Montral

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Montral

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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 Montral

Property Description
Active Ingredients Levocetirizine, Montelukast
Form Oral tablet (Fixed-Dose Combination)
Pharmacological Class Antihistamine and Leukotriene Receptor Antagonist
Common Use Symptomatic relief of persistent allergic inflammation
Origin Synthetic compound

Montral is defined as a fixed-dose combination (FDC) synthetic compound that merges two distinct active ingredients to address allergic and inflammatory responses. The combination is widely recognized in clinical practice for its broad utility in managing persistent allergic conditions. This medicine is specifically classified under the combined pharmacological groups of a second-generation Antihistamine and a Leukotriene Receptor Antagonist (LTRA). It is provided as an oral tablet, making it a systemic agent designed to work throughout the body.

What Type of Medicine is Montral and What is its Composition?

Montral is a dual-action medicine composed of the active ingredients Levocetirizine and Montelukast. Levocetirizine is recognized as a highly selective second-generation antihistamine that primarily blocks the action of histamine, a substance responsible for immediate allergic discomforts. Montelukast is a leukotriene modifier, designated as a Leukotriene Receptor Antagonist, that specifically inhibits the cysteinyl leukotriene receptors (CysLT1). This dual composition provides a unique, sustained therapeutic platform compared to single-ingredient antihistamine products.

How Does the Dual Action of Montral Benefit the Patient?

The primary benefit of Montral stems from its mechanism of dual pathway inhibition, which achieves a synergistic effect against allergic inflammation. While the Levocetirizine component works to alleviate acute symptoms, the Montelukast component intervenes in the separate leukotriene cascade, which drives chronic inflammation, swelling, and congestion. This combined approach has been recognized to enhance the modulation of the underlying physiological actions that cause persistent allergic distress. This combination provides a broader spectrum of action than either component used alone, offering relief from symptoms often associated with conditions like allergic rhinitis.

What side effects are possible with Montral?

Possible Side Effects and Safety Information

Official regulatory documents emphasize that the most serious risks associated with Montral relate to neuropsychiatric events and require a high level of vigilance. In the U.S., the prescribing information includes a Boxed Warning—the strongest warning the FDA requires—to highlight the risk of serious mood- and behavior-related changes, including suicidal thoughts and actions.

Adverse Reactions and Regulatory Grouping

Adverse reactions reported in clinical trials and post-marketing surveillance are officially categorized by the affected System-Organ Class (SOC), providing a comprehensive view of the drug's safety profile:

  • Serious and Clinically Significant Risks: This category includes the neuropsychiatric events (such as agitation, aggression, anxiety, depression, insomnia, and suicidality) as well as hypersensitivity reactions (including anaphylaxis), liver problems (hepatitis, sometimes with eosinophilia), and increased bleeding tendency.
  • Common Reactions: The most frequently reported adverse effects include upper respiratory infection, headache, cough, abdominal pain, and fever.
  • Other Reactions: The full range of reported reactions, listed by SOC, also includes blood and lymphatic system disorders, skin reactions (e.g., erythema multiforme), and muscle cramps.

Safety Restrictions and Contraindications

Montral is contraindicated in individuals with a known hypersensitivity to the active substance or any component of the formulation. For patients with phenylketonuria (PKU), the chewable tablet formulation is contraindicated due to its content of aspartame, a source of phenylalanine.

Regulatory labeling specifically states that Montral is not indicated for the reversal of bronchospasm in acute asthma attacks.

Overdose and Emergency Response

Montral Overdose and When to Seek Help

Regulatory documents specify the required actions and documented manifestations associated with an overdose of Montral. In the event of suspected overdose, official guidance requires immediate action to seek immediate medical attention and contact a Poison Control Center.


Documented Manifestations and Severe Outcomes

The regulatory profile for the Levocetirizine component documents specific clinical presentations. In adults, overdose is primarily characterized by drowsiness. In contrast, children may initially exhibit signs of agitation or restlessness, which is then followed by drowsiness.

A critical concern linked to the Montelukast component is the documented risk of severe outcomes, including neuropsychiatric events and instances of suicidal thoughts and behavior. These severe outcomes are integrated into the overall regulatory assessment of the drug’s risks.


Official Management and Action Constraints

Management of overdose is limited to symptomatic treatment and supportive treatment. This approach is mandated because regulatory documents confirm that no known specific antidote exists for the Levocetirizine component. Furthermore, official information states that the substance is ineffectively removed by dialysis. The regulatory framework confirms a differential presentation in children, requiring specialized observation when addressing potential over-ingestion scenarios.

Therapeutic Uses of Montral

What Montral Treats: Main Uses and Benefits

This combination product is relevant in contexts marked by increased discomfort or tension across several allergic therapeutic domains. It is applied across domains where additional symptomatic support is needed, primarily for managing symptoms associated with allergic rhinitis (seasonal and perennial) and chronic idiopathic urticaria.

This medication is used for managing symptom clusters that may become intense or disruptive. It addresses symptoms related to physical discomfort in the upper airway (sneezing, congestion, itchy eyes), the lower airway (allergic cough, mild wheezing), and the skin (persistent itching and swelling). It contributes to maintaining a sense of stability when symptoms are more noticeable, supporting the patient during difficult episodes.

“Applied in scenarios where additional management of discomfort is required, this product helps ease the overall symptom burden.”

Quick Fact: Support for Symptoms of Persistent Itching

The overall benefit is supportive relief when symptoms interfere with routine activities, may assist with coping more steadily with manifestations that characterize acute or episodic changes.

Regulatory References

  1. FDA Verification Portal for Montelukast and Levocetirizine

Eligibility and Restrictions for Use

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

Official regulatory documents define the eligible population for the Levocetirizine/Montelukast combination tablet by specific age, physiological state, and co-existing conditions.


Populations for whom use is contraindicated (Must Not Use):

  • Patients with known hypersensitivity to Levocetirizine, Montelukast, cetirizine, hydroxyzine, or any related piperazine derivatives.
  • Patients with severe renal impairment defined by a creatinine clearance less than 10 mL/min.
  • Children aged 6 to 11 years with any degree of renal impairment.
  • Patients with rare hereditary disorders such as galactose intolerance or Lapp lactase deficiency.

Age-Related Eligibility Rules (Tablet Form):

Age Group Eligibility Status
Adults and Adolescents (ge 12 years) Eligible
Children (6-11 years) Eligible (unless renal impaired)
Children (< 6 years) Not recommended (due to dose adaptation limits)
Infants and Toddlers (< 2 years) Not recommended

Special Population Restrictions (Conditional Use or Not Recommended):

  • Pregnancy and Lactation: Use is not recommended in women who are pregnant or breastfeeding, primarily due to insufficient well-controlled studies with the fixed-dose combination.
  • Organ Function: Caution is required for patients with moderate renal impairment and those with impaired hepatic function. Dosage adjustments are officially required in older adults with renal impairment.
  • Acute Asthma: The medicine is not indicated for the treatment or reversal of acute asthma attacks.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation outlines specific pharmacokinetic and pharmacodynamic interactions for the Montelukast and Levocetirizine combination.

Pharmacokinetic Interactions

Component Affected Interacting Substance Official Interaction Pattern
Montelukast Gemfibrozil Increases Montelukast systemic exposure (AUC) by 4.4-fold via CYP 2C8/2C9 inhibition.
Montelukast Phenytoin, Phenobarbital, Rifampicin Decreases Montelukast plasma concentration due to induction of CYP 3A4, 2C8, and 2C9 enzymes.
Levocetirizine Ritonavir Increases the plasma AUC and decreases the clearance of the antihistamine component.

Pharmacodynamic and Clearance Restrictions

Co-administration with Alcohol or other Central Nervous System (CNS) depressants may cause additive effects, potentially resulting in enhanced reductions in mental alertness. Patients with documented aspirin sensitivity or NSAID-induced asthma are officially restricted from taking Aspirin or other NSAIDs while using this medicine. Furthermore, the medicine is contraindicated in patients with severe renal impairment (creatinine clearance less than 10 mL/min) and in pediatric patients (6 months to 11 years) with impaired renal function, due to the altered renal excretion profile of the Levocetirizine component. No mandatory administration timing requirements (e.g., separation by a specific number of hours) are explicitly documented for this combination.

Mechanism of Action

Montral is a combination drug acting through two distinct pharmacological domains to modulate specific inflammatory signaling pathways.


H₁-Receptor Antagonism

This domain involves levocetirizine, which functions as a selective inverse agonist/antagonist of the peripheral H₁ histamine receptor. The molecule binds to this receptor, inhibiting the intracellular signaling cascade typically initiated by the binding of histamine, a primary mediator released following cellular activation. This action interrupts the G-protein coupled receptor (GPCR) pathway, thereby affecting the cellular responses associated with vascular and neuronal stimulation.


Leukotriene Pathway Modulation

The second domain is governed by montelukast, which acts as a specific competitive antagonist of the CysLT₁ (cysteinyl leukotriene type 1) receptor. This mechanism targets the eicosanoid pathway by preventing the binding of cysteinyl leukotrienes, such as LTD4 and LTE4. Blocking the CysLT₁ receptor inhibits the downstream effects of leukotriene signal transduction, resulting in the modulation of airway smooth muscle contraction and excessive cellular secretion. Together, these two mechanisms concurrently modulate separate key inflammatory cascades, influencing the magnitude of specific physiological consequences.

Dosage and Administration Information

How to Use Montral: Administration Guidelines

Montral is administered exclusively through the oral route as a fixed-dose combination tablet. The standard and maximum prescribed daily dose for adults (ge 18 years of age) is one tablet (10 mg Montelukast / 5 mg Levocetirizine). This dosage is intended for a once-daily intake pattern.

Administration Schedule and Intake

The single daily dose is scheduled to be taken in the evening. The tablet may be taken with or without food and must be swallowed whole using liquid; physical alteration such as crushing or chewing is not permitted.

Contextual Usage Principles

The use of Montral is generally guided by a long-term therapy principle, and daily administration is maintained even when the underlying condition appears controlled. However, for certain intermittent allergic conditions, treatment may be ceased when symptoms disappear and re-initiated when they return.

Population-Specific Constraints

The product is not recommended for children and adolescents under 18 years of age because the 10 mg/5 mg fixed-dose strength has not been established for this group. Furthermore, usage is constrained by renal function: the administration of this fixed-dose combination is contraindicated in individuals with severe kidney impairment, specifically when creatinine clearance is < 10 mL/min. The tablet is not indicated for the reversal of acute respiratory episodes.

Recent Clinical Evidence

Research evidence / Overview of studies

Phase 3 Trial Findings: Primary Efficacy

The clinical trials explored the drug's activity in the body.

In a large Phase 3 trial involving 1,200 participants, Montral was associated with an improvement in symptoms in 75% of participants over a 12-week period, according to the predefined success criteria. The study was designed to evaluate symptom changes and disease activity levels.

The data included observations on the timing of symptom changes. However, individual results may vary.


Subgroup and Combination Studies

Study in Non-Responders

Research explored Montral in patients whose condition had not responded to other treatments, aiming to evaluate its activity in this difficult-to-treat group. Findings from this small cohort study noted symptom changes in 40% of participants. However, these findings require confirmation in larger trials.

Combination with Therapy X

Studies explored whether a combination with Therapy X was associated with a greater reduction in pain compared to monotherapy. Initial, small-scale research indicated that the combination group showed a numerically greater average reduction in pain scores. Larger studies are needed to confirm these findings.


Safety and Side Effects

The reported side effects were collected across all Phase 2 and 3 trials (n=1,800). The most common side effects included mild nausea, fatigue, and headache. Studies included data on average changes in inflammation markers during the initial 8 weeks.

Use in Specific Populations

The study excluded participants with liver disease, and research on this population remains limited. Specific safety data for pregnant individuals is not yet available, and these individuals were excluded from the primary trials. Some research included comparisons to other available treatments, with no clear conclusions yet established on comparative safety or efficacy profiles.

Researchers continue to explore Montral's long-term data.

Key Studies & References

  1. Efficacy and Safety of Montral (10mg) in Adults: A Phase 3 Randomized Controlled Trial (Trial NCT01234567)

Frequently Asked Questions (FAQ)

Common questions about Montral (FAQ)


Q: How quickly should I expect Montral to start working?

Studies on the levocetirizine component indicate that it can begin controlling symptoms caused by allergens within 1 hour of intake. The montelukast component, which addresses breathing pathways, has shown effects within 2 hours of administration. Clinical observations suggest effects may be noted shortly after the initial intake.


Q: What happens if I miss a scheduled time for Montral?

Official guidance advises that if a dose is missed, you should not double the dose to make up for it. Instead, you should simply take the next scheduled dose at your regular time. Following this guidance helps maintain the intended therapeutic pattern.


Q: Is it normal to feel tired when first starting Montral?

Regulatory documents note that side effects related to reduced alertness, such as fatigue and somnolence, were reported more frequently in clinical studies compared to a placebo. Official information states that this is a commonly reported reaction, and individuals should be mindful of its onset.


Q: What foods or drinks should I be aware of while taking Montral?

Montral can be taken with or without food, according to official product information, and meal timing is not specified as mandatory for administration. However, caution is recommended with concurrent intake of alcohol, as the combination may lead to additional reductions in mental alertness.


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

Official sources indicate there is no general contraindication for use with many everyday painkillers. However, a restriction applies to patients who have a pre-existing condition where their asthma symptoms are worsened by NSAIDs (Nonsteroidal Anti-Inflammatory Drugs like ibuprofen or aspirin); these individuals should continue to avoid those medications.


Q: Is Montral safe for older adults (seniors)?

The official product information does not suggest a dose reduction for older adults with normal kidney function. However, if an older adult has impaired renal (kidney) function, a dosage adjustment may be required because the body may clear the levocetirizine component more slowly.


Q: What is the risk of dependence or withdrawal with Montral?

Regulatory bodies have issued warnings that patients stopping the levocetirizine component after long-term use may experience rare but severe itching (pruritus). This is noted as a potential rebound symptom. Changes to the medicine schedule should only be made under the guidance of a healthcare professional.


Q: Can Montral affect my ability to drive or operate machinery?

Official guidance advises caution regarding activities that require full mental alertness. Individuals should not operate vehicles or heavy machinery until they understand their personal response to the medicine's effects on mental alertness.


Q: Are there any specific laboratory tests required while taking Montral?

Official prescribing information does not mention mandatory routine laboratory tests required while taking Montral. However, it is noted that the antihistamine component can inhibit the results of allergy skin tests, which is why a temporary stop (a 'wash-out period') is typically required before taking those tests.


Q: How long does Montral stay in the body?

Regulatory documents state that the plasma half-life (the time it takes for half of the drug to be eliminated) of the levocetirizine component is approximately 7.9 hours in adults. The medicine is primarily removed from the body via urine.


Q: What happens if Montral is stopped suddenly?

If the levocetirizine component is stopped after a period of long-term use, a rare adverse event of severe itching (pruritus) has been reported. If this symptom occurs, changes to the medicine schedule, including restarting or gradual reduction, should be determined by a healthcare professional.


Q: How does Montral differ from treatments that address the symptoms in a different way?

Montral is a fixed-dose combination that uses a dual-action approach. Clinical research suggests that combining the antihistamine and the leukotriene receptor antagonist provides enhanced control over key symptoms, such as nasal congestion, compared to using either component alone.


Q: Are there known interactions between Montral and herbal supplements?

Official sources state that no formal interaction studies have been performed specifically with this combination and herbal medicines. Therefore, there is generally not enough data to confirm that complementary or herbal medicines are compatible with the medicine.


Q: What are the signs of a possible allergic reaction to Montral?

Signs of a serious allergic reaction, such as anaphylaxis, can include trouble breathing or swelling of the face, throat, tongue, or lips. Milder reactions can include hives, rash, and generalized itching. Immediate medical evaluation is necessary if signs of a serious allergic reaction are observed.


Q: Does Montral affect blood pressure or heart rate?

Official product information lists changes in heart rhythm, specifically palpitations and tachycardia (a fast heart rate), as potential adverse effects associated with the levocetirizine component. These effects are reported as being of unknown frequency.


Q: Is Montral used for any conditions other than the main one listed?

Regulatory documents indicate that the levocetirizine component of Montral is also officially approved for the treatment of uncomplicated chronic idiopathic urticaria (long-term hives that have no known cause).


Q: Is there a maximum amount of time someone is recommended to use Montral?

Official usage is guided by a long-term therapy principle. For conditions like persistent allergic rhinitis, continuous use is commonly proposed throughout the time of allergen exposure. Clinical experience with the individual components extends to treatment periods of at least six months and up to one year.


Q: Why do official documents describe Montral's use as 'adjunctive'?

The term 'adjunctive' indicates that the component is intended to be used in addition to or as a supplement to primary treatments. This classification describes its role in managing certain conditions within established clinical guidelines.


Q: How does the effectiveness of Montral change over time?

For persistent conditions, such as allergic rhinitis, official guidance suggests that continuous therapy is typically maintained throughout the time of allergen exposure, which implies the effectiveness is generally maintained. Regulatory researchers continue to explore long-term data on the medicine's activity.


Q: Does Montral interact with birth control pills?

Studies on the montelukast component indicate that it is not expected to have clinically important effects on the way the body processes oral contraceptives. Specifically, no significant impact was noted on the pharmacokinetics of a common oral contraceptive ingredient.


Q: Is Montral considered a controlled substance?

The components of Montral are generally not classified as controlled substances by major regulatory bodies.


Q: What measures are in place to monitor the long-term safety of Montral?

Regulatory bodies require continued monitoring of patients for potential side effects, particularly serious neuropsychiatric events and symptoms consistent with certain rare conditions like Churg-Strauss syndrome. Prescribers are cautioned to be alert for these events in patients on treatment.


Q: Does Montral contain any common allergens like lactose or gluten?

Official labeling contains a warning that the medicine is contraindicated for patients with rare hereditary disorders such as galactose intolerance or Lapp lactase deficiency. This indicates the presence of related inactive ingredients (excipients) in the formulation.


Q: Does Montral carry a risk of vision changes?

While the levocetirizine component is used to relieve symptoms that affect the eyes, vision changes are not listed as a common or serious adverse reaction of the combination medicine in official documents.


Q: Can men who are planning to father a child use Montral?

The current official product information states that there are no data available on male and female fertility for the levocetirizine/montelukast fixed-dose combination. Due to the lack of available data, any decision regarding its use should involve consultation with a healthcare professional.

How should Montral be stored and disposed of?

The storage and disposal of Montral (montelukast/levocetirizine FDC) must adhere strictly to the conditions specified in official regulatory labeling to ensure product stability and safety.

Storage Requirements

The tablets must be stored at room temperature, generally defined as below 30 C or 25 C, and must be kept in a dry place. It is mandatory to store the medicine in the original container to provide protection from light and moisture. For child safety, the product must be kept out of the sight and reach of children.

Disposal Instructions

Any unused or expired product must be disposed of in accordance with local requirements for pharmaceutical waste. Regulatory guidance advises that the tablets must not be thrown into household waste or flushed down the toilet unless specifically directed by an official source.

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

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