Levocert

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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 Levocert

What is Levocert? Definition and Classification

Property Description
Active ingredient Levocetirizine dihydrochloride
Form Oral tablet, Oral solution
Pharmacological class Second-generation Antihistamine
Common use General relief of allergic conditions
Origin Synthetic compound (R-enantiomer of Cetirizine)

What Type of Drug is Levocert?

Levocert is a branded pharmaceutical product whose active ingredient is Levocetirizine dihydrochloride, a synthetic compound designed to mitigate symptoms caused by allergic conditions. It is formally classified as a second-generation antihistamine, a functional category recognized for its ability to target the effects of histamine with high specificity. The active substance is categorized under the Anatomical Therapeutic Chemical (ATC) code R06AE09, as a piperazine derivative suitable for systemic anti-allergic use.

A key differentiating feature of the compound is its origin: Levocetirizine is the purified R-enantiomer, or the active isomer, derived from Cetirizine. This refinement provides enhanced receptor affinity compared to its parent compound, establishing it as a highly selective histamine H1-receptor antagonist. This identity positions it as a single active ingredient product focused on therapeutic effect through a precise molecular structure.

Levocetirizine: Understanding the Form and Function

Levocert is supplied for oral route of administration in two primary dosage forms: a film-coated oral tablet and an oral solution. The availability of the oral solution distinguishes it, enabling flexible administration for patient populations who may have difficulty swallowing tablets, such as pediatric subjects.

The medication operates as an anti-allergic medication by preventing the effects of the chemical messenger, histamine. Levocetirizine's highly selective antagonism competitively blocks the effects of histamine released by the body. This mechanism of selective inhibition ensures the drug provides general relief from the symptoms associated with allergic responses.

What side effects are possible with Levocert?

Levocetirizine: Possible Side Effects and Safety Information

This information describes the documented adverse reactions and safety constraints for Levocetirizine, strictly based on official government regulatory documents (e.g., FDA, EMA). It does not include advice, dosing, or therapeutic uses.

Documented Adverse Reactions by Frequency

The frequency of side effects is categorized by regulatory authorities as follows:

Frequency Category Examples of Documented Side Effects
Common (Occurs in 1 in 10 to 1 in 100 people) Somnolence (drowsiness), Headache, Fatigue, Dry mouth
Uncommon (Occurs in 1 in 100 to 1 in 1,000 people) Asthenia (weakness), Abdominal pain
Rare (Occurs in 1 in 1,000 to 1 in 10,000 people) Tachycardia (increased heart rate), Hypersensitivity reactions
Not Known (Cannot be estimated from available data) Anaphylaxis, Convulsions, Hepatitis, Suicidal ideation, Urinary retention

Serious and Clinically Significant Reactions

The most serious reactions reported in regulatory documentation include rare post-marketing events such as anaphylaxis (a severe allergic reaction), convulsions (seizures), hepatitis, and certain psychiatric disturbances including aggression and suicidal ideation.

Safety Constraints and Precautions

Official labeling defines specific constraints:

  • Kidney Impairment: The medication is contraindicated in patients with End-Stage Renal Disease or severe kidney impairment (creatinine clearance less than 10 mL/min). Dose adjustment is required for all other degrees of reduced kidney function.
  • Time-Related Pattern: Regulatory documents note that severe pruritus (itching) has been reported after stopping the medication, particularly following long-term daily use.
  • Urinary Retention: Caution is advised in patients with predisposing factors for urinary retention (e.g., prostatic enlargement).

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory guidance states that if an overdose of Levocert (levocetirizine dihydrochloride) is suspected, immediate medical attention must be sought, and a Poison Control Center should be contacted without delay. The documented clinical signs of overdose are primarily linked to effects on the Central Nervous System.

In adults, the most common documented manifestation is drowsiness (somnolence). However, in pediatric subjects, the overdose pattern differs, presenting initially with agitation and restlessness, followed by the onset of drowsiness. Taking doses significantly higher than the recommended amount may also result in a cluster of symptoms indicative of severe CNS or anticholinergic effects, including confusion, stupor, dizziness, tachycardia, tremor, and urinary retention.

Management of a Levocert overdose is focused on symptomatic and supportive treatment. Authoritative regulatory labeling confirms that there is no known specific antidote for levocetirizine dihydrochloride. It is also officially documented that the substance is not effectively removed by dialysis, and therefore, dialysis procedures are generally ineffective in managing the overdose unless another dialyzable agent has been ingested concurrently. Seeking urgent medical intervention remains the mandatory priority in all documented scenarios.

Therapeutic Uses of Levocert

Main Uses and Benefits of Levocert

Levocert (levocetirizine) is a second-generation antihistamine used to manage symptoms associated with allergic conditions. It works by blocking the action of histamine, a natural substance in the body that triggers allergic reactions when the immune system responds to an allergen.

Allergic Rhinitis

Levocert is primarily used to relieve symptoms of allergic rhinitis, which include:

  • Seasonal Allergic Rhinitis: Also known as hay fever, this condition is triggered by outdoor allergens such as pollen from trees, grasses, and weeds.
  • Perennial Allergic Rhinitis: This condition occurs year-round and is typically caused by indoor allergens, including dust mites, animal dander, and mold.

In both cases, the medication helps reduce common symptoms such as sneezing, an itchy or runny nose, and red, itchy, or watery eyes.

Chronic Idiopathic Urticaria

Levocert is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria. This condition is characterized by the long-term appearance of hives (urticaria) that occur without a known cause. The medication helps to:

  • Reduce the occurrence and severity of itchy skin rashes.
  • Decrease the number and size of hives or welts on the skin.

Benefits of Levocetirizine

As a second-generation antihistamine, the active ingredient in Levocert offers specific characteristics in the management of allergies:

  • Long-Lasting Action: The medication is typically effective for a full day, providing 24-hour symptom relief.
  • Selectivity: It is designed to be highly selective for H1-receptors, which helps focus its effect on allergy symptoms.
  • Reduced Sedation: Unlike first-generation antihistamines, second-generation options like levocetirizine are generally less likely to cross the blood-brain barrier, which may result in a lower incidence of drowsiness for many users, though individual responses can vary.

Eligibility and Restrictions for Use

The eligibility for using Levocert (levocetirizine dihydrochloride) is governed by rules documented in official government regulatory information, primarily based on age and kidney function.

Eligibility Scope

Classification Population Rule
Approved Age Groups Adults, adolescents, and children mathbfgeq 6 months of age.
Conditional Use Patients mathbfgeq 12 years old with renal impairment (mild to severe) require a specific dose adjustment.
Use Not Established Safety and efficacy are not established in children under 6 months of age.

Official Non-Eligibility Rules (Contraindications)

Levocert is strictly contraindicated (must not be used) in patients with the following conditions:

  • Hypersensitivity: A known allergy to levocetirizine, its parent compound cetirizine, or any other piperazine derivatives.
  • End-Stage Renal Disease (ESRD): Patients with creatinine clearance below 10 mL/ min or those undergoing hemodialysis.
  • Pediatric Renal Impairment: Children aged 6 months to 11 years with any degree of impaired renal function.

Official prescribing information also advises caution for use in patients with predisposing factors for urinary retention (e.g., prostatic hyperplasia). Use during pregnancy is advised only if clearly needed, and it is not recommended while breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products for Levocert

The interaction profile for Levocert (levocetirizine) focuses primarily on pharmacodynamic constraints and pharmacokinetic modifications, as documented in official regulatory labeling.


Pharmacodynamic and CNS Depressant Interactions

Concurrent use with alcohol and other Central Nervous System (CNS) depressants (such as sedatives or tranquilizers) should be avoided. This restriction is due to a pharmacodynamic interaction that may cause an additive reduction in alertness and further impairment of CNS performance. This requirement is a primary constraint within the official interaction profile.


Pharmacokinetic and Exposure Modifications

Levocert is minimally metabolized; therefore, it is unlikely to be involved in clinically significant interactions via the major CYP enzyme pathways. However, specific drugs have been documented to alter levocetirizine exposure, likely by affecting renal excretion:

  • Ritonavir: Co-administration has been shown to significantly increase the plasma levels (AUC) of cetirizine (the racemate) and decrease its clearance.
  • Theophylline: Co-administration results in a small but measurable decrease in the clearance of cetirizine.

Food and Other Product Constraints

Levocert may be taken with or without food. Although a meal, especially one high in fat, can delay the time to maximum concentration (Tmax) and lower the peak concentration (Cmax), the overall total amount of drug absorbed (AUC) remains unchanged. No specific interactions with herbal products have been widely or officially documented as clinically significant.

Mechanism of Action

How Levocert Works

Levocert’s primary pharmacodynamic action involves selectively binding to the H1 histamine receptor, functioning as an antagonist to competitively block the signaling of the natural chemical, histamine. This molecular blockade interferes with the rapid, histamine-mediated signals that increase microvascular permeability and stimulate afferent sensory nerves. The resulting physiological consequence is a reduction in tissue fluid extravasation and decreased sensory nerve activation.

Beyond the immediate receptor effects, Levocert also engages secondary mechanisms by modulating the function of specific immune cells. It influences the cellular dynamics of delayed physiological responses by interfering with the movement and activation of cells like eosinophils and limiting the subsequent release of their prolonged inflammatory mediators. This mechanism influences the overall magnitude of sustained inflammatory mediator release in targeted tissues.

Dosage and Administration Information

Levocert (levocetirizine dihydrochloride) is used exclusively via the oral route of administration and is supplied as a 5 mg film-coated tablet or an oral solution. The tablets are often manufactured to be scored, which permits the accurate administration of a 2.5 mg dose when required. The core dosing principle for all approved age groups is a once-daily schedule, with administration generally recommended in the evening to maintain consistent systemic concentration.

For most adults and adolescents 12 years of age and older, the standard regimen is 5 mg once daily. The medication provides flexibility regarding intake, as it may be taken with or without food. For children 6 to 11 years of age, the standard dose is 2.5 mg once daily, and the 5 mg tablet is generally not suitable for children under six years due to the inability to accurately measure the lower required doses.

The duration of use is determined by the condition being managed; for seasonal symptoms, use is often intermittent, while chronic conditions often involve continuous therapy. A critical instruction for proper use is that the dosage must be reduced for adult patients with confirmed renal impairment, with the frequency of administration potentially being extended (e.g., to once every other day or twice weekly) based on the severity of the decline in kidney function. No dose adjustment is typically specified for isolated hepatic impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Levocert


Evidence for use in Seasonal Allergies

Research has explored what patterns relate to Levocert in individuals experiencing seasonal allergic rhinitis, a condition characterized by fluctuating or episodic manifestations often linked to environmental triggers. Studies monitored how outcomes related to physical discomfort, such as sneezing and itchy eyes, change over defined time intervals. Findings describe patterns observed in the studies related to a temporary physiological imbalance. Results apply only to the populations studied, and certainty remains low regarding individual outcomes. Comparative evidence is lacking in some areas, and data for certain groups remain insufficient. Research provides context but not individual predictions.


Evidence for use in Year-Round Allergies

Research has explored what patterns relate to Levocert in conditions characterized by chronic or year-round (perennial) allergic rhinitis, which are marked by functional limitations and where symptoms may vary in intensity. Studies explored outcomes related to systemic or functional imbalance over time, focusing on episodes where symptoms become more noticeable. While studies monitored responses over defined time intervals, follow-up durations were limited in some research. There is limited information for long-term outcomes, and long-term follow-up data are still emerging.


Evidence for use in Chronic Hives (Urticaria)

Research has explored what patterns relate to Levocert in research contexts involving fluctuating or unstable symptoms of chronic idiopathic urticaria. Studies monitored how outcomes related to physical discomfort, such as itchiness and the number and size of welts, were reported. Evidence quality varies across studies, and findings were mixed in some areas regarding the most severe manifestations. Subgroup findings are uncertain, and research is ongoing to clarify all aspects.


What is still uncertain about Levocert

This section synthesizes the areas where research is still actively being conducted or where evidence is limited. Comparative evidence is lacking in some areas, which means it is difficult to fully contextualize the patterns observed with Levocert. Findings were mixed in some studies, indicating areas where further research is needed to provide clearer context. Data are still emerging for many aspects, and research is ongoing to fully describe all patterns observed in the studies and contribute to the contextualization of how patients reported their experience across all conditions.

How should Levocert be stored and disposed of?

Official Storage and Disposal Requirements

Official regulatory documents define the required storage and disposal procedures for Levocert (Levocetirizine Dihydrochloride).

Storage Component Official Requirement
Temperature Does not require any special temperature storage conditions.
Packaging Store in the original package.
Stability Do not use after the expiry date shown on the carton and blister.
Child Safety Keep this medicine out of the sight and reach of children.
Disposal Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to correctly dispose of medicines you no longer use, which helps protect the environment.

These constraints ensure the product remains stable until its expiry date and support safe disposal practices.

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

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