Алерон

Quick links to important sections

Алерон

Selected form

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 Алерон

What is Алерон? (Levocetirizine)

The following overview defines the nature, classification, and general purpose of the medication Алерон, which contains the active substance Levocetirizine.


Quick Facts

Property Description
Active Ingredient Levocetirizine (Dihydrochloride)
Pharmacological Class Second-Generation H1-Antihistamine
Forms Film-coated tablets, oral solution, drops
Origin Synthetic (Pure R-enantiomer, chiral switch)
Common Use Counteracting allergic reactions

Composition, Origin, and Brand Differentiation

Алерон is a pharmaceutical preparation intended for systemic use, containing Levocetirizine as its sole active ingredient. This medication is a synthetic compound derived from the older, racemic antihistamine, Cetirizine. It results from a chemical refinement known as a chiral switch, meaning it contains only the pure R-enantiomer, the specific molecular configuration responsible for the primary therapeutic action.

As a single-component product, Алерон is administered orally and offers different dosage forms—including film-coated tablets and a liquid oral solution—to suit various patient groups, such as adults and the pediatric population. The brand positioning focuses on providing targeted, consistent relief.


Pharmacological Class and General Purpose

Алерон is classified as a second-generation H1-antihistamine, a modern class of drug designed for allergic symptom relief. Its mechanism involves acting as a peripheral H1-receptor antagonist. This classification is clinically recognized, indicating the drug is engineered to have minimal penetration into the central nervous system, thereby focusing its therapeutic effect on the peripheral allergic pathways in the body.

The general purpose of the drug is to intervene in the body's acute response to allergens. By blocking the activity of the histamine H1-receptors, Levocetirizine helps prevent the development of common physical manifestations of allergic conditions. This function provides consistent interference with the chemical signals that trigger symptoms, such as those that occur during seasonal allergic rhinitis.

What side effects are possible with Алерон?

Possible Side Effects and Safety Information

The safety profile of Aleрон (Levocetirizine) is officially documented by regulatory agencies, detailing adverse reactions by system-organ class and frequency. The most common side effects observed in clinical trials, classified as Common (affecting ge 1/100 to <1/10 patients), typically involve the nervous system and general disorders. These include somnolence (drowsiness), fatigue, and headache. Gastrointestinal effects such as dry mouth are also commonly reported.

Reactions categorized as Uncommon (affecting ge 1/1,000 to <1/100 patients) include asthenia and abdominal pain. A wide range of other effects, encompassing psychiatric, cardiac, and hepatobiliary disorders, are reported in post-marketing surveillance and classified with a Not Known frequency.

Serious Adverse Reactions and Safety Constraints

The prescribing information highlights specific safety considerations. Post-marketing reports include rare but serious adverse reactions, such as severe hypersensitivity (including anaphylaxis), convulsion, and urinary retention. Caution is advised regarding concurrent use with alcohol or other Central Nervous System (CNS) depressants due to the potential for increased impairment of alertness.

Safety notes specify that somnolence has been documented to be dose-dependent. Furthermore, the safety profile notes a risk of severe pruritus (itching) upon the discontinuation of long-term daily use of the medication.

Population-Specific Notes

The medication is substantially excreted by the kidneys, necessitating specific safety constraints. It is contraindicated in individuals with end-stage renal disease (Creatinine Clearance <10 mL/min) or those on hemodialysis. Dose adjustment is explicitly required for patients with any degree of renal impairment. Caution is also advised for geriatric patients due to the high probability of age-related decrease in renal function.

Overdose and Emergency Response

Overdose and When to Seek Help

The official overdose profile for Levocetirizine (the active ingredient in Алерон) is based on effects primarily observed in the Central Nervous System (CNS) following ingestion of doses at least five times the maximum recommended daily amount.


Documented Overdose Manifestations

Overdose presentations are age-dependent, as detailed in regulatory documents:

  • Adults: The predominant symptom is drowsiness (somnolence).
  • Children: Overdose symptoms typically begin with signs of CNS stimulation, including excitation and restlessness, which may be followed by drowsiness.

Other adverse effects documented in overdose cases include confusion, dizziness, fatigue, headache, tachycardia (rapid heart rate), stupor, and urinary retention. Severe manifestations, such as stupor and significant tachycardia, warrant urgent attention.


Emergency Actions and Management

Regulatory authorities explicitly mandate that if an overdose is suspected or has occurred, the individual must seek immediate medical attention or contact a certified Poison Control Center immediately.

  • Supportive Care: The treatment is symptomatic and supportive, as there is no known specific antidote for levocetirizine. Healthcare professionals may consider procedures like gastric lavage following recent ingestion.
  • Monitoring: The drug is not effectively removed by dialysis. Monitoring for severe CNS or cardiovascular effects is implicit in the requirement for symptomatic and supportive care.

Therapeutic Uses of Алерон

What Алерон treats: Main Uses and Benefits

Алерон is applied across domains where additional symptomatic support is needed for allergic conditions. It is commonly used to help manage symptoms related to allergic rhinoconjunctivitis (both seasonal and perennial) and chronic urticaria (long-term hives). This medication is relevant for easing discomfort when symptoms cluster into patterns requiring supportive management.

Symptom Relief and Stability

This medication is often used during phases when symptoms become more noticeable, helping to address the physical discomfort of allergic reactions. The therapeutic benefit supports the patient during difficult episodes by easing the distressing manifestations of upper respiratory symptoms, such as persistent sneezing, rhinorrhea (runny nose), and nasal pruritus, as well as associated ocular symptoms (itchy, watery eyes). Furthermore, it is applied in clinical settings that involve episodic or fluctuating manifestations on the skin, notably pruritus (severe itching) and the presence of wheals.

“This medication is applied in scenarios where additional management of discomfort is required, helping patients cope more steadily with difficult episodes.”

By assisting with maintaining functional stability and supporting general well-being during symptomatic phases, Алерон helps manage recurrent or episodic manifestations like perennial allergic rhinitis.

Primary Therapeutic Focus
Symptom Easing Pruritus (Itching) in the skin, nose, and eyes
Conditions Seasonal/Perennial Allergic Rhinitis, Chronic Urticaria
Benefit Supports stability during symptomatic periods

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Official Eligibility Profile

The eligibility for using Алерон (Levocetirizine) is strictly governed by regulatory criteria focusing on age, organ function, and pre-existing conditions.

Contraindicated Populations (Must NOT Use) Condition-Based Restrictions
Known hypersensitivity to levocetirizine, cetirizine, or any piperazine derivative. Moderate to severe renal impairment (dose adjustment required).
End-Stage Renal Disease ( CLcr < 10 mL/min) or hemodialysis. Predisposing factors for urinary retention (use with caution).
Pediatric patients aged 6 months to 11 years with any degree of renal impairment. Patients with solely hepatic impairment typically require no dose change.

Age-Related Eligibility

The medicine is generally approved for adults and adolescents ge 12 years. Pediatric use is established for children ge 6 months (with appropriate formulations), but the 5 mg tablet formulation is not recommended for children under 6 years due to the inability to accurately adjust the dose. Safety and effectiveness have not been established for infants under 6 months of age.

Pregnancy and Lactation Status

Use during pregnancy should be considered only if clearly needed, based on available data. Use is generally not recommended for breastfeeding women due to the likelihood of levocetirizine being excreted in human milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Алерон (Levocetirizine) primarily through pharmacodynamic risk and constraints related to the drug’s renal clearance.


Interaction Scope

Category Official Regulatory Statement
Medicinal product categories with documented interactions Central Nervous System (CNS) Depressants (including alcohol/ethanol).
Specific interacting medicines (if explicitly listed) Ritonavir, Theophylline (data derived from the racemate, Cetirizine).
Mechanistic basis of interactions (only if stated in label) Pharmacokinetic exposure modification (reduced clearance resulting in increased plasma levels of antihistamine); Pharmacodynamic additive effects (CNS impairment).
Timing-based interaction rules (if applicable) Food may be co-administered; the interaction is limited to a decreased rate of absorption without affecting the extent of exposure ( AUC).
Population-specific interaction notes (if applicable) End-Stage Renal Disease ( CrCl < 10 mL/min) and Pediatric Renal Impairment are contraindicated due to renal clearance restrictions.
Interaction-related restrictions Concurrent use with alcohol or other CNS depressants is avoided (due to additive impairment risk).

Official Interaction Statements

  • Co-administration with alcohol or other CNS depressants is officially documented to carry the risk of additional reduction in alertness and impairment of CNS performance.
  • The use is contraindicated in patients with end-stage renal disease due to the drug's heavy reliance on renal excretion.
  • Ritonavir co-administration is associated with an approximate 40% increase in the extent of antihistamine exposure ( AUC), which is a documented pharmacokinetic interaction.
  • Theophylline (400 mg once daily) co-administration is officially noted to cause a 16% decrease in antihistamine clearance.
  • Levocetirizine is officially stated not to inhibit or induce major CYP isoenzymes at therapeutic concentrations, suggesting a low potential for metabolic drug-drug interactions.

Connection to the overall interaction profile: Government regulatory documents define the product’s interaction structure primarily through the risk of additive CNS impairment and the constraints imposed by its renal clearance pathway. The official profile highlights specific exposure-modifying effects from Ritonavir and Theophylline, which are detailed as pharmacokinetic outcomes, while confirming that the drug has low potential for involvement in CYP-mediated interactions.

Mechanism of Action

How Алерон Works

The action of Алерон (Levocetirizine) is based on a selective pharmacodynamic process that interrupts the body’s acute chemical signaling cascade.


Antagonism of the Histamine H1 Receptor

The drug’s primary mechanism is the high-affinity, selective inverse agonism at the Histamine H1 receptor ( H1 R), found on cells of the vasculature, smooth muscle, and sensory nerves. This action rapidly blocks the binding of the inflammatory messenger histamine, interrupting the signaling cascade that would otherwise increase vascular permeability and activate nerve endings, which results in rapid cessation of H1 R-mediated signal transduction.

Modulation of Vascular Permeability and Sensory Nerve Signaling

By stabilizing the H1 R in its inactive state, the drug limits the key cellular event—the widening of gaps between vascular endothelial cells—that causes fluid to leak into tissues. Simultaneously, the blockade of H1 R on peripheral sensory neurons directly suppresses the transmission of signals on these neurons. This dual effect on fluid balance and neural excitation modulates the physiological response driven by histamine.

Secondary Anti-inflammatory Modulation

Beyond simple receptor blockade, Levocetirizine contributes to the regulation of the inflammatory process through an independent action that restricts the movement of key immune cells. By limiting the chemotaxis and adhesion of eosinophils, the drug engages mechanisms that restrict the movement of these cells and the release of their secondary mediators.

Dosage and Administration Information

Official Administration Guidelines for Levocetirizine

The following instructions describe the use of levocetirizine, the active ingredient in Алерон.

Administration Scope

The approved route of administration is oral (by mouth). Levocetirizine is a once-daily medication that should be taken in the evening for optimal scheduling. The dose may be taken with or without food.

Standard Labeled Dosing and Preparation

Age Group Standard Recommended Daily Dose Form Consideration
Adults and Children 12 Years and Older 5 mg once daily. (2.5 mg may be sufficient for some patients.) Available as a 5 mg scored tablet or oral solution.
Children 6 to 11 Years 2.5 mg once daily. Tablet may be broken (scored) to achieve the 2.5 mg dose.
Children 6 Months to 5 Years 1.25 mg (2.5 mL oral solution) once daily. Oral solution must be measured accurately with a suitable device.

Dose Limits: The maximum recommended dose of 5 mg for adults and 2.5 mg for children aged 6 to 11 years should not be exceeded.

Missed Dose: If a dose is missed, it should be skipped, and the patient should return to the regular evening dosing schedule. A double dose should not be taken to make up for the missed one.

Population-Specific Dose Adjustments

Renal Impairment: For adults and children 12 years and older with reduced kidney function, the dose and frequency must be adjusted based on creatinine clearance (CLCR). For example, patients with mild impairment (CLCR = 50-80 mL/min) should take 2.5 mg once daily, while those with moderate impairment (CLCR = 30-50 mL/min) are recommended 2.5 mg once every other day. Use of the drug is contraindicated in patients with end-stage renal disease (CLCR < 10 mL/min) and in children 6 months to 11 years with any degree of renal impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Алерон (Levocetirizine)

The body of research for Алерон (Levocetirizine) includes Randomized Controlled Trials (RCTs) and scientific syntheses published in peer-reviewed literature. These studies explore how symptoms change over time and are relevant in evidence describing how symptoms are measured for specific allergic conditions.


Evidence for Use in Conditions Marked by Allergic Rhinitis

Research on Levocetirizine for allergic rhinitis (both seasonal and perennial) centers on short-term and longer-term RCTs, which research examined in adult and pediatric populations. These trials were primarily conducted during periods of increased symptom activity and utilized a non-active comparator group.

The studies focused on outcomes related to physical discomfort and outcomes reflecting daily functioning or activity level. In these trials, findings describe patterns observed in the studies where participants experienced measured changes in symptom severity compared to those in the non-active group.


Evidence for Use in Conditions Associated with Chronic Urticaria

Aléron was studied for chronic urticaria, which is a condition characterized by fluctuating or episodic manifestations on the skin. The evidence mainly comes from 4- to 6-week placebo-controlled RCTs that included adults and children.

These studies focused on outcomes capturing phases of heightened symptom activity, primarily measuring the intensity of pruritus (itching) and monitoring the size and number of visible wheals. The trials reported that, in the studied populations, research explored core symptom scores for itching and hives and observed data show patterns related to those taking Levocetirizine.


Evidence in Specific Populations and Uncertainty

Aléron was evaluated in specific age groups, particularly the pediatric population. However, data for certain groups remain insufficient or varied; for instance, evidence for the tablet formulation in children under 6 years is less comprehensive than for liquid forms. While studies up to six months exist, limited information for long-term outcomes beyond that period is available. The results apply only to the populations studied, meaning the patterns observed may not reflect outcomes in individuals with unstudied comorbidities.

Key Studies & References

  1. Levocetirizine Dihydrochloride (Oral Route) - MedlinePlus Overview
  2. Public Assessment Report - Levocetirizine Dihydrochloride (Assessment of Pediatric Evidence)

Frequently Asked Questions (FAQ)

Common questions about Алерон (FAQ)

Q: Is Алерон the same kind of medicine as other allergy drugs?

A: According to official product information, Алерон is classified as a second-generation H1-antihistamine. This modern class of medicine is intended for the relief of symptoms associated with allergic conditions. This classification indicates that its primary action is focused on the body's peripheral allergic responses.

Q: Why do people sometimes use Алерон for conditions that aren't typical allergies?

A: Official regulatory documents define the approved uses for this medicine. It is indicated for the relief of symptoms associated with typical allergic rhinitis (seasonal and perennial). It is also officially indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (hives).

Q: How quickly should someone expect Алерон to start working?

A: Studies and official information indicate that the onset of symptom improvement typically begins within the first two hours after the medicine is taken. The medicine is labeled for once-daily use, which suggests the intended duration of effect.

Q: How long does the effect of one dose of Алерон typically last?

A: The official administration guidelines describe the medicine as a once-daily treatment. This suggests that the intended duration of action for a single dose is approximately 24 hours.

Q: Can Алерон cause drowsiness, and if so, how common is it?

A: Drowsiness, also known as somnolence, is a commonly reported side effect. Official data from controlled clinical trials indicates that this effect was observed in approximately 5.2% of adult patients at the recommended dose.

Q: Is it known if Алерон can affect mental clarity or concentration?

A: Official warnings advise that the drug may cause somnolence and impairment of performance. Official warnings state that caution should be exercised regarding activities requiring mental alertness, such as driving or operating heavy machinery.

Q: Do experts suggest any specific time of day is best for taking Алерон?

A: Official administration guidelines simply state that the drug should be taken once daily in the evening. The official dosing schedule aligns with the drug’s pharmacological profile.

Q: What happens if I forget a dose of Алерон?

A: Official guidelines indicate that if a dose is missed, it is advised that it be skipped, and the person should return to their regular evening schedule. Documents state that taking a double dose to make up for the missed one should be avoided.

Q: Does Алерон interact with common pain relievers like ibuprofen?

A: Official documents suggest a low potential for metabolic drug-drug interactions. Levocetirizine is unlikely to cause pharmacokinetic interactions by affecting major liver drug-metabolizing enzymes, which are often involved in how the body processes common pain relievers.

Q: Can Алерон be used alongside cold and flu remedies?

A: Regulatory information warns that the co-administration of this medicine with other Central Nervous System (CNS) depressants may result in an additional reduction in alertness and impairment of performance. This warning is based on the risk of additive effects.

Q: What are the most commonly reported side effects of Алерон in studies?

A: The most common side effects reported in clinical studies include somnolence (drowsiness), fatigue, dry mouth, and headache. These effects are classified as Common in official safety documents.

Q: What are the general population limitations for using Алерон?

A: The drug is officially contraindicated in individuals with known hypersensitivity to levocetirizine or its components. It is also contraindicated in patients with end-stage renal disease, which is defined as a Creatinine Clearance below 10 mL/min.

Q: Can Алерон be used for treating hives or skin rashes?

A: Yes, the official indications for the drug include the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria. This use is detailed in official regulatory documents.

Q: Is it okay to take Алерон if I also take a multivitamin?

A: Official data indicates the drug is unlikely to interact with other medicines by affecting major liver drug-metabolizing enzymes. This suggests a low potential for interaction with standard, non-medicinal components found in multivitamins.

Q: Are there reports of long-term use concerns with Алерон?

A: Official safety warnings have been issued regarding the risk of severe itching, known as pruritus, upon discontinuation. This has been reported rarely in patients who stop taking the drug after long-term, daily use, typically spanning months to years.

Q: What is known about the use of Алерон in pregnant or breastfeeding populations?

A: Official prescribing information indicates that use during pregnancy should be considered only if clearly needed. For women who are breastfeeding, the medicine is generally not recommended due to the likelihood of it being excreted in human milk.

Q: Do studies suggest any specific groups of people respond better to Алерон?

A: Clinical trials for the medicine included diverse study populations, such as adults and children, with specific conditions. However, official regulatory documents do not draw conclusions about specific groups responding 'better' than others.

How should Алерон be stored and disposed of?

How to Store and Dispose of Алерон (Levocetirizine)

Official regulatory information details specific requirements for the storage, handling, and disposal of levocetirizine products to maintain stability and ensure safety.

Storage Requirements

Storage conditions can vary by formulation. Some levocetirizine products are required to be stored below 30 C in a dry place and be protected from light.

Specific film-coated tablet formulations may not require special storage conditions, provided they remain in their original packaging. All forms must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired medicinal product and waste material must be disposed of in accordance with local requirements. Official labeling mandates that disposal procedures should comply with environmental guidelines for pharmaceutical waste, which generally prohibits flushing the medicine down a toilet or discarding it in household trash.

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

Available in countries:

Equivalent of Алерон found in:

A-Z Index: