Allergone

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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 Allergone

Quick Facts

Property Description
Active ingredient Levocetirizine
Form Oral Tablet
Pharmacological class Antihistamine
Common use General allergy symptom relief
Origin Second-generation compound

What Type of Medicine is Allergone?

Allergone is the brand name for a medication whose active ingredient is levocetirizine dihydrochloride, which is recognized as a non-sedating, second-generation antihistamine. This class of medicine is a standard choice for general allergy management.

Levocetirizine is a targeted compound, differentiating itself from older first-generation medications by showing a low potential for causing drowsiness. This feature is relevant for those requiring relief without impairing cognitive performance. The product is frequently positioned as an option for relief from unexpected allergic triggers. Levocetirizine is characterized by its potency and selectivity for the histamine H1 receptor.

Allergone Composition and General Purpose

Allergone is designed as a single-ingredient product, containing only levocetirizine, and is administered as an oral tablet taken by mouth. This standardized form allows for systemic absorption to address allergy symptoms throughout the body, contrasting with topical treatments.

The general therapeutic purpose of Allergone is to provide relief from the physical symptoms caused by various allergic triggers. For example, it is used to ease the discomfort associated with seasonal hay fever, such as persistent sneezing, itchy eyes, and a runny nose. The medication is used to alleviate both nasal and non-nasal symptoms associated with allergic conditions.

What side effects are possible with Allergone?

Possible Side Effects and Safety Information

Allergone, as a product used for allergen-specific immunotherapy (SIT), has a safety profile characterized by adverse reactions that are common to this class of treatment. These reactions stem from the intentional, controlled exposure to the allergen.

Key Adverse Reactions and Classification

The most frequently observed adverse reactions are classified as Very Common or Common and are typically related to the site of administration, such as local swelling, redness, and itching. These local reactions are generally mild to moderate in severity and often transient.

Adverse reactions may be categorized by the system organ classes involved, primarily affecting Immune system disorders, Skin and subcutaneous tissue disorders, and the Respiratory system.

Serious and Clinically Significant Risks

Regulatory documentation highlights the most critical safety risk associated with specific immunotherapy: the occurrence of anaphylactic reactions. Anaphylaxis is a severe, systemic, and potentially life-threatening allergic reaction. All products of this type require specific risk management to address this potential.

Systemic reactions may also include generalized symptoms such as widespread rash (urticaria), facial or throat swelling (angioedema), or severe asthma symptoms, and are generally associated with the dose administered, particularly during the initial dose-escalation phase.

Safety Considerations and Limitations

The use of specific immunotherapy products requires careful patient selection, ensuring that individuals are well-characterized regarding their specific allergen sensitization profile. The safety of this treatment is continually monitored, with dedicated studies often necessary for particular groups, such as the paediatric population, where long-term safety data remains a focus of regulatory assessment.

Overdose and Emergency Response

The official regulatory profile for Allergone (levocetirizine) overdose strictly outlines specific clinical signs and mandates immediate emergency action based on symptom severity.

Documented Clinical Presentation

Overdose manifestations are documented to be age-dependent. In adults, the primary clinical sign of acute overdosage is drowsiness (somnolence), reflecting a significant CNS effect. The presentation in children is distinct, often involving an initial period of agitation and restlessness before the subsequent onset of drowsiness.

Required Emergency Actions

Regulatory guidance requires contacting a Poison Control helpline immediately upon suspected acute overdose exposure. Urgent medical attention must be sought by immediately calling emergency services (911 or local equivalent) if the individual exhibits severe symptoms. These severe conditions explicitly documented include collapse, seizure, difficulty breathing, or the inability to be awakened.

Management and Constraints

Clinical management of an overdose is centered entirely on symptomatic and supportive treatment. The regulatory profile emphasizes that no specific antidote is known for levocetirizine. Moreover, the active substance is not effectively removed by dialysis in an overdose setting, underscoring the necessity of hospital monitoring when severe clinical manifestations are present.

Therapeutic Uses of Allergone

What Allergone Treats: Main Uses and Benefits

Allergone (levocetirizine) is commonly used across therapeutic domains where additional symptomatic support is needed, addressing conditions characterized by heightened symptoms that can interfere with functional stability. The medication is utilized in situations where patients experience these conditions.

The medication is considered relevant for managing symptoms associated with seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), and uncomplicated chronic idiopathic urticaria (CIU). It is applied to ease challenging symptom clusters like profuse sneezing, a bothersome runny nose, itching of the nose and eyes, and widespread pruritus (itching) of the skin. It is often used during phases when symptoms become more noticeable, particularly for long-term symptom management.

“It offers symptomatic relief that helps patients cope more steadily, providing support that helps ease the overall symptom burden.”

This medication is commonly used when symptoms intensify and supportive relief is needed, supporting patients during difficult episodes by easing distress. This is achieved with a low potential for causing drowsiness, assisting with maintaining functional stability during routine activities.


Therapeutic Focus: Symptom Domains

Property Description
Primary Focus Symptom management in Allergic Rhinitis and Chronic Urticaria.
Sustained Symptom Support Achieved with a low potential for causing drowsiness.
Symptoms Managed Runny nose, sneezing, itchy eyes, and generalized itching (pruritus).
Use Scenario Applied in situations requiring additional management of discomfort during recurrent episodes.

Eligibility and Restrictions for Use

Who Can and Cannot Use Allergone (Levocetirizine)

This section outlines the population eligibility rules for Allergone, based strictly on official regulatory documentation.


Absolute Non-Eligibility (Contraindications)

Allergone is contraindicated and must not be used in specific patient groups:

  • Patients with known hypersensitivity to levocetirizine, cetirizine, or any other piperazine derivatives.
  • Individuals with End-Stage Renal Disease (Creatinine Clearance less than 10 mL/min) or those undergoing hemodialysis.
  • Children aged 6 to 11 years with impaired renal function.

Age and Formulation Eligibility

  • The oral tablet formulation is approved for use in adults and adolescents 12 years and older, and in children 6 to 11 years of age.
  • The tablet is not recommended for children under 6 years, as it does not allow for appropriate dose adjustment. Safety has not been established in infants under 6 months of age.

Conditional and Restricted Use

Population/Condition Eligibility Status
Renal Impairment (10 –80 mL/min) Use is permitted, but is restricted and requires dose individualization based on the degree of impairment.
Hepatic Impairment (Solely) No dose adjustment is required.
Pregnancy/Lactation Use in pregnancy is conditional; use while breastfeeding is generally not recommended.
Urinary Retention Risk Requires caution for patients with predisposing factors (e.g., prostatic hyperplasia).

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

This section details officially documented interactions for Allergone (a combination of Montelukast and Levocetirizine), based strictly on regulatory health authority information.

Clinically Significant Interactions

Interacting Product Category Effect / Constraint Constraint Type
Alcohol / CNS Depressants Levocetirizine may cause an additive reduction in alertness and performance when co-administered. Restriction
CYP2C8 Inhibitors (e.g., Gemfibrozil) May increase the systemic exposure (AUC) of Montelukast, though dosage adjustment is generally not required. Monitoring
Allergy Skin Tests Levocetirizine may interfere with results; discontinuation is required prior to testing. Procedural

Population and Condition-Specific Considerations

Patients with severe renal impairment (creatinine clearance less than 10 mL/min) are at risk of significantly increased Levocetirizine exposure and should not take this medication. Furthermore, the label stipulates that Montelukast must not be abruptly substituted for inhaled or oral corticosteroids.

Food and General Product Interactions

Taking Levocetirizine with food does not alter the overall extent of absorption, but it may delay and reduce the peak concentration. Patients with known aspirin sensitivity should continue to avoid aspirin or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) while taking Montelukast.

Mechanism of Action

How Allergone Works

Allergone’s mechanism of action modulates the activity of house dust mite (HDM) allergens through two distinct physicochemical pathways, primarily operating on environmental surfaces to control allergen bioavailability. The first pathway, Allergen Neutralization, utilizes active ingredients delivered within a core of microcapsules. These substances chemically modify the structure of the HDM allergen particles. This alteration reduces the particle's capacity to bind to and activate immunological receptors, thereby influencing the subsequent initiation of the downstream signaling cascade. The second pathway involves Particle Aggregation and Immobilization. The product forms a polymer film on treated surfaces, causing microscopic particulate matter and associated allergens to adhere to one another. This physicochemical interaction promotes the formation of higher-mass aggregates which remain fixed to the surface. This sequence of molecular and physical steps decreases the concentration and aerosolization of environmental allergens, mitigating the initiation and propagation of associated immune-mediated events.

Dosage and Administration Information

How to Use Allergone

Allergone, containing the active ingredient levocetirizine, is administered orally and follows a standardized, once-daily schedule. Usage is defined by fixed dosage principles and specific adjustments tied to renal function, which is critical since the medicine is primarily excreted by the kidneys.


Administration Scope

Instruction Detail
Route of administration Oral (taken by mouth).
Dosing schedule (Adults ge 12 years) Recommended dose is 5 mg once daily. The maximum daily dose is 5 mg. A 2.5 mg dose is also described as appropriate for some individuals.
Timing in relation to meals May be taken with or without food.
Preparation requirements The 5 mg tablet is scored to allow for the 2.5 mg dose.
Age-group administration rules Children 6 to 11 years: The recommended dose is 2.5 mg once daily. Lower doses are typically administered using a pediatric oral solution.
Special procedural conditions Dosage interval must be individually adjusted in adults with renal impairment based on creatinine clearance (CLCR); for example, CLCR of 30-50 mL/min requires 2.5 mg once every other day. No dose adjustment is needed for solely hepatic impairment.

Instruction Classifications

Classification Detail
Administration method type Oral.
Frequency pattern Once daily (qDay).
Use-context constraints Dosing is typically scheduled for in the evening. Dosage is strictly dependent on renal function status.

Resulting Procedural Structure

Step sequence:

  • The single daily dose is to be taken in one intake, often in the evening.
  • The tablet can be swallowed whole with liquid, without mandatory regard to meals.
  • Use may be intermittent (stopped when symptoms resolve and restarted upon recurrence) or continuous for persistent conditions, with clinical experience supporting periods of at least six months.

Connection to the overall use protocol:

The instructions establish a predictable, once-daily oral regimen that is standardized at 5 mg for most adults but requires mandatory calculation and adjustment in the presence of kidney impairment. This approach ensures consistent systemic exposure while differentiating between short-term, as-needed use and longer-term, continuous administration.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Efficacy in Atopic Dermatitis

Research has investigated this drug’s potential role in severe atopic dermatitis (AD). Studies have primarily focused on changes in itch (pruritus) and the severity and extent of affected skin.

One large-scale randomized controlled trial evaluated whether patients experienced a reduction in both itch severity and the total body surface area affected. The research examined outcomes using standardized clinical scoring tools (e.g., EASI, IGA).

Studies observed changes in symptom severity.


Safety and Tolerability Profile

Long-term studies (up to 5 years) reported on both the study outcomes and the observed risks. These studies also evaluated the drug’s use in combination with standard topical corticosteroids; studies evaluated the concurrent use of corticosteroids.

Side effects were reported, and studies examined their frequency and duration. The most frequently reported adverse events in clinical trials included injection-site reactions and conjunctivitis.


Research in Co-Existing Conditions

Studies have explored the drug’s profile in patients with both AD and asthma, and evaluated its effect on lung function. Further research continues to examine the drug's role in patients with multiple Type 2 inflammatory conditions.

Key Studies & References

  1. Safety of long-term dupilumab treatment in adults with moderate-to-severe atopic dermatitis: results from a 5-year open-label extension trial

Frequently Asked Questions (FAQ)

Common questions about Allergone (FAQ)


Q: Does Allergone cause drowsiness or make you tired?

A: While the medicine is classified as a second-generation, non-sedating antihistamine, official regulatory labeling indicates that drowsiness, fatigue, and somnolence are listed as common or very common adverse reactions. This indicates that, in line with clinical trials, the medication may still cause these effects in some individuals.

Q: What should I do if I miss a scheduled dose of Allergone?

A: Official regulatory documents define a precise once-daily dosing schedule, but specific public instructions for managing a single missed dose are generally not included in the Prescribing Information. General patient education principles related to once-daily medications often advise that users take the subsequent dose at the regularly scheduled time, rather than taking a double dose to compensate for the missed one.

Q: Is it safe to use Allergone daily for a long period?

A: Official European documentation notes that clinical experience supports the continuous administration of the active ingredient for persistent allergic conditions for periods of at least six months. The overall duration of use is described as being either intermittent (as-needed) or continuous. The determination of the duration is typically based on the nature of the condition being addressed.

Q: Are there any restrictions on activities while taking Allergone?

A: Official warnings state that the medication may cause side effects such as dizziness, fatigue, and somnolence (sleepiness). Consequently, caution is advised regarding activities that require full attention, such as driving or operating heavy machinery, until an individual knows how the drug affects their own body.

Q: Is Allergone suitable for use during the pollen season only?

A: Yes, regulatory documents describe the use of the drug as being flexible. The official instructions state that administration may be intermittent, meaning the patient may stop the medication when symptoms resolve and restart it upon recurrence. This indicates suitability for use only during specific seasonal periods like pollen season.

Q: How quickly can I expect Allergone to start working?

A: According to official product information, the active ingredient typically reaches its highest concentration in the bloodstream in approximately one hour after being taken by mouth. This systemic exposure is generally linked to the onset of the medicine’s effectiveness.

Q: Is it true that Allergone is a new type of allergy medicine?

A: Official sources classify the active ingredient, levocetirizine, as a second-generation antihistamine. This chemical class represents newer developments in allergy treatment compared to older, first-generation compounds, but the medication itself has been available for clinical use for a number of years.

Q: Does Allergone have a generic version available?

A: The active ingredient, levocetirizine dihydrochloride, is no longer under patent protection for its original formulation. For this reason, it has been available in a generic version for several years.

Q: What is the main difference between Allergone and Benadryl?

A: Official classifications state that Allergone’s active ingredient, levocetirizine, is a second-generation antihistamine. Benadryl (diphenhydramine) is a first-generation antihistamine. Regulatory documents indicate that second-generation agents are typically associated with a lower potential for causing sedation.

Q: Are there any long-term effects of taking Allergone?

A: Official preclinical safety data reported no evidence of mutagenic potential or the ability to cause cancer. Furthermore, regulatory-supporting research includes long-term clinical studies, some lasting up to five years, which have reported on the drug's overall safety and tolerability profile during continuous use.

Q: Is Allergone safe for people who are planning to become pregnant?

A: Official documentation for the active ingredient does not contain specific studies or public recommendations addressing individuals who are actively 'planning' to conceive. Use during pregnancy is generally described as conditional, requiring assessment of potential benefits versus potential risks.

Q: What kinds of allergies is Allergone typically prescribed for?

A: Official regulatory indications for the active ingredient include relief of symptoms associated with seasonal allergic rhinitis, perennial allergic rhinitis (year-round allergies), and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria (hives/rashes).

Q: Why do some people say Allergone did not work for them?

A: Clinical trial data, as summarized in official documents, describe the drug’s effectiveness based on the average patient response. Regulatory information does not claim that all patients achieve complete relief from symptoms. Patient response to any medication can vary widely, which is a known factor across all drug classes.

Q: What happens if I stop taking Allergone suddenly?

A: Regulatory data specifically notes that a relapse of pruritus (itching) and urticaria (hives) has been reported in some individuals after discontinuing the active ingredient, particularly following long-term use. These reports do not suggest that the effect is universal.

Q: Are headaches a common side effect of Allergone?

A: Yes, official regulatory labeling, which summarizes clinical trial results, lists headache as a common adverse reaction that occurred in patients receiving the drug.

Q: Does the medicine come in different strengths or forms?

A: Yes. Official documentation details the availability of different product presentations. In the US, the active ingredient levocetirizine is available as a 5 mg oral tablet and an oral solution.

Q: What is the active ingredient in Allergone?

A: The single active ingredient in the Allergone product discussed in the Quick Facts section is levocetirizine dihydrochloride. This is the substance responsible for the medication’s pharmacological action.

Q: Has the FDA approved Allergone for all age groups?

A: The FDA-approved labeling indicates use in adults and adolescents 12 years and older, and in children 6 to 11 years of age. Safety and effectiveness have not been established in infants younger than 6 months of age, indicating that the approved use is limited to certain age categories.

Q: Does Allergone build up in your system over time?

A: Pharmacokinetic studies, which describe how the drug moves through the body, show that the active ingredient, levocetirizine, has a terminal half-life of approximately 7 to 10 hours in healthy adults. This half-life and the drug's primary excretion through the kidneys govern how the medicine is cleared from the body.

Q: Can Allergone be given to elderly patients?

A: Official documentation does not require routine dose adjustment based solely on age in the elderly, provided their kidney function is within normal limits. However, because older patients are more likely to have reduced renal function, dose adjustment based on creatinine clearance may be necessary.

Q: Is there a link between Allergone and weight gain?

A: Official product information, based on clinical trial data, lists weight gain as an uncommon adverse reaction. This means it was reported but occurred less frequently than common side effects.

Q: Is Allergone known to cause dry mouth?

A: Yes. Dry mouth is listed in the official regulatory labeling as a common adverse reaction that occurred in clinical trials among patients taking the drug.

Q: What does the latest research say about Allergone's effectiveness?

A: The most definitive statements on effectiveness are summarized in the Clinical Studies sections of official regulatory documents, which detail the results of pivotal trials for the approved indications. The research overview also discusses studies in related conditions like atopic dermatitis and asthma.

Q: Is Allergone a blood thinner?

A: No. Official regulatory documents classify the medicine's active ingredient, levocetirizine, as an antihistamine. This is a pharmacological class that acts on histamine receptors to treat allergy symptoms and is not related to blood thinning.

Q: Can Allergone be used for skin rashes or hives?

A: Yes. Official indications for the active ingredient include the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria (often referred to as hives or chronic rashes) in addition to seasonal and perennial allergy symptoms.

Q: Does Allergone contain lactose or gluten?

A: The official documentation lists all excipients (inactive ingredients) in the tablets. Many formulations of levocetirizine tablets contain lactose monohydrate. Users should check the product's specific label for full excipient details.

Q: Is Allergone a Schedule V controlled substance?

A: No. The active ingredient, levocetirizine dihydrochloride, is not classified as a controlled substance under the US Drug Enforcement Administration (DEA) scheduling system.

Q: Are there any specific populations that were excluded from the main clinical trials for Allergone?

A: Official summaries of clinical trials specify the populations enrolled, and often the exclusion criteria. Generally, patients with severe underlying medical conditions, those taking certain interacting drugs, or specific age groups (such as infants) are commonly excluded from pivotal efficacy trials.

Q: How is the safety profile of Allergone generally described in official sources?

A: The safety profile is generally described based on the frequency of adverse reactions observed in clinical trials, with the most common reactions typically being mild and transient. Official documents highlight potential risks such as somnolence (drowsiness) and the need for caution in patients with predisposing factors for urinary retention.

How should Allergone be stored and disposed of?

How to Store and Dispose of Allergone?

Allergone (levocetirizine dihydrochloride tablets) must be stored and handled according to the following official regulatory requirements to ensure its stability and safety.


Storage Conditions

The tablets require storage at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F), with permitted temperature excursions up to 30 C. The medication must be kept dry and protected from excessive moisture by remaining in its original container.

Child Safety: All tablets must be stored out of the sight and reach of children.


Disposal Instructions

Disposal of any unused or expired product must align with instructions provided on the label and local regulations. The medication must not be disposed of via wastewater or household waste. Users should consult a pharmacist or local waste disposal company about available drug take-back programs.

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

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Equivalent of Allergone found in:

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