Montemar

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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 Montemar

Property Description
Active ingredient Montelukast (as Montelukast sodium)
Form Oral tablets, chewable tablets, and oral granules
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
General purpose Preventive reduction of airway inflammation
Origin Synthetic (chemically synthesized)

Montemar: Identity and Pharmacological Classification

The medicine Montemar is defined as an orally active, synthetic chemical compound containing the active ingredient Montelukast sodium. It belongs to the therapeutic and pharmacological class known as Leukotriene Receptor Antagonists (LTRA), often broadly categorized as a Leukotriene Modifier. This classification sets Montemar apart from traditional allergy and asthma treatments, as its action is supported by pharmacological studies specifically confirming its role in modifying leukotriene activity. Montelukast is clinically recognized for providing a unique, non-corticosteroid approach to the long-term maintenance of respiratory function.

Composition and General Purpose

The core of Montemar's composition is the monosodium salt of Montelukast, designed for simple oral administration. The availability of preparations like the chewable tablet and oral granule distinguishes it, ensuring patient-friendly options are provided. The general purpose of Montemar relates directly to its mechanism: it functions by selectively binding to the CysLT1 receptors, thereby blocking the effects of naturally occurring inflammatory mediators called cysteinyl leukotrienes. By inhibiting the action of potent agents like Leukotriene D4 (LTD4), Montemar helps to reduce airway inflammation and prevent bronchoconstriction. This mechanism helps stabilize breathing in situations requiring continuous preventive control.

Regulatory References

  1. NIH MedlinePlus Drug Information: Montelukast

What side effects are possible with Montemar?

Official Safety Profile and Documented Adverse Reactions

The safety profile for Montemar (Montelukast) is defined by official government regulatory documents, classifying adverse reactions by frequency and the body systems affected. These classifications communicate the documented incidence of possible effects observed in clinical trials and post-marketing surveillance.

Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized based on incidence rates:

  • Very Common (occurring in ge 1 in 10 patients): Upper respiratory infection, Headache.
  • Common (occurring in ge 1 in 100 patients): Abdominal pain, Diarrhea, Nausea, Vomiting, Rash, Pyrexia/Fever.
  • Uncommon (occurring in ge 1 in 1,000 patients): Sleep disorders, Agitation, Anxiety, Depression, Dizziness, Hypersensitivity reactions.

System-Organ Classes and Serious Reactions

The most commonly affected System-Organ Classes (SOCs) listed in the official label include Infections and Infestations, Gastrointestinal Disorders, Nervous System Disorders, and Psychiatric Disorders.

Serious adverse reactions are officially documented by regulatory authorities. These include a spectrum of Neuropsychiatric Events, which encompass changes in behavior and mood, such as aggression, depression, and reports of suicidal thinking and behavior. Rare but clinically significant systemic reactions such as Churg-Strauss Syndrome (a form of vasculitis) and Hepatitis have also been reported post-marketing.

Population-Specific Notes and Safety Restrictions

Safety data contains specific notes for certain populations. Neuropsychiatric events have been documented across all age groups, with specific post-marketing reports of dysphemia/stuttering linked to the pediatric population. The chewable tablet formulation contains aspartame, which requires a specific safety note for individuals with Phenylketonuria (PKU).

Montemar is officially restricted and is not indicated for the treatment of acute asthma attacks. Patients who have known aspirin sensitivity must continue avoiding aspirin or other non-steroidal anti-inflammatory agents while taking this medicine.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents for Montemar (Montelukast) define the drug's overdose profile based on clinical observations and mandated emergency actions.

Documented Overdose Manifestations Acute overdose reports documented clinical signs primarily affecting the central nervous and gastrointestinal systems. The most frequently observed manifestations include abdominal pain, vomiting, somnolence (drowsiness), headache, thirst, and psychomotor hyperactivity (restlessness/irritability). These reports included both adult and pediatric cases. Regulatory reviews state that the majority of acute overdose cases did not result in adverse experiences, even following exposures up to 1,000 mg.

Emergency Response and Required Actions In the event of an acute overdose, regulatory guidance specifies that treatment is generally based on symptomatic and supportive measures. The official labeling confirms that no specific antidote is known for Montelukast overdose. Clinical monitoring should be employed as a standard supportive measure. It is also noted that it is not known whether the substance is removed by dialysis.

When Immediate Medical Help is Required Official labeling mandates an urgent response for specific serious events. Patients and/or caregivers must contact a healthcare provider immediately if new or worsening neuropsychiatric symptoms occur, including agitation or suicidal thoughts and behavior.

Therapeutic Uses of Montemar

WHAT MONTEMAR TREATS: MAIN USES AND BENEFITS

Montemar (Montelukast) is commonly used for managing conditions characterized by periods of heightened symptoms related to chronic respiratory and allergic processes.

The medication is considered relevant for three primary therapeutic domains. It is applied across conditions presenting with persistent asthma symptoms in adults and children, where it plays a role in managing symptoms that create noticeable physiological strain, such as wheezing and chest tightness. The medicine is also used to help manage the symptomatic discomfort of both seasonal and perennial allergic rhinitis, and for the prophylaxis of exercise-induced bronchoconstriction (EIB).

The use of this medicine is relevant in contexts where additional symptomatic support is needed. This proactive use helps maintain a sense of stability when symptoms are more noticeable, supporting the patient during difficult episodes associated with exertion. By addressing these symptomatic domains, Montemar contributes to easing the overall symptom load and helps improve day-to-day comfort during symptomatic periods.

Quick Fact: Symptomatic Support

Quick Fact: Symptomatic Support Montemar assists with maintaining functional stability and helps ease the overall symptom load associated with both persistent asthma and activity-triggered breathing problems.

Eligibility and Restrictions for Use

Eligibility Scope

Category Official Regulatory Status
Populations for whom use is contraindicated Patients with known hypersensitivity to Montelukast or any component of the product.
Age-related eligibility rules Minimum approved age ranges from 6 months (Perennial Allergic Rhinitis) to 6 years (EIB prophylaxis). Safety and effectiveness are not established in patients below these specific age thresholds. No special restriction applies to older adults in the general population.
Condition-specific eligibility Severe Hepatic Impairment: Pharmacokinetics have not been evaluated in this population. Renal or Mild-to-Moderate Hepatic Impairment: No dosage adjustment is required.
Pregnancy and lactation eligibility Use is permitted only if considered clearly essential by a healthcare professional (conditional use status).

Eligibility-Context Constraints

Classification Constraints Defined in Official Documents
Non-Acute Use The medicine must not be used for the reversal of acute asthma attacks.
Allergic Rhinitis Use Use for allergic rhinitis is officially reserved for patients who cannot be treated effectively with or cannot tolerate alternative allergy medications.

This official eligibility profile for Montemar strictly limits its use by setting specific minimum age limits for each condition and establishing an absolute contraindication for hypersensitivity. Regulatory documents classify use in certain populations, such as during pregnancy or for those with severe liver impairment, as requiring specific professional consideration or being not established.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Montemar (Montelukast) is primarily defined by the way other medicines influence its clearance through hepatic metabolism, as documented in regulatory information.

Pharmacokinetic Interactions

Montelukast is metabolized by Cytochrome P450 (CYP) enzymes, chiefly CYP3A4, CYP2C8, and CYP2C9.

Interacting Product Official Regulatory Finding
Gemfibrozil (Inhibitor) Increases Montelukast systemic exposure (AUC) significantly, by approximately 4.5-fold, due to inhibition of CYP2C8 and CYP2C9.
Phenobarbital (Inducer) Decreases Montelukast systemic exposure (AUC) by approximately 40%, consistent with its known role as a potent inducer of hepatic metabolism.
Rifampicin (Inducer) Noted for caution; co-administration with this potent enzyme inducer may require appropriate clinical monitoring.

Montelukast does not cause clinically important effects on the pharmacokinetics of many other drugs, including Warfarin, Theophylline, and oral contraceptives, based on official studies.

Pharmacodynamic and Other Constraints

  • Aspirin and NSAIDs: Patients with known aspirin-sensitive asthma must continue to avoid aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), as treatment with Montemar does not alter this required restriction.
  • Food Effect: Co-administration of the oral granule formulation with a high-fat meal decreases the peak plasma concentration (Cmax) by 35%, though the total exposure (AUC) is not affected.
  • Population Note: Caution regarding enzyme inducers (like Phenobarbital and Rifampicin) is specifically recommended in the pediatric population. Patients with mild-to-moderate hepatic impairment may also exhibit a higher systemic exposure of Montelukast.

Mechanism of Action

How Montemar Works

Montemar's mechanism of action is defined by its highly targeted intervention in the leukotriene signaling pathway, a key mediator of inflammation in the respiratory system.

Selective CysLT1 Receptor Antagonism

Montemar contains Montelukast, a molecule that acts as a highly selective antagonist of the Cysteinyl Leukotriene Receptor Type 1 (CysLT1). It achieves functional blockade by competitively binding to this receptor, thus preventing the pro-inflammatory signaling molecule, Leukotriene D4 ( LTD4), from initiating its biological effects. This selective mechanism results in the neutralization of a major inflammatory signal.

Modulation of Airway Smooth Muscle and Edema

By preventing LTD4 from binding to CysLT1 receptors on airway smooth muscle cells, the drug eliminates a powerful stimulus for muscle contraction, thus regulating airway smooth muscle tone. The same blockade also reduces LTD4-induced increases in vascular permeability, which restricts fluid leakage and edema (swelling) within the respiratory mucosa. This action results in a physiological modulation of airway reactivity.

Attenuation of Eosinophil-Driven Inflammation

CysLT1 receptor signaling promotes the migration and activation of eosinophils and other inflammatory cells into the airways. Montelukast's mechanism suppresses this signaling cascade, which reduces the infiltration of these cells into bronchial tissues. This reduces the overall level of chronic sub-mucosal inflammation associated with the leukotriene pathway.

Dosage and Administration Information

How to Use Montemar

Montemar (Montelukast) is intended for oral administration as a long-term maintenance treatment, requiring continuous, daily administration. It is not used for treating sudden, acute episodes.


Administration and Dosage Regimens

The required dose and physical form of Montemar are determined strictly by age and body weight, as outlined in official labeling:

Age Group Standard Daily Dose Approved Formulations
Adults and Adolescents ( 15 years) 10 mg Film-coated tablets
Children (6 to 14 years) 5 mg Chewable tablets
Children (6 months to 5 years) 4 mg Chewable tablets or oral granules

The standard frequency for chronic management is once daily. For patients managing asthma, or both asthma and allergic rhinitis, the dose is typically administered in the evening. Dosing should be maintained daily, even during periods when symptoms appear to be controlled.


Procedural Instructions and Constraints

The official instructions detail specific conditions for taking the medicine. Montemar may be taken with or without food.

For Exercise-Induced Bronchoconstriction (EIB) prophylaxis, a single dose (10 mg or 5 mg, based on age) is administered at least two hours before exercise. Instructions strictly forbid taking an additional EIB dose if the patient is already receiving a once-daily dose for chronic management.

If a dose is missed, patients should skip that dose and resume the normal daily schedule; double doses must not be taken to compensate.

Recent Clinical Evidence

Montemar: Overview of Clinical Evidence

This summary provides a neutral overview of the research structure for Montemar (Montelukast), focusing on the types of studies conducted and areas of remaining uncertainty, strictly avoiding clinical advice or safety information.


Evidence for Use in Persistent Asthma

Research exploring how symptoms change over time has relied on Randomized Controlled Trials (RCTs) and Meta-analyses. Studies included assessment of objective Lung Function measures (such as FEV1), as well as subjective patient-reported outcomes describing perceived discomfort and symptom scores. Findings included measurements related to lung function and patient-reported outcomes reflecting daily functioning.

Long-term effects are not fully established for continuous use beyond one year, as follow-up durations were limited in the core trials. There is also limited information for certain subgroups, such as older adults or patients with the most severe forms of the condition.


Evidence for Use in Allergic Rhinitis and EIB

The medicine was studied for conditions characterized by fluctuating or episodic manifestations of allergic rhinitis in short-term controlled trials. These studies reported measurements of nasal and eye symptoms over defined time intervals, contributing to understanding symptom patterns.

For Exercise-Induced Bronchoconstriction (EIB), research examined patients with conditions associated with acute episodes following exertion, primarily using crossover trial designs. Studies monitored objective outcomes describing episodic or acute changes in lung function after a standardized exercise challenge.

Subgroup findings are uncertain for certain younger pediatric populations, as the regulatory evidence involved a degree of extrapolation from adult data. Furthermore, comparative evidence is lacking for certain regimens, and research is ongoing to explore these areas.

Key Studies & References

  1. Montelukast in paediatric asthma and allergic rhinitis: a systematic review and meta-analysis

Frequently Asked Questions (FAQ)

Common questions about Montemar (FAQ)


Q: Is Montemar a type of antibiotic or something else?

A: Montemar is not an antibiotic. According to official documents, its active ingredient, Montelukast, is classified as a Leukotriene Receptor Antagonist (LTRA). This means it works by targeting a specific chemical pathway in the body to reduce inflammation and prevent airway narrowing, rather than fighting bacteria.

Q: Can Montemar be taken for conditions other than its main approved use?

A: Montemar is officially indicated only for its approved uses. These include the long-term chronic treatment of asthma, the prevention of Exercise-Induced Bronchoconstriction (EIB), and the relief of symptoms from allergic rhinitis. Regulatory documents do not provide information or guidance on using the medicine for other conditions.

Q: How quickly does Montemar usually start to work?

A: Official clinical data indicates that improvements in lung function have been observed in studies within one day of starting daily treatment. Montemar is indicated for long-term maintenance and prevention, and is not used for providing relief during sudden, acute symptoms.

Q: Are there any common over-the-counter pain relievers that interact with Montemar?

A: The official product label requires that patients with known aspirin-sensitive asthma must continue to avoid aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), as Montemar treatment does not remove this restriction. For other common over-the-counter pain relievers, specific interactions are not widely noted in the regulatory documents.

Q: Does Montemar make you feel tired or drowsy?

A: Regulatory data documents headache as a very common adverse reaction. Less common effects include sleep disorders and dizziness. Patient information from regulatory bodies also describes the possibility of experiencing tiredness or sleepiness while taking the medication.

Q: Is it normal to feel a mild stomach discomfort when starting Montemar?

A: Experiencing some stomach discomfort is classified in regulatory data as a Common adverse reaction. Common effects include abdominal pain, diarrhea, nausea, and vomiting. As with any drug-related effect, official guidance suggests following the direction of a healthcare provider.

Q: Is Montemar generally considered a long-term or short-term treatment?

A: Montemar is officially indicated for the prophylaxis and chronic treatment of persistent asthma, meaning it is designed for continuous, long-term use. It is specifically not intended for short-term use to treat acute asthma attacks.

Q: Is Montemar suitable for older adults to use?

A: Official regulatory documents indicate that no special restriction or dosage adjustment is typically required for older adults (age 65 years and over) compared to younger adults. The core clinical trials, however, had limited enrollment for the oldest age groups.

Q: Does Montemar interact with common vitamins like Vitamin D or B12?

A: Regulatory documents primarily detail interactions with certain prescription medicines that affect how Montemar is cleared by the liver. There is no explicit mention in the official labeling regarding clinically significant interactions with common vitamins such as Vitamin D or Vitamin B12.

Q: What is the difference between the brand name Montemar and its chemical name?

A: The active ingredient in the medicine Montemar is known by its chemical name, Montelukast (specifically, Montelukast sodium). Montemar is the brand name used for the product, while Montelukast is the name of the drug itself.

Q: Can Montemar be taken indefinitely?

A: The medicine is indicated for chronic treatment. However, regulatory documents state that the safety and efficacy of continuous use in asthma patients are based on clinical studies of up to one year of continuous use. Duration of treatment is a decision determined by a healthcare provider.

Q: What should be done if I suspect a side effect from Montemar?

A: Official documents state the importance of monitoring for any changes in behavior or new neuropsychiatric symptoms. If an adverse event is suspected, clinical guidance suggests seeking immediate direction from a healthcare provider. Suspected adverse reactions can also be formally reported to the relevant government regulatory body using their official reporting systems.

Q: Is there a generic version of Montemar available?

A: Yes, the active ingredient in Montemar, Montelukast, is widely available in a generic formulation. Regulatory authorities document and list the availability of these generic equivalents.

Q: What is the difference between Montemar and other drugs used for the same purpose?

A: Regulatory documents classify Montemar as a Leukotriene Receptor Antagonist (LTRA). This pharmacological class works differently from other common classes of respiratory medicines, such as inhaled corticosteroids or rapid-acting bronchodilators.

Q: Can Montemar cause changes in mood or anxiety levels?

A: Yes, regulatory documents contain strong warnings about the risk of serious Neuropsychiatric Events. These documented events include changes in behavior and mood, such as agitation, anxiety, depression, and, rarely, reports of suicidal thinking and behavior. The potential for neuropsychiatric effects means that all medications affecting mood are typically reviewed by a healthcare provider.

Q: What is the general experience of patients who have been on Montemar for several months?

A: Clinical trial summaries describe that the medicine significantly improved patient-reported endpoints when compared to placebo. These improvements reflect better daily functioning and a reduction in the use of quick-relief medicines for patients managing chronic asthma.

Q: Is Montemar a medicine that needs to be tapered off slowly?

A: There are no general regulatory instructions requiring a slow taper for discontinuation under normal circumstances. Official guidance advises that treatment should be discontinued if serious neuropsychiatric symptoms occur, noting that symptoms often resolved after stopping the therapy.

Q: Is Montemar affected by alcohol consumption?

A: Regulatory documents do not list a specific pharmacokinetic interaction between Montelukast and alcohol. However, since the medicine carries warnings regarding rare effects like hepatitis (liver inflammation), guidance on alcohol consumption is typically provided by a healthcare provider.

Q: Can Montemar cause skin sensitivity to the sun?

A: The official adverse reaction list includes rash (Common) and documented hypersensitivity reactions. However, regulatory documents do not specifically mention photosensitivity or increased skin sensitivity to the sun as a documented adverse effect.

Q: What are the most common reasons a doctor would stop prescribing Montemar?

A: Official regulatory labels specifically instruct healthcare professionals to discontinue treatment if a patient develops serious neuropsychiatric events or exhibits a known hypersensitivity to the drug. These are the most critical reasons for stopping the medication documented in safety warnings.

Q: Does Montemar cause weight changes?

A: Regulatory documents classify adverse reactions based on their frequency in clinical trials and post-marketing reports. Weight change is not listed as a common, uncommon, or rare adverse reaction in the official regulatory label.

Q: How does the drug label describe the clinical trial results for Montemar?

A: Regulatory summaries describe that clinical trials demonstrated the drug significantly improved pulmonary lung function, which is measured by objective metrics like FEV1. The results also showed that the medicine reduced the frequency of using quick-relief medicines (like beta2-agonists) versus placebo.

Q: What are the typical conditions or patient demographics Montemar is intended for?

A: Regulatory documents state Montemar is indicated for patients with persistent asthma (of a certain severity), seasonal and perennial allergic rhinitis, and for the prevention of Exercise-Induced Bronchoconstriction (EIB). The approved use spans patients as young as 6 months for certain conditions.

Q: Does Montemar interact with common antidepressant medications?

A: Official regulatory labels do not cite a known pharmacokinetic interaction between Montelukast and most common antidepressant medications. However, the drug itself carries warnings about its own neuropsychiatric adverse effects. The potential for neuropsychiatric effects means that all medications affecting mood are typically reviewed by a healthcare provider.

Q: What is the maximum duration of use described in regulatory documents for Montemar?

A: While intended for chronic treatment, regulatory documents state that the safety and efficacy of continuous use in asthma patients are based on studies of up to one year of continuous use. The duration of treatment is determined by a healthcare provider.

Q: Is it normal to still have some symptoms while taking Montemar?

A: Clinical trial summaries report that Montemar significantly improves symptoms of asthma and allergic rhinitis compared to placebo. However, this does not mean it completely eliminates all symptoms. Treatment is intended to reduce inflammation and prevent complications, but some residual symptoms may persist.

Q: Does Montemar require any special considerations for people with kidney disease?

A: According to official regulatory documents, patients with renal impairment (kidney disease) do not typically require a dosage adjustment. The official label provides no specific restrictions for this population.

How should Montemar be stored and disposed of?

How to Store and Dispose of Montelukast Sodium

All forms of Montelukast sodium (Montemar) must be kept out of the sight and reach of children for safety.


Storage Conditions

Requirement Official Instruction
Temperature Store at controlled room temperature, typically not exceeding 30, C
Protection Store in the original package to protect from light and moisture

Montelukast is sensitive to environmental conditions, and the container provides necessary protection.


Stability and Disposal

The medicine has specific handling rules for stability. For oral granules, the sachet must not be opened until ready to use, and the full contents must be administered immediately (within 15 minutes). If mixed with food, the mixture must not be stored for future use.

Any unused or expired product must be disposed of in accordance with local requirements; it should not be thrown away via wastewater or household waste.

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

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