Astair

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Astair

Quick Facts

Property Description
Active Ingredient Montelukast sodium
Form Oral tablet, chewable tablet, oral granule
Pharmacological Class Leukotriene receptor antagonist (LTRA)
General Role Maintenance treatment / long-term control
Origin Synthetic prescription medicine

Astair: Identity, Composition, and Pharmacological Class

Astair is a synthetic, prescription-only medication containing Montelukast sodium as its sole active ingredient. This compound is chemically defined as a highly selective Leukotriene receptor antagonist (LTRA), which is the official pharmacological class for the drug. Astair is administered orally and is available in formulations designed for ease of use across different age groups, specifically a standard film-coated tablet, a chewable tablet, and oral granule forms. The drug's classification and method of administration are well-established: Montelukast is clinically recognized for its targeted anti-inflammatory role.

The General Therapeutic Role of Astair

The fundamental purpose of Astair is to serve as a maintenance treatment or long-term controller for conditions where persistent inflammation and airway narrowing are key factors. The medication operates by blocking the action of cysteinyl leukotrienes—powerful chemical messengers in the body that normally bind to receptors in the lungs, triggering muscle contraction and swelling. By inhibiting this binding at the CysLT1 receptor, Montelukast helps to prevent the progression of this inflammatory cascade, thus assisting in the sustained management of respiratory function. Its role is strictly preventive and continuous; it is not indicated for the immediate, acute relief of sudden symptoms.

Regulatory References

  1. maintenance treatment
  2. blocking the action of cysteinyl leukotrienes

What side effects are possible with Astair?

Possible Side Effects and Safety Information

The safety profile of Astair (Montelukast sodium) is structured by regulatory authorities based on the frequency and the organ system affected by reported adverse reactions. This classification ranges from Very Common (ge 1/10 of patients) to Very Rare (< 1/10,000 of patients), as documented in official regulatory sources.

Frequency Category Examples of Associated Reactions (SOCs)
Very Common Upper respiratory infection
Common Headache, diarrhea, nausea, vomiting, fever, and elevations in liver enzyme levels (ALT, AST)
Uncommon Hypersensitivity reactions, dizziness, insomnia, and psychiatric events like anxiety and depression
Very Rare Systemic conditions such as Churg-Strauss Syndrome (CSS) and Hepatitis

A serious regulatory safety consideration involves Neuropsychiatric Events, which are highlighted in the official labeling. These events include severe reactions such as agitation, aggression, hallucinations, and, rarely, suicidal thinking and behavior. These effects have been reported to occur during treatment and, in some cases, may persist after the medicine has been stopped.

Safety notes for specific populations and conditions exist in the labeling. Patients with hepatic impairment may experience higher systemic exposure to Montelukast. The medicine is not indicated for use during acute asthma attacks, nor should it be abruptly substituted for inhaled or oral corticosteroids; any change in corticosteroid dosage must be gradual.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Astair overdose is based on clinical studies and post-marketing reports, including cases involving adults and pediatric patients, with documented doses as high as 1000 mg. The regulatory documentation notes that in the majority of reports, no adverse experiences were observed following acute overdosage.

Documented Overdose Manifestations

When manifestations are reported, they are consistent with the established safety profile, primarily affecting the central nervous and gastrointestinal systems. Officially documented clinical manifestations of overdose include abdominal pain, headache, somnolence (drowsiness), thirst, vomiting, and psychomotor hyperactivity.

Required Emergency Action

Regulators explicitly mandate that emergency medical attention must be sought immediately following any suspected overdosage. Prompt contact with the Poison Help line or equivalent emergency services is required for management guidance.

No specific antidote is known for Astair. Consequently, official guidance states that treatment is procedural and symptomatic. Management must employ usual supportive measures, continuous clinical monitoring, and potentially the removal of unabsorbed material from the gastrointestinal tract.

Connection to the overall overdose profile: The regulatory documents define the overdose profile by listing non-specific symptoms and simultaneously stressing the requirement for immediate help due to the lack of a known targeted treatment. This emphasizes that management is reliant on timely professional evaluation and supportive care.

Therapeutic Uses of Astair

What Astair Treats: Main Uses and Benefits

Astair is a medication commonly used to provide symptomatic support for conditions related to inflammatory or irritative states. Its primary therapeutic domains include symptom management for persistent asthma, prophylaxis of exercise-induced breathing difficulties, and supportive symptom management for allergic rhinitis (seasonal and perennial).

Astair is commonly applied across conditions involving episodic or fluctuating manifestations characterized by symptoms that become more disruptive during flare-ups, such as persistent coughing, wheezing, and chest tightness. The medication is also relevant in clinical scenarios where physical exertion reliably precipitates breathing difficulties. This approach assists with maintaining a sense of stability, helping to ease the overall burden of symptoms.

“The primary role of this medication is to support a steady level of symptom control over time, which may assist patients in coping more steadily with their condition.”

Astair is applied across therapeutic domains involving symptoms related to inflammatory or irritative states in the nasal passages, where it helps address the symptom cluster of sneezing, nasal congestion, and a runny nose, providing supportive relief that supports comfort during symptomatic periods.


Quick Fact: Relief for Inflammatory Symptoms

Symptom Cluster Targeted Condition Therapeutic Benefit
Persistent Coughing/Wheezing Chronic Asthma Supports general well-being and stability
Nasal Congestion/Sneezing Allergic Rhinitis Supports comfort during symptomatic periods
Breathing Difficulty upon Exertion Exercise-Induced Symptoms Assisting with maintaining functional stability

Regulatory References

  1. NIH DailyMed official drug information

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Astair — Official Regulatory Information

Astair (Montelukast sodium) is governed by strict population eligibility rules defined by regulatory authorities.


Populations for Whom Use is Prohibited or Restricted

Classification Rule Applicable Population
Contraindicated Known Hypersensitivity to montelukast. Patients with drug/component allergy.
Contraindicated Not indicated for acute reversal. Patients experiencing extbfacute asthma attacks.
Conditional Use Use only if clearly essential. extbfPregnant or extbfbreastfeeding patients.
Conditional Use Chewable tablets prohibited. Patients with extbfPhenylketonuria (PKU) due to aspartame.
Not Recommended Safety/efficacy not assessed. Patients with extbfsevere hepatic impairment.
Special Caution Risk of extbfneuropsychiatric events reported. All patients, regardless of age or psychiatric history.

Age-Specific Eligibility

The minimum age for Astair use varies by the specific condition being addressed:

  • Chronic Asthma: Permitted for patients extbf12 months of age and older.
  • Perennial Allergic Rhinitis (PAR): Permitted for patients extbf6 months of age and older.
  • Exercise-Induced Bronchoconstriction (EIB): Permitted for patients extbf6 years of age and older.

No dosage adjustment is required for older adults ( extbfge 65 years ) or patients with extbfrenal insufficiency or extbfmild-to-moderate hepatic impairment, as per regulatory documentation.

What should I know about interactions with other medicines?

Astair Interactions with other medicines and products

Official regulatory information documents interactions for Astair based on its metabolism by multiple liver enzymes, primarily Cytochrome P450 (CYP) enzymes 3A4, 2C8, and 2C9.

Interacting Product Categories

Interaction Domain Example Agent Regulatory Implication
Strong CYP Enzyme Inducers Phenobarbital Reduced effectiveness of Astair due to decreased plasma concentration.
CYP2C8 Substrates Rosiglitazone No clinically significant interaction observed.

Pharmacokinetic and Clinical Interaction Basis

Astair is a substrate for the CYP enzymes 3A4, 2C8, and 2C9. Concomitant use of Astair with strong inducers of these enzymes has been shown to result in a clinically significant decrease in Astair plasma exposure, which may lead to reduced efficacy. For instance, coadministration with Phenobarbital—a documented strong inducer—decreased the product's systemic exposure (AUC) by approximately 40% in clinical studies. This combination requires monitoring for reduced effectiveness.

Conversely, in vitro studies suggested Astair could inhibit CYP2C8, but a clinical drug-drug interaction study demonstrated no significant change in the plasma concentrations of the CYP2C8 substrate Rosiglitazone. This indicates that Astair does not inhibit CYP2C8 in vivo, thereby removing a potential interaction constraint with medicines primarily metabolized by that enzyme.

Mechanism of Action

Specific Blockade of Leukotriene Receptors

Astair is an antagonist that binds selectively to the Cysteinyl Leukotriene 1 Receptor (CysLT1), which is expressed on key cells in the airways, including smooth muscle cells and pro-inflammatory cells. The molecule exerts a competitive blockade by preventing the binding of inflammatory mediators, specifically Leukotrienes D₄ (LTD₄), without activating the receptor itself. This targeted molecular step prevents the initiation of the LTD4-mediated signaling cascade, which is fundamental to its mechanism of action.


Dual Modulation of Airway Physiology

The molecular blockade results in two primary physiological consequences in the airways. First, it inhibits smooth muscle contraction, directly counteracting the leukotriene-mediated increase in smooth muscle tone. Second, it reduces inflammatory cascades by decreasing the migration of cells like eosinophils and lowering vascular permeability, which in turn minimizes mucosal edema (swelling). These combined anti-contractile and anti-inflammatory actions result in the modulation of chronic physiological instability in the respiratory system.


Mechanistic Constraints and Specificity

The mechanism of Astair is highly specialized, meaning its action is functionally constrained to pathways where cysteinyl leukotrienes are the dominant mediator. The drug demonstrates little to no effect against physiological processes driven by other mediators, such as histamine or acetylcholine. Its mechanism dictates a sustained, gradual pattern of physiological modulation, making its action functionally irrelevant for processes requiring immediate reversal of sudden, severe physiological dysfunction.

Dosage and Administration Information

Astair is an orally administered medication, used based on fixed, age-specific regimens. The medication is available in three distinct dose forms: a 10 mg film-coated tablet, a 5 mg or 4 mg chewable tablet, and a 4 mg oral granule packet.

General Dosing Principles

The established frequency for maintenance treatment is once daily. Adults and adolescents 15 years and older are administered the 10 mg dose once a day. For pediatric patients, the dose is tiered: 5 mg once daily for children 6 to 14 years, and 4 mg once daily for those 2 to 5 years of age. The total dose must not exceed the specified daily fixed amount for the age group.

When Astair is used for chronic asthma, the fixed dose is generally taken in the evening. For treatment focused solely on allergic rhinitis, the time of day for administration may be individualized, provided the once-daily pattern is maintained. When the medicine is used for the prophylaxis of exercise-induced breathing difficulties, a single dose must be taken at least two hours before the activity. Patients already on a daily maintenance regimen should not take this prophylactic dose, as an additional dose must not be taken within the same 24-hour period.

Administration Requirements

The 10 mg film-coated tablets are swallowed whole and can be taken with or without food. Chewable tablets must be completely chewed before swallowing. The 4 mg oral granules have time-sensitive preparation requirements: they must be administered within 15 minutes of opening the packet. The granules may be mixed with a spoonful of cold or room-temperature soft food, such as applesauce, or a small amount of baby formula or breast milk. No dose adjustment is typically required for geriatric patients or those with mild-to-moderate hepatic or renal impairment.

Recent Clinical Evidence

Research evidence / Overview of studies


Overview of Clinical Research

Research has examined Compound-X as a potential intervention for acute pain. Studies have evaluated whether Compound-X may affect pain scores in the short term. The available research focuses primarily on the way the substance may act and dose-response characteristics.


Single-Dose Studies

  • Pain Reduction Findings:
    • A Phase II trial examined Compound-X and its association with pain reduction relative to the intended pharmacological target.
    • Study endpoints included various metrics to assess changes in reported pain intensity.
    • The evidence remains limited regarding direct comparison to common non-opioid analgesics.
  • Tolerability Profile:
    • Mild, temporary adverse events, such as headache and nausea, were reported during single-dose administration.
    • Study protocols included specific administration conditions; research evaluated whether this affected the incidence of side effects.
    • Studies excluded participants with a history of Y-condition.

Extended-Use Protocols

Research explored whether long-term use may be associated with a sustained effect on inflammation. These studies primarily involved participants with chronic inflammatory conditions.

  • Dose Regimens:
    • Protocols involved administration at regular intervals over a period of up to 12 weeks.
    • Researchers monitored inflammatory biomarkers and general well-being metrics.
  • Comparative Evaluations:
    • Compound-X has been evaluated against placebo and other comparator treatments. Findings were mixed regarding differences in efficacy measures over the treatment period.
    • It is not yet clear whether a higher dose provides a consistently better outcome in terms of symptom control.

Pharmacokinetic and Safety Profile

  • Absorption and Metabolism:
    • Studies evaluated the time to peak plasma concentration and half-life; these parameters exhibited low variability among trial participants.
    • Research confirmed the primary pathway by which the substance is broken down.
  • Safety Data:
    • Adverse event reporting focused on the incidence of gastrointestinal and cardiovascular events.
    • Overall, the evidence from the studies remains under review regarding the effects of this combination.

Key Studies & References

  1. Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain (Primary Efficacy/Safety Data)
  2. Mechanism-based nonopioid analgesic targets (Context for NaV1.8/X-receptor pathway)
  3. Evaluating Drug Efficacy and Safety (General context for Phase 1/2/3 study design and terminology)

Frequently Asked Questions (FAQ)

Common questions about Astair (FAQ)

Q: If I miss a dose of Astair, what is the best way to catch up?

Official regulatory instructions indicate that if a dose is missed, the next scheduled dose is taken at the regular time. The labeling specifies that two doses are not to be taken together to replace the missed dose.

Q: Can I take Astair with my meals, or does it have to be taken on an empty stomach?

Official product information indicates that the medicine can be administered without regard to the time of food ingestion when used for asthma or allergic rhinitis. The oral granules may be mixed with soft foods, breast milk, or baby formula, as described in the official administration requirements.

Q: When is the best time of day to take the Astair dose for the long-term treatment of asthma?

Regulatory documents outline the general dosing principles. For the chronic treatment of asthma, the fixed dose is generally specified to be taken once daily in the evening.

Q: Which specific diseases or conditions is Astair approved to treat?

Astair's official regulatory indications list the conditions it is approved to treat. These include the chronic treatment of asthma, the prevention of exercise-induced bronchoconstriction (EIB), and the relief of symptoms for seasonal and perennial allergic rhinitis.

Q: Is it okay to crush the 10 mg film-coated tablet if I have trouble swallowing pills?

The official administration requirements for the 10 mg film-coated tablet state it is to be swallowed whole. The regulatory information does not contain instructions for crushing this specific dosage form. Other dosage forms, such as chewable tablets or oral granules, are part of the available formulations.

How should Astair be stored and disposed of?

How to Store and Dispose of Astair (Montelukast Sodium)

Astair must be stored according to official regulatory specifications to maintain its stability.

Storage Conditions

Requirement Official Specification
Temperature Store at controlled room temperature, not exceeding 30 C (86 F), with excursions permitted between 15 C and 30 C
Protection Must be protected from both light and moisture
Container Keep the medicine in its original package to safeguard against environmental exposure
Child Safety Must be stored out of the sight and reach of children

Disposal Instructions

Any unused or expired Astair must be disposed of in accordance with local, state, and federal regulations. Disposal should follow established governmental waste protocols, such as drug take-back programs. The medicine is not recommended for flushing down the toilet or disposal in general wastewater.

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

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