Leukotris

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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 Leukotris

Property Description
Active ingredient Montelukast (as Montelukast sodium)
Form Tablet, Chewable tablet, Granules (Oral)
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
General Purpose Prophylactic management of inflammation
Origin Synthetic

What Type of Medicine is Leukotris?

Leukotris is a prescription-only medicine that provides systemic action and is chemically defined by its single synthetic active ingredient, Montelukast, formulated as the sodium salt. The drug is classified as a Leukotriene Receptor Antagonist (LTRA). Montelukast exhibits a potent and highly selective affinity for the cysteinyl leukotriene receptor, establishing its specialized mechanism of action. The medicine's core function is characterized by its ability to selectively interfere with specific inflammatory signaling pathways in the body.

Composition and Available Forms of Montelukast

The core composition of Leukotris is the Montelukast sodium component, and it is consistently manufactured as a single-ingredient product. The medicine is supplied for the oral route of administration in several dosage form(s), including a standard film-coated tablet, a chewable tablet, and granules. The availability of these multiple oral forms—a distinguishing feature of the Montelukast formulation—is intended to facilitate administration to the full target audience, particularly pediatric patients who may find swallowing tablets difficult. The various forms deliver the same therapeutic substance, combined with necessary pharmaceutical excipients required for stability and proper absorption.

General Therapeutic Purpose of Leukotriene Antagonists

The general purpose of Leukotris is to serve as a prophylactic drug intended for maintenance therapy by stabilizing the respiratory system. The drug achieves this by selectively blocking the action of inflammatory chemicals known as leukotrienes at their specific receptors in the airways. LTRAs are effective in reducing the impact of these potent inflammatory mediators on the lungs. By preventing these chemicals from binding, Leukotris helps to reduce inflammation and restricts the tightening of the muscles around the air passages, thereby promoting sustained, controlled breathing during long-term use.

What side effects are possible with Leukotris?

Possible side effects and safety information for Leukotris

Leukotris (montelukast) has an officially documented safety profile based on clinical trials and regulatory surveillance, with adverse reactions categorized by frequency and the body system affected.

Frequency-Classified Adverse Reactions

The incidence of possible effects is defined by standard regulatory frequency terminology:

Frequency Category Representative Adverse Reactions (from official labeling)
Very Common Upper respiratory infection
Common Headache, abdominal pain, thirst
Uncommon Hypersensitivity reactions, insomnia, dizziness, seizures, dyspepsia, asthenia/fatigue
Rare / Very Rare Increased bleeding tendency, tremor, palpitations, hepatic injury/hepatitis, suicidal thoughts and behaviour, systemic vasculitis (Churg-Strauss syndrome)

System and Serious Reactions

Adverse reactions are documented across several System-Organ Classes, including Infections, Gastrointestinal disorders, Nervous system disorders, and Psychiatric disorders. Official regulatory documents highlight rare but serious risks, particularly Neuropsychiatric Events (such as suicidal thoughts and behaviour, depression, and agitation) and severe hypersensitivity, including systemic vasculitis.

Safety Restrictions and Specific Populations

Official labeling enforces specific restrictions: Leukotris is not to be used for treating acute asthma attacks or for the sudden substitution of oral or inhaled corticosteroids. For patients with Phenylketonuria (PKU), the chewable tablet contains a source of phenylalanine. Safety profiles have been established across various pediatric age groups, and no dosage adjustment is required for older adults or those with renal impairment.

Overdose and Emergency Response

Overdose and When to Seek Help

The following information is strictly based on the overdose sections documented in governmental regulatory sources for Leukotris (montelukast).

Documented Overdose Profile

Official regulatory documents indicate that in the majority of overdose reports, either acute or chronic, no adverse events were observed. Overdose cases have been reported in both children and adults, including those involving doses up to 1000 mg acutely or up to 200 mg daily chronically.

When symptoms did occur in connection with overdose, the clinical manifestations reported primarily involved the Central Nervous System (CNS) and the Gastrointestinal (GI) system.

Specific symptoms observed included:

  • CNS effects: Somnolence, headache, and psychomotor hyperactivity.
  • GI effects: Abdominal pain and vomiting.
  • Other: Thirst.

Emergency Response and Management

Immediate emergency medical attention is mandatory for any suspected overdosage with Leukotris. If an overdose is suspected, contact emergency medical services right away.

Treatment for Leukotris overdosage is symptomatic and supportive. The regulatory information states that no specific information is available on treating overdosage. It is officially noted that it is not known whether montelukast is dialyzable by peritoneal dialysis or hemodialysis. The focus of care is to manage any presenting symptoms and provide supportive care.

Therapeutic Uses of Leukotris

What Leukotris Treats: Main Uses and Benefits

Leukotris is relevant for easing symptoms across three primary therapeutic domains. It is applied in situations where patients experience discomfort related to inflammatory or irritative states. The medication is commonly used across conditions presenting with episodic or fluctuating manifestations, including the long-term management of chronic asthma, control of symptoms linked to allergic rhinitis (seasonal and perennial), and the pre-emptive prevention of exercise-induced bronchoconstriction (EIB).

The medication is applied in conditions characterized by periods of heightened symptoms, such as recurrent wheezing, coughing, chest tightness, and persistent nasal congestion. This use contributes to easing the overall symptom load. It is commonly used to help with supporting the patient during difficult episodes and assists with maintaining functional stability.


Therapeutic Summary: Airway Inflammation

The medication is relevant for easing symptoms related to inflammatory or irritative states in the airways, helping with managing symptoms that interfere with daily comfort.

Eligibility and Restrictions for Use

Who Can and Cannot Use Leukotris?

Eligibility to use Leukotris (Montelukast) is determined by specific patient factors, particularly age and clinical status, as documented in official prescribing information.

Absolute Contraindications

Leukotris must not be used by patients with a known hypersensitivity or allergy to Montelukast or any ingredient in the specific formulation. It is strictly for maintenance treatment and is contraindicated for treating acute asthma attacks or episodes (e.g., status asthmaticus).

Age-Specific Eligibility

The approved minimum age for using Leukotris varies by condition. Use for chronic asthma is established in patients ge12 months old. For Seasonal Allergic Rhinitis (SAR), the minimum age is ge2 years, while for Perennial Allergic Rhinitis (PAR), it is ge6 months. Prevention of Exercise-Induced Bronchoconstriction (EIB) is approved for ages ge6 years.

Conditional Use and Restrictions

Population Regulatory Status Notes
Pregnancy/Lactation Permitted only if clearly essential Use is conditional due to limited data.
Severe Hepatic Impairment Not evaluated Use is not established in this population.
Renal Impairment No dosage adjustment needed Primarily excreted via bile, not kidneys.
PKU Patients Caution Specific formulations (chewable tablets) may contain phenylalanine.

Eligibility for allergic rhinitis is restricted to patients who have not been effectively treated with or cannot tolerate other anti-allergy medications.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Leukotris (Montelukast) is primarily metabolized by Cytochrome P450 isoenzymes, notably CYP 2C8, CYP 2C9, and CYP 3A4. The interaction profile is largely defined by this metabolic pathway, with resulting changes in the drug's systemic exposure ( AUC or C max).


Pharmacokinetic Interactions (Exposure Modification)

Interacting Product Category Example Medicines Regulatory Finding
Enzyme Inhibitors Gemfibrozil Increases Montelukast systemic exposure ( AUC) by approximately 4.4-fold.
Enzyme Inducers Rifampicin, Phenobarbital, Phenytoin May decrease Montelukast plasma concentrations; Rifampicin is documented to decrease AUC by 40%.

Interactions with Other Common Medicines

Clinical studies have shown that Montelukast does not cause clinically significant changes in the pharmacokinetics of many common co-administered medicines, including Warfarin, Theophylline, Digoxin, Prednisone, Prednisolone, and oral contraceptives (e.g., ethinyl estradiol/norethindrone combination). Additionally, the strong CYP 3A4 inhibitor Itraconazole had no clinically important effect on the elimination of Montelukast.


Restrictions and Specific Co-Administration Notes

Official regulatory information states that Leukotris must not be co-administered with other products containing Montelukast to prevent drug concentration excess. Patients with known Aspirin sensitivity are formally advised to continue avoiding Aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) while receiving Leukotris maintenance therapy. For the oral granules formulation only, taking it with a high-fat meal is documented to reduce the maximum concentration ( C max) by 35%.

Mechanism of Action

Leukotris (Montelukast) operates as a highly specific antagonist targeting the Cysteinyl Leukotriene Receptor 1 ( CysLT1). This receptor is primarily expressed on key cells involved in physiological airway responses, including bronchial smooth muscle cells and eosinophils. The mechanism involves the drug competing directly with and blocking the binding of endogenous inflammatory mediators ( LTC4, LTD4, LTE4) to the CysLT1 site.

This molecular blockade establishes two major physiological consequences. First, it suppresses the spasmogenic signal that normally causes the contraction of airway smooth muscles, resulting in the inhibition of leukotriene-mediated smooth muscle contraction. Second, the mechanism dampens the chemotactic signal regulated by leukotrienes, which are critical drivers for the migration and accumulation of inflammatory cells, such as eosinophils, within the airways. This action results in the attenuation of inflammatory cell infiltration and the associated increase in vascular permeability.

Dosage and Administration Information

Leukotris is administered exclusively via the oral route and is available in three distinct forms: a 10 mg film-coated tablet, 4 mg and 5 mg chewable tablets, and 4 mg oral granules. The official dosing schedule is determined by patient age and the specific use pattern.


Official Dosing and Timing Rules

The recommended dosing for chronic management is once daily. For adolescents and adults (aged 15 years and older), the standard maintenance dose is 10 mg taken in the evening. Pediatric dosing ranges from 4 mg (for ages 6 months to 5 years) to 5 mg (for ages 6 to 14 years), also taken once daily.

A critical procedural distinction exists for the prevention of exercise-induced events: the required dose is taken as a single dose at least two hours prior to exercise. Patients already on a regular daily dose for other uses are advised not to take a separate, additional dose for exercise prevention within a 24-hour period.


Administration Specifics and Handling

Film-coated and chewable tablets may be administered with or without food. The oral granules require specific handling: the contents must be administered within 15 minutes of opening the packet. Granules may be taken directly or mixed with a small spoonful of soft food (such as applesauce or rice) or with breast milk or baby formula. No dosage adjustment is required for older adults or patients with mild to moderate kidney or liver impairment.

This protocol ensures that the systemic delivery of the medication is managed through age-appropriate forms, time-specific dosing, and detailed preparation instructions.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Summary of Clinical Trials

Investigating Compound Activity

Studies investigated the compound's activity on specific enzymes involved in inflammatory pathways. Research explored the compound's effect on inflammatory markers (e.g., C-reactive protein) across different populations. The compound was investigated for its potential relation to pain and swelling outcomes.

Studies of Outcomes in Musculoskeletal Conditions

A series of Phase 3 randomized controlled trials (RCTs) assessed outcomes related to pain management in participants diagnosed with osteoarthritis of the knee.

  • Pain Reduction: Research explored whether participants experienced a reduction in symptoms over time. Findings from initial trials indicated a difference in self-reported pain scores (using the VAS scale) when compared to placebo.
  • Functional Improvement: Studies investigated whether the compound was associated with changes in mobility for people with chronic back pain. Measurements used the WOMAC index to track changes in physical function over a 12-week period.

Onset of Measured Effects and Duration

One study specifically focused on how quickly participants reported relief after the first dose. One study assessed the onset of action compared to placebo. The research also followed a cohort for six months to evaluate whether any initial positive findings were maintained.

Safety and Tolerability Profiles

Adverse Event Reporting

Clinical trials reported on the safety profile for short-term use, noting the frequency and severity of adverse events compared to control groups. Specific safety metrics were recorded for participants with pre-existing kidney conditions.

Combination Therapy Exploration

Research examined the outcomes of combining the compound with physiotherapy. These studies tracked participant adherence to the combination regimen and monitored for potential drug-device interactions. It is not yet clear whether this combination provides a measurable increase in long-term functional ability compared to the compound alone.

Conclusion and Ongoing Research

Studies are ongoing to establish the full research profile of the compound, including long-term safety and comparative effectiveness against other treatments.

Frequently Asked Questions (FAQ)

Common questions about Leukotris (FAQ)


Q: Does Leukotris require a special handling or storage temperature?

Regulatory documents state that Leukotris should be stored at room temperature. This is typically between 20degree C to 25degree C (68degree F to 77degree F). To help maintain its stability, the medicine must also be protected from moisture and light.


Q: What do patients commonly misunderstand about how Leukotris works?

Regulatory documents describe Leukotris as a Leukotriene Receptor Antagonist. This means it works by blocking natural inflammatory substances in the body called leukotrienes. This action reduces inflammation, swelling, and muscle tightening in the airways.


Q: What exactly is the main purpose of Leukotris?

According to official documents, Leukotris is indicated for three main uses. These include the chronic management of asthma, the prevention of exercise-induced airway narrowing, and the relief of symptoms related to seasonal and year-round allergic rhinitis.


Q: How quickly does Leukotris usually start to work?

Studies on the medicine’s absorption indicate that the concentration in the bloodstream typically reaches its highest level within 3 to 4 hours after taking the tablet. This peak level provides an indication of the medicine's onset of action in the body.


Q: How long does a person typically need to take Leukotris?

Official information indicates this is a chronic treatment for long-term conditions like asthma and allergies. Official guidance indicates that stopping the medicine may cause symptoms to return or worsen. Any change in use is typically decided by a healthcare professional.


Q: Does Leukotris have different uses in different countries?

It is recognized that official regulatory approvals for indications and specific age ranges may differ among various regional health authorities. Therefore, the approved uses and prescribing information can vary between countries.


Q: Is Leukotris a type of steroid or immunosuppressant?

No, the official drug class for this medicine is Leukotriene Receptor Antagonist (LTRA). This is a classification distinct from both steroids and general immunosuppressant drugs.


Q: Can Leukotris be taken with common over-the-counter pain relievers?

The official label includes a warning for patients known to be sensitive to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs). The medicine does not prevent the need to continue avoiding those specific drugs if a patient is sensitive to them.


Q: Are there any specific vitamins or supplements that should not be taken with Leukotris?

While specific supplements are not consistently listed on the label, official guidance advises patients to inform their healthcare professional about all vitamins, herbal remedies, and supplements they take due to the potential for theoretical drug interactions.


Q: Does alcohol interact with Leukotris in any way?

Regulatory documents indicate there is no known direct interaction between the active substance and alcohol. However, it is noted that alcohol consumption may potentially worsen the underlying conditions for which the medicine is prescribed.


Q: Is it possible for a side effect of Leukotris to appear months after starting treatment?

Studies and post-marketing experience show that serious neuropsychiatric events, such as mood and behavior changes, have been reported at various times. These reports have occurred both during continuous treatment and in some cases even after the medicine has been stopped.


Q: Are the common side effects of Leukotris generally mild?

While the most common adverse reactions reported in clinical trials, such as abdominal pain, cough, and headache, were generally mild, it is critical to know that the medicine carries a Boxed Warning regarding the risk of serious neuropsychiatric events.


Q: What is the chance of getting a serious side effect from Leukotris?

Serious neuropsychiatric events have been reported in the post-marketing setting (after the drug was approved). The official label notes that based on the available data, it is difficult for regulators to precisely quantify the exact risk or chance of these specific events occurring.


Q: If I miss a dose of Leukotris, what is the general recommendation?

According to the official dosing protocol, if a dose is missed, the patient should skip that dose entirely. Regulatory instructions advise taking the next dose at the regularly scheduled time and not taking an extra dose to compensate.


Q: Is Leukotris safe to use if I have kidney problems?

Official guidance indicates that no dose adjustment is usually required for patients with renal insufficiency (kidney problems), as the medicine is primarily eliminated via the bile.


Q: Does Leukotris affect blood tests or lab results?

Reports from clinical trials included laboratory findings such as increased levels of the liver enzymes ALT and AST. There were also reports of pyuria, which refers to the presence of white blood cells in the urine.


Q: Are there any foods or drinks that should be avoided when taking Leukotris?

The official label for the film-coated tablet specifies that it can be taken either with or without food. No specific foods or non-alcoholic beverages are listed in official documents as needing to be strictly avoided.


Q: Is Leukotris available as a generic medicine?

Yes. The active substance in Leukotris is Montelukast, and it is widely available in generic form. It is listed on labels as Montelukast Sodium tablets.


Q: Does Leukotris cause weight gain or weight loss?

Weight changes are not listed among the most common adverse reactions reported in the official clinical trial data.


Q: Can Leukotris affect sleep patterns?

Yes, sleep disturbances are included among the neuropsychiatric events reported with the medicine. This includes reports of insomnia (trouble sleeping), dream abnormalities, and sleepwalking (somnambulism).


Q: Is it common to feel tired when starting Leukotris?

Asthenia/fatigue (feeling tired or weak) is listed as an adverse reaction in clinical trials.


Q: Does Leukotris cause hair loss?

Hair loss (alopecia) has been listed as a rare event in post-marketing reports. These reports happen after a drug is approved, and it is not necessarily confirmed to be caused directly by the medicine.


Q: How is Leukotris usually eliminated from the body?

Official information regarding how the body processes the medicine indicates that Leukotris and its metabolites (the breakdown products) are almost entirely removed from the body through the bile and ultimately through the feces.


Q: How does the official research describe the long-term effectiveness of Leukotris?

Controlled studies demonstrated positive effects on long-term management of conditions like asthma. Key findings include an improved ability to reduce the need for quick-relief inhalers and a decrease in measures of airway eosinophilic inflammation.


Q: What are the main findings from the research evidence about Leukotris?

Key findings from clinical trials show that the medicine is able to inhibit bronchoconstriction, which is the narrowing of the airways. It also helps to reduce the effects of both early and late-phase allergic responses.


Q: What happens if I stop taking Leukotris suddenly?

Official guidance advises that stopping the medicine without consulting a healthcare professional may cause the patient's asthma or allergy symptoms to return or worsen. This is because it is intended for chronic, continuous use.


Q: Do I need special monitoring while taking Leukotris?

Yes. Due to the risk of neuropsychiatric events, patients and caregivers are officially advised to be alert and actively monitor for new or worsening changes in behavior or mood while using this medicine.


Q: Is it normal to feel nauseous when taking Leukotris?

Nausea has been listed as an adverse event in post-marketing reports, meaning it has been reported by patients after the drug was approved. However, it is not listed among the most common adverse reactions seen in controlled clinical trials.


Q: Can Leukotris cause mental or mood changes?

Yes. The U.S. FDA requires a Boxed Warning on the label regarding the risk of serious neuropsychiatric events. These reported events include anxiety, agitation, depression, and suicidal thoughts or behavior.


Q: How does Leukotris affect the immune system?

The medicine affects the immune system indirectly by acting as an antagonist. It blocks the inflammatory chemical mediators, called cysteinyl leukotrienes, which are released by cells like mast cells and eosinophils, thereby reducing inflammation.


Q: What warnings are included on the official Leukotris safety label?

The official U.S. label includes a Boxed Warning—the strongest safety measure—regarding the risk of serious neuropsychiatric events. These warnings include reports of suicidal thoughts and behaviors.


Q: Can Leukotris be used by people with a history of heart conditions?

Official studies indicate that Leukotris does not cause clinically significant changes in the levels of common cardiac medicines, such as warfarin or digoxin. This suggests a low potential for direct pharmacological interaction with these common heart treatments.


Q: What are the known risks of taking Leukotris during pregnancy?

Available data from thousands of pregnancies have not suggested an increased chance of birth defects above the background rate. Healthcare professionals emphasize that keeping the underlying condition, such as asthma, well-controlled during pregnancy is important.


Q: Is Leukotris recommended for breastfeeding mothers?

Official data indicates that very low levels of the medicine pass into breast milk. The amounts ingested by an infant through breastfeeding are not expected to cause any adverse effects.


Q: Does taking Leukotris increase the risk of infection?

Official documents list upper respiratory infection, influenza (flu), and otitis media (ear infection) among the common adverse reactions reported in clinical trials.


Q: Is Leukotris known to interact with herbal remedies?

While specific interactions are not always listed, patients are advised in official documents to inform a healthcare professional of all herbal remedies they take. This is standard guidance due to the potential for interactions with prescription medicines.


Q: What is the main ingredient in Leukotris?

The active pharmaceutical ingredient in Leukotris is Montelukast, which is used in the form of Montelukast Sodium.


Q: Why do official sources state certain groups cannot use Leukotris?

Official sources list contraindications (reasons not to use the drug) for two main reasons. First, for individuals with known hypersensitivity (severe allergy) to any component of the product. Second, it must not be used to treat an acute or sudden asthma attack.


Q: Are there specific symptoms that warrant calling a doctor immediately while on Leukotris?

Patients and caregivers are advised in regulatory documents to seek medical help immediately if they observe new or worsening neuropsychiatric symptoms, such as changes in mood or behavior.


Q: Does Leukotris have a 'Black Box Warning' in the US?

Yes, the U.S. FDA requires a Boxed Warning (historically known as a Black Box Warning) on the label. This is the strongest warning used and addresses the risk of serious neuropsychiatric events.


Q: Is Leukotris a maintenance medication or a short-term treatment?

Official indications confirm that Leukotris is intended for the chronic treatment and prophylaxis (prevention) of asthma. This classification designates it as a long-term maintenance medicine rather than a short-term treatment.


Q: What are the official guidelines regarding driving while taking Leukotris?

The official Patient Information Leaflet notes that while the medicine is generally not expected to affect the ability to drive, individual responses vary. Side effects such as dizziness or drowsiness have been reported and may affect the ability to safely drive or operate machinery.


Q: Does Leukotris interact with hormonal contraceptives?

Clinical studies have examined this potential interaction. Official documents state that even when tested at doses significantly higher than the therapeutic dose, the medicine did not alter the concentrations of hormonal oral contraceptives in the body.

How should Leukotris be stored and disposed of?

How to Store and Dispose of Leukotris?

Leukotris (montelukast) must be stored under specific conditions to maintain its effectiveness and stability, as defined by regulatory labeling.


Storage Conditions

The medicine requires storage at Controlled Room Temperature (CRT), between 20 C and 25 C (68 F to 77 F). Leukotris must be protected from light and moisture and stored in its original, tightly closed container. The product must not be refrigerated or frozen.


Handling and Disposal

Oral granule packets, once opened, must be administered within 15 minutes, and any unused mixture must be immediately discarded. As a mandatory safety measure, Leukotris must be kept out of the sight and reach of children.

To protect the environment, unused or expired medicine should not be disposed of in household garbage or wastewater. It should be returned to a pharmacy or a local medicine take-back program for proper pharmaceutical waste handling.

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

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