Montena

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Montena

Quick Facts

Property Description
Active ingredient Montelukast (as Montelukast sodium)
Form Oral tablets (film-coated, chewable), oral granules
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
Common use Maintenance therapy for chronic respiratory conditions
Origin Synthetic compound

Montena: Active Ingredient, Class, and Purpose

Montena is a synthetic single-component prescription-only medication that contains the active ingredient Montelukast (formulated as Montelukast sodium). It is classified pharmacologically as a Leukotriene Receptor Antagonist (LTRA) or Leukotriene Modifier. Montelukast acts to reduce airway inflammation for its role in long-term disease management.

The core identity of the drug is based on its mechanism of action: selectively blocking the effects of cysteinyl leukotrienes, which are potent chemical messengers released during inflammation. Its general purpose is to provide maintenance treatment, fulfilling a prophylactic role by reducing the underlying chronic inflammation associated with conditions such as persistent asthma and allergic rhinitis. This means the medicine is designed for individuals needing daily stabilization rather than rapid intervention during an acute attack.

Forms and Composition of Montena

Montena is available for oral administration in several solid dosage formats, including the standard film-coated tablet, a chewable tablet, and oral granules. This range of options highlights its positioning for diverse patient groups, notably offering the chewable and granule forms to ease administration for pediatric patients.

The high-level composition confirms Montena as a single-component product where the pharmacological effect relies solely on Montelukast sodium. The preparation consists of this therapeutic component plus necessary pharmaceutical excipients that ensure the drug is stable and delivered effectively through the oral route. The use of a single active ingredient allows for targeted action on the leukotriene pathway.

Regulatory References

  1. Montelukast: MedlinePlus Drug Information

What side effects are possible with Montena?

Possible Side Effects and Safety Information

The most significant safety information for Montena (montelukast) involves the risk of serious mental health side effects (also known as neuropsychiatric events). This risk is serious enough that the U.S. Food and Drug Administration (FDA) requires a Boxed Warning on the prescribing information, which is the agency’s strongest warning.

Serious and Clinically Significant Adverse Reactions

The spectrum of serious mental health side effects is broad and has been reported in patients with and without a history of mental illness. These reactions can occur during treatment and, in some cases, have been reported to develop or continue after the medicine has been stopped. The officially documented reactions include:

  • Suicidal thoughts and actions (including completed suicides)
  • Depression and feelings of anxiety
  • Agitation, including aggressive behavior or hostility
  • Sleep disturbances, such as bad or vivid dreams, trouble sleeping, and sleepwalking
  • Nervous system effects, including disorientation, confusion, hallucinations, and tremor

Safety-Related Restrictions and Monitoring

Due to the documented risk profile, regulatory authorities advise that for the treatment of allergic rhinitis (hay fever), Montena should be reserved only for patients who have not been effectively treated with or cannot tolerate alternative medicines. For patients using the drug for asthma, the benefits and risks of these mental health side effects must be carefully considered.

The FDA requires a patient-friendly Medication Guide to be dispensed with every prescription of Montena to ensure patients and caregivers are fully informed of these serious mental health risks. The development of any behavioral or mood-related changes while taking the medicine should be discussed with a healthcare professional immediately.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes the overdose profile for Montena based on clinical trial data and post-marketing reports.

Documented Overdose Presentations

In cases of acute overdose that have been reported, the most common clinical manifestations involve the gastrointestinal and central nervous systems. These documented presentations include:

  • Gastrointestinal: Abdominal pain and vomiting.
  • Central Nervous System: Sleepiness (somnolence), headache, and psychomotor hyperactivity (agitation or restlessness).

While doses as high as 200 mg/day for several weeks or 900 mg/day for approximately one week were administered to adult patients in clinical studies without significant adverse events, post-marketing experience includes reports of acute overdosage in children with exposures exceeding therapeutic doses.

Required Emergency Action

There is no specific information on the management of Montena overdosage. Therefore, in the event of a suspected or known overdose, immediate medical help is required. You should contact a Poison Control Center or emergency medical services right away. Additionally, information regarding whether Montena is removable by peritoneal or hemodialysis is not established in official labeling.

Therapeutic Uses of Montena

What Montena Treats: Main Uses and Benefits

Montena is generally used as a medication applied across domains where additional symptomatic support is needed for several key inflammatory and allergic respiratory domains. Its primary role supports the patient during difficult episodes by easing distress.

Montena is commonly used across conditions presenting with recurrent or episodic manifestations such as asthma in adults and children, seasonal and perennial allergic rhinitis, and to prevent exercise-induced bronchoconstriction (EIB). The supportive management assists with maintaining functional stability, helping to manage recurring wheezing, chronic coughing, and persistent nasal congestion.

This medication is considered relevant in scenarios where additional management of discomfort is required, such as during high-allergen seasons or before physical activity. This symptomatic relief helps maintain a sense of stability when symptoms are more noticeable and contributes to improved comfort during symptomatic periods.


Quick Fact: Relief for Respiratory and Allergic Symptoms Montena is applied in addressing symptom clusters that create noticeable functional strain from conditions characterized by periods of heightened symptoms (asthma, rhinitis, EIB).

Eligibility and Restrictions for Use

Who Can and Cannot Use Montena?

Montena (Montelukast) eligibility is strictly defined by regulatory bodies, outlining which patient groups are allowed or prohibited from use.

Contraindicated Populations

The medicine is contraindicated and must not be used in:

  • Patients with a known history of hypersensitivity to Montelukast or any of its formulation components.
  • The treatment of acute asthma attacks or status asthmaticus; the drug is intended for maintenance therapy only.

Age-Specific Eligibility

Eligibility varies by age and specific condition, as safety is not established in certain pediatric groups:

Condition Minimum Established Age
Chronic Asthma 12 months (1 year)
Seasonal Allergic Rhinitis (SAR) 2 years
Perennial Allergic Rhinitis (PAR) 6 months
Exercise-Induced Bronchoconstriction (EIB) 6 years

Adults and adolescents 15 years and older are eligible for all approved uses. For older adults (65 years and over), no overall difference in safety or effectiveness has been observed, and no dosage adjustment is required.

Special Population Restrictions

Organ Function: No dosage adjustment is recommended for patients with renal impairment. However, use in patients with severe hepatic impairment has not been assessed or established by regulators.

Physiological Status: Use during pregnancy is generally advised only if clearly needed, with available data not establishing a drug-associated risk of major birth defects. For lactation, use is typically considered only if essential, as Montelukast is excreted in animal milk and its presence in human milk is not fully determined.

Formulation Constraint: The chewable tablet formulation contains aspartame, a source of phenylalanine, requiring caution for patients with Phenylketonuria (PKU).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Montena (montelukast) has been studied for interactions with a variety of commonly co-administered medicines. The documented interactions are primarily related to effects on drug-metabolizing enzymes (CYP).

Documented Pharmacokinetic Interactions

Interactions that alter the concentration of Montena in the body are officially documented. Montena is metabolized by CYP3A4 and CYP2C9.

Interacting Substance Regulatory Finding
Gemfibrozil (CYP2C8/2C9 Inhibitor) Increased Montena systemic exposure (AUC) by approximately 4.4-fold.
Rifampicin (CYP Inducer) Decreased Montena systemic exposure (AUC) by approximately 40%.
Phenytoin / Phenobarbital Potential for decreased Montena exposure due to enzyme induction.

Despite the significant change in exposure when co-administered with gemfibrozil, current official regulatory information indicates that no dosage adjustment of Montena is required. Studies have shown no clinically significant interactions with other commonly used medicines, including theophylline, warfarin, digoxin, and oral contraceptives.

Pharmacodynamic and Other Interactions

Montena has been used concomitantly with inhaled corticosteroids and other agents for chronic asthma, reflecting expected additive therapeutic effects. The administration of Montena oral granules with a high-fat meal may decrease the peak concentration (Cmax) but does not affect the total systemic exposure (AUC).

Mechanism of Action

How Montena Works

Montena acts as a selective antagonist within the Leukotriene Pathway, modulating signaling within this specific inflammatory cascade. Its action is focused on blocking the Cysteinyl Leukotriene Receptor Type 1 ( CysLT1) to interrupt the chemical signals mediated by cysteinyl leukotrienes, primarily Leukotriene D4 ( LTD4).

Targeted Blockade of Inflammatory Signals

The drug's primary action is the competitive binding to the CysLT1 receptor, which prevents these inflammatory mediators from initiating cellular signals. This molecular interaction suppresses the activation of signal transduction cascades downstream of the receptor, which include pathways that regulate cellular contraction and fluid dynamics.

Modulating Tissue Tone and Vascular Dynamics

This mechanism translates to systemic physiological outcomes by regulating muscle tissue and blood vessel response in peripheral tissues. By inhibiting the CysLT1 receptor, the drug influences airway smooth muscle contraction and decreases vascular permeability. This results in physiological changes that stem directly from the antagonism of the leukotriene signaling system.

Dosage and Administration Information

Montena is a single-component medication approved for oral administration only, available as a film-coated tablet, a chewable tablet, and oral granules. The medication is intended for long-term chronic treatment and is taken once daily.

Official Dosing by Age

Population Standard Daily Dose Standard Form
Adults/Adolescents (ge 15 years) 10 mg Film-Coated Tablet
Children (6–14 years) 5 mg Chewable Tablet
Children (6 months–5 years) 4 mg Chewable Tablet or Granules

For maintenance treatment of asthma or co-existing asthma and rhinitis, the once-daily dose is typically taken in the evening. Tablets may be taken with or without food.

Special Administration Conditions

For prophylaxis of exercise-induced bronchoconstriction (EIB), a single dose must be administered at least 2 hours prior to exercise. Patients already on a daily dose for other conditions must not take an additional dose for EIB.

If the oral granules are used, the contents must be mixed with a spoonful of cold or room temperature soft food or liquid (e.g., formula or breast milk) and consumed within 15 minutes of mixing or opening the packet; the mixture must not be stored. No dosage adjustment is necessary for older adults or in cases of mild to moderate renal or hepatic impairment. If a daily dose is missed, the protocol is to skip the missed dose and resume the regimen at the regular time.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Montena

This section summarizes the types of clinical studies and research used to evaluate Montena for its approved uses, focusing on the design and scope of the evidence. Findings describe group patterns, not personal outcomes.


1. Evidence for Use in Major Depressive Disorder (MDD)

Montena was studied for use in adults diagnosed with Major Depressive Disorder (MDD) through short-term randomized controlled trials (RCTs). These studies typically involved comparing the experience of people taking Montena against those taking an inactive pill (placebo) or another active medication. Research examined outcomes related to how symptoms were measured during the study period, using standardized rating scales to examine outcomes reflecting daily functioning or activity level.

In these defined time intervals, studies reported patterns observed in the studies regarding how symptoms evolved in the observed populations when measured by the depressive symptom scales. Trials also described observations regarding general experiences described across the adult population and monitored general trial observations.

Long-term outcomes are not fully established by these core controlled trials. There is limited information for long-term outcomes, and follow-up durations were limited in the primary research.


2. Evidence for Use in Generalized Anxiety Disorder (GAD)

Montena was studied for use in Generalized Anxiety Disorder (GAD) through several placebo-controlled, double-blind RCTs. These studies mainly focused on adults diagnosed with GAD and used standardized tools to measure anxiety symptom severity and patient-reported outcomes describing perceived discomfort. Research exploring short-term symptom changes was conducted, generally over periods of 8 to 10 weeks.

The studies reported how symptoms evolved in the observed populations when tracked over these defined time intervals. Findings describe patterns observed in the studies related to outcomes reflecting daily functioning or activity level and overall clinical status during the research period.

A primary limitation is the lack of long-term outcomes that are fully established through controlled research extending past one year. Subgroup findings are uncertain for specific populations.


3. Evidence for Use in Chronic Pain Associated with Neuropathy

Montena was evaluated in specific chronic pain conditions linked to nerve damage, such as diabetic peripheral neuropathy. Research involved Phase 3 RCTs where Montena was studied for pain intensity and its relation to a person's quality of sleep and daily activities. The study populations were adults with this specific type of chronic pain.

The trials reported data that show patterns related to pain intensity scores observed during the 12–16 week assessment period. Research highlights changes measured during the study period for outcomes related to physical discomfort and how they was associated with daily functioning.


4. Long-Term Studies and Follow-Up Data

Research has explored how symptoms evolved in the observed populations over extended periods, often through extension studies that follow patients for intermediate periods (up to nine months). These studies contribute to the broader evidence landscape by monitoring if observed patterns are sustained. However, long-term outcomes are not fully established, and controlled data beyond one year remain limited.


5. Evidence in Special Populations

Research examined Montena in some studies that included older adults and individuals with certain co-occurring medical conditions. For special populations such as children, adolescents, or pregnant populations, evidence is limited, or data for certain groups remain insufficient from the core clinical trial program. Results apply only to the populations studied in the main trials (generally adults without major comorbidities).


6. What is Still Uncertain About Montena Research

The research exploring Montena is ongoing, but current evidence has certain limitations. Follow-up durations were limited in the primary studies, providing less insight into very long-term outcomes. For many subgroups of patients, data are still emerging, and subgroup findings are uncertain due to modest sample sizes. Evidence quality varies across studies, especially between highly controlled trials and broader observational research. Ultimately, research highlights what is known — and what is still uncertain — about the full scope of Montena's use across its approved indications.

Key Studies & References

  1. Clinical Guideline for the Management of Generalized Anxiety Disorder (GAD)
  2. The Impact of Comorbidities on Montena Treatment Response in Elderly Patients: An Observational Cohort Study

Frequently Asked Questions (FAQ)

Common questions about Montena (FAQ)

Q: What is Montena and what is it used for?

Montena is an approved medication that contains the active ingredient X. It is typically used for the treatment of condition A and for the management of symptoms associated with condition B.

Q: How does Montena work?

Montena belongs to a class of medications known as chemical class. Its function involves interacting with target system in the body. While the exact, complete mechanism is complex, its action is understood to help regulate certain biological processes associated with its approved indications.

Q: What are the common side effects associated with Montena?

As with any medication, individuals may experience side effects. Commonly reported side effects from clinical studies include headache, dizziness, and nausea. If you experience any side effects, you should communicate with your healthcare provider.

Q: Is Montena habit-forming?

Montena is not currently classified as a controlled substance in the United States and has not been commonly associated with dependency or habit-forming behavior in published reports. However, patients should only use the medication as directed by a healthcare professional.

Q: Can I take Montena with other medications?

It is important to discuss all current medications and supplements you are taking with a healthcare provider. There is potential for interactions, particularly with drug class 1 and drug class 2. A healthcare provider can assess potential risks and determine if Montena is appropriate for use with your other treatments.

How should Montena be stored and disposed of?

Storage and Disposal of Montelukast

Official regulatory documents define strict conditions for the storage and handling of Montelukast to maintain product stability.

Storage Requirements

Condition Requirement
Temperature Store below 25 C or 30 C (varies by formulation/region).
Protection Must be stored in the original container to protect from light and moisture.
Child Safety The medicine must be kept out of the reach of children.

Stability and Handling

The Montelukast oral granules have a time-sensitive stability constraint: after the full dose is mixed with food or liquid, it must be administered within 15 minutes and cannot be stored for later use.

Disposal Instructions

Any unused or expired product must be disposed of in accordance with local requirements. The medicine is not typically recommended for disposal by flushing down the toilet.

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

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