Lukastma

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 Lukastma

Property Description
Active ingredient Montelukast (as Montelukast sodium)
Form Oral (Film-coated tablets, Chewable tablets, Granules)
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
General Purpose Prophylactic Maintenance Therapy
Origin Synthetic Compound

Lukastma is a systemic-acting prescription medicine whose active ingredient is Montelukast, typically formulated as Montelukast sodium, belonging to the specialized pharmacological class of Leukotriene Receptor Antagonists (LTRA). This synthetic compound is used for the long-term management and prophylaxis of chronic inflammatory conditions involving the airways. The medication is clinically recognized for its high affinity and selectivity to the target receptors in the respiratory system.

Identity and Pharmacological Classification

The core identity of Lukastma is defined by the International Nonproprietary Name (INN) Montelukast, an orally active agent that offers anti-inflammatory properties. Its classification as a Leukotriene Receptor Antagonist means it operates by interfering directly with the effects of specific inflammatory messengers, known as leukotrienes. This mechanism positions the drug among systemic treatments for obstructive airway diseases, highlighting its foundational role in long-term therapy. This differentiation from traditional bronchodilators allows it to address the underlying biochemical pathway of inflammation, specifically targeting the CysLT1 receptors.

Composition, Forms, and General Therapeutic Purpose

Lukastma is primarily available as a single active ingredient product for oral delivery. The active substance, Montelukast monosodium salt, is prepared with appropriate pharmaceutical excipients, resulting in varied forms suitable for broad patient groups, including film-coated tablets, chewable tablets, and oral granules. This flexibility in form makes Montelukast a frequently used option in pediatric asthma management. The overall therapeutic purpose is prophylactic maintenance, providing continuous, daily inhibition of the inflammatory cascade that causes airway swelling and bronchial smooth muscle contraction, thereby stabilizing respiratory function.

Regulatory References

  1. Montelukast

What side effects are possible with Lukastma?

Possible Side Effects and Safety Information

The most important safety consideration for Lukastma (montelukast) involves the risk of neuropsychiatric events. For this reason, the U.S. Food and Drug Administration (FDA) requires a prominent Boxed Warning on the labeling for all montelukast products.

Serious and Clinically Significant Risks

  • Neuropsychiatric Events: These serious side effects include mood and behavior changes, such as agitation, aggression, anxiety, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, suicidal thoughts and actions (including completed suicides), and tremor. These events have been reported in adults, adolescents, and children, and can occur in patients with or without a prior history of mental illness.
  • Eosinophilic Conditions: In rare cases, patients taking this medication may develop systemic eosinophilia, sometimes presenting with features consistent with Churg-Strauss syndrome, a form of vasculitis. Symptoms may include a flu-like illness, worsening pulmonary symptoms, rash, or neuropathy (pins and needles/numbness).
  • Hypersensitivity: Severe allergic reactions, including anaphylaxis and angioedema (swelling of the face, lips, tongue, and throat), have been reported.

Common Adverse Reactions

The most common side effects reported in clinical trials (occurring in 5% or more of patients and greater than placebo) include upper respiratory infection, headache, fever, cough, abdominal pain, diarrhea, and otitis media (ear infection).

Safety Restrictions

Due to the potential for serious neuropsychiatric effects, the drug's use is officially restricted by regulatory bodies. Lukastma should only be prescribed for allergic rhinitis (hay fever) if the patient has an inadequate response to, or cannot tolerate, other available therapies. It is not indicated for the treatment of acute asthma attacks and should not be abruptly substituted for oral or inhaled corticosteroids.

Overdose and Emergency Response

Overdose Scope

Documented Overdose Presentations:

  • Gastrointestinal effects: Symptoms reported following overexposure include abdominal pain, vomiting, and thirst.
  • Central Nervous System (CNS) effects: Manifestations include sleepiness (somnolence), headache, and psychomotor hyperactivity or restlessness. These reports are commonly associated with pediatric patients, though most overdosage exposures, even at very high doses (up to 900 mg/day short-term in studies), were not reported with clinically important adverse experiences.

Emergency-Response and Management Statements:

  • Required Supportive Measures: In the event of suspected overdose, official regulatory guidance mandates that usual supportive measures and careful clinical monitoring be employed. Efforts to remove any unabsorbed material from the gastrointestinal tract should also be considered.
  • Antidote Status: The regulatory labeling states that no specific information is available regarding the definitive treatment for Montelukast overdosage, and it is not known if the substance is dialyzable.

When Immediate Medical Help is Required:

  • Urgent Action: Immediate medical attention or contact with emergency services is strictly required if the individual has severe manifestations such as collapse, a seizure, significant trouble breathing, or cannot be awakened. Contacting a certified Poison Help line is mandated for any suspected case of overexposure.

Connection to the Overall Overdose Profile: The official overdose profile is defined by reported mild-to-moderate symptoms and a high level of tolerance even at supratherapeutic doses, which reduces the severity classification. The mandated emergency actions focus on addressing acute, life-threatening clinical signs, given the absence of a known specific antidote, thereby centering management on supportive care and observation as documented by regulatory authorities.

Therapeutic Uses of Lukastma

What Lukastma Treats: Main Uses and Benefits

Lukastma is a maintenance medication primarily focused on providing sustained control and support for conditions involving inflammatory or irritative processes and symptoms that interfere with daily functioning affecting the airways. Its applications include managing symptoms associated with asthma and allergic rhinitis.

It is commonly used to help with symptoms across key domains, including the long-term control of persistent asthma, relief of symptoms from both seasonal and perennial allergic rhinitis, and acute prevention of exercise-induced breathing difficulty (EIB). The medication plays a role in managing the symptomatic burden associated with these recurring issues.

In clinical scenarios, Lukastma is commonly used to help with persistent symptoms, such as wheezing, night-time coughing, nasal congestion, and sneezing. The therapeutic benefit is centered on continuous symptom management, which contributes to easing the overall symptom load and assists with maintaining functional stability when symptoms are more noticeable.


Quick Fact: Support for Symptoms of Irritative States Lukastma is applied in addressing symptom clusters that may become intense or disruptive, supporting the patient during difficult episodes by easing distress and managing symptoms related to heightened physiological activity in the respiratory system.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Lukastma is a maintenance medication with specific eligibility criteria defined by regulatory bodies across age, known allergies, and certain medical conditions.

Populations for Whom Use is Restricted or Prohibited

Classification Eligibility Rule
Contraindication The drug is prohibited for patients with known hypersensitivity to the active ingredient (Montelukast) or any of the formulation’s components.
Non-Indication Lukastma is not indicated for use in reversing bronchospasm during acute asthma attacks or status asthmaticus; it is reserved for chronic, prophylactic treatment.
Genetic/Metabolic The chewable tablet forms contain phenylalanine and are therefore restricted for use in patients with phenylketonuria (PKU).

Age-Group Eligibility Rules

Official eligibility is specific to the patient's age and the condition being managed:

  • Adults and Adolescents (15 years): Eligible for all approved maintenance uses.
  • Pediatric Patients: Eligibility begins at 12 months for asthma prophylaxis, 6 months for perennial allergic rhinitis, and 6 years for the prevention of exercise-induced bronchoconstriction. Use is not established below these minimum age thresholds for each specific indication.
  • Older Adults: No dosage adjustment is recommended, as safety and effectiveness are comparable to younger adults.

Condition-Specific Eligibility

  • Renal Impairment: No dosage adjustment is recommended for patients with renal insufficiency, as the drug is primarily eliminated via bile.
  • Hepatic Impairment: No dosage adjustment is needed for mild-to-moderate hepatic insufficiency. However, use status has not been evaluated or established in patients with severe hepatic impairment.

Pregnancy and Lactation Status

  • Use during pregnancy and lactation is generally restricted and is only permitted if considered clearly essential by the prescribing authority.

What should I know about interactions with other medicines?

The official interaction profile for Lukastma is defined by documented pharmacokinetic (PK) and pharmacodynamic (PD) patterns, as detailed in government regulatory sources.

Metabolic and Exposure Interactions

Lukastma is primarily metabolized by Cytochrome P450 enzymes 2C8, 2C9, and 3A4. A clinically relevant PK interaction occurs when co-administered with the enzyme inhibitor Gemfibrozil, which is documented to increase the systemic exposure of Lukastma by approximately 4.4-fold. Conversely, co-administration with enzyme inducers such as Rifampicin, Phenobarbital, and Phenytoin may potentially decrease Lukastma plasma concentrations, and the official label notes that caution is required. Conversely, studies document that Montelukast does not have clinically important effects on the systemic exposure of several co-administered drugs, including Theophylline, Digoxin, and Warfarin.

Pharmacodynamic Restrictions

Official regulatory restrictions mandate that patients with known aspirin sensitivity must continue to avoid aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) while using Lukastma. The drug should also not be abruptly substituted for oral or inhaled corticosteroids.

Food and Administration Timing

The regulatory documentation includes specific timing rules for the oral granule formulation; if mixed with certain soft foods (such as applesauce, rice, carrots, or ice cream), the dose must be administered within 15 minutes of mixing. The label also advises that the potential for dizziness or drowsiness may be worse if taken concurrently with alcohol.

Mechanism of Action

Lukastma (Montelukast) functions by providing a targeted mechanistic blockade against specific inflammatory mediators, disrupting a key biochemical cascade.

Targeted Antagonism of the CysLT1 Receptor

Lukastma acts as a selective antagonist of the Cysteinyl Leukotriene Receptor Type 1 (mathbfCysLT1), which is prevalent on airway smooth muscle and inflammatory cells. By occupying this receptor site, the molecule halts the signal initiated by the endogenous inflammatory mediators, the cysteinyl leukotrienes (LTD4), preventing them from activating their cellular targets.

Modulation of Inflammatory and Smooth Muscle Signals

This receptor blockade initiates two primary physiological outcomes: it limits the leukotriene-driven increase in vascular permeability, resulting in attenuation of airway edema and swelling. Concurrently, the mechanism indirectly prevents the leukotriene-mediated contraction of the bronchial smooth muscle. This continuous dual action affects the signaling of inflammation and smooth muscle excitation, modulating the inherent responsiveness of the airways.

Constraints of Mechanism Specificity

The drug's high specificity to the leukotriene pathway means its mechanism is confined to modulating processes driven by CysLTs, and it does not affect pathways mediated by other rapid-onset mediators like histamine. Consequently, the mechanism facilitates sustained modulation of the CysLT pathway but is functionally unable to provide the rapid reversal of muscle contraction necessary to override non-CysLT mediated bronchoconstrictive signals.

Dosage and Administration Information

How to Use Lukastma: Official Administration Guidelines

Lukastma is an oral medicine intended for long-term, continuous prophylactic use. Its administration pattern is defined by adherence to dose, frequency, and specific timing for optimal maintenance. It is explicitly not intended for use in acute asthma attacks; appropriate rescue medication must be available.

The standard pattern is to take the medicine once daily. For the ongoing management of chronic asthma or when treating both asthma and allergic rhinitis, the dose should be taken in the evening. If the medicine is being used solely for allergic rhinitis, the time of administration may be flexible.


Patient Age Group Dosage Strength Frequency & Timing
Adults 15 years 10 mg (Film-coated tablet) Once daily, preferably evening (Asthma/Combined)
Pediatric 6–14 years 5 mg (Chewable tablet) Once daily, evening
Pediatric 12 mos–5 years 4 mg (Chewable tablet or Granules) Once daily, evening

Administration Requirements

The medicine is designed for daily intake and should not be discontinued even when symptoms are fully controlled. Tablets and chewable tablets may be taken with or without food. Chewable tablets must be fully chewed before swallowing.

Oral granules require precise handling: the entire contents of the packet must be mixed with a specified soft food or liquid (e.g., applesauce) and administered completely within 15 minutes of opening. If a dose is missed, patients should resume the schedule with the next dose; doubling the dose is not permitted.

Recent Clinical Evidence

Evidence for use in Persistent Asthma Management

Lukastma was studied for its role as a controller therapy for chronic, persistent asthma primarily through short-term and long-term Randomized Controlled Trials (RCTs). These studies examined changes in lung function (FEV1) and monitored the evolution of symptoms, such as nocturnal coughing, alongside the frequency of acute asthma episodes. Trials report how symptoms evolved in the observed populations, and studies described the medicine’s inclusion in treatment regimens. Findings varied across comparisons against other standard long-term controller therapies.


Evidence for the Prevention of Exercise-Induced Breathing Difficulty

Lukastma was evaluated in research exploring short-term symptom changes related to breathing difficulty triggered by physical activity (EIB). Acute RCTs used standardized exercise challenges to monitor the change in lung function following exertion. These studies contributed data related to acute, short-term functional response, but follow-up durations were limited for continuous daily use in EIB prevention.


Evidence for the Relief of Allergic Rhinitis Symptoms

For the relief of allergic rhinitis symptoms, short-term RCTs examined outcomes related to physical discomfort, such as nasal congestion and sneezing. Findings describe patterns observed where symptom scores evolved in comparison to placebo. The evidence base describes that comparative evidence is limited when assessed against other treatments for allergic rhinitis.


Evidence Gaps and Areas of Research Uncertainty

Research has been evaluated in special populations, including pediatric patients, but data for certain groups, such as the elderly, remain insufficient. The long-term effects are not fully established, particularly concerning comparative performance against other long-term controller medicines over several years. This research contributes to the broader evidence landscape, but evidence quality varies across studies, and data are still emerging in several areas.

Frequently Asked Questions (FAQ)

Common questions about Lukastma (FAQ)


Q: Will this medicine make me feel sleepy?

Official product information for pregabalin (the active ingredient in Lukastma) states that dizziness and somnolence (sleepiness) are common side effects. Patients are advised to consider that these effects may potentially impair the ability to drive or operate complex machinery.


Q: Can I drink alcohol while taking this medication?

Regulatory documents indicate that combining this medication with alcohol is not advised. Combining pregabalin with alcohol can increase the risk of certain side effects, such as heightened sleepiness and dizziness, as they may enhance each other's effects.


Q: Is it safe to take this drug for long-term conditions?

The medication is approved for the management of chronic conditions, such as certain types of neuropathic pain and fibromyalgia. Official information details potential serious adverse reactions, such as angioedema (severe swelling), that may occur at any time during treatment, requiring close attention throughout use.


Q: Can children who are 2 years old use this medicine?

Official labeling states that for the use as adjunctive therapy for partial-onset seizures, the product is indicated for patients 1 month of age and older. However, for indications such as pain conditions or fibromyalgia, it may not be approved for this very young age group. Use in children is limited to certain approved conditions and specific age ranges.

How should Lukastma be stored and disposed of?

Lukastma (montelukast sodium) must be stored under specific conditions defined in regulatory labeling to maintain its stability and effectiveness.

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature (20^circmathrmC to 25^circmathrmC), with permissible excursions between 15^circmathrmC and 30^circmathrmC.
Protection Must be stored in the original container and protected from light and moisture.

Child Safety: The medication must be kept out of the reach of children.

Disposal Instructions

Official regulatory guidelines require that any unused or expired Lukastma product be disposed of strictly according to local requirements. The product should not be flushed down a toilet or poured down a drain unless specifically advised by local regulations.

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

Available in countries:

Equivalent of Lukastma found in:

A-Z Index: