Lukast

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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 Lukast

Lukast is a prescription medicine intended for the long-term, chronic management of respiratory and allergic conditions characterized by airway inflammation. As a single-component drug, it is a purely synthetic compound that works to stabilize lung and nasal function over time. The fundamental aim of therapy with Lukast is to improve patients' control over persistent symptoms of asthma and allergic rhinitis.

Quick Facts Description
Active ingredient Montelukast sodium
Form Oral tablets (film-coated, chewable) and granules
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
Common use Chronic management of airway inflammation
Origin Synthetic compound

What Type of Medicine is Lukast (Montelukast)?

The active ingredient in Lukast is Montelukast sodium, which definitively classifies the medication as a Leukotriene Receptor Antagonist (LTRA). This pharmacological class is clinically recognized for its high specificity in targeting inflammatory pathways, setting it apart from broader anti-inflammatory agents. Montelukast operates by selectively blocking the function of certain inflammatory chemicals known as leukotrienes. By intervening at the CysLT1 receptor, Montelukast stops these mediators from causing the undesirable physiological effects, such as the tightening and swelling of airways.

This mechanism of blocking inflammatory leukotriene receptors helps minimize the harmful physical effects of these naturally occurring substances in the body. This targeted approach positions it as a non-corticosteroid option used in foundational maintenance therapy, particularly when additional control is needed alongside other treatments.

Form and General Purpose of Leukotriene Antagonists

Lukast is designed for oral administration and is available in several high-level dosage forms, specifically film-coated tablets, chewable tablets, and oral granules. This unique presentation as an oral solid dose ensures convenient, non-invasive intake for various age groups, which is a key differentiator from many traditional inhalation therapies.

The general purpose of administering this leukotriene antagonist is to reduce the chronic inflammation underlying conditions like asthma and persistent allergic rhinitis. The drug’s mechanism prevents bronchoconstriction and helps prevent the tightening of the bronchial tubes. By controlling the pro-inflammatory action of leukotrienes, the medication helps prevent the sustained development of airway edema and muscle contraction, thereby supporting consistent, easier breathing.

Regulatory References

  1. NIH Montelukast Drug Profile
  2. Montelukast Drug Information – NIH
  3. NIH Drug Profile

What side effects are possible with Lukast?

Possible Side Effects and Safety Information

The safety profile of Lukast (Montelukast sodium) is officially defined by regulatory authorities based on classification by frequency and affected body system. Adverse reactions are grouped using standard System-Organ Classes (SOCs), which include nervous system, gastrointestinal, skin, and, notably, psychiatric disorders.

Frequency-Classified Adverse Reactions

The frequency of side effects ranges across official categories:

  • Very Common (ge 1/10): Upper respiratory infection.
  • Common (ge 1/100 to < 1/10): Headache, abdominal pain, nausea, vomiting, diarrhea, rash, and elevated levels of serum transaminases.
  • Uncommon (ge 1/1000 to < 1/100): Hypersensitivity reactions, agitation, depression, anxiety, insomnia, dizziness, and seizures.
  • Rare (ge 1/10,000 to < 1/1000): Increased bleeding tendency and palpitations.
  • Very Rare (< 1/10,000): Cases of suicidal thinking and behaviour, Churg-Strauss Syndrome (CSS), and various forms of hepatitis have been documented.

Serious Adverse Reactions and Regulatory Constraints

The official label highlights specific serious adverse reactions, including the risk of Neuropsychiatric Events, which encompass agitation, aggression, and suicidal thinking and behaviour. Systemic conditions such as Churg-Strauss Syndrome and various forms of Hepatitis are also reported as very rare events.

Lukast is strictly for chronic maintenance and must never be used to treat acute asthma attacks. Furthermore, the regulatory profile advises that observation for neuropsychiatric events is particularly important during treatment initiation or dose increment.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Lukast overdosage details specific reported symptoms and outlines the required emergency actions, strictly based on government prescribing information.

Regulatory Focus Documented Statements
Documented Presentations Overdosage cases have included the clinical manifestations of abdominal pain, vomiting, thirst, headache, sleepiness (somnolence), restlessness, and agitation.
Exposure-Related Factors Regulatory data indicates that high single-dose exposures, including those up to 200 mg in adults and 536 mg in young children, were generally not associated with serious adverse effects in the cases reported.

Emergency Response and Required Actions

Immediate medical attention is mandated: contact a Poison Control Center or a healthcare professional immediately upon suspected overdosage.

  • Urgent Help Required: Immediate emergency services must be contacted if the patient has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened.

Official Management Statements:

The established protocol for overdosage emphasizes clinical monitoring and supportive measures. Specifically, management must include efforts to remove unabsorbed material from the gastrointestinal tract. No specific antidote is known for Lukast, and dialysis has not been established as effective for drug removal in overdose situations. The absence of a specific reversal agent underscores the need for prompt supportive care as the established intervention.

Therapeutic Uses of Lukast

What Lukast Treats: Main Uses and Benefits

Lukast is a medication commonly used to help with conditions involving heightened physiological activity and inflammatory or irritative states. The therapeutic scope includes three main areas of use, each providing assistance in easing the overall symptom load.

The medication is primarily relevant for the prophylaxis and chronic treatment of asthma, for providing supportive symptomatic relief from both seasonal and perennial allergic rhinitis, and for the prevention of exercise-induced bronchoconstriction (EIB).

This approach may be part of symptomatic management when symptoms related to physical discomfort and inflammation become disruptive. It is a long-term strategy that assists with managing persistent signs like wheezing, chronic coughing, nasal congestion, and itchiness.

The therapeutic benefit is that the support assists with maintaining functional stability and contributes to easing the overall symptom load related to these recurrent or episodic manifestations.

“This approach supports general well-being during symptomatic phases and is a foundational element of sustained control.”

Quick Fact: Relief for Respiratory and Allergic Symptoms
Primary Therapeutic Goal Long-term approach to managing persistent respiratory and allergic symptoms
Common Symptom Axis Symptoms that create noticeable physiological strain (e.g., wheezing, congestion)
Clinical Scenarios Chronic management and targeted use in specific clinical scenarios (e.g., related to physical activity)
Overall Benefit Assists with maintaining functional stability during symptomatic periods

Eligibility and Restrictions for Use

Official Eligibility Profile

The eligibility criteria for Lukast (Montelukast) are defined by patient age, specific contraindications, and coexisting health conditions as documented in governmental regulatory sources.

Populations for Whom Use is Contraindicated

Lukast must not be used by patients with:

  • A known history of hypersensitivity to Montelukast sodium or any component of the drug.
  • An acute asthma attack or status asthmaticus; the medication is not indicated for this use.

Age-Related Eligibility Rules

Official approval for use is based on the condition and a minimum age threshold:

Condition Minimum Approved Age
Chronic Asthma 12 months and older
Seasonal Allergic Rhinitis (SAR) 2 years and older
Perennial Allergic Rhinitis (PAR) 6 months and older
Exercise-Induced Bronchoconstriction (EIB) 6 years and older

Use is not established below these specified minimum ages.

Conditional Use and Restrictions

  • Allergic Rhinitis: Use for allergic rhinitis symptoms is generally reserved for patients who have had an inadequate response to or intolerance of alternative treatments.
  • Organ Function: No dosage adjustment is recommended for patients with renal impairment or mild-to-moderate hepatic insufficiency. Pharmacokinetics in patients with severe hepatic impairment have not been officially assessed.
  • Pregnancy/Lactation: The medication should be used during pregnancy only if clearly needed. Available data show that very low levels appear in breast milk, and use during lactation is generally considered compatible.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information describes interactions based on the potential for other medicines to alter the exposure of Lukast, as well as specific constraints related to co-administered treatments and patient conditions.


Documented Pharmacokinetic Interactions

Co-administration of Lukast with certain enzyme-inducing medicines may lead to a reduction in Lukast's plasma exposure. Regulators have documented that the Area Under the Curve (AUC) for Lukast was decreased by approximately 40% when co-administered with Phenobarbital. This effect is attributed to medicines that induce cytochrome P450 (CYP) enzymes, including CYP3A4, 2C8, and 2C9.

  • Medicines that may reduce Lukast exposure: Phenobarbital, Rifampicin (Rifampin), and Phenytoin are noted as inducers of these relevant CYP enzymes. Caution is advised when co-administering Lukast with such inducers, particularly in pediatric patients.

  • Medicines with No Clinically Significant Pharmacokinetic Effect: Lukast did not demonstrate clinically important effects on the pharmacokinetics of co-administered medicines such as theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin, and warfarin.

Clinical and Procedural Constraints

  • Aspirin and NSAIDs: Patients with known aspirin sensitivity must continue to avoid aspirin or non-steroidal anti-inflammatory agents while taking Lukast. Lukast does not affect the need for this avoidance.

  • Corticosteroids: Lukast must not be abruptly substituted for inhaled or oral corticosteroids. The dosage reduction of corticosteroids, if pursued, must be gradual and supervised by a healthcare professional.

Mechanism of Action

Selective Antagonism of the CysLT1 Receptor

Lukast (Montelukast) exerts its effect by acting as a highly selective antagonist, blocking the Cysteinyl Leukotriene 1 ( CysLT1) receptor in the airways. This antagonism prevents the leukotrienes ( LTC4, LTD4, and LTE4) from binding and activating this site, thereby inhibiting the specific pro-inflammatory and contractile cellular signals.

️ Inhibition of Airway Smooth Muscle Contraction

By blocking the CysLT1 receptor, the drug directly interferes with the primary molecular instruction for bronchial smooth muscle to contract. This mechanism prevents the leukotriene-mediated bronchoconstriction and reduces the signaling that leads to excessive muscle tone, which maintains the diameter of the bronchial tubes.

Attenuation of Inflammation and Edema Formation

The antagonism also inhibits the leukotriene-driven signals that cause increased vascular permeability and fluid leakage into the airways. This action reduces the formation of airway edema and attenuates mucus hypersecretion. The consequence is a physiological state maintaining consistent airway patency.

Dosage and Administration Information

Official Administration Guidelines for Lukast

The administration of Lukast (Montelukast) involves specific dosing based on age, formulation, and administration timing.

Dosage Form & Strength Age Group Standard Daily Dose & Timing
Film-Coated Tablet (10 mg) 15 years and older One 10 mg tablet, once daily in the evening.
Chewable Tablet (5 mg) 6 to 14 years One 5 mg tablet, once daily in the evening.
Chewable Tablet (4 mg) 2 to 5 years One 4 mg tablet, once daily in the evening.
Oral Granules (4 mg) 6 months to 5 years One 4 mg packet, once daily in the evening.

Administration Instructions

Route and Timing: Lukast is for oral administration and is generally taken once daily in the evening for chronic use. The 10 mg film-coated tablet may be taken with or without food. Chewable tablets must be chewed completely before swallowing.

Oral Granules: The 4 mg granules must be administered within 15 minutes of opening the sachet. They can be swallowed directly or mixed with a spoonful of cold or room-temperature soft food (such as applesauce, carrots, rice, or ice cream) or 5 mL of baby formula or breast milk. The mixed dose must not be stored for later use.

Exercise-Induced Bronchoconstriction (EIB): For EIB prophylaxis, a single dose (10 mg for 15 years and older; 5 mg for 6–14 years) is taken at least two hours before exercise. An additional dose for EIB must not be taken within 24 hours of a previous dose.

Recent Clinical Evidence

Research evidence / Overview of studies for Lukast

Evidence for use in Chronic Management of Asthma

The research examining Lukast for the long-term management of asthma has primarily involved Randomized Controlled Trials (RCTs) and systematic reviews. These studies were used in research exploring how symptoms change over time across a variety of patients, including children, adolescents, and adults. Researchers monitored functional outcomes, such as measurements of lung capacity like the FEV1, and patient-reported outcomes describing perceived discomfort related to breathing and nighttime awakenings. Findings describe patterns observed in the studies related to symptom evolution over trial periods, which often lasted several months. Comparative evidence against inhaled corticosteroids (ICS) was studied, with varying findings described for achieving core maintenance control, especially in longer-term trials.

Evidence for use in Supportive Relief of Allergic Rhinitis

Research for Lukast in seasonal and perennial allergic rhinitis is based on short-term, placebo-controlled trials. These studies focused on episodes where symptoms become more noticeable, measuring outcomes linked to inflammatory or irritative states in the nose and eyes. Studies report how symptoms evolved in the observed populations, indicating that Lukast was studied for managing these outcomes related to physical discomfort when compared to placebo. Comparative evidence is lacking for a comprehensive understanding of Lukast's role versus the consistent use of intranasal corticosteroids as monotherapy. Follow-up durations were limited in many of these trials.

What is Still Uncertain About Lukast

Evidence highlights what is known—and what is still uncertain—about Lukast. The main research limitation frames relate to the data record for Lukast in the long-term, chronic management pathway. Comparative evidence is lacking in large, head-to-head trials lasting two years or more, especially when comparing its overall role as a foundational controller therapy against inhaled corticosteroids. Research is ongoing regarding the specific patient characteristics that are associated with the observed changes in symptoms.

Key Studies & References Montelukast: MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about Lukast (FAQ)

Q: How long does it typically take before I start noticing the effects of Lukast?

The active ingredient in Lukast is rapidly absorbed, with the highest concentration typically reached in the bloodstream within 2 to 4 hours. However, because Lukast works over time to control inflammation, the full therapeutic effect of the medication may take several days of consistent, daily use to fully develop.

Q: Why is Lukast sometimes taken in the evening?

Lukast is often prescribed for evening administration because the clinical studies that demonstrated its effectiveness were conducted using this timing. Evening dosing is believed to help control nighttime symptoms of asthma and allergic rhinitis, which can often be more disruptive.

Q: What happens if a dose of Lukast is forgotten?

If a dose of Lukast is missed, the official guidance is to skip the missed dose entirely. Official guidance indicates that the next dose should be taken at the regular scheduled time. Patients are cautioned against taking a double dose to make up for a missed one.

Q: Does Lukast build up in the body over time?

Official studies examining the drug’s behavior in the body indicate that when Lukast is taken once daily, there is little accumulation of the active ingredient in the bloodstream over time. The drug is largely eliminated from the system between doses.

Q: How long does Lukast stay in your system after stopping treatment?

Lukast has a relatively short mean plasma half-life, ranging from approximately 2.7 to 5.5 hours in healthy adults. Based on this elimination rate, the drug is typically cleared from the body's system within 24 to 48 hours after the last dose.

Q: Are there certain types of food or drinks that should be avoided when using Lukast?

Lukast can generally be taken with or without food. However, official prescribing information notes that the chewable tablets contain aspartame, which is a source of phenylalanine. For patients with the rare genetic disorder phenylketonuria (PKU), this ingredient is noted in the official prescribing information.

Q: What does the patient information leaflet say about alcohol and Lukast?

The official prescribing information does not list a direct or specific interaction between Lukast and alcohol. However, regulatory documents mention that liver problems have been reported in some people using Lukast, particularly when other risk factors, such as alcohol use, are present.

Q: Is it okay to take Lukast with over-the-counter pain relievers?

Official information indicates that Lukast may generally be used alongside common, everyday pain relievers. However, the official prescribing documents caution that patients with known sensitivity to aspirin should continue to avoid aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) while using Lukast.

Q: Are there any reported interactions between Lukast and herbal supplements?

Official regulatory sources state that there is not enough specific information available to confirm whether herbal remedies, complementary medicines, or vitamin supplements are safe to take with Lukast. This is because these products are not tested in the same way as prescription medicines.

Q: What are the known potential interactions with commonly prescribed heart medications?

Lukast has been studied for its potential interactions with several common medications. Official regulatory documents indicate that co-administering Lukast with certain heart-related drugs, such as digoxin (used for heart rhythm) and warfarin (a blood thinner), did not show clinically important effects on the levels of Lukast in the body.

Q: What official warnings or boxed warnings are associated with Lukast?

Regulatory documents highlight a serious risk of neuropsychiatric events, which include suicidal thoughts and behavior. For some patients with mild symptoms, regulators advise that the benefits may not outweigh the risks associated with this medication.

Q: How is the safety profile of Lukast viewed for long-term use?

Lukast is intended for long-term, chronic use as a maintenance treatment. Regulatory authorities state that continuous observation for the risk of neuropsychiatric events is recommended throughout the entire course of treatment, regardless of duration.

Q: Do official documents mention any potential for withdrawal symptoms if Lukast is stopped?

While the term 'withdrawal symptoms' is not used, official documents note that the serious neuropsychiatric symptoms linked to Lukast generally resolved after stopping therapy. However, in some cases, symptoms persisted even after the medication was discontinued.

Q: Is it true that Lukast is sometimes used for symptoms of chronic hives (urticaria)?

The officially approved uses for Lukast do not include the treatment of chronic hives, also known as urticaria. However, official documents refer to clinical studies and post-marketing reports that have examined its effect in patients with chronic hives whose symptoms were not adequately controlled by other treatments.

Q: How long do regulatory agencies permit Lukast to be used in children?

Lukast is officially indicated for the chronic (long-term) management of conditions like asthma and perennial allergic rhinitis in children as young as six months. Since it is designed for maintenance, the drug does not have an official maximum duration limit specified for its use in children or adults.

Q: Are the safety concerns different for children compared to adults using Lukast?

The overall safety profile for Lukast is similar across different age groups. However, official guidance notes that specific caution is warranted in pediatric patients due to the reported risk of sleep disturbances and other neuropsychiatric symptoms observed in children.

Q: Can Lukast cause drowsiness or impact ability to drive?

Regulatory documents list both dizziness and drowsiness (somnolence) as reported adverse reactions to Lukast. The official guidance states that patients should determine how they typically react to the medication before driving or operating machinery.

Q: Does Lukast affect blood tests or lab results?

Official reports of side effects include the occurrence of elevated liver enzyme levels, also known as serum transaminases. These increases are detectable through routine blood tests.

Q: What is the purpose of the 'patient counseling' section in Lukast's official documents?

This section informs patients and caregivers about the need to be vigilant for any new or worsening neuropsychiatric symptoms or changes in behavior. The official guidance emphasizes seeking immediate medical advice if these events are noticed.

How should Lukast be stored and disposed of?

Lukast (Montelukast) should be stored properly to maintain its efficacy and safety.

Storage

  • Keep the medication in its original container, tightly closed, and protected from excessive moisture and heat.
  • Store at room temperature, typically between 20°C and 25°C (68°F and 77°F). Brief excursions are permitted between 15°C and 30°C (59°F and 86°F).
  • Protect it from light. Do not store it in the bathroom or near a sink.
  • Always keep Lukast out of the reach and sight of children and pets.

Disposal

  • Do not use Lukast past the expiration date printed on the packaging.
  • The safest method for disposal of unused or expired medicine is often through a drug take-back program or an authorized collector location.
  • If a take-back program is unavailable, consult the medicine's patient information leaflet or a pharmacist for guidance on safe disposal in household trash, ensuring it is mixed with an undesirable substance (like coffee grounds or kitty litter) and sealed in a container to deter accidental ingestion by children or pets. Do not flush Lukast down the toilet unless specifically instructed to do so by the FDA's flush list or your local waste management.

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

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