utility in managing persistent symptoms. For specific approved indications for the product, patients should review the official prescribing information for the region.


Q: Can Airpass affect the results of an allergy skin test?

The levocetirizine component of the product functions as a selective antihistamine. Antihistamines are known to potentially interfere with the results of diagnostic allergy skin tests by blocking the histamine reaction. Official product information typically advises patients to seek guidance from their healthcare provider regarding the appropriate discontinuation period before testing.

How should Airpass be stored and disposed of?

How to Store and Dispose of Airpass?

This section summarizes the official requirements for storing, handling, and disposing of Airpass, as defined by regulatory documents.

Storage Requirements

Storage Classification Official Instruction
Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F).
Environment Protect from excessive heat, direct sunlight, and freezing.
Handling Do not puncture or incinerate the pressurized container.
Child Safety Keep the medicine strictly out of the sight and reach of children and pets.

Disposal Instructions

Do not flush Airpass down the toilet or pour it down a sink. Unused or expired medication should be disposed of through a drug take-back program when available. If a take-back program is not available, the medicine must be mixed with an unpalatable substance, such as dirt or used coffee grounds, sealed in a plastic bag, and placed in the household trash. Consult local waste guidelines for the proper disposal of the aerosol canister.

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

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