Эльцет

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Эльцет

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 Эльцет

What is Elcet (Levocetirizine)? An Overview

Property Description
Active ingredient Levocetirizine dihydrochloride
Form Film-coated tablets, Oral solution
Pharmacological class H1-Histamine Receptor Blocker
General purpose Alleviating allergic symptoms
Origin Synthetic compound (Active metabolite)

Elcet (Эльцет) is a systemic antiallergic agent whose primary purpose is to quickly alleviate common allergic symptoms. The drug works by counteracting the effects of histamine, the main chemical that triggers allergic responses in the body. The typical scenario for its use is providing relief during periods of increased exposure to seasonal allergens, such as hay fever (allergic rhinitis).


Composition and Type

The sole active ingredient in Elcet is Levocetirizine dihydrochloride (Левоцетиризин дигидрохлорид), a synthetic compound. Levocetirizine is classified as an active enantiomer of the older drug Cetirizine (Цетиризин), placing it among the more selective agents in its class. As a monopreparation, Elcet focuses entirely on the activity of Levocetirizine, which is structurally part of the piperazine derivatives chemical group.


Pharmacological Differentiation

Elcet (Levocetirizine) is classified as a second-generation H1-histamine receptor blocker. This generation is pharmacologically distinguished by its high selectivity for peripheral H1-receptors. The key differentiating feature—minimal penetration of the blood-brain barrier—is widely clinically recognized for reducing the sedative effects often associated with first-generation antihistamines.

Levocetirizine is effective for providing relief from allergic symptoms with a low propensity for sedation. This benefit is crucial for patients who require reliable symptom management while maintaining alertness.

What side effects are possible with Эльцет?

Possible side effects and safety information

The safety profile for Elcet (Levocetirizine) is characterized by adverse reactions classified according to their frequency in regulatory documentation. The most frequently documented effects, classified as Common (affecting 1 in 10 to 1 in 100 people), generally involve the central nervous system and general conditions.

System-Organ Class Common Adverse Reactions
Nervous System Disorders Somnolence (Drowsiness), Headache
General Disorders Fatigue
Gastrointestinal Disorders Dry mouth, Pharyngitis

Less frequently observed effects, classified as Uncommon, include asthenia (lack of energy) and abdominal pain. A separate category of reactions with Frequency Not Known is compiled from post-marketing surveillance, documenting rare but clinically significant events.

These Serious Adverse Reactions include severe hypersensitivity events, such as anaphylaxis and angioneurotic edema. Rare neuropsychiatric effects like seizures, suicidal ideation, and aggression have also been reported through official channels. The high-level safety restrictions are driven by the drug's primary elimination route. Levocetirizine is contraindicated in patients with severe renal impairment (End-Stage Renal Disease) due to the risk of accumulation. Special safety considerations apply to older adults, for whom dosage adjustment may be necessary based on their renal function. Concurrent use with alcohol or other CNS depressants may increase central nervous system effects.

Overdose and Emergency Response

The official regulatory documents for levocetirizine define the necessary actions and manifestations associated with overdose.

The primary documented clinical presentation in adults following an overdose is severe central nervous system depression, manifesting as profound drowsiness (somnolence). The documented profile differs significantly in children, who initially display signs of agitation and restlessness before the onset of drowsiness. These manifestations highlight the central nervous system as the system primarily affected in overdose situations.

In the event of a suspected overdose, the required action is to seek immediate medical attention and contact a Poison Control Center without delay. This instruction reflects the high-level emergency guidance provided in official labeling.

Official regulatory information states explicitly that there is no known specific antidote for levocetirizine. Consequently, management procedures are restricted to providing symptomatic and supportive treatment. The drug is also not effectively removed by haemodialysis, which places constraints on specific advanced procedures. This comprehensive overdose structure is based exclusively on the facts and procedural requirements found in regulatory prescribing information.

Therapeutic Uses of Эльцет

What Эльцет Treats: Main Uses and Benefits

This medication is commonly used to help with symptoms related to heightened physiological activity caused by allergens, specifically those affecting the nasal passages, eyes, and skin. It is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis (hay fever and year-round allergies) and chronic idiopathic urticaria (hives).

In clinical settings where symptoms create noticeable functional strain, such as persistent sneezing, a blocked nose, or intense itching, this medication is applied across therapeutic domains for supportive management. It is relevant for managing symptoms that interfere with daily comfort, and may assist with maintaining functional stability when symptoms are more noticeable.

Quick Fact: Relief for Itchy Skin and Hives

This therapy is relevant for easing symptoms linked to allergic reactions on the skin. It helps address symptoms that may become intense or disruptive, such as persistent itching and the appearance of raised welts (hives), supporting patients during episodes of heightened discomfort.

Eligibility and Restrictions for Use

The official regulatory profile for Эльцет (Levocetirizine) strictly defines patient eligibility based on specific contraindications and conditional use requirements.

Absolute Contraindications

  • Hypersensitivity: Use is prohibited in patients with known allergies to levocetirizine, its parent compound cetirizine, or any piperazine derivative.
  • Severe Renal Disease: The medicine is contraindicated for patients with end-stage renal disease (creatinine clearance < 10 mL/min) or those undergoing hemodialysis.
  • Pediatric Renal Impairment: Children aged 6 months to 11 years with any degree of impaired renal function must not use this medication.

Conditional Eligibility

  • Adult Renal Impairment: Adults and adolescents (12 years) with mild to severe renal impairment are eligible only under specific, restricted conditions. No special restriction is required for isolated hepatic impairment.
  • Age-Based Use: Eligibility is established for children 6 months of age and older (formulation-dependent), but safety is not established for infants under 6 months.
  • Pregnancy and Lactation: Use is not recommended during pregnancy or breastfeeding due to limited human data and the expected excretion of the drug into human milk. Caution is also advised for patients with predisposing factors for urinary retention.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Levocetirizine is defined by documented effects on drug exposure and additive central nervous system activity. No substance is formally classified as absolutely contraindicated for co-administration in major regulatory documents.


Documented Interaction Patterns

Interacting Entity Interaction Type Official Regulatory Description
Ritonavir Pharmacokinetic (PK) - Transporter Co-administration increases Levocetirizine exposure (AUC by 42%, Cmax by 16%) due to reduced clearance (P-gp inhibition).
Alcohol / CNS Depressants Pharmacodynamic (PD) - Additive Co-administration may lead to additive impairment of central nervous system function and a potential decrease in alertness.
Food Pharmacokinetic (PK) Does not affect the overall extent of drug exposure (AUC), though the time to peak concentration (Tmax) may be slightly delayed.
CYP Enzyme System Pharmacokinetic (PK) - Metabolic Interactions are unlikely, as the drug is primarily excreted unchanged and not significantly metabolized by the Cytochrome P450 system.

Official Restrictions and Constraints

The most significant interaction constraint relates to the additive CNS effects; concurrent use with alcohol or other central nervous system depressants should be avoided due to the documented risk of additional functional impairment. Population-specific considerations note that patients with renal impairment show reduced clearance of the drug, which increases total exposure and heightens the risk of pharmacodynamic effects.

Mechanism of Action

Эльцет (Levocetirizine) functions as a selective inverse agonist and antagonist at the histamine H1 receptor ( H1 R). The H1 R is a G q-protein coupled receptor expressed on various cell types, including vascular endothelial cells, smooth muscle cells, and cells of the immune system like eosinophils and basophils.

Levocetirizine binds to the H1 R primarily in peripheral tissues. By acting as an inverse agonist, it shifts the receptor equilibrium toward the inactive state, stabilizing the H1 R and diminishing its constitutive activity. This action, coupled with its antagonistic properties, competitively blocks the binding and signaling cascade initiated by endogenous histamine. Blocking the H1 R inhibits G q protein activation and the subsequent increase in intracellular inositol trisphosphate ( IP3) and diacylglycerol ( DAG), thereby suppressing the release of secondary pro-inflammatory mediators from mast cells and basophils. The system-level consequence is a reduction in H1 R-mediated effects, including decreased G q-dependent smooth muscle contraction and attenuated increases in capillary permeability and vasodilatation within the microvasculature.

Dosage and Administration Information

Official Administration Guidelines for Эльцет

This section outlines the administration instructions for Эльцет (levocetirizine), focusing on the procedural aspects of use.

Administration Protocol

Route of Administration: The film-coated tablet must be taken orally. The tablet should be swallowed whole with liquid, regardless of meals, as it may be taken with or without food. The daily dose should be taken in one single intake, preferably in the evening, to align with the pharmacodynamic profile.

Standard Dosing Schedule:

Age Group Standard Dose Frequency
Adults and Adolescents (12+ years) 5 mg (1 tablet) Once Daily
Children (6 to 12 years) 5 mg (1 tablet) Once Daily

Special Dosing Rules

Renal Impairment: Dosing must be adjusted based on creatinine clearance (CLcr). For patients with moderate impairment (CLcr = 30-49 mL/min), the recommended interval is one tablet every 2 days. For severe impairment (CLcr < 30 mL/min), the interval is one tablet every 3 days. The use of this drug is contra-indicated in patients with end-stage renal disease (CLcr < 10 mL/min).

Missed Dose Instructions: If a dose is missed, take it as soon as possible. If it is almost time for the next scheduled dose, skip the missed dose and resume the regular schedule. Do not double the dose to make up for a missed one. The film-coated tablet formulation is not recommended for children under 6 years of age.

Recent Clinical Evidence

Research Evidence Overview: Understanding the Studies

Evidence for Seasonal Allergic Rhinitis (Hay Fever)

Research for seasonal allergies is primarily based on short-term, placebo-controlled trials used in research exploring how symptoms change over time. These studies were applied in trials assessing episodic symptom patterns that occur during a specific pollen season. Researchers monitored outcomes related to physical discomfort by tracking changes in the Total Symptom Score (TSS). Studies reported patterns of change in measured symptom scores over follow-up periods of around 14 days to 6 weeks. Evidence describes patterns related to symptom patterns during these periods of heightened symptom activity.

Evidence for Chronic Idiopathic Urticaria (Hives)

For chronic idiopathic urticaria (hives), research primarily involves short-term to intermediate Randomized Controlled Trials (RCTs) and systematic reviews. Studies monitored patient-reported outcomes describing perceived discomfort by using the Urticaria Activity Score (UAS), which assesses the severity of itching and the number/size of wheals. These trials included Adults and Children (6 years and older) with the condition. Studies report how symptoms evolved in the observed populations over intervals typically ranging from 4 to 6 weeks.

What Remains Uncertain in the Research Landscape

A consistent finding in regulatory and peer-reviewed summaries is the need for more extensive, long-term research. Evidence quality varies across studies, and many of the reported results apply only to the specific populations studied, where sample sizes were modest for certain subgroups. Furthermore, comparative evidence examining levocetirizine against every other available second-generation agent over extended periods is an area where research is ongoing and subgroup findings are uncertain.

Frequently Asked Questions (FAQ)

Common questions about Эльцет (FAQ)

Q: What is the difference between Elcet and similar medicines/analogues?

Official documents describe the active substance in Elcet (levocetirizine) as the active enantiomer of the older drug, cetirizine. It belongs to the second generation of antihistamines. Official classification notes that this second-generation agent exhibits minimal penetration of the blood-brain barrier, a characteristic associated with a reduced potential for sedation.

Q: How soon does Elcet start to work?

According to the clinical pharmacology data, the highest concentration of the active substance in the blood is typically reached in about 0.9 hour after a single dose. The peak effects on measured pharmacological activity are generally observed within 3 to 6 hours of administration.

Q: How long can Elcet be taken for?

The official product documentation does not define a maximum duration for use. Regulatory warnings note that abrupt discontinuation after daily use for several months or years may rarely result in the development of severe itching (pruritus).

Q: What should be done if a dose of Elcet is missed?

Official instructions describe the protocol: if a dose is missed, it is generally recommended to take it as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped to avoid taking two doses at once.

Q: Can Elcet be given to children?

Official regulatory documents state that the active ingredient is permitted for use in children 6 months of age and older. However, the film-coated tablet formulation is specifically not recommended for children under 6 years of age.

Q: From what age is Elcet permitted?

The active ingredient is generally approved for use in children 6 months of age and older, depending on the specific condition being treated and the formulation being used.

Q: What are the atypical or rare side effects associated with Elcet?

Post-marketing surveillance reports document rare, but serious, adverse reactions with a Frequency Not Known. These reports include severe hypersensitivity events (such as anaphylaxis) and rare neuropsychiatric effects like seizures, aggression, and suicidal ideation.

Q: How soon does the effect of Elcet stop after discontinuation?

The official pharmacokinetic data indicate that the average half-life of the drug in adults is approximately 7 to 8 hours. The half-life is the time it takes for the concentration of the medication in the plasma to decrease by half.

Q: Are there restrictions on taking Elcet for elderly people?

Special safety considerations are noted for older adults. Since the drug is eliminated via the kidneys, the official documents mention that dosage adjustment may be considered based on an assessment of renal function.

Q: Why does the leaflet mention caution for certain diseases?

Official documents list cautions related to conditions that may increase the risk of known effects, such as predisposing factors for urinary retention and existing renal impairment because the medication is primarily excreted by the kidneys.

Q: What is the difference between taking Elcet during the day and at night?

The official administration protocol recommends that the daily dose should be taken in a single intake, preferably in the evening. This timing is suggested to align with the drug's intended pharmacological activity and effect on symptoms.

Q: Can Elcet be taken every day?

The dosage schedule is described as once daily for the treatment of the approved conditions.

Q: Can Elcet be taken during pregnancy?

Official regulatory guidance states that use during pregnancy is not recommended due to limited data from adequate and well-controlled human studies.

Q: Are there side effects people usually do not know about?

Official sources mention a rare effect: abruptly discontinuing the medication after long-term daily use (months or years) may rarely result in the development of severe, generalized itching (pruritus). This is a post-discontinuation effect noted in safety warnings.

Q: Does Elcet affect driving or operating machinery?

The official label states that drowsiness may occur as a common side effect. Because of the potential for central nervous system effects, the label states that patients should use caution when driving or operating machinery.

Q: How does Elcet affect the liver or kidneys?

The drug is primarily eliminated from the body via the kidneys. Since the drug is primarily eliminated by the kidneys, the official product information indicates that caution is necessary in cases of impaired kidney function. The medication is not significantly metabolized by the liver.

Q: Does Elcet help with all types of allergies?

The official indications for this drug are limited to providing relief from symptoms associated with Seasonal and Perennial Allergic Rhinitis (hay fever and year-round allergies) and the treatment of Chronic Idiopathic Urticaria (hives).

Q: Can Elcet cause weight gain?

Official drug information documents list weight gain as a potential adverse reaction.

Q: Does Elcet interact with herbal remedies or supplements?

Formal clinical studies documenting specific interactions with most herbal remedies or dietary supplements are generally not available. However, laboratory data suggests that metabolic interactions via the major CYP enzyme systems are unlikely to occur.

Q: Can Elcet affect the heart?

A specific study was conducted to examine the drug's effect on the electrical activity of the heart (the QTc interval). This research indicated that the drug did not appear to prolong the QTc interval in a clinically meaningful way.

Q: Is there a risk of Elcet overdose?

Taking more than the instructed dose poses a risk of overdose. Symptoms may include severe drowsiness (in adults) or, potentially, agitation or restlessness (in children). Official documents state that if an overdose is suspected, emergency medical attention should be sought.

Q: Can Elcet be taken while breastfeeding?

Official regulatory instructions state that use during breastfeeding is not recommended.

Q: What is known about Elcet's interaction with caffeine?

Formal clinical studies specifically investigating the interaction with caffeine are not documented. However, in vitro (laboratory) data suggests that metabolic interactions via the major CYP enzyme systems are unlikely to occur.

Q: Are there any dietary restrictions when taking Elcet?

According to official administration guidelines, the medication may be taken with or without food. No specific dietary restrictions are mentioned in the regulatory documents.

Q: Does Elcet cure or just relieve symptoms?

The general purpose of the drug, as officially described, is the alleviation of allergic symptoms. Its action is centered on counteracting the effects of the chemical histamine in the body.

How should Эльцет be stored and disposed of?

Storage and Disposal Requirements

Official regulatory information requires Эльцет (levocetirizine) to be stored under controlled conditions to maintain its stability. Tablets and oral solution must be kept at room temperature, typically between 20 C to 25 C (68 F to 77 F), with permitted excursions to 15 C to 30 C.

The medicine must be protected from excessive heat, moisture, and freezing. It should remain in the original, tightly closed container or outer carton for protection. As a standard requirement, the product must be stored out of the sight and reach of children.

For disposal, unused or expired Эльцет should not be flushed down the toilet or placed in household trash. Instead, patients must dispose of the medicine in accordance with local environmental regulations, typically by utilizing an authorized drug take-back program or returning it to a designated collection point.

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

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