Lecope M

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Lecope M

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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 Lecope M

Understanding Lecope M

Lecope M is a combination medication primarily used to manage symptoms associated with allergic rhinitis and chronic asthma. It is formulated to address respiratory discomfort caused by environmental triggers, such as pollen, dust mites, or animal dander.

Composition and Mechanism

This medication contains two active ingredients that work through different pathways to alleviate allergic symptoms:

  • Levocetirizine: This component is an antihistamine. It works by blocking the effects of histamine, a natural substance in the body that causes allergic reactions. By inhibiting histamine receptors, it helps reduce symptoms like sneezing, runny nose, and watery eyes.
  • Montelukast: This component is a leukotriene receptor antagonist. It works by blocking leukotrienes, which are chemicals the body releases when an allergen is inhaled. These chemicals cause swelling in the lungs and tightening of the muscles around the airways.

Therapeutic Use

Lecope M is typically utilized for the relief of symptoms including:

  • Persistent sneezing and nasal congestion
  • Itching of the nose or throat
  • Red, itchy, or watery eyes
  • Inflammation of the airways associated with allergic asthma

By combining an antihistamine with a leukotriene modifier, the medication provides a dual approach to managing both the immediate and delayed phases of an allergic response, helping to maintain clearer airways and reduce nasal sensitivity.

What side effects are possible with Lecope M?

Possible side effects and safety information

The safety profile for this medicine is established through clinical trials and post-marketing surveillance, classified by frequency and organ system as documented in official regulatory sources. The most frequently reported adverse reactions, categorized as Common in clinical data, include Somnolence (drowsiness), Fatigue, Dry mouth, and Headache. Upper Respiratory Infection is often classified as a Very Common effect associated with one of the active components.

Safety concerns are primarily grouped by System-Organ-Class (SOC). Notable effects involve the Nervous System (e.g., headache, dizziness) and, critically, Psychiatric Disorders. Officially documented neuropsychiatric events associated with one component include changes in behavior, aggression, agitation, and, rarely, reports of Suicidal thoughts and behavior.

Serious adverse reactions reported in the post-marketing setting also include systemic events such as severe Hypersensitivity reactions, including Anaphylaxis, and the rare occurrence of systemic eosinophilia consistent with Churg-Strauss syndrome.

Regulatory documents highlight specific constraints for certain populations. The medicine is contraindicated in patients with severe renal impairment (creatinine clearance less than 10 mL/min). Caution is advised in patients with risk factors for urinary retention and when used concurrently with CNS depressants or alcohol, due to potential additive effects on alertness. Some neuropsychiatric events have been reported both during treatment and after discontinuation.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documentation for Lecope M, which contains Levocetirizine and Montelukast, advises on specific clinical manifestations and mandated emergency actions. Suspected overdosage requires immediately contacting a Poison Control Center or seeking emergency medical attention.

Overdose data is primarily derived from the individual components, as there is no specific data documented for the combination. Symptoms of Montelukast overdosage may include abdominal pain, headache, vomiting, somnolence, thirst, and psychomotor hyperactivity. The Levocetirizine component is documented to cause drowsiness in adults. In children, Levocetirizine overdose may present with initial agitation and restlessness before progressing to drowsiness.

Management is centered on symptomatic or supportive treatment, as no specific antidote is known for the Levocetirizine component. Furthermore, official labeling indicates the Levocetirizine component is not effectively removed by dialysis, and it is not known whether the Montelukast component is removed by hemodialysis. These constraints underscore the mandatory requirement for urgent medical oversight in any overdose scenario.

Therapeutic Uses of Lecope M

What Lecope M Treats: Main Uses and Benefits

Lecope M may be part of symptomatic management, applied across domains where additional symptomatic support is needed for symptoms related to inflammatory or irritative states. The combination of ingredients is commonly used to help with the relief of symptoms associated with allergic rhinitis and chronic idiopathic urticaria. The combination of ingredients is commonly used in contexts involving heightened systemic burden due to allergic responses.

The medication is relevant for easing symptoms linked to conditions characterized by periods of heightened symptoms, such as sneezing, a runny or stuffed nose, itchy eyes, and persistent skin itching and swelling. Applied in scenarios where additional management of discomfort is required, it supports the patient during difficult episodes by easing distress.

“In general, this medication is applied across domains where additional symptomatic support is needed for conditions presenting with acute episodes.”

Quick Fact: Applied in addressing symptoms that become more disruptive during flare-ups.

This medication is relevant for managing symptoms that interfere with daily comfort, offering symptomatic relief that may help patients cope more steadily with symptom fluctuations. The primary benefit supports general well-being during symptomatic phases.

Regulatory References

  1. U.S. National Library of Medicine MedlinePlus

Eligibility and Restrictions for Use

Lecope M eligibility is strictly defined by regulatory documents, which establish specific age, condition, and physiological restrictions for use.

Populations Who Must Not Use (Contraindicated)

Use of Lecope M is contraindicated and must be avoided in the following groups, as stated in official labeling:

  • Patients with known hypersensitivity to the active ingredients (Levocetirizine or Montelukast), or the parent compound Cetirizine.
  • Patients with severe renal impairment defined by a creatinine clearance of less than 10 mL/min.
  • Individuals with rare hereditary problems such as Lapp lactase deficiency or galactose malabsorption.

Age and Condition Restrictions

The medicine is officially approved for adults and adolescents aged 15 years and older.

Population Group Regulatory Status Restriction Basis
Pediatric (Under 15) Not Recommended Safety and efficacy are not established for the fixed-dose tablet.
Pregnancy/Lactation Not Recommended Lack of adequate studies; Levocetirizine excretion in human milk.
Impaired Renal Function Restricted Use Requires individualized dosage adjustment (unless severe, which is contraindicated).
Risk of Urinary Retention/Epilepsy Use with Caution Requires caution due to effects of the Levocetirizine component.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Lecope M, which combines Levocetirizine and Montelukast, is structured by regulatory-documented constraints concerning metabolism, pharmacodynamic effects, and clearance.

Pharmacokinetic and Exposure Interactions

Category Official Regulatory Documentation Statement
Interacting Medicines Rifampicin, Gemfibrozil, Theophylline, Ritonavir
Enzyme Modulation Montelukast is primarily metabolized by CYP 3A4, 2C8, and 2C9 enzymes.
Exposure Impact Co-administration with strong CYP inducers like Rifampicin results in a significant decrease in Montelukast exposure (AUC). Conversely, the CYP2C8 inhibitor Gemfibrozil causes a substantial increase in Montelukast exposure. The clearance of the Levocetirizine component can be altered by medicines like Theophylline and Ritonavir.
Food Interaction Food does not change the total extent of Levocetirizine absorption (AUC), but it may decrease the rate of absorption.

Pharmacodynamic and Clearance Restrictions

Classification Official Regulatory Documentation Statement
Pharmacodynamic Risk Concurrent use of alcohol or other Central Nervous System (CNS) depressants may cause an additive reduction in mental alertness and performance.
Contraindicated Combination The combination product is contraindicated in patients with severe renal impairment (creatinine clearance < 10 mL/min) or those on hemodialysis.
Population Note Patients with hepatic insufficiency (e.g., cirrhosis) show decreased metabolism of Montelukast.

This structure defines the risk profile, highlighting major pharmacokinetic shifts caused by CYP enzyme modulation and emphasizing the restriction against co-administration with substances that reinforce CNS depression. The regulatory label also specifies severe renal impairment as a formal restriction due to the clearance pathway of the Levocetirizine component.

Mechanism of Action

Dual Inhibition of Inflammatory Mediators

The action of the drug is defined by two distinct pharmacological mechanisms that simultaneously engage pathways associated with acute and chronic inflammatory responses. Levocetirizine acts as an antagonist of the peripheral Histamine mathbfH1 receptor, blocking the effects of histamine—a key mediator of immediate physiological responses. In parallel, Montelukast works by selectively inhibiting the Cysteinyl Leukotriene Receptor 1 (mathbfCysLT1), thereby preventing pro-inflammatory leukotrienes (LTC4, LTD4, LTE4) from activating their target. This complementary dual-pathway blockade results in a broader engagement across the physiological cascade.


Mechanisms for Physiological Modulation

The specific blockade of the mathbfH1 receptor initiates a mechanism that restricts the ability of histamine to increase vascular permeability and stimulate sensory nerves, resulting in the modulation of microvascular dynamics and the suppression of sensory nerve signaling. The mathbfCysLT1 antagonism inhibits the signaling that leads to the contraction of airway smooth muscles and the sustained accumulation of fluid (edema) in the respiratory tract. These actions modulate the underlying systems responsible for both rapid-onset physiological effects and chronic inflammatory changes, contributing to the adjustment of activity within targeted physiological pathways. This dual molecular targeting results in a broader modulation across the spectrum of inflammatory physiological changes, which defines the resulting physiological effect profile.

Dosage and Administration Information

How to Use Lecope M: Official Administration Guidelines

Lecope M is a fixed-dose combination tablet administered according to specific guidelines to ensure appropriate use. All instructions regarding dosage, frequency, and administration conditions are derived strictly from prescribing information.

Standard Dosing and Schedule

Key Instruction Standard Guidance
Route of Administration For oral use only (taken by mouth).
Standard Dose One tablet (10 mg Montelukast / 5 mg Levocetirizine) once daily.
Dosing Frequency Once daily (every 24 hours).
Timing Generally advised to be taken in the evening or at bedtime.
Food Intake May be taken with or without food (without regard to meals).

Administration Requirements

The tablet must be swallowed whole with a liquid. The tablet should not be chewed, crushed, or broken, as this is essential for maintaining the intended release of the active ingredients. The maximum dose is strictly one tablet per day.

Special Procedural Rules

If a dose is missed, guidance instructs the patient to skip the missed dose and continue the regular schedule with the next dose; do not take a double dose to compensate. As a treatment intended for continuous relief, the medication is prescribed for maintenance therapy over time and should not be stopped abruptly unless directed by a healthcare provider.

Population-Specific Use

Specific adjustments are specified for certain patient groups. The 10 mg/5 mg fixed-dose tablet is not recommended for children under 15 years of age. Furthermore, patients with moderate to severe renal impairment must have their dosing interval adjusted, based on the clearance rate of the Levocetirizine component.

Recent Clinical Evidence

Lecope M: Recent Clinical Evidence

This overview provides a descriptive summary of the clinical research structure for the fixed-dose combination of Levocetirizine and Montelukast (Lecope M), detailing the types of studies conducted and the specific patient outcomes that were measured. This context is strictly descriptive and does not offer clinical advice, interpretation of results, or recommendations for use.


Evidence for Use in Allergic Rhinitis (Seasonal and Perennial)

Research exploring this combination has involved short-term Randomized Controlled Trials (RCTs) and systematic reviews. The trials were primarily used in research examining conditions characterized by fluctuating or episodic manifestations like allergic rhinitis. In these studies, researchers monitored patient-reported outcomes describing perceived discomfort and functional imbalance. This included specifically looking at total symptom scores for the nose and eyes, and applying studies examining patient-reported experiences using Quality-of-Life (QoL) scales to measure changes in symptoms. Studies reported measurements of various symptom scores in populations including both adults and children, and these findings describe group patterns.


Research in Comorbid Conditions: Rhinitis and Mild-to-Moderate Asthma

Research also examined patients experiencing allergic rhinitis concurrent with confirmed mild-to-moderate asthma, conditions involving periods of heightened symptom activity. Beyond assessing nasal symptoms, these trials monitored physiological strain, such as standard lung function tests (like FEV1), and overall asthma control scores. The evidence base for this specific use is limited in volume. Studies reported measurements of both nasal scores and lung function tests during the defined intervals, but the overall research base is less extensive than for allergic rhinitis alone.

How should Lecope M be stored and disposed of?

How to Store and Dispose of Lecope M

Lecope M (levocetirizine/montelukast) must be stored under specific environmental constraints to maintain product stability and integrity, as required by official regulatory labeling.

Storage Requirements

Condition Regulatory Requirement
Temperature Store below 25 C or 30 C; do not freeze.
Protection Keep in the original package to protect from light and moisture.
Safety Store out of the sight and reach of children.

Handling and Disposal

The product should be used only until the expiration date (EXP) printed on the package. Disposal of unused or expired medicine must be executed in accordance with local requirements.

Regulatory instructions state that medicines should not be disposed of via waste water or household waste as a primary option. Consult a pharmacist or local authority for proper guidance on pharmaceutical waste management.

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

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