Lelipel

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Medically reviewed

Marina Burgos

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 Lelipel

Quick Facts

Property Description
Active ingredient Montelukast sodium
Form Oral tablets, chewable tablets, oral granules
Pharmacological class Leukotriene Receptor Antagonist (LTRA)
Common purpose Chronic management of inflammation in airways
Origin Synthetic

What Type of Medicine is Lelipel?

Lelipel is a prescription-only medicine whose active component is Montelukast sodium, a chemically defined synthetic sodium salt. It is formally classified as a Leukotriene Receptor Antagonist (LTRA), functioning broadly as an Antiasthmatic agent and Anti-allergic drug. This designation establishes it as a single-ingredient product designed for systemic administration through the oral route.

As an LTRA, Montelukast sodium is clinically recognized for its high selectivity and affinity for the CysLT1 receptor, distinguishing it from general bronchodilators. Understanding this characteristic clarifies that Lelipel provides specific, targeted support for chronic management to help stabilize airway function over extended periods.

Understanding the Pharmacological Class (LTRA)

The primary purpose of Lelipel stems directly from its function as a Leukotriene Receptor Antagonist. The active ingredient, Montelukast sodium, acts as an antagonist, preventing natural inflammatory substances called cysteinyl leukotrienes from binding to their target receptors in the airways, which means the medicine is designed to reduce the body's inflammatory response internally.

This targeted antagonism helps to stabilize the hyperactivity and reduce the inflammatory response within the bronchial tubes and nasal passages, confirming its role as an effective anti-inflammatory drug and an Antiasthmatic agent. This sustained effect provides foundational support for maintenance therapy aimed at stabilizing respiratory function over time.

Forms and Administration of Lelipel (Montelukast)

Lelipel is supplied for oral administration in multiple solid dosage forms, including film-coated oral tablets, chewable tablets, and oral granules. The basic composition includes the active substance, Montelukast sodium, combined with specific solid pharmaceutical excipients required to create the final form, ensuring effective delivery via the mouth for subsequent absorption and systemic administration.

Regulatory References

  1. National Library of Medicine

What side effects are possible with Lelipel?

Possible Side Effects and Safety Information

Official regulatory documents emphasize that Lelipel may be associated with a risk of serious neuropsychiatric events, a category that includes suicidal thoughts and behavior, aggression, hostility, agitation, depression, and hallucinations. This specific risk is highlighted by a Boxed Warning from the U.S. Food and Drug Administration (FDA) and strengthened warnings by other global regulators.

Key Adverse Reactions and Frequencies

Classification System-Organ Class Involved Examples (Adverse Reactions)
Very Common (ge1/10) Infections and Infestations Upper respiratory infection
Common (ge1/100 to <1/10) General, Gastrointestinal Headache, fever, abdominal pain, diarrhea, cough
Rare/Very Rare Nervous System, Immune System, Skin, Hepato-biliary Suicidal thoughts and behavior, Churg-Strauss syndrome, hepatotoxicity, severe skin reactions, hypersensitivity reactions (e.g., anaphylaxis)

Safety Considerations and Restrictions

Serious Adverse Reactions: In addition to the neuropsychiatric events, cases of systemic eosinophilia and vasculitis, often consistent with Churg-Strauss syndrome, have been reported, sometimes in association with the reduction of oral corticosteroid therapy. Rare instances of hepatotoxicity (liver injury) and severe skin reactions have also been documented in postmarketing reports.

Safety Restrictions: Lelipel is contraindicated for use in patients with known hypersensitivity to the product. It must not be used to treat acute asthma attacks. For patients who are sensitive to aspirin, the continued avoidance of aspirin and non-steroidal anti-inflammatory agents is recommended by official documents.

Monitoring: Prescribers and patients should be vigilant for new or worsening behavior and mood changes at all times during treatment. The drug is not to be abruptly substituted for inhaled or oral corticosteroids.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents address acute overdose of Lelipel (Montelukast) by detailing reported clinical signs and establishing explicit emergency response protocols.

Documented Overdose Manifestations

Reported signs following acute, high-dose exposure, including doses up to 1000 mg, primarily involve the gastrointestinal and central nervous systems:

  • Gastrointestinal: Abdominal pain, Vomiting, and Thirst.
  • Neuropsychiatric: Headache, Sleepiness (somnolence), Psychomotor hyperactivity, Restlessness, and Agitation.

Overdose cases have been specifically documented in both adult and pediatric patients, including children as young as 42 months old.

Required Emergency Actions

The regulatory guidance clearly defines the conditions that mandate seeking immediate medical help:

  • Immediate Emergency Services: Contact emergency services (e.g., 911) if the affected individual has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened.
  • Poison Control: Contacting a poison control helpline is the recommended initial action for guidance.

Supportive Management and Antidote Status

Official labeling states that no specific antidote is known for Montelukast overdose. Consequently, the required treatment for overdose is defined as symptomatic and supportive care. Furthermore, it is officially documented that it is not known if Montelukast is dialyzable by peritoneal or hemodialysis. The lack of a specific antidote and the non-dialyzability status emphasize the reliance on supportive clinical management for overdose events.

Therapeutic Uses of Lelipel

Quick Facts: Lelipel's Approved Uses

  • Primary Indications: Long-term maintenance of Chronic Obstructive Pulmonary Disease (COPD).
  • Asthma: Maintenance treatment of asthma in eligible adult and pediatric patients.
  • Key Function: Supports the reduction of disease exacerbations and assists with improved airflow.
  • Limitation of Use: Not for relief of acute, sudden breathing symptoms.

Lelipel is a therapeutic option approved for the long-term, ongoing management of several chronic respiratory conditions. It is specifically indicated for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD), which encompasses chronic bronchitis and emphysema, in adult patients.

Furthermore, Lelipel is a treatment option for the maintenance of asthma control in patients aged 5 years and older. The medication is used to support improved airflow within the respiratory system and is intended to assist with the reduction of disease exacerbations in individuals with a relevant history. It is a scheduled medication intended to help manage the overall course of the condition and is not indicated for immediate use to relieve sudden breathing difficulties, known as acute bronchospasm.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Lelipel — Official Regulatory Information

Category Official Regulatory Statement
Populations for whom use is allowed Adults and pediatric patients 12 months of age and older for chronic asthma. Patients 6 months of age and older for perennial allergic rhinitis. Older adults (geriatric) show no overall differences in safety or effectiveness compared to younger adults.
Populations for whom use is not recommended Use in children under 12 months for asthma or under 6 months for perennial allergic rhinitis is not established. For allergic rhinitis, use may be reserved for patients who have an inadequate response or intolerance to alternative therapies.
Populations for whom use is contraindicated Patients with known hypersensitivity to Montelukast sodium or any component of the product. The medicine is not indicated for use in the reversal of bronchospasm in acute asthma attacks.
Condition-specific eligibility rules Renal Insufficiency: No dosage adjustment is recommended. Severe Hepatic Impairment: Pharmacokinetics in this population have not been evaluated. Phenylketonuria (PKU): The chewable tablets contain phenylalanine (aspartame).
Pregnancy and lactation eligibility status Use during pregnancy and lactation is conditional and generally only recommended if clearly essential, as it is unknown if it is excreted into human milk.

Eligibility Classifications (High-Level)

Category Official Regulatory Wording
Eligibility severity classification Contraindicated (Hypersensitivity, Acute Asthma); Not Established (Infants); No Dosage Adjustment Necessary (Renal/Mild-to-Moderate Hepatic Impairment)
Eligibility-context constraints Conditional Use (Allergic Rhinitis); Monitoring Required (Neuropsychiatric Risk)

Resulting Eligibility Structure

  • The medicine is contraindicated for all patients with known hypersensitivity or during an acute asthma attack.
  • Eligibility is granted to adults and pediatric patients above certain minimum age thresholds, which vary by indication (e.g., as young as 6 months for some allergic rhinitis uses).
  • Patients with severe hepatic impairment are restricted because clinical data for this population are not evaluated.

The official regulatory documents define who can and cannot use the medicine through specific absolute contraindications and minimum age thresholds. Eligibility is further guided by conditional use requirements for certain populations and explicit confirmation that no dose adjustment is required for renal or mild-to-moderate hepatic impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Lelipel is defined by its metabolic pathway and specific co-administration restrictions documented by regulatory authorities.

Documented Interaction Patterns

Category Officially Documented Finding
Exposure-Altering Medicines Co-administration with potent enzyme inducers, such as Rifampicin, significantly decreases Montelukast plasma concentration (AUC) through the induction of CYP enzymes. Conversely, Gemfibrozil, an inhibitor of CYP2C8, is documented to increase Montelukast plasma concentration.
Pharmacodynamic Restrictions Patients with known aspirin sensitivity are restricted from co-administering this medicine with aspirin or non-steroidal anti-inflammatory agents (NSAIDs). This is a requirement related to the underlying disease state.
Formulation and Timing The film-coated tablet is intended for administration without regard to the timing of food ingestion. For chewable tablets, a high-fat meal reduces the maximum concentration ( C max), but overall exposure (AUC) remains unaffected. If oral granules are mixed with food, the full dose must be administered immediately and cannot be stored.
Prohibited Combinations Co-administration is formally prohibited with any other product that contains the same active ingredient, Montelukast.

Interaction Context

No clinically significant pharmacokinetic interactions have been documented with the co-administration of theophylline, digoxin, warfarin, or oral contraceptives. Studies on pharmacokinetics in patients with severe hepatic impairment or renal insufficiency have not been evaluated in regulatory documents.

Mechanism of Action

How Lelipel Works

Lelipel's active component, montelukast, exerts its pharmacodynamic effects through highly selective, competitive antagonism of the Cysteinyl Leukotriene Receptor CysLT1. This receptor is a key component of the leukotriene signaling pathway, primarily expressed on airway smooth muscle cells, eosinophils, and other inflammatory cells.

By occupying the CysLT1 binding site, Lelipel prevents the action of primary inflammatory ligands, particularly Leukotriene D4 ( LTD4). This molecular block inhibits the downstream signal transduction cascade mediated by CysLT1 activation.

This early-stage molecular modification results in the modulation of the leukotriene signaling pathway across relevant biological systems. The consequence is a predictable adjustment in systemic physiological responsiveness, limiting the effects associated with unregulated leukotriene activity.

Dosage and Administration Information

How to Use Lelipel

Lelipel (Montelukast sodium) is a prescription medicine intended for systemic administration solely through the oral route. It is structured as a long-term, once-daily treatment regimen and is not indicated for the acute management of sudden breathing symptoms. Consistent adherence to the daily schedule is essential for the intended use protocol.


Official Dosing and Administration Schedule

Age Group Standard Daily Dose Dosing Form Dosing Time
Adults and Adolescents (ge 15 years) 10 mg Film-Coated Tablet Once daily, typically in the evening
Pediatric Patients (6 to 14 years) 5 mg Chewable Tablet Once daily, typically in the evening
Pediatric Patients (6 months to 5 years) 4 mg Chewable Tablet or Granules Once daily, typically in the evening

The 10 mg film-coated tablets can be taken with or without food. However, it is specified that the chewable tablets should be taken either 1 hour before or 2 hours after food. When managing both asthma and allergic rhinitis, patients should adhere to the single, daily dose taken in the evening.


Specific Preparation and Handling

The 4 mg oral granules are designed for administration directly into the mouth, or they may be mixed with a spoonful of cold or room-temperature soft food (e.g., applesauce or rice). Crucially, the granules must be administered within 15 minutes of opening the packet to maintain integrity. Chewable tablets must be chewed fully before swallowing.

Lelipel may also be used as a single dose for the prevention of exercise-induced bronchoconstriction, taken at least 2 hours before exercise. If a dose is missed, patients should resume the schedule with the next planned dose; a double dose should not be taken to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Lelipel

Evidence for Use in Chronic Asthma Management

The core evidence base for Lelipel was evaluated in numerous Randomized, Double-Blind, Placebo-Controlled Trials (RCTs). These studies were observed in both adults and pediatric patients (down to one year of age) with persistent asthma. Researchers examined outcomes related to systemic or functional imbalance, such as lung function measurements (like the FEV1 test) and patient-reported symptom scores.

Trials report how symptoms evolved in the observed populations, and trials reported measured lung function as a key outcome when compared to those who received a placebo. Studies also explored its use as an add-on treatment to inhaled steroids, where the use of short-acting rescue inhalers was monitored as an outcome. This evidence contributes to the broader evidence landscape regarding the management of conditions presenting with cycles of stability and flare-ups.

Evidence for Use in Chronic Obstructive Pulmonary Disease (COPD)

Research was evaluated in adults with COPD, a condition marked by functional limitations. This evidence is limited, relying on a smaller number of RCTs and systematic reviews. The studies examined outcomes such as Health-Related Quality of Life (HRQoL) scores and FEV1. The data show patterns related to functional changes in the overall COPD population that were mixed and inconsistent across different studies.

What Remains Uncertain About the Research

Comparative evidence is lacking for certain treatment scenarios, particularly when comparing Lelipel directly against other common controller medications as monotherapy for asthma. Furthermore, due to the chronic nature of the conditions, the long-term effects (over many years) are not fully established through continuous, controlled RCTs. Research provides context but not individual predictions, and findings describing group patterns do not determine whether an individual will respond similarly.

Key Studies & References

  1. Clinical Trials Examining the Effects of Montelukast on Exercise-Induced Bronchoconstriction (EIB)
  2. Systematic Review of Leukotriene Receptor Antagonists in Chronic Obstructive Pulmonary Disease (COPD)

Frequently Asked Questions (FAQ)

Common questions about Lelipel (FAQ)


Q: How quickly is Lelipel expected to start working?

Lelipel is a long-term medicine used for the chronic management of conditions like asthma, not for immediate relief of sudden symptoms. According to official product information, effects on specific measures of lung function are generally evident within one day of beginning treatment. For the chronic management intended, continuous adherence to the prescribed daily schedule is described in official use protocols.


Q: What are the most common reasons a doctor might prescribe Lelipel?

Regulatory documents indicate that Lelipel is primarily approved for two main uses in adults and children over specific ages. These uses are the prophylaxis and chronic treatment of asthma, and the relief of symptoms related to perennial allergic rhinitis. It is also approved for the prevention of symptoms related to exercise-induced bronchoconstriction.


Q: Does Lelipel interact with birth control pills?

Based on official documents, no clinically significant pharmacokinetic interactions have been documented when Lelipel is taken at the same time as oral contraceptives. This indicates that clinically significant interference with oral contraceptives has not been documented in studies.


Q: Are there any specific foods or drinks to avoid when using Lelipel?

Official information states that the film-coated tablets can be taken with or without food. However, for the chewable tablets and oral granules, there are specific instructions related to timing relative to meals to ensure proper administration. While direct drug interaction with alcohol is not cited, consultation with a healthcare provider about all food and drink considerations is part of general prescribing guidelines.


Q: Can Lelipel affect my mood or behavior?

Yes, official regulatory documents, including a U.S. Boxed Warning, highlight the risk of serious neuropsychiatric events. These adverse reactions, reported across all age groups, include changes in mood and behavior such as agitation, aggression, anxiety, depression, insomnia, and suicidal thoughts or behavior. Patients and caregivers are generally advised to monitor for any new or worsening symptoms.


Q: What should I do if the expected benefits of Lelipel don't seem to happen?

Official patient guidance directs that if you have concerns about the medicine's effectiveness or notice any new or worsening symptoms, you should contact your healthcare provider. The healthcare provider is the resource for discussing the current condition and the ongoing treatment plan.


Q: Is it necessary to have regular check-ups or tests while using Lelipel?

Regulatory documents recommend that prescribers and patients should be vigilant and monitor for new or worsening mood and behavior changes during treatment. Given the rare reports of liver injury and systemic eosinophilia, monitoring for these adverse reactions may be included as part of individualized care.


Q: What distinguishes Lelipel from other medicines listed for this use?

Lelipel is classified as a Leukotriene Receptor Antagonist (LTRA). This means its primary function is to selectively block the action of inflammatory substances called cysteinyl leukotrienes in the body's airways. This specific mechanism distinguishes it from other common respiratory medicines, such as inhaled steroids or general bronchodilators.


Q: Is Lelipel safe to use with certain vitamin products?

In general, authoritative patient information often suggests that there may not be enough specific data to confirm the safety of taking herbal remedies and most supplements simultaneously with Lelipel. Official guidance includes informing the healthcare provider about all over-the-counter products, vitamins, and supplements being used.


Q: Can Lelipel impact the results of laboratory blood tests?

Lelipel has been associated with rare postmarketing reports of systemic eosinophilia and vasculitis, which are sometimes consistent with Churg-Strauss syndrome. These conditions involve changes in blood cell counts and other physiological markers that may be detected during routine or specialized laboratory blood testing.


Q: Can women who are pregnant or breastfeeding use Lelipel?

Regulatory documents state that using Lelipel during pregnancy and lactation is considered conditional. Official information indicates that use during pregnancy and lactation is conditional and determined by a clear assessment of potential benefit versus potential risk. It is currently unknown whether the medicine is transferred into human breast milk.


Q: Is Lelipel generally taken long-term or short-term?

Lelipel is a prescription medicine intended for long-term, once-daily treatment for the chronic management of conditions like asthma. However, its use for allergic rhinitis may be short-term or conditional, depending on the patient's response and their previous use of alternative therapies.


Q: Can Lelipel interact with alcohol?

Official documents do not describe a direct pharmacokinetic interaction between Lelipel and alcohol. However, regulatory warnings note that a history of alcohol use is sometimes listed as a potential confounding factor in rare reports of liver injury (hepatotoxicity) associated with the medicine.


Q: Does Lelipel stay in your system for a long time?

Official pharmacokinetic data indicates that the active ingredient is extensively processed by the body’s metabolic system. The mean plasma half-life of Lelipel, which is the time it takes for half of the medicine to be cleared, is approximately 2.7 to 5.5 hours in healthy young adults.


Q: Is it normal to feel [general, non-specific symptom, e.g., tired/lightheaded] when starting Lelipel?

Official documents list drowsiness (sleepiness), headache, and fatigue as adverse reactions reported in clinical trials. Official guidance directs patients to contact a healthcare provider if any new or worsening symptoms are experienced, particularly when beginning a new medication.


Q: Does Lelipel have any known interactions with common over-the-counter pain relievers?

In general, it is often safe to take everyday pain relievers with this medication. However, official warnings state that people with known aspirin sensitivity should continue to strictly avoid aspirin and other non-steroidal anti-inflammatory agents (NSAIDs), as this restriction relates to the underlying disease being treated.


Q: Has Lelipel been studied for use in older adults?

Regulatory documents confirm that clinical studies did not find any overall differences in safety or effectiveness between older adults (geriatric patients) and younger adult patients. For this reason, official prescribing information states that no dosage adjustment is typically recommended for the elderly.


Q: Can people with kidney issues use Lelipel?

According to official regulatory information, no dosage adjustment is recommended for patients who have renal insufficiency (kidney issues). The medicine is primarily cleared from the body through metabolic pathways that do not heavily rely on kidney function.


Q: Are there any specific warnings about driving or operating machinery while taking Lelipel?

Lelipel is generally not expected to impact a patient's ability to drive or operate machinery. However, due to the rare possibility of experiencing side effects such as drowsiness, patients are generally informed that they should be aware of their response to the medication before driving or operating complex machinery.


Q: What is the risk of having an allergic reaction to Lelipel?

A known hypersensitivity to the active ingredient is an absolute contraindication for use. While rare, official documents list hypersensitivity reactions, including anaphylaxis (a severe, immediate allergic reaction), as post-marketing adverse reactions that have been reported.


Q: Is Lelipel considered a first-line treatment option?

Prescribing guidelines for specific conditions can vary. Official warnings and prescribing guidance indicate that the medicine may be reserved for use in patients with specific conditions, such as those who have not responded adequately to or cannot tolerate alternative therapies.


Q: Does Lelipel have any known effect on fertility?

Official data indicates that studies specifically examining the medicine’s effect on the ability to conceive in humans have not been performed. However, non-clinical studies conducted in animals showed no adverse effect on fertility.


Q: Can Lelipel affect my sleep schedule?

Yes, official documents list insomnia (difficulty sleeping) and dream abnormalities (including nightmares) as reported adverse reactions. Additionally, sleep disorders are classified as part of the serious neuropsychiatric risks associated with the medicine.

How should Lelipel be stored and disposed of?

Official Storage and Disposal Requirements

Lelipel (Montelukast sodium) must be stored strictly according to the conditions defined in the official regulatory labeling to ensure product quality and stability.

Storage & Disposal Scope Regulatory Requirements
Labeled Storage Temperature Controlled room temperature: 20 C to 25 C (68 F to 77 F). Excursions are permitted between 15 C and 30 C.
Protection Requirements Protect from moisture and protect from light. Store in the original container or package.
Child-Protection Storage Keep this medicine out of the sight and reach of children.
Disposal Instructions Unused or expired product must not be disposed of via wastewater or household waste. Dispose of waste material in accordance with local requirements.
In-Use Stability (Granules) If Lelipel oral granules are mixed with food or liquid, the dose must be administered within 15 minutes and cannot be stored for later use.

These statements ensure the medication remains stable and guides proper disposal to minimize environmental impact, as directed by official health authorities.

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

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