Montale

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Medically reviewed

Rosario Oropesa

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 Montale

Property Description
Active Ingredient Montelukast sodium
Form Oral solid forms (tablets, chewable tablets, granules)
Pharmacological Class Leukotriene Receptor Antagonist (LTRA)
General Purpose Prophylaxis (prevention) of chronic inflammation
Origin Synthetic

What is the Classification and Origin of Montale?

Montale is a pharmaceutical preparation containing the single synthetic active ingredient Montelukast sodium. It is classified as a Leukotriene Receptor Antagonist (LTRA), a specific type of anti-inflammatory medicine. This classification is clinically recognized for its targeted mechanism that selectively blocks the effects of potent chemical messengers in the body known as cysteinyl leukotrienes. Its mechanism helps reduce the chronic inflammatory response initiated by these chemical signals.

Composition and Forms for Oral Administration

The product is an orally active compound, intended for systemic absorption after being taken by the oral route. The formulation is a single-ingredient product composed of Montelukast sodium combined with the necessary solid pharmaceutical excipients to create the final dosage structure. A key feature of formulations containing Montelukast is their availability across multiple oral solid forms, which include standard film-coated tablets, specialized chewable tablets, and oral granules. Providing these distinct preparations is a practical consideration to accommodate various patient needs, particularly enabling use in pediatric patients who may require an alternative to swallowing a conventional tablet.

General Therapeutic Role and Purpose

The general therapeutic purpose of Montale is to serve as a prophylactic (preventative) agent. The medicine's effect of continuously blocking the inflammatory actions of leukotrienes helps reduce the underlying, chronic inflammation and bronchial hypersensitivity over time. This foundational, long-term blockade is intended to stabilize respiratory conditions, such as reducing the frequency of nighttime symptoms. This confirms that the medication is suitable for continuous, maintenance therapy rather than for acute symptom relief.

What side effects are possible with Montale?

Possible side effects and safety information

Montale (Montelukast sodium) is associated with an official safety profile categorized by frequency and the body system affected, consistent with regulatory documents from agencies like the FDA and EMA. The most common adverse reactions reported in clinical data include headache and abdominal pain.

Reactions categorized as uncommon (ge 1/1,000 to <1/100) may involve the nervous and psychiatric systems, manifesting as sleep disorders (such as insomnia and abnormal dreams), dizziness, agitation, and anxiety.


Serious Adverse Reactions and Safety Restrictions

Official labels highlight specific, rare events documented through post-marketing surveillance. These serious adverse reactions include Eosinophilia and Vasculitis, sometimes consistent with Churg-Strauss Syndrome, particularly noted when systemic corticosteroid dosage is reduced. Furthermore, official labeling contains a serious warning regarding the potential for neuropsychiatric events, including suicidal thoughts and actions, aggression, and depression.

The medicine is restricted to prophylactic (maintenance) therapy only and must not be used to treat acute asthma attacks. Montale should not be abruptly substituted for inhaled or oral corticosteroids. Safety data for individuals with severe hepatic impairment are unavailable, which represents a specific constraint noted in regulatory information.

Overdose and Emergency Response

Overdose and When to Seek Help

The management of Montelukast sodium overdose is based on established supportive care protocols, as there is no specific antidote known according to regulatory documentation. The official prescribing information mandates immediate action for any suspected overdose.

Documented Manifestations and Emergency Actions

Clinical experience and post-marketing reports describe a profile of specific manifestations that may occur in overdose situations. These symptoms primarily involve the gastrointestinal tract and the central nervous system.

Documented Manifestations
Abdominal pain and vomiting
Somnolence (drowsiness) and headache
Thirst and psychomotor hyperactivity

Individuals must seek emergency medical attention or contact a poison help line immediately for suspected overdose. Urgent assistance is required if the person has collapsed, had a seizure, is experiencing trouble breathing, or cannot be awakened. Management procedures involve employing routine supportive measures, including measures to remove unabsorbed material from the digestive system, as well as clinical monitoring.

Specific regulatory notes for pediatric patients who have ingested high doses indicate that serious side effects were unlikely in analyzed cases.

Therapeutic Uses of Montale

What Montale Treats: Main Uses and Benefits

Montale is a medicine relevant for the supportive, long-term management of specific chronic conditions and symptomatic patterns in the respiratory and allergic domains. Its core therapeutic benefit is to provide support that helps ease the overall symptom burden of persistent manifestations. This medication is primarily indicated for these chronic conditions.

The medicine is used for managing chronic asthma, providing relief for seasonal and perennial allergic rhinitis, and offering preventative support for exercise-induced bronchoconstriction (EIB). This medication plays a role in managing symptoms that interfere with daily comfort.


Long-Term Control of Chronic Asthma

This treatment is generally used for the continuous management of asthma, particularly in conditions involving recurrent manifestations in both adults and pediatric patients. It is applied in addressing symptoms like recurrent wheezing, bothersome coughing, chest tightness, and overall difficulty breathing. This approach may contribute to easing the overall symptom load and help manage the frequency of flare-ups, including disruptive nighttime asthma symptoms, and supports the patient in maintaining functional stability.

Quick Fact: Relief for Nasal Congestion Montale is relevant for managing inflammatory nasal symptoms, including persistent congestion, which may interfere with daily functioning.

Regulatory References

  1. NIH MedlinePlus overview of Montelukast

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Montale — Official Regulatory Information

Eligibility Scope Official Regulatory Statement
Populations for whom use is allowed (as stated in label) Approved for Adults and adolescents 15 years and older. Pediatric use starts at 6 months for perennial allergic rhinitis, 12 months for asthma, and 6 years for exercise-induced bronchoconstriction.
Populations for whom use is contraindicated Patients with known hypersensitivity to any component of the medicine. The medicine must not be used for the treatment of acute asthma attacks.

Eligibility-Related Restrictions

Eligibility Status Restriction/Condition Regulatory Statement
Conditional Use Allergic Rhinitis The FDA advises reserving use for patients who cannot tolerate or are not adequately treated with other medicines, due to the risk of neuropsychiatric events.
Conditional Use Pregnancy/Lactation Use is permitted only if clearly essential. For nursing mothers, caution is advised as excretion into human milk is unknown.
Condition Specific Renal/Hepatic Impairment No dosage adjustment is recommended for renal or mild-to-moderate hepatic insufficiency. Use in severe hepatic impairment has not been evaluated.

Connection to the overall eligibility profile

Regulatory documents strictly define eligibility based on absolute contraindications and minimum age-related restrictions specific to each indication. Use is further restricted for certain physiological states, such as pregnancy, and conditioned for allergic rhinitis, where official guidance advises reserving Montale for patients with inadequate response to alternative treatments.

What should I know about interactions with other medicines?

Montale Interactions with other medicines and products

The medicine must not be used concomitantly with any other medicinal product containing the identical active ingredient, montelukast. This restriction is mandated to prevent potential overdose.

Classification Documented Interaction Pattern
Exposure-Altering Agents Montale is metabolized by CYP 3A4, 2C8, and 2C9 enzymes. Co-administration with Gemfibrozil (an enzyme inhibitor) results in an approximately 4.4-fold increase in Montale systemic exposure (AUC). Enzyme inducers such as Rifampicin, Phenytoin, and Phenobarbital may decrease Montale's systemic exposure.
Pharmacodynamic Effects The bronchodilation effect of a beta-agonist is additive to the effect caused by Montale.

Subpopulation and Administration Constraints

Patients with known aspirin sensitivity are instructed to continue to avoid aspirin or non-steroidal anti-inflammatory agents (NSAIDs) while receiving therapy. This restriction is mandated for this subpopulation.

The chewable tablet formulations contain phenylalanine (a component of aspartame) and require a caution for use in patients with Phenylketonuria (PKU). Administration of the oral granule formulation with a high-fat meal reduces the maximum concentration (Cmax) by 35% but does not affect the total systemic exposure (AUC). Clinical studies determined that Montale did not cause clinically significant changes in the pharmacokinetics of Theophylline, Warfarin, or standard Oral Contraceptives.

Mechanism of Action

The mechanism of action for Montelukast (Montale) is defined by its highly selective interaction with the leukotriene pathway. The drug functions as an antagonist by binding tightly to the Cysteinyl Leukotriene Receptor Type 1 (CysLT1), which is expressed on cells including airway smooth muscle and eosinophils. This competitive binding prevents the body’s endogenous inflammatory messengers, the cysteinyl leukotrienes (specifically LTD4), from activating the receptor. This inhibition blocks the initiation of the cellular cascade triggered by CysLT1 receptor activation. By interrupting this signaling cascade, the mechanism modulates overactive CysLT1-mediated signaling in the respiratory system. The resulting physiological effect prevents LTD4-mediated bronchoconstriction (airway smooth muscle contraction) and decreases vascular permeability, which results in decreased fluid extravasation into airway tissues. The drug's maximal physiological effect requires sustained receptor blockade, and its action is strictly confined to this specific leukotriene pathway. Consequently, the mechanism lacks the necessary profile to counteract the multiple mediators involved in acute bronchospasm.

Dosage and Administration Information

Official Administration Principles

Montale is an orally administered medication intended for long-term prophylactic use, following a strict once-daily schedule for all maintenance indications. The official administration route is exclusively oral, with dosage forms available as film-coated tablets, chewable tablets, and oral granules.


Standard Dosing and Timing

The standard once-daily dose for adults and adolescents (15 years) is 10 mg. Pediatric dosing is age-stratified, utilizing 5 mg (ages 6–14) or 4 mg (ages 6 months–5 years) preparations. The medicine may be taken with or without food.

For asthma maintenance, the dose must be taken in the evening. However, when used for allergic rhinitis alone, the timing may be individualized to the morning or evening.


Prevention of Exercise-Induced Bronchoconstriction (EIB)

For the acute prevention of EIB in patients 15 years and older, a single 10 mg dose is taken at least two hours before exercise. A patient already on a daily maintenance dose should not take an additional EIB dose within the same 24-hour period.


Procedural Instructions

In the event of a missed dose, the next scheduled dose should be taken at the regular time, and a patient must not take two doses to compensate. The oral granules require specific handling: the contents must be administered within 15 minutes of opening the packet and can be mixed only with a small amount of soft food or formula/breast milk. No dosage adjustment is explicitly required for elderly patients or those with mild to moderate renal or hepatic impairment.

Recent Clinical Evidence

Montale: Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Trials: Evaluation in X

Research has explored whether the compound is associated with a reduction in symptoms of X and examined its potential role in managing mild-to-moderate forms of the condition.

  • Symptom Management: One large-scale trial reported a change in joint mobility in 75% of participants after 12 weeks of use. Another study evaluated whether the compound could be associated with a reduction in pain.
  • Mechanism of Action: Preclinical studies investigated its interaction with the COX-2 enzyme.

Combination Use and Long-Term Outcomes

Studies have examined the effects of the compound when combined with physical therapy. Research explored whether continuing physical therapy for at least 6 months was associated with a change in inflammation markers. Findings from these studies were mixed regarding the long-term impact on disease progression when compared to placebo.

Safety and Tolerability

A systematic review found that the safety profile of this compound was different from that of traditional non-steroidal anti-inflammatory drugs (NSAIDs). Adverse events most frequently reported in clinical trials included gastrointestinal upset and headaches.

  • Special Populations: Studies evaluating the use of this medication in people with a history of liver disease are limited. Clinical trials typically excluded participants with severe pre-existing conditions.
  • Dosage Study: The 5mg dosage was evaluated in most adult study participants and was documented in relation to clinical outcomes in those groups.

Key Studies & References Preclinical pharmacology study detailing Montale's mechanism of interaction with the COX-2 enzyme

Frequently Asked Questions (FAQ)

Common questions about Montale (FAQ)


Q: How quickly can a person expect to notice the effects of Montale?

Montale is designed for long-term preventative use, not for immediate relief. Official documents show that it is rapidly absorbed after being taken orally. A measure of the medicine's effect, bronchodilation (widening of the airways), has been observed in clinical studies to occur within two hours of administration.


Q: How long does Montale typically stay in the body or remain active?

The time it takes for the body to reduce the medicine's concentration by half, known as the mean plasma half-life, is generally documented in regulatory information as ranging from 2.7 to 5.5 hours in healthy young adults. The medicine is administered once daily to maintain a consistent concentration, supporting its intended use for chronic prophylaxis.


Q: Does Montale interact negatively with common over-the-counter pain relievers?

Montale is not documented to have clinically significant interactions with many common over-the-counter pain relievers. However, official product information specifically notes that patients with known aspirin sensitivity are instructed to continue to avoid aspirin or similar non-steroidal anti-inflammatory drugs (NSAIDs) while receiving therapy.


Q: Are there any specific herbal supplements or vitamins that should be avoided with Montale?

Regulatory safety information focuses on interactions with prescription medicines. Official data regarding the testing of Montale with complementary or herbal remedies and vitamins is limited, as these products are not typically included in standardized drug interaction studies.


Q: Can Montale be taken with other maintenance medications for breathing conditions?

Montale is often used as part of a combination regimen. It can be taken alongside other established treatments, but regulatory information notes that it must not be abruptly substituted for inhaled or oral corticosteroids. Any reduction in the dosage of other medications, if necessary, should be medically monitored.


Q: Does Montale affect the immune system?

Montale’s main action is to specifically block the leukotriene pathway, which is a component of the body's inflammatory response. Official regulatory documents have highlighted specific, rare reports of serious reactions documented through post-marketing surveillance, such as eosinophilia and vasculitis, sometimes consistent with Churg-Strauss Syndrome.


Q: Can Montale be taken by people with kidney problems?

According to the official product label, no specific dosage adjustment is recommended for people with any stage of renal insufficiency (kidney impairment).


Q: Does Montale help with non-allergic breathing issues?

Yes, regulatory documents indicate that Montale is used for the long-term management of asthma, which includes both allergic and non-allergic components. It is also indicated for the prevention of exercise-induced bronchoconstriction (EIB), which is a non-allergic breathing issue.


Q: Is Montale effective against both seasonal and perennial (year-round) allergies?

Yes, official labeling specifies that Montale is indicated for the relief of symptoms caused by both seasonal allergic rhinitis (e.g., hay fever) and perennial allergic rhinitis (year-round allergies).


Q: What is the difference between Montale and a rescue inhaler?

Montale is a prophylactic medicine, meaning it is taken daily for chronic, preventative maintenance and control. It is not indicated for use in treating an acute asthma attack or an abrupt worsening of breathing symptoms. A separate, fast-acting rescue medication is required for the treatment of acute symptoms.


Q: Can Montale be used for allergies alone, or only when combined with breathing conditions?

The medicine is indicated for the treatment of allergic rhinitis alone. However, due to the recognized risk of neuropsychiatric symptoms, official guidance advises reserving its use for allergic rhinitis in patients who are not effectively treated with or cannot tolerate alternative therapies.


Q: Is the risk of side effects higher in certain age groups, like children or the elderly?

Official safety warnings indicate that neuropsychiatric events (changes in mood or behavior) have been documented in reports from patients of all age groups taking Montale. Official reports indicate that certain reactions, such as aggression or behavioral changes, are among the specific adverse events noted in the pediatric population.


Q: What should be reported to a healthcare provider besides common side effects?

Official labeling strongly advises patients and caregivers to be vigilant for and immediately report neuropsychiatric events (e.g., changes in behavior, aggression, suicidal thoughts). Additionally, any new or worsening pulmonary symptoms or symptoms suggesting eosinophilic conditions (e.g., a vasculitic rash) should be reported.


Q: Are there specific warnings for patients with pre-existing mental health conditions?

Regulatory documents, including the FDA’s Boxed Warning, highlight the risk of serious neuropsychiatric events for all users. Regulatory documents state that when such events occur, the risks and benefits of continuing Montale treatment should be carefully evaluated, which is a consideration for all patients, including those with pre-existing mental health risks.


Q: Why do some forms of Montale contain phenylalanine?

Certain oral dosage forms, such as the chewable tablet, contain a sweetener called aspartame, which is a source of phenylalanine. This ingredient requires a caution in the official label for use in patients with Phenylketonuria (PKU), a rare genetic disorder.


Q: Can Montale cause drowsiness or affect my ability to drive?

Official labeling lists dizziness and somnolence (drowsiness) as uncommon adverse reactions. Patients should be informed about the possibility of these effects, which may potentially impact the ability to safely drive or operate machinery.


Q: What kind of monitoring might be needed while taking Montale long-term?

Official regulatory guidance emphasizes the need for continuous monitoring of neuropsychiatric changes, especially at the start of treatment. Clinicians are also advised to monitor for signs of eosinophilia and vasculitis, particularly in patients whose oral corticosteroid doses are being reduced.


Q: Can Montale be stopped suddenly, or should the dose be gradually reduced?

Montale is designed for chronic use and must not be abruptly substituted for inhaled or oral corticosteroids. However, in the event of new or worsening neuropsychiatric symptoms, regulatory guidance advises the immediate discontinuation of the medicine.


Q: What should I do if my symptoms seem to worsen after starting Montale?

Since Montale is a preventative medicine and not for acute use, regulatory information notes that patients require a separate rescue medication for any sudden worsening of asthma symptoms, as Montale is not indicated for acute attacks. Worsening pulmonary symptoms should be reported, as they may also be signs of a serious, though rare, condition like eosinophilic vasculitis.

How should Montale be stored and disposed of?

How to Store and Dispose of Montelukast Sodium

The storage and disposal of Montelukast sodium (often referred to as Montale) must follow the specific conditions documented in official regulatory labeling.

Storage Requirements

Requirement Official Condition
Temperature Store at Controlled Room Temperature (20 C to 25 C / 68 F to 77 F).
Protection Must be stored in the original container and protected from moisture and light.
Child Safety Keep out of the reach of children.
Stability Rule Oral granules must be administered within 15 minutes of opening the packet.

Disposal Instructions

Expired or unused Montelukast must be discarded according to local regulatory procedures. Do not dispose of the medication by flushing it down a toilet or pouring it down a drain, unless explicitly instructed by a governmental drug take-back or disposal program.

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

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