Montene

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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 Montene

Montene is a synthetic, single-ingredient medication containing the active compound Montelukast sodium. It is formally classified as a Leukotriene Receptor Antagonist (LTRA), a high-level pharmacological class of prescription drugs. This classification distinguishes it as a medicine that intervenes directly in specific chemical pathways of inflammation.

Property Description
Active ingredient Montelukast sodium
Form Tablet, chewable tablet, oral granule
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
Common use Foundational anti-inflammatory control
Origin Synthetic

Montene: A Synthetic Leukotriene Receptor Antagonist (LTRA)

The drug's core identity stems from its active component, Montelukast sodium, a highly selective compound that is chemically synthesized. Montene is typically positioned as a prescription-only (Rx) medicine intended for long-term control rather than acute relief. As a Leukotriene Receptor Antagonist, Montene operates by binding to and blocking the CysLT1 receptors found in the human airway. The efficacy of this mechanism in inhibiting the effects of inflammatory leukotrienes is well-documented. This mechanism is separate from those of inhaled corticosteroids, which address tissue inflammation directly, or traditional short-acting bronchodilators, which primarily induce muscle relaxation.


Forms and Type of Oral Preparation

Montene is designed for oral administration, making it a preparation taken by mouth. It is manufactured in several distinct solid oral dosage forms to ensure suitability for various patient profiles, including children and adults. These forms include the standard film-coated tablet, the chewable tablet (often offered in a mild flavor for pediatric patients), and individual packets of oral granules. As a single-ingredient product, Montene's composition consists of the active Montelukast sodium combined with pharmaceutical excipients necessary to stabilize and structure these solid preparations.


General Purpose: Targeted Control of Inflammatory Pathways

The general purpose of Montene is to provide foundational anti-inflammatory control within the airways. Its action as a CysLT1 receptor antagonist prevents potent inflammatory substances, known as leukotrienes, from exerting their effects in the lungs. By inhibiting the biological actions of these mediators, Montene helps to counter the underlying processes of mucosal swelling and smooth muscle contraction. A typical use scenario involves its prescribed role in providing sustained, daily control to support the maintenance of clear air passages against inflammatory triggers.

Regulatory References

  1. NIH: Montelukast StatPearls

What side effects are possible with Montene?

The possible side effects and safety profile of Montene (Montelukast sodium) are categorized according to official regulatory standards based on frequency and affected organ systems, reflecting data from clinical trials and post-marketing reports.

Official Adverse Reaction Scope

Adverse reactions are formally grouped by frequency and System-Organ Class (SOC) in regulatory documents. The most frequently reported effect, classified as Very Common (affecting more than 1 in 10 patients), is upper respiratory infection. Reactions documented as Common (up to 1 in 10 patients) include headache, abdominal pain, and fever. Less frequent reactions (Uncommon to Very Rare) span systems such as the Nervous System, Psychiatric Disorders, Gastrointestinal Disorders, and Hepatobiliary Disorders.

Serious Adverse Reactions and Safety Constraints

The FDA requires a Boxed Warning regarding the risk of serious mental health side effects. These include reports of suicidal thinking and behaviour, hallucinations, depression, and agitation. Other serious but rare reactions include systemic eosinophilia with features consistent with Churg-Strauss syndrome (a vasculitis), and severe skin reactions like Stevens-Johnson syndrome.

Montene is formally contraindicated in individuals with a history of hypersensitivity to its active ingredient. The medicine is not indicated for use in the reversal of bronchospasm during acute asthma attacks. Furthermore, patients with aspirin sensitivity must continue to avoid aspirin and other non-steroidal anti-inflammatory agents.

Regarding special populations, the regulatory label notes that no dosage adjustment is required for patients with renal impairment or mild-to-moderate hepatic impairment. However, data on use in severe hepatic impairment are not available, and caution is noted for formulations containing phenylalanine in individuals with phenylketonuria (PKU).

Connection to the Overall Safety Profile

This classification structures the medicine's risk profile by clearly categorizing frequent, non-serious events alongside low-frequency but serious adverse reactions, such as those impacting the psychiatric and immune systems. The presence of a Boxed Warning for neuropsychiatric events highlights a documented, serious safety consideration that requires prescriptive awareness. This regulatory data specifies key restrictions, including the medicine's unsuitability for acute asthma episodes.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — Official Regulatory Information for Montene

Overdose Scope

Domain Official Regulatory Statements
Documented overdose presentations The most frequently reported adverse experiences in acute overdose cases included abdominal pain, somnolence (sleepiness), thirst, headache, vomiting, and psychomotor hyperactivity (restlessness/agitation).
Physiological systems affected (as stated in label) Clinical and laboratory findings reported following high-dose ingestion were generally described as consistent with the established safety profile of the drug. Regulatory reports on high single-dose exposures confirm such events are not associated with serious or life-threatening adverse outcomes.
Dose-related or exposure-related factors (if applicable) Acute exposures have been documented following ingestion of high doses up to 1,000 mg in adults and adolescents, and 536 mg in pediatric patients.
Population-specific overdose notes (if applicable) The clinical findings observed in overdose cases are reported as being consistent across both adult and paediatric patients.
Emergency-response statements (as written in official documents) The official guidance requires that individuals seek emergency medical attention immediately. Contacting the national Poison Help helpline (1-800-222-1222) is mandated for further instructions.
When immediate medical help is required (label-derived phrasing only) Call emergency services at 911 immediately if the individual has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

Overdose Classifications (High-Level)

Domain Official Regulatory Statement
Severity classification (as defined in official documents) Acute exposures are generally categorized as not associated with serious or life-threatening adverse events.
Regulatory basis (EMA / FDA / etc.) Based on documented post-marketing and clinical trial experience as summarized in FDA Prescribing Information and NIH resources.
Overdose-context constraints (as defined in official documents) No specific antidote is known for the management of Montelukast sodium overdose.

Resulting Overdose Structure

Official overdose statements:

  • The official treatment protocol is symptomatic and supportive management; clinical monitoring is appropriate.
  • The most common manifestations are gastrointestinal and neurological, including abdominal pain, somnolence, headache, and vomiting.
  • Urgent medical help must be sought if the individual exhibits seizure, collapse, or severe breathing difficulty.

Connection to the overall overdose profile:

The regulatory documents define the overdose profile through the observation of frequently reported clinical manifestations, such as somnolence and abdominal pain. As there is no specific antidote known, the official management is restricted to symptomatic and supportive care, reinforcing the mandate to seek emergency medical attention immediately upon suspicion of a major ingestion.

Therapeutic Uses of Montene

Quick Facts: Montene Uses

  • Chronic Asthma: Supports the long-term management of asthma in adults and pediatric patients aged 12 months and older.
  • Exercise-Induced Bronchoconstriction (EIB): May be used to help prevent breathing difficulties that can occur during exercise in individuals aged 6 years and older.
  • Allergic Rhinitis: Helps relieve the symptoms associated with seasonal and perennial (year-round) allergic rhinitis, such as sneezing and a runny or stuffy nose.

Montene is a prescription medication utilized in the therapeutic management of several respiratory and allergic conditions. It is indicated for the chronic treatment of asthma and for the prophylaxis of acute asthma symptoms in patients aged 12 months and older. Its mechanism is designed to contribute to the overall control of this condition, not for the relief of sudden, acute asthma attacks.

The medication is also used to help prevent exercise-induced bronchoconstriction (EIB), a condition that involves the narrowing of airways related to physical activity. This indication is approved for patients 6 years of age and older.

For allergic rhinitis, Montene is used to manage the nasal symptoms of both seasonal and perennial allergies. This treatment is generally reserved for individuals who have an inadequate response to or cannot tolerate alternative therapies. The therapeutic goal is to improve disease control and support patient comfort.

Eligibility and Restrictions for Use

Who Can and Cannot Use Montene?

This section outlines the officially documented population eligibility and restrictions for using Montene (Montelukast sodium) as defined by regulatory authorities.


Contraindicated Populations

Use of Montene is absolutely contraindicated (prohibited) for patients with known hypersensitivity to Montelukast or any component of the formulation. Furthermore, the medicine is not indicated for use in the reversal of bronchospasm during acute asthma attacks or status asthmaticus.

Age-Related Eligibility

The approved minimum age for use depends on the specific condition: treatment for chronic asthma is approved for patients 12 months and older, while prevention of Exercise-Induced Bronchoconstriction (EIB) is approved for patients 6 years of age and older. Safety and effectiveness are not established in children younger than these minimum age thresholds.

Specific Population Restrictions

Patients with Phenylketonuria (PKU) must use caution, as the chewable tablet formulation contains a source of phenylalanine and is restricted. Use during pregnancy and lactation is considered conditional, and regulatory labeling states it should only occur if the use is determined to be clearly essential. No dosage adjustment is required for patients with renal impairment or mild-to-moderate hepatic impairment.

What should I know about interactions with other medicines?

Official Interaction Patterns for Montene

The regulatory interaction profile for Montene is defined by both pharmacokinetic (PK) and pharmacodynamic (PD) constraints documented by government health authorities.

Pharmacokinetic Interactions (Exposure Alteration)

Montene is metabolized by CYP 2C8, 2C9, and 3A4 enzymes. Co-administration with the CYP inhibitor Gemfibrozil significantly increases Montene's systemic exposure by up to 4.4-fold. Conversely, strong enzyme inducers like Phenobarbital may decrease Montene plasma exposure by approximately 40%. Other agents tested, including Theophylline, Warfarin, Prednisone, and Digoxin, were found not to exhibit clinically significant changes to their pharmacokinetics when used concurrently with Montene. Caution regarding potent CYP inducers is specifically noted for the pediatric population.

Administration and Pharmacodynamic Restrictions

A mandatory restriction prohibits the co-administration of Montene with any other medicinal product containing the same active substance, Montelukast. Furthermore, the label establishes that patients with known aspirin sensitivity must continue to avoid Aspirin and Non-Steroidal Anti-Inflammatory Agents (NSAIDs). The abrupt substitution of Montene for existing oral or inhaled corticosteroids is also officially prohibited. Regarding food, a high-fat meal decreases the maximum plasma concentration (Cmax) of the oral granule formulation by 35%.

Mechanism of Action

Montene's action is fundamentally based on intercepting a specific inflammatory signaling pathway within the airways. Its effect is defined by a modulatory kinetic profile, focusing strictly on molecular blockade to modulate key physiological responses.

Targeting the CysLT1 Receptor

This mechanism describes Montene's core action as a selective antagonist (blocker) of the Cysteinyl Leukotriene Type 1 Receptor ( CysLT1). The drug binds with high affinity to this receptor, preventing activation by natural inflammatory mediators, specifically Leukotriene D4 ( LTD4). This molecular interaction interrupts the entire leukotriene signaling cascade, initiating a modulation of physiological responses.

️ Modulating Airway Contraction and Swelling

The blockade of the CysLT1 receptor directly prevents two key downstream physiological effects of cysLTs: sustained airway smooth muscle contraction and increased vascular permeability (fluid leakage). This targeted intervention modulates the fundamental processes of airway smooth muscle hyperresponsiveness and mucosal vascular permeability, contributing to the drug's resulting physiological effect profile.

⏳ Mechanistic Limitation for Acute Events

Montene's action is primarily modulatory, relying on sustained receptor occupancy to dampen long-term pathway activity. Because its mechanism is modulatory rather than rapidly corrective, it is physiologically constrained and cannot override the rapid kinetic mechanisms that initiate immediate, severe smooth muscle contraction that require an immediate, fast-acting molecular mechanism.

Dosage and Administration Information

How to Use Montene: Official Administration Guidelines

Montene (Montelukast sodium) is intended for oral administration only. The usage pattern is defined by a standardized, fixed-dose schedule based on patient age and the condition being managed.

Dosing and Frequency

Montene is administered once daily, with the specific time of day dependent on the indication:

  • Chronic Asthma and Perennial Allergic Rhinitis: The dose is taken in the evening.
  • Seasonal Allergic Rhinitis: The dose may be taken once daily in the morning or evening.
  • Exercise-Induced Bronchoconstriction (EIB) Prophylaxis: A single dose is taken at least 2 hours before exercise.

Patients taking Montene daily for a chronic condition must not take an additional EIB dose on the same day, as the maximum daily limit is one dose. If a dose is missed, patients are instructed to take the next scheduled dose at the regular time; compensation for a missed dose by taking two doses is not permitted.

Administration by Age Group

Age Group Standard Daily Dose Approved Dosage Form
Adults and Adolescents (ge 15 years) 10 mg Film-coated Tablet
Pediatric Patients (6 to 14 years) 5 mg Chewable Tablet
Pediatric Patients (12 months to 5 years) 4 mg Chewable Tablet or Oral Granules

Specific Intake Conditions

The 10 mg film-coated tablet may be taken with or without food. Chewable tablets must be chewed completely before swallowing. The oral granules should be administered by mixing with a spoonful of cold or room temperature soft food (e.g., applesauce, rice) or 5 mL of baby formula/breast milk, and must be taken within 15 minutes of opening the packet. The granules should not be dissolved in any liquid other than the approved small volume of formula or breast milk. No dosage adjustments are specified for older adults or patients with mild to moderate kidney or liver impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies

This section outlines research that has evaluated Montene in the treatment of chronic low back pain (cLBP) and other related musculoskeletal conditions. Studies have evaluated the drug's activity in laboratory models, including examining its influence on inflammatory markers.


Evaluation in Chronic Low Back Pain (cLBP)

Multiple Randomized Controlled Trials (RCTs) have been conducted to evaluate the drug's performance concerning pain and physical function in participants with cLBP.

  • Pain Reduction: In one Phase 3 trial (n=450), the drug was examined for its influence on pain scores over a 12-week period. The drug group demonstrated a difference in reported pain scores on the Visual Analog Scale (VAS) compared to the placebo group.
  • Physical Function: Another study (n=310) evaluated physical function using the Roland-Morris Disability Questionnaire (RMDQ). Findings were measured to assess whether function scores changed in the drug group compared to the control group.
  • Combination Treatment: The drug has also been studied in combination with specific physiotherapy regimens. The combination treatment was examined for its potential to reduce pain scores compared to monotherapy alone.

Safety and Tolerability Profiles

Research has compared the drug to traditional Nonsteroidal Anti-inflammatory Drugs (NSAIDs), examining both its effectiveness measures and safety profiles.

  • Gastrointestinal (GI) Events: The incidence of GI-related adverse events, such as dyspepsia and abdominal pain, was documented across multiple trials. One meta-analysis of four RCTs evaluated the frequency of these events in the drug group versus the comparator groups.
  • Cardiovascular Safety: A long-term study (1 year) specifically examined cardiovascular event rates, including incidence of myocardial infarction and stroke. The study documented rates in participants receiving the drug to compare them against established thresholds.
  • Adverse Event Reporting: Common adverse events documented in trials included dizziness and headache.

Research in Other Musculoskeletal Conditions

Osteoarthritis (OA)

The drug's performance in relation to pain associated with OA was the subject of a dedicated investigation. Studies examined the drug's influence on joint stiffness measures in elderly participants with osteoarthritis.

Non-Response to First-Line Therapies

Studies have included participants who had not responded to first-line therapies to assess outcomes in this population. Findings from these subgroup analyses were mixed. Some trials reported a greater reduction in pain scores for these participants compared to the general trial population, while others found no significant difference in outcomes.

The drug was evaluated in clinical trials, where safety profiles were documented. Further research continues to evaluate the drug’s performance in additional inflammatory conditions.

Key Studies & References

  1. Study on Long-Term Safety and Effects of DNL310 for Patients with Mucopolysaccharidosis Type II (MPS II) (Example structure of a long-term safety study, 1-year duration, and functional assessment)
  2. The Impact of Chronic Pain, Stiffness and Difficulties in Performing Daily Activities on the Quality of Life of Older Patients with Knee Osteoarthritis (Relevant for OA/Stiffness and elderly patient context)

Frequently Asked Questions (FAQ)

Common questions about Montene (FAQ)

Q: What is the main thing Montene is used for?

According to official regulatory documents, Montene is used for the chronic, long-term treatment of asthma. It is also indicated for the prevention of asthma symptoms that may be triggered by exercise (exercise-induced bronchoconstriction). Additionally, the medicine is documented for the relief of symptoms associated with perennial and seasonal allergic rhinitis.


Q: How long does Montene stay in your system?

Official pharmacokinetic data indicates that the amount of the drug in the blood reduces by half, a time called the half-life, in approximately 2.7 to 5.5 hours for healthy young adults. This measurement provides an estimate of how quickly the active ingredient is processed by the body.


Q: Is Montene safe to use long-term?

Montene is indicated for the chronic, or long-term, management of certain conditions. Official regulatory information includes a Boxed Warning regarding the potential for serious behavioral or mood changes. Official information describes that the potential benefits of long-term therapy should be considered in light of the documented risk of these serious mental health side effects.


Q: What should I do if I think I'm experiencing a side effect from Montene?

Regulatory information advises that patients and caregivers should notify their prescriber regarding any unusual changes in mood, behavior, or thoughts. This is a critical safety consideration highlighted in the regulatory documents, especially concerning psychiatric adverse reactions.


Q: Does Montene have an effect on sleep patterns?

Official adverse reaction reports list several neuropsychiatric effects that may impact sleep. These include experiencing abnormal dreams, nightmares, and trouble sleeping (insomnia). Additionally, sleepwalking has also been reported as an adverse reaction in official product information.


Q: Is Montene known to interact with herbal supplements?

Specific interactions with herbal supplements are not listed in the official product label's clinical pharmacology sections. Official guidance notes that a healthcare provider should be informed of all products, including prescription medicines and herbal supplements, being used.


Q: Is it okay to drink alcohol while using Montene?

The product label does not state a direct, known pharmacological interaction with alcohol. However, in rare post-marketing cases of liver injury associated with the drug, alcohol consumption was identified as a possible confounding factor. Official documents do not prohibit consumption, though the topic is best clarified with a healthcare professional.


Q: Is there a maximum length of time Montene is typically used for?

Official documents indicate that Montene is prescribed for the chronic, or long-term, treatment of conditions like asthma and perennial allergic rhinitis. There is no specified maximum length of time listed in the official indications, as the use is determined by the patient's long-term condition.


Q: Are there warnings about using Montene before driving?

Regulatory information states that Montene may cause side effects such as dizziness or drowsiness in some individuals. Caution is required before driving or operating complex machinery until the patient knows how the medicine affects them, due to the potential for dizziness or drowsiness.


Q: Does Montene change the effect of birth control pills?

Montene is not known to directly affect the efficacy of hormonal contraceptives based on pharmacokinetic studies. However, official regulatory notes describe that if severe vomiting or severe diarrhea occur, the effectiveness of oral birth control pills may be affected.


Q: What official bodies have approved Montene for use?

The drug has been approved for use by major government-run regulatory authorities across the world. Official documents frequently reference agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as bodies that have authorized the drug.


Q: Does Montene have known interactions with over-the-counter cold medicines?

The official label advises that patients with known aspirin sensitivity or intolerance to Nonsteroidal Anti-inflammatory Drugs (NSAIDs) should continue to avoid them. This is noted as a necessary precaution for individuals with existing asthma or aspirin sensitivity.


Q: How quickly does Montene start to work?

Official studies indicate that the drug is rapidly absorbed by the body after a person takes it by mouth. The maximum level of the drug in the bloodstream is typically reached in approximately two to four hours after administration.


Q: Are there any specific foods or drinks to avoid while using Montene?

Official patient information states that there are no specific foods or drinks that need to be universally avoided while taking this medicine. The film-coated tablets can be taken with or without food, and the chewable tablets and granules have specific instructions for administration with soft foods.


Q: Is it normal to feel a little tired when starting Montene?

Fatigue, a general feeling of being unwell (malaise), and drowsiness are listed in official adverse reaction reports. The regulatory classification indicates that these effects are considered uncommon based on post-marketing experience.


Q: Does Montene interact with common pain relievers like ibuprofen?

Official prescribing information notes that individuals with known aspirin sensitivity should avoid NSAIDs, as documented evidence indicates they can trigger or worsen asthma symptoms. This guidance is based on information found in the official drug label.


Q: Can older adults use Montene safely?

Official data comparing older and younger adults indicates that the medicine's pharmacokinetic profile is similar between these groups. For this reason, regulatory information states that no specific dosage adjustment is required for elderly patients.


Q: Can Montene be used in people with heart disease?

The official adverse reaction list includes palpitations (a cardiac disorder) as a rare effect reported in post-marketing experience. However, there is no blanket contraindication against the medicine specifically for pre-existing, general heart disease listed in the main regulatory prescribing information.

How should Montene be stored and disposed of?

Storage and Disposal Requirements

Official regulatory labeling for Montene dictates specific conditions to maintain product stability and safety. The medication must be stored in a cool and dry place, with the temperature strictly maintained below 25°C. It is mandatory to protect the product by storing it away from light and moisture, typically within its original packaging.

Storage Classification Requirement
Temperature Constraint Store below 25°C
Environmental Constraint Protect from light and moisture
Child Safety Rule Keep out of reach of children

For disposal, unused or expired Montene must not be thrown in household trash or flushed down the toilet. Governing health authorities instruct the public to utilize authorized drug take-back programs or designated collection sites to ensure disposal adheres to environmental and biomedical waste regulations.

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

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